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That is unreal! I read the news and it's gonna get worldwide attention in the pre-market. I'm setting my alarm to 4 am, I'm not gonna miss this action. I wanna thank you for turning me onto CCCC this morning and keeping me up to date. That is very kind. Have a good night :)
Haha HUGE!!!!!!!!!!!!!!!!!!!
Do you think we can top over $3.00 tonight and gap up pre-mkt? tia
Petros Pharmaceuticals Successfully Completes Important Study in Effort to Make STENDRA(R) (avanafil) the First Erectile Dysfunction Medication to Achieve OTC Status
Human Factor Study represents important component of FDA requirements for technology to pave way for STENDRA OTC approval
NEW YORK, NY / ACCESSWIRE / December 12, 2023 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the completion of a Human Factors Study, whose objective was to assess the technology component developed to facilitate patient's access to its erectile dysfunction drug, STENDRA® (avanafil), associated with the Company's intended FDA application for prescription to OTC switch.
The objective of the study was to determine the strengths and weaknesses of the interface of a developmental technology tool, as well as potential use errors in critical tasks, such as navigating and reporting medical history, entering birth date and other key call to action prompts. These tasks, if performed incorrectly - or not performed at all - have the potential to contribute to inappropriate use by the patient or user. The results of the study showed that most participants were able to navigate the tool correctly. Data from the study provided an opportunity for the Company to further optimize this technology, including reformatting of text to improve interaction, which Petros intends to implement in future studies, including additional Human Factor Studies and Self Selection studies. These components are all integral to FDA guidelines for technology-driven OTC access to medications.
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "The initial usability of the emerging technology platform was encouraging, and provides us with a clear pathway forward. Participants in the study engaged with the application as intended and provided areas of improvement and/or enhancement. Under continued FDA guidance, we expect to continue our pursuit of achieving OTC designation for STENDRA, and toward the optimization of our process, which we hope to be able to replicate for other mature products looking to make the OTC switch in the future."
About Petros Pharmaceuticals
And hitting HOD bro! :)
These same jackoff manipulators did the same to PLSE in late August and look at the chart to see how it's now up 300% since the defamatory report.https://www.otcmarkets.com/stock/PLSE/overview
DIRTY POOL. DRCT needs to come out with a rebuttal and burn these scumbags.
A Mountain of Evidence Suggests That Much of Direct Digital Holdings Revenue May Be Fake and Is Hiding Its Uncollectible Accounts Receivable – 90%+ Downside
12/11/2023 AT 9:50 AM
https://whitediamondresearch.com/
Amazing HUGE volumes
HALTED at open
Can this possibly be true? As of November 13, 2023, the registrant had 441,902 and 441,851 shares of common stock, $0.001 par value per share, issued and outstanding, respectively.
NEWS
Candel Therapeutics Receives FDA Fast Track Designation for CAN-2409 in Pancreatic Cancer
NEEDHAM, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.
“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “This milestone follows our first interim data report from the randomized phase 2 clinical trial in patients with borderline resectable PDAC that showed prolonged and sustained survival after experimental treatment with CAN-2409, especially when compared to real-world data on patients receiving radiotherapy treatment. Candel remains on track to release updated overall survival data from the interim analysis of this clinical trial in the second quarter of 2024. We are grateful to the patients, caregivers, investigators and clinical sites that have taken part in this clinical trial.”
In November 2023, the Company presented encouraging overall survival and immunological biomarker data based on an interim analysis of the randomized, phase 2 clinical trial of CAN-2409 plus prodrug together with standard of care (SoC) neoadjuvant chemoradiation followed by resection for borderline resectable non-metastatic PDAC at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. An estimated survival rate of 71.4% at both 24 and 36 months in patients who received 2 or 3 injections of the CAN-2409 plus prodrug regimen, together with SoC chemoradiation prior to surgery was observed, versus only 16.7% estimated survival at both 24 and 36 months in patients treated with SoC chemoradiation prior to surgery alone. In parallel, the immunological changes observed in the resected pancreatic tissue after CAN-2409 administration suggested that this investigational treatment can activate an effective immunologic antitumoral response in this otherwise “cold” tumor.
About Candel Therapeutics
NEWS
Aditxt, Inc. Enters into Definitive Agreement to Acquire Evofem Biosciences, Inc., Creator of Phexxi®, the First and Only FDA-Approved Hormone-Free Contraceptive Gel, to Address Diverse Reproductive Health Needs of Women Globally
Evofem posted $13.4 million in net sales of Phexxi for the first nine months of 2023;
Aditxt looks to accelerate Evofem into the global non-hormonal birth control market valued at $27.7 billion in 2022 and is projected to grow to $52.2 billion by 2031
RICHMOND, Va. & SAN DIEGO--(BUSINESS WIRE)-- Aditxt, Inc. (“Aditxt” or the “Company”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, and Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM), a pioneer in women’s health, today announced the signing of a definitive agreement (the “Agreement”) under which Aditxt is to acquire Evofem in consideration of the issuance of a combination of common stock and preferred stock, and the assumption of certain senior indebtedness, having an aggregate amount of approximately $100 million (the “Transaction”). Pending a successful Transaction, it will also mark the establishment of a women's health mission within Aditxt's platform, aligning with global healthcare needs.
Revolutionizing Women’s Reproductive Health with Phexxi®
Evofem is a commercial-stage women's health company with a strong focus on innovation. Evofem is the creator of the first and only FDA-approved hormone-free contraceptive gel, Phexxi® (lactic acid, citric acid, and potassium bitartrate). Phexxi® empowers women with a convenient, discreet, and flexible contraception method, putting control in their hands. By allowing on-demand usage within one hour before intercourse, Phexxi® addresses a critical need in the United States and global contraception market, offering women greater autonomy over their reproductive health decisions.
Phexxi® represents a groundbreaking shift in women's healthcare, offering a non-daily, hormone-free contraceptive choice for the 23 million women who need alternatives to traditional methods in the United States alone. Like male contraception, female contraception should be adaptable to personal needs – not a daily burden, irrespective of actual necessity. This innovation not only challenges the decades-long norm of daily hormonal contraception but empowers women with more personalized healthcare choices. Phexxi® is a testament to the urgent need for more focused innovation in women's health, ensuring choices are made for their benefit, not by chance or default.
Aditxt Unlocking Evofem’s Global Potential for Non-Hormonal Contraception
The global need for effective family planning is evident, with nearly 1.1 billion women worldwide desiring contraception, according to the UN Department of Economic and Social Affairs. This demand is mirrored in the significant market growth projections for non-hormonal birth control; Growth Plus Reports highlights an increase from $27.7 billion in 2022 to $52.2 billion by 2031. The success of Phexxi® in the U.S., with an 82% approval rate for claims and escalating sales, reflects this rising demand. With Aditxt's acquisition of Evofem, there is an opportunity to leverage this momentum, access untapped markets, and potentially capture a significant global market share. This move is poised to meet commercial objectives and address a crucial aspect of women’s healthcare. The power to decide when to have a family should rest firmly in each woman's hands, aligning with her life choices and aspirations and thus playing a crucial role in shaping her economic and social future.
Furthermore, Evofem's consistent sales growth aligns with the rising demand for innovative contraceptive solutions. The post-acquisition integration into the Aditxt platform will strengthen Evofem's ability to enter global markets through organic expansion, product acquisitions, and licensing agreements, positioning it to capture a substantial market share and address crucial women's healthcare needs globally.
Aditxt – A Platform for Accelerating Promising Innovations
As a company focused on discovering, developing, and deploying promising health innovations, Aditxt offers a dynamic environment dedicated to helping ground-breaking innovations thrive. As a public company with global stakeholders, Aditxt aims to engage society in supporting innovations addressing autoimmunity, health by the numbers, life-extending transplant technologies, population health, and now, with the proposed Evofem acquisition, women’s health, rendering its collaborative ecosystem a powerful tool for realizing the full potential of each subsidiary.
Amro Albanna, co-Founder, chairman, and CEO of Aditxt, shared his insights on this announcement: “At Aditxt, our mission is to make promising innovations possible together. Evofem represents precisely the kind of groundbreaking innovation that aligns with our mission. Aditxt will provide Evofem with a global platform to amplify their transformative innovation in women’s health. As we move forward, we aim to empower our shareholders to participate in this journey through their votes. This approach ensures that our stakeholders are integral in advancing these vital health innovations on the Aditxt platform, truly socializing how health innovations advance and impact lives worldwide.”
“We are excited about the opportunity to accelerate our growth trajectory, as a subsidiary of Aditxt, into a multi-product women’s health franchise,” said Evofem’s CEO, Saundra Pelletier. “We believe this Transaction is in the best interests of our shareholders and are confident that they and the women we serve will benefit from our expanded offering and stronger voice.”
Details of the Proposed Transaction
The Transaction is intended to create significant strategic advantages for both companies. Evofem’s growing revenue base may allow Aditxt to catalyze future growth by leveraging synergies by and amongst Evofem, Aditxt, and Aditxt’s other subsidiaries. The boards of directors of both companies have unanimously approved the Transaction.
Aditxt has assumed Evofem’s senior secured debt that was issued to the investor under the Securities Purchase and Security Agreement dated April 2020, as amended, and shall pay $5.0 million to Evofem’s senior secured debtholder by year-end 2023, $8.0 million by September 2024, and up to an additional $5 million thereafter.
Aditxt has also agreed to provide a $3.0 million loan to Evofem between the date of signing of the Agreement and closing and to cover Evofem’s legal costs related to the Transaction. At closing, the holders of Evofem’s common stock will exchange their shares for an aggregate of 610,000 shares of Aditxt common stock. In addition, Aditxt has agreed to issue up to an aggregate of 89,126 shares of preferred stock to the holders of Evofem’s currently outstanding unsecured notes, purchase rights, certain warrants, and preferred stock. Upon closing of the Transaction, which is currently anticipated to occur in the first half of 2024, Evofem will be a wholly owned subsidiary of Aditxt, with the Evofem management team to receive equity grants in the subsidiary of up to ten percent on a fully diluted basis after closing, and will continue to be led by Saundra Pelletier, Chief Executive Officer of Evofem, and the current management team.
The boards of directors of Aditxt and Evofem have unanimously approved the proposed Transaction. The Transaction is subject to, among other things, the approval of both Aditxt and Evofem stockholders and satisfaction or waiver of the conditions stated in the Agreement.
The description of the business combination contained herein is only a high-level summary. Additional information about the proposed Transaction, including a copy of the business combination agreement, will be provided in a Current Report on Form 8-K to be filed by Aditxt with the Securities and Exchange Commission ("SEC") and will be available at the SEC's website at www.sec.gov. In addition, Aditxt intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus and will file other documents regarding the proposed Transaction with the SEC.
About Aditxt, Inc.
Aditxt is focused on discovering, developing, and deploying life-changing health innovations. Aditxt’s diverse portfolio includes Adimune™, Inc., developing a new class of therapeutics designed to retrain the immune system to address organ rejection, autoimmunity, and allergies; and Pearsanta™, Inc., offering timely, convenient, and high-quality personalized lab testing anytime and anywhere, backed by its CLIA-certified and CAP-accredited monitoring center. For more information, visit Aditxt.com.
About Evofem Biosciences, Inc.
Evofem is focused on commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com.
Aditxt® is a registered trademark and Adimune™, Adivir™, and Pearsanta™ are trademarks of Aditxt, Inc.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
Sources
United Nations Department of Economic and Social Affairs, Population Division (2022). World Family Planning 2022: Meeting the changing needs for family planning: Contraceptive use by age and method. UN DESA/POP/2022/TR/NO. 4. Accessed 29 November 2023 via https://www.un.org/development/desa/pd/sites/www.un.org.development.desa.pd/files/files/documents/2023/Feb/undesa_pd_2022_world-family-planning.pdf
Growth Plus Reports. Non-Hormonal Birth Control Market by Type (Contraceptive Devices, Sterilization), Gender (Male, Female) – Global Outlook & Forecast 2023-2033. 05 May 2023. Accessed 28 November 2023 via https://www.growthplusreports.com/report/nonhormonal-birth-control-market/8914
Additional Information and Where to Find It
In connection with the Agreement and the proposed Transaction, Aditxt intends to file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 (the “Registration Statement”), which will include a joint preliminary proxy statement/prospectus certain other related documents; this will be both the proxy statement to be distributed to the respective stockholders of Aditxt and Evofem in connection with Aditxt’s and Evofem’s solicitation of proxies for the vote by their respective stockholders with respect to the proposed Transaction and other matters as may be described in the definitive proxy statement. This press release does not contain any information that should be considered by Aditxt’s or Evofem’s stockholders concerning the proposed Transaction and is not intended to constitute the basis of any voting or investment decision in respect of the proposed Transaction. The respective stockholders of Aditxt and Evofem and
NEWS
Harbor Custom Development, Inc., Announces Chapter 11 Bankruptcy Protection Filing
TACOMA, Wash, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Harbor Custom Development, Inc. (Nasdaq: HCDI, HCDIP, HCDIW, HCDIZ) (collectively with certain of its wholly owned subsidiaries described below, “HCDI” or “the Company”), a real estate company involved in all aspects of the land development cycle, and certain of its wholly owned subsidiaries today announced that the Company has voluntarily filed for protection under Chapter 11 of the United States Bankruptcy Code in the Western District of Washington at Tacoma (collectively, the “Chapter 11 cases”) to pursue an orderly wind down or restructuring of its business. The Company has filed a number of customary first day motions with the Bankruptcy Court that will allow it to continue operating in the ordinary course of business while it prepares a Plan of Reorganization to ensure that it can maximize value for the benefit of its creditors. HCDI will continue to market and sell finished lots and homes and to operate multi-family projects as they work towards stabilization.
Jeff Habersetzer, Interim CEO of HCDI, stated, “The Chapter 11 cases will provide the Company with time and breathing-room needed to market and sell its real estate assets and right-size operations for the benefit of the Company’s creditors and stakeholders.”
Additional Information
Resources for HCDI’s creditors and equity interest holders can be found by visiting the website at https://cases.creditorinfo.com/hcdi, including court filings and other documents related to the Chapter 11 process. Aditi Paranjype at Cairncross & Hempelmann, P.S. is serving as lead bankruptcy legal counsel to the Company.
About Harbor Custom Development, Inc.
Harbor Custom Development, Inc. is a real estate development company involved in all aspects of the land development cycle, including land acquisition, entitlements, construction of project infrastructure, home and apartment building, marketing, and sales of various residential projects in Western Washington's Puget Sound region; Sacramento, California; Austin, Texas; and Punta Gorda, Florida.
Forward-Looking Statements
Nice News = NEWS
LightPath Announces Initial $4.7m Order from Lockheed Martin
ORLANDO, FL / ACCESSWIRE / December 11, 2023 / LightPath Technologies, Inc. (NASDAQ:LPTH), ("LightPath" or the "Company"), a leading vertically integrated global manufacturer and integrator of proprietary optical and infrared technologies, announced that the Company has received a phase I order to develop an advanced infrared camera system for a key Army program (or the "Program"). The Company has received the phase one order from Lockheed Martin Missiles & Fire Control of $4.7 million as part of the Program announced in September.
The initial phase one order is for development and initial prototypes of an advanced thermal camera system to be delivered over the next 12 to 24 months. Positive results of the phase one development will result in a phase two order valued at approximately $3 million. The decision to move the Program to production is expected in 2026, at which point an initial production of 10,000 systems will commence. A fully in-production program would likely have average selling prices of between $5,000 and $10,000 per system, for LightPath's contribution, and significant follow-on orders after the initial 10,000 systems.
LightPath's President and CEO, Sam Rubin commented, "Winning this program of record is a major milestone in the successful implementation of our strategy. Over the last three years LightPath has been pivoting from a pure components manufacturer to leveraging its key technologies and capabilities to becoming an imaging solutions provider. Winning a major program of record, in which we will provide a complete imaging solution, is where we have been aiming and aspiring. Production of these systems will be done in our newly expanded Orlando manufacturing facility.
"Our business is currently driven by three independent pillars of growth: camera solutions, defense, and new applications such as automotive. In each of those pillars of growth we have multiple opportunities that are potentially in the order of tens of millions of dollars per year. Today one of those opportunities is moving forward and we look forward to announcing more such programs in the near future."
Mr. Rubin concluded: "I would like to congratulate the entire LightPath team on this successful implementation of our strategy and on this very important step achieved."
About LightPath Technologies:
China Pneumonia Outbreak | China Pneumonia Spreads To Us And Europe | China Pneumonia 2023 | N18V
China Pneumonia Outbreak | China Pneumonia Spreads To Us And Europe | China Pneumonia 2023 | N18V
China Pneumonia Outbreak | China Pneumonia Spreads To Us And Europe | China Pneumonia 2023 | N18V
NEWS
Therapeutic Solutions International Announces Formation of ALS Biologics Inc to Commercialize Regenerative Technologies Related to Dreaded Motor Neuron Disease
Clinical Stage Stem Cell Company to Expand on Promising Patient Experiences by Launching Subsidiary Company
ELK CITY, Idaho--(BUSINESS WIRE)--
Therapeutic Solutions International, Inc. (TSOI), announced today the formation of ALS Biologics Inc, a subsidiary company dedicated to accelerating development of the Company’s assets related to Amyotrophic Lateral Sclerosis, a progressive motor neuron degenerative disease for which no cure exists. The company was formed based on previous positive observations in patients treated with the Company’s ALScell™ (JadiCell™) product under the Right to Try Law.
“Stem cells do not work in isolation. By having had the opportunity to treat numerous patients with neurodegenerative conditions such as ALS in a practical setting, we have learned numerous ways to improve outcome, with practical techniques that we are packaging into this new company dedicated to providing new directions in eventually curing this terrible disease,” said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. “Current treatments offer marginal benefit with the average survival time of patients with ALS being two to five years according to the ALS Association1. This needs to change. We plan to take our current intellectual property and findings and position them in a manner for greater clinical development and accelerated patient access.”
“Having been coinventor of the numerous intellectual properties amassed in Therapeutic Solutions International, I believe it is important to place certain indications into specific companies in order to facilitate focus and concentration of expertise,” said Thomas Ichim, Ph.D., Interim CEO of ALS Biologics and Board Member of Therapeutic Solutions International.
“I am proud to say that the team at TSOI has truly transformed itself into a medical 'Innovation Factory' of ideas, patents, and clinical protocols,” stated Timothy Dixon, President, and CEO of Therapeutic Solutions International. “We anticipate IND filing for treatment of ALS on or before the second quarter of 2024.”
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com.
Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting
82% ORR and deep clinical responses from off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients receiving adequate lymphodepletion
100% ORR in these patients who were not previously treated with a BCMA-targeted bispecific T cell-engaging antibody
Favorable emerging safety and reliability profile, with all (100%) intent-to-treat (ITT) patients receiving therapy, no GvHD or dose-limiting toxicities and low incidences of CRS and neurotoxicity observed (all ≤ Grade 2)
Preliminary data show allogeneic TSCM-rich CAR-T cells trafficking to bone marrow, differentiating to cell-killing effector T cells and persisting at least 6 weeks
Two additional poster presentations highlight advancements across the Company's cell and gene therapy programs and platforms
Company to host webcast and conference call today at 11:00 AM PST
SAN DIEGO, Dec. 10, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced early efficacy and safety results from its Phase 1 study of P-BCMA-ALLO1, its BCMA-targeted allogeneic, T stem cell memory (TSCM)-rich chimeric antigen receptor (CAR)-T therapy candidate. The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM). Detailed study findings, along with two additional Company poster presentations in cell and gene therapy, are being featured at the 65th ASH Annual Meeting and Exposition being held in San Diego on December 9-12, 2023.
"Today, far too many patients are unable to benefit from autologous CAR-T therapy due to its limited supply, lengthy timelines, complex logistics, and cost," said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. "We have long believed that readily produced, off-the-shelf allogeneic, TSCM-rich CAR-T products have the potential to offer a compelling efficacy and safety profile while also supporting patient access. TSCM-rich CAR-T products can be difficult to produce with older virus-based technology, but we are able to create a portfolio of such products using Poseida's unique, non-viral set of technologies. We see these early P-BCMA-ALLO1 results in multiple myeloma, in which all enrolled patients received CAR-T therapy and most patients receiving adequate lymphodepletion achieved a stringent complete response (sCR) or very good partial response (VGPR), as validating our vision and eagerly await additional data yet to come from this study. This is also the first known publicly presented data set that provides clear clinical evidence supporting the hypothesis that TSCM cells are the ideal cell type for allogeneic CAR-T, extending our previous findings with autologous TSCM cells to the allogeneic setting. We hope that TSCM-rich allogeneic CAR-T therapies may potentially offer the optimal combination of clinical results, on-demand availability and high-volume production, while supporting broader access to CAR-T therapies. We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results. They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
P-BCMA-ALLO1 program data presentations
At the time of the October 23, 2023 data cut off, 39 patients were enrolled as an intent-to-treat (ITT) population in the ongoing Phase 1 multicenter, open-label dose-escalation study (NCT04960579). Enrolled patients had previously failed protease inhibitor, immunomodulatory drug (IMiD), and anti-CD38 antibody treatments or were otherwise triple-refractory. Previous treatment with B cell maturation antigen (BCMA)-targeted therapy was allowed including autologous BCMA CAR-T and bispecific T cell-engaging (TCE) antibodies. All enrolled patients completed lymphodepletion and went on to receive P-BCMA-ALLO1 a median of 7 days after enrollment for a 100% ITT treatment rate with no use of bridging therapy. Six patient cohorts varying in size (n=1 to n=6) received one of three fludarabine/cyclophosphamide (flu/cy) lymphodepleting conditioning regimens including 3 days of fludarabine at 30 mg/m2/day for all patients and, depending upon the patient cohort, 3 days of cyclophosphamide at 300, 500, or 1,000 mg/m2/day followed by infusion of P-BCMA-ALLO1 cells at cell doses varying by cohort up to 6x106 cells/kg to date.
Evaluable patients with at least 4 weeks of follow up (n=33) were heavily pretreated with a median of 7 prior lines of therapy. Additionally, 30% of these patients had high risk disease by cytogenetics and nearly 2 in 5 (39%) had received previous BCMA-targeted therapy. 11 of the 33 evaluable patients were in the two cohorts receiving 2x106 cells/kg of P-BCMA-ALLO1 and higher cyclophosphamide preconditioning doses at either 500 mg/m2 ('P1 arm'; n=5) or 1,000 mg/m2 ('P2 arm'; n=6).
An overall objective response rate (ORR) of 82% (9/11 total patients) was reached among patients in the pooled P1 and P2 arms. ORR in the P2 arm was 83% (5/6) with 100% (5/5) of the responding P2 patients achieving a VGPR or better and 40% (2/5) achieving sCR. 80% ORR was obtained in the P1 arm (4/5) with 50% of responding patients achieving VGPR. Both nonresponding patients, one in each of the P1 and P2 arms, had received and not achieved clinical response with the BCMAxCD3 bispecific TCE antibody therapy teclistamab prior to receiving P-BCMA-ALLO1.
A 100% ORR (9/9) was achieved among patients in P1 and P2 arms who had not received a prior BCMA-targeting bispecific TCE antibody as well as 100% ORR (2/2) in patients who had received prior autologous CAR-T BCMA targeted therapy.
P-BCMA-ALLO1 was very well tolerated, with no graft-vs-host disease (GvHD) at any dose and low rates of cytokine release syndrome (CRS) and neurotoxicity, all Grade 2 or less, found among all evaluable patients.
Expansion and persistence of the CAR-T cells in patients after infusion was found to be highly dependent upon the conditioning dose of cyclophosphamide, with P-BCMA-ALLO1 levels measured in the blood much higher in patient cohorts in the P1 and P2 arms receiving the 500 mg/m2 and 1,000 mg/m2 conditioning doses than in any of the 300 mg/m2 (arm 'S', n=20) cohorts. Clinical responses in patients receiving arm S conditioning treatment were inferior to those achieved by patients in P1 or P2.
Analysis of P-BCMA-ALLO1 cellular kinetics in two patients with high CAR-T expansion showed CAR-T cells persisted and were measurable in the peripheral blood of one patient for at least 4 weeks and engrafted and persisted at a high level in the bone marrow of the other for at least 6 weeks. Moreover, in both cases cells in the TSCM-rich CAR-T infused drug product underwent differentiation after infusion to generate a much more effector T cell-rich population, particularly among the important CD8+ 'killer T cell' subpopulation. These findings are the first known direct clinical evidence supporting the theory that allogeneic TSCM-based CAR-T cells can act as effective prodrugs because they can expand, traffic to the relevant tissues, differentiate into effector cells and persist, all of which may contribute to driving deep clinical responses in patients while also being well-tolerated.
"Despite the emergence of autologous BCMA-targeted therapies, multiple myeloma remains an incurable malignancy. Autologous CAR-T therapies may be associated with numerous challenges for patients and physicians, including prolonged manufacturing times, inconsistent drug quality and serious safety issues," said Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center. "Allogeneic CAR-T therapies have the potential to overcome many of these challenges. Today's data demonstrate that P-BCMA-ALLO1 is a well-tolerated off-the-shelf therapy with a favorable emerging safety profile and encouraging evidence of early clinical activity. In addition, the data show that P-BCMA-ALLO1 can achieve deep clinical responses in patients with high-risk disease and those who have previously received BCMA targeting therapies. Importantly, P-BCMA-ALLO1 was delivered to all patients in the ITT population with all drug product meeting all quality specifications. We look forward to continuing to enroll patients in this study."
Enrollment is ongoing including additional exploration of dose regimens and lymphodepleting conditioning regimens. While still early to assess durability, at the time of the data cut off 8 of the 9 responding patients in P1 and P2 arms remained in response. The Company, together with Roche, plans to present additional clinical data updates for P-BCMA-ALLO1 at scientific meetings in 2024, subject to coordination with Roche.
A second Poseida-sponsored poster highlights the development of an in vivo bioassay for assessing BCMA CAR-T final product potency and presents data suggesting P-BCMA-ALLO1 drug product may have greater potency than drug products produced in the Company's earlier, autologous P-BCMA-101 CAR-T program.
P-FVIII-101 program data presentation
The Company has also presented a third poster describing P-FVIII-101, a fully non-viral liver-directed gene therapy combining Poseida's proprietary piggyBac® DNA Delivery System with nanoparticle delivery for the treatment of Hemophilia A. This poster demonstrates the capabilities of the piggyBac DNA insertion system and non-viral approach in providing stable Factor VIII (FVIII) transgene expression through genomic integration, along with the potential for redosing. The poster highlights 52-week durability in an adult Hemophilia A model along with a favorable tolerability profile of Poseida's liver-targeted non-viral delivery platform providing further proof-of-principle toward developing an effective and durable treatment for Hemophilia A.
Company-Hosted Webcast and Conference Call Information:
Poseida will host a webcast and conference call today, December 10th at 11:00 AM PST / 2:00 PM EST. The conference call can be accessed by dialing 800-225-9448 (United States) or 203-518-9708 (International) with the conference ID PSTX23. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for 90 days.
Poster Presentation Details:
Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
Presenting Author: Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center
Session Date & Time: Sunday, December 10, 2023, at 6:00 – 8:00 PM PT
Publication Number: 3479
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Location: Halls G-H
Title: A Tumor-Bearing Murine Xenograft Model as a Bioassay for Assessing CAR-T Product Potency Shows Positive Predictive Value for Clinical Performance
Presenting Author: Stacey Cranert, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 – 7:30 PM PT
Publication Number: 2293
Session Title: 803. Emerging Tools, Techniques and Artificial Intelligence in Hematology: Poster I
Location: Halls G-H
Title: Effective Gene Therapy for Hemophilia A: Novel Re-Dosable Non-Viral Formulation That Provides Stable, and Durable FVIII Expression with Improved Tolerability
Presenting Author: Brian Truong, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 – 7:30 PM PT
Publication Number: 1232
Session Title: 321. Coagulation and Fibrinolysis: Basic and Translational: Poster I
Location: Halls G-H
About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. This allogeneic program includes a VH-based binder that targets BCMA and has shown early evidence of encouraging safety and efficacy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.
About P-FVIII-101
P-FVIII-101 is a liver-directed gene therapy combining Poseida's non-viral piggyBac platform and nanoparticle delivery technologies for the in vivo treatment of Hemophilia A. Hemophilia A is a bleeding disorder caused by a deficiency in Factor VIII production with a high unmet need. P-FVIII-101 utilizes the piggyBac gene integration system delivered via lipid nanoparticle, which has demonstrated stable and sustained Factor VIII expression in juvenile and adult animal models.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. The Company's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, and nanoparticle and hybrid gene delivery technologies as well as in-house GMP cell therapy manufacturing. The Company has formed a global strategic collaboration with Roche to unlock the promise of cell therapies for patients with hematological malignancies. Learn more at www.poseida.com and connect with us on X and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy and safety profile of such product candidates; the quotes from Dr. Yarema and Dr. Dholaria; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; and the other risks described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting
82% ORR and deep clinical responses from off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients receiving adequate lymphodepletion
100% ORR in these patients who were not previously treated with a BCMA-targeted bispecific T cell-engaging antibody
Favorable emerging safety and reliability profile, with all (100%) intent-to-treat (ITT) patients receiving therapy, no GvHD or dose-limiting toxicities and low incidences of CRS and neurotoxicity observed (all ≤ Grade 2)
Preliminary data show allogeneic TSCM-rich CAR-T cells trafficking to bone marrow, differentiating to cell-killing effector T cells and persisting at least 6 weeks
Two additional poster presentations highlight advancements across the Company's cell and gene therapy programs and platforms
Company to host webcast and conference call today at 11:00 AM PST
SAN DIEGO, Dec. 10, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced early efficacy and safety results from its Phase 1 study of P-BCMA-ALLO1, its BCMA-targeted allogeneic, T stem cell memory (TSCM)-rich chimeric antigen receptor (CAR)-T therapy candidate. The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM). Detailed study findings, along with two additional Company poster presentations in cell and gene therapy, are being featured at the 65th ASH Annual Meeting and Exposition being held in San Diego on December 9-12, 2023.
"Today, far too many patients are unable to benefit from autologous CAR-T therapy due to its limited supply, lengthy timelines, complex logistics, and cost," said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. "We have long believed that readily produced, off-the-shelf allogeneic, TSCM-rich CAR-T products have the potential to offer a compelling efficacy and safety profile while also supporting patient access. TSCM-rich CAR-T products can be difficult to produce with older virus-based technology, but we are able to create a portfolio of such products using Poseida's unique, non-viral set of technologies. We see these early P-BCMA-ALLO1 results in multiple myeloma, in which all enrolled patients received CAR-T therapy and most patients receiving adequate lymphodepletion achieved a stringent complete response (sCR) or very good partial response (VGPR), as validating our vision and eagerly await additional data yet to come from this study. This is also the first known publicly presented data set that provides clear clinical evidence supporting the hypothesis that TSCM cells are the ideal cell type for allogeneic CAR-T, extending our previous findings with autologous TSCM cells to the allogeneic setting. We hope that TSCM-rich allogeneic CAR-T therapies may potentially offer the optimal combination of clinical results, on-demand availability and high-volume production, while supporting broader access to CAR-T therapies. We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results. They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
P-BCMA-ALLO1 program data presentations
At the time of the October 23, 2023 data cut off, 39 patients were enrolled as an intent-to-treat (ITT) population in the ongoing Phase 1 multicenter, open-label dose-escalation study (NCT04960579). Enrolled patients had previously failed protease inhibitor, immunomodulatory drug (IMiD), and anti-CD38 antibody treatments or were otherwise triple-refractory. Previous treatment with B cell maturation antigen (BCMA)-targeted therapy was allowed including autologous BCMA CAR-T and bispecific T cell-engaging (TCE) antibodies. All enrolled patients completed lymphodepletion and went on to receive P-BCMA-ALLO1 a median of 7 days after enrollment for a 100% ITT treatment rate with no use of bridging therapy. Six patient cohorts varying in size (n=1 to n=6) received one of three fludarabine/cyclophosphamide (flu/cy) lymphodepleting conditioning regimens including 3 days of fludarabine at 30 mg/m2/day for all patients and, depending upon the patient cohort, 3 days of cyclophosphamide at 300, 500, or 1,000 mg/m2/day followed by infusion of P-BCMA-ALLO1 cells at cell doses varying by cohort up to 6x106 cells/kg to date.
Evaluable patients with at least 4 weeks of follow up (n=33) were heavily pretreated with a median of 7 prior lines of therapy. Additionally, 30% of these patients had high risk disease by cytogenetics and nearly 2 in 5 (39%) had received previous BCMA-targeted therapy. 11 of the 33 evaluable patients were in the two cohorts receiving 2x106 cells/kg of P-BCMA-ALLO1 and higher cyclophosphamide preconditioning doses at either 500 mg/m2 ('P1 arm'; n=5) or 1,000 mg/m2 ('P2 arm'; n=6).
An overall objective response rate (ORR) of 82% (9/11 total patients) was reached among patients in the pooled P1 and P2 arms. ORR in the P2 arm was 83% (5/6) with 100% (5/5) of the responding P2 patients achieving a VGPR or better and 40% (2/5) achieving sCR. 80% ORR was obtained in the P1 arm (4/5) with 50% of responding patients achieving VGPR. Both nonresponding patients, one in each of the P1 and P2 arms, had received and not achieved clinical response with the BCMAxCD3 bispecific TCE antibody therapy teclistamab prior to receiving P-BCMA-ALLO1.
A 100% ORR (9/9) was achieved among patients in P1 and P2 arms who had not received a prior BCMA-targeting bispecific TCE antibody as well as 100% ORR (2/2) in patients who had received prior autologous CAR-T BCMA targeted therapy.
P-BCMA-ALLO1 was very well tolerated, with no graft-vs-host disease (GvHD) at any dose and low rates of cytokine release syndrome (CRS) and neurotoxicity, all Grade 2 or less, found among all evaluable patients.
Expansion and persistence of the CAR-T cells in patients after infusion was found to be highly dependent upon the conditioning dose of cyclophosphamide, with P-BCMA-ALLO1 levels measured in the blood much higher in patient cohorts in the P1 and P2 arms receiving the 500 mg/m2 and 1,000 mg/m2 conditioning doses than in any of the 300 mg/m2 (arm 'S', n=20) cohorts. Clinical responses in patients receiving arm S conditioning treatment were inferior to those achieved by patients in P1 or P2.
Analysis of P-BCMA-ALLO1 cellular kinetics in two patients with high CAR-T expansion showed CAR-T cells persisted and were measurable in the peripheral blood of one patient for at least 4 weeks and engrafted and persisted at a high level in the bone marrow of the other for at least 6 weeks. Moreover, in both cases cells in the TSCM-rich CAR-T infused drug product underwent differentiation after infusion to generate a much more effector T cell-rich population, particularly among the important CD8+ 'killer T cell' subpopulation. These findings are the first known direct clinical evidence supporting the theory that allogeneic TSCM-based CAR-T cells can act as effective prodrugs because they can expand, traffic to the relevant tissues, differentiate into effector cells and persist, all of which may contribute to driving deep clinical responses in patients while also being well-tolerated.
"Despite the emergence of autologous BCMA-targeted therapies, multiple myeloma remains an incurable malignancy. Autologous CAR-T therapies may be associated with numerous challenges for patients and physicians, including prolonged manufacturing times, inconsistent drug quality and serious safety issues," said Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center. "Allogeneic CAR-T therapies have the potential to overcome many of these challenges. Today's data demonstrate that P-BCMA-ALLO1 is a well-tolerated off-the-shelf therapy with a favorable emerging safety profile and encouraging evidence of early clinical activity. In addition, the data show that P-BCMA-ALLO1 can achieve deep clinical responses in patients with high-risk disease and those who have previously received BCMA targeting therapies. Importantly, P-BCMA-ALLO1 was delivered to all patients in the ITT population with all drug product meeting all quality specifications. We look forward to continuing to enroll patients in this study."
Enrollment is ongoing including additional exploration of dose regimens and lymphodepleting conditioning regimens. While still early to assess durability, at the time of the data cut off 8 of the 9 responding patients in P1 and P2 arms remained in response. The Company, together with Roche, plans to present additional clinical data updates for P-BCMA-ALLO1 at scientific meetings in 2024, subject to coordination with Roche.
A second Poseida-sponsored poster highlights the development of an in vivo bioassay for assessing BCMA CAR-T final product potency and presents data suggesting P-BCMA-ALLO1 drug product may have greater potency than drug products produced in the Company's earlier, autologous P-BCMA-101 CAR-T program.
P-FVIII-101 program data presentation
The Company has also presented a third poster describing P-FVIII-101, a fully non-viral liver-directed gene therapy combining Poseida's proprietary piggyBac® DNA Delivery System with nanoparticle delivery for the treatment of Hemophilia A. This poster demonstrates the capabilities of the piggyBac DNA insertion system and non-viral approach in providing stable Factor VIII (FVIII) transgene expression through genomic integration, along with the potential for redosing. The poster highlights 52-week durability in an adult Hemophilia A model along with a favorable tolerability profile of Poseida's liver-targeted non-viral delivery platform providing further proof-of-principle toward developing an effective and durable treatment for Hemophilia A.
Company-Hosted Webcast and Conference Call Information:
Poseida will host a webcast and conference call today, December 10th at 11:00 AM PST / 2:00 PM EST. The conference call can be accessed by dialing 800-225-9448 (United States) or 203-518-9708 (International) with the conference ID PSTX23. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for 90 days.
Poster Presentation Details:
Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
Presenting Author: Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center
Session Date & Time: Sunday, December 10, 2023, at 6:00 – 8:00 PM PT
Publication Number: 3479
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Location: Halls G-H
Title: A Tumor-Bearing Murine Xenograft Model as a Bioassay for Assessing CAR-T Product Potency Shows Positive Predictive Value for Clinical Performance
Presenting Author: Stacey Cranert, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 – 7:30 PM PT
Publication Number: 2293
Session Title: 803. Emerging Tools, Techniques and Artificial Intelligence in Hematology: Poster I
Location: Halls G-H
Title: Effective Gene Therapy for Hemophilia A: Novel Re-Dosable Non-Viral Formulation That Provides Stable, and Durable FVIII Expression with Improved Tolerability
Presenting Author: Brian Truong, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 – 7:30 PM PT
Publication Number: 1232
Session Title: 321. Coagulation and Fibrinolysis: Basic and Translational: Poster I
Location: Halls G-H
About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. This allogeneic program includes a VH-based binder that targets BCMA and has shown early evidence of encouraging safety and efficacy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.
About P-FVIII-101
P-FVIII-101 is a liver-directed gene therapy combining Poseida's non-viral piggyBac platform and nanoparticle delivery technologies for the in vivo treatment of Hemophilia A. Hemophilia A is a bleeding disorder caused by a deficiency in Factor VIII production with a high unmet need. P-FVIII-101 utilizes the piggyBac gene integration system delivered via lipid nanoparticle, which has demonstrated stable and sustained Factor VIII expression in juvenile and adult animal models.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. The Company's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, and nanoparticle and hybrid gene delivery technologies as well as in-house GMP cell therapy manufacturing. The Company has formed a global strategic collaboration with Roche to unlock the promise of cell therapies for patients with hematological malignancies. Learn more at www.poseida.com and connect with us on X and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy and safety profile of such product candidates; the quotes from Dr. Yarema and Dr. Dholaria; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; and the other risks described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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I wish everyone a nice safe weekend. :))
Onconova Therapeutics’ Preclinical Narazaciclib Data at SABCS Highlights Differentiated Anti-Tumor Activity v. Other CDK4/6i’s
Differentiated profile of narazaciclib supported by positive results of studies demonstrating broad multi-kinase activity, with significant anti-tumor activity and increased anti-tumor immunity, compared to approved CDK4/6 inhibitors
Data support the potential use of narazaciclib in breast and ovarian cancers
Narazaciclib progressing towards RP2D and preparation for registrational studies, with a planned update in H1 2024
NEWTOWN, Pa., Dec. 08, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preclinical data highlighting narazaciclib’s multi-kinase profile, broad anti-tumor activity and increased anti-tumor immunity, compared to palbociclib and other CDK4/6 inhibitors, in a poster presented at the San Antonio Breast Cancer Symposium (SABCS) on December 8, 2023.
“We are very pleased to share new data characterizing narazaciclib’s differentiated activity, compared to palbociclib and other CDK4/6 inhibitors, especially in breast and ovarian cell lines, in a poster presentation at this year’s San Antonio Breast Cancer Symposium (SABCS 2023),” said Steve Fruchtman, M.D., President and Chief Executive Officer.
Dr. Fruchtman continued, “Narazaciclib impacts a wider array of kinase targets and produced a more substantial reduction in cell viability across several large panels of breast and ovarian cell lines carrying a range of mutations, compared to palbociclib. In addition, narazaciclib treatment induced higher levels of T-cell recruiting chemokines, supporting greater anti-tumor immune activity.”
“We believe that the totality of the data presented at SABCS supports narazaciclib’s multi-kinase activity, its ability to target resistance pathways missed by other CDK4/6 inhibitors, and its differentiated anti-tumor and immunomodulatory activity. We hope to further demonstrate the promise of narazaciclib’s differentiated profile in patients as we progress the clinical program in 2024 towards the definition of a recommended Phase 2 dose (RP2D). We are also preparing to initiate pivotal studies in the lead indication of low grade endometrioid endometrial cancer (LGEEC), and to expand into investigator-sponsored studies in breast and ovarian cancers,” concluded Dr. Fruchtman.
Poster Overview
Title: Narazaciclib’s differential targets and kinase inhibitory activity compared to the approved CDK4/6 inhibitors (CDK4/6is) contribute to the enhanced inhibition of tumor growth in preclinical models
Objectives: To explore the activity of narazaciclib and its metabolite, ON1232580, in comparison to the FDA-approved CDK4/6 inhibitor (CDK4/6i) palbociclib, and identify additional targets engaged by narazaciclib. Activity was measured by exposing narazaciclib and other CDK4/6 inhibitors (CDK4/6i’s) to panels of resistant, mutated, or modified tumor cell lines to evaluate each agent’s activity and potency to inhibit growth and reduce cell line viability.
Results:
Comprehensive analysis of cellular targets: “Thermal Shift” assays affirmed that while narazaciclib and palbociclib impact a handful of similar, expected cell pathway targets, including Rb, Akt, and mTOR, narazaciclib and its main metabolite impact more kinases than palbociclib. We believe this observation could contribute to improved efficacy for narazaciclib by overcoming cancer resistance pathways not targeted by other CDK4/6i’s.
Deeper analysis in human breast and ovarian cells/cell lines: Using bioinformatics data from human cancer databases showed that high BUB1 kinase expression is associated with low survival in patients with breast and uterine corpus endometrial carcinomas (UCEC) and was degraded by low doses of narazaciclib. Western blot analysis of data from several breast cancer cell line panels (including those with known mutations or the overexpression of the membrane receptor, FGFr, an independent prognostic factor in some solid tumor cancers and a driver of resistance to CDK4/6 inhibitors), showed that narazaciclib and its metabolite resulted in a more substantial reduction in cell viability compared to other CDK4/6i’s dosed as monotherapy or in combination with autophagy inhibitors. These data support the potential use of narazaciclib in breast cancer and UCEC, either as monotherapy or in combination with other agents.
Ability to induce senescence and T-cell recruiting chemokines: Treatment with narazaciclib/metabolite produced more profound reductions in cell viability in PYMT murine breast cancer cells, compared to palbociclib and other CDK4/6i’s (combined with autophagy inhibitors). In addition, narazaciclib treatment produced significantly higher increases in T-cell recruiting chemokines, including CXCL10, than palbociclib. These results suggest that narazaciclib has the differentiated potential to promote greater levels of anti-tumor immunity, which could enhance its efficacy.
Conclusions: Expansive analysis of narazaciclib and its metabolite, compared to palbociclib and other CDK4/6i’s, shows that narazaciclib has the potential to be differentiated by its:
Multi-kinase profile, including its impact on BUB1 which is associated with poor prognosis in breast and uterine cancers;
Potent ability to inhibit cell viability in a wide range of breast and ovarian cancer cell panels, including those with common mutations and over-expression of the FGFr, with or without autophagy inhibitors;
Ability to produce significantly higher increases in T-cell recruiting chemokines and promote greater anti-tumor immunity.
These data support the potential use of narazaciclib in patients with breast and ovarian cancer, as well as its potential in LGEEC, based on broad, differentiated multi-kinase activity, supported by potential anti-tumor activity and anti-tumor immunity, compared to palbociclib and other CDK4/6i’s. Evaluation across a range of cell lines, mutations, and prognostic factors, with or without autophagy inhibitors, underscores the strength and consistency of these data.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer, and mantle cell lymphoma.
Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).
For more information, please visit www.onconova.com.
Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," “preliminary,” “encouraging,” "approximately" or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova's clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/
Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com
What are they intending to use to buy the stock back? Food stamps? News is BS!
Thanks, Wolf
EXPLODING! On what? I have no clue
ORGANIZED CRIME.
Somebody left the water running!
Wow! This is HUGE news! Thank you.
$11.75 on the dip this morning looks fantastic now!
On November 30, 2023, Harbor Custom Development, Inc., a Washington corporation (the “Company”), received a notice of event of default for failure to make payment of $8,000,000 of principal and $55,555.56 of prorated interest due on November 25, 2023 pursuant to the Company’s Loan Agreement with Fratelli’s LLC (the “Lender”), dated May 23, 2022 (the “Loan”). All amounts are now due and payable under the Loan. Additionally, a default interest rate of 18% is in effect as of the date of default.
Additionally, as previously reported on November 27, 2023, the Company failed to make a payment when due pursuant to the Company’s Loan Agreement with BankUnited, N.A. (the “Lender”), dated March 7, 2022 (the “Loan”) and the Amendment to the Loan Agreement, dated February 22, 2023 (the “Amendment”). On December 4, 2023, the Company received a notice of event of default and acceleration of all amounts due under the Loan from the Lender. According to the Lender, the principal amount due is $14,197,706.88 plus interest of $111,992.10 as of December 4, 2023 (the “Debt”). The Debt will accrue additional interest at the default rate from December 4, 2023, which rate floats at the contract rate plus 3%, until the Debt is paid in full.
WiMi Developed Explainable Artificial Intelligence (XAI)-based fNIRS Neuroimage Classification
BEIJING, Dec. 7, 2023 /PRNewswire/ -- WiMi Hologram Cloud Inc. (NASDAQ: WIMI) ("WiMi" or the "Company"), a leading global Hologram Augmented Reality ("AR") Technology provider, today announced that it developed explainable artificial intelligence (XAI)-based fNIRS neuroimage classification, bringing a breakthrough in the development of BCI technology. By combining the latest AI technology and BCI parsing, this system is expected to bring advances in BCI technology.
WiMi's XAI-based fNIRS neuroimage classification system consists of several key modules that work together to process, analyze, and interpret data for accurate brain activity classification and interpretation. The system architecture is designed to improve classification accuracy and interpretability, and to ensure the accuracy and utility of the system. The system includes a data preprocessing module for filtering, denoising and normalizing the raw fNIRS data to improve the accuracy of subsequent data analysis.
WiMi's XAI-based fNIRSfNIRS neuroimage classification system employs two key classification modules, i.e., a one-dimensional sliding-window-based convolutional neural network (CNN) and a long short-term memory (LSTM) neural network. These two modules are used to classify different types of brain activity patterns respectively, thus improving the applicability and generalization ability of the system. To address the need for interpretation of model outputs, the system introduces an interpretability module, which employs the machine learning interpretability tool SHapley Additive exPlanations (SHAP) for interpreting the outputs of CNN models. By interpreting the model input variables, the system is able to identify the features that contribute the most to the classification of a particular brain activity, helping researchers to gain insight into the association between brain activity patterns and external device control.
Through these methods and techniques, the system is able to efficiently transform fNIRS data into interpretable classification results. The preprocessing of the data, the application of CNN and LSTM models, and the SHAP interpretation module together form the core of the system, enabling it to improve the accuracy of brain activity classification and provide researchers with interpretable results.
WiMi's XAI-based fNIRSfNIRS neuroimage classification system shows good application prospects and potential. In real brain-controlled robots, prosthesis control and virtual reality scenarios, the system's high-precision classification results provide reliable support for device control and offer new possibilities for the application of BCI technology in medical rehabilitation and virtual reality.
The research and application of WiMi's XAI-based fNIRSfNIRS neuroimage classification system brings new insights to the field of brain science. By parsing brain activity patterns through the interpretation module, the system reveals for researchers the association and mechanism of action between functional regions of the brain, and promotes the development of the entire field of brain science. These important results show that the XAI-based fNIRSfNIRS neuroimage classification system not only improves the classification accuracy of brain activities, but also brings new perspectives to the development and application of BCI. It is foreseeable that it will promote the development and popularization of BCI in the future, and bring a revolutionary change to the interaction between humans and machines.
About WIMI Hologram Cloud
WIMI Hologram Cloud, Inc. (NASDAQ:WIMI) is a holographic cloud comprehensive technical solution provider that focuses on professional areas including holographic AR automotive HUD software, 3D holographic pulse LiDAR, head-mounted light field holographic equipment, holographic semiconductor, holographic cloud software, holographic car navigation and others. Its services and holographic AR technologies include holographic AR automotive application, 3D holographic pulse LiDAR technology, holographic vision semiconductor technology, holographic software development, holographic AR advertising technology, holographic AR entertainment technology, holographic ARSDK payment, interactive holographic communication and other holographic AR technologies.
Safe Harbor Statements
This press release contains "forward-looking statements" within the Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," and similar statements. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Among other things, the business outlook and quotations from management in this press release and the Company's strategic and operational plans contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the US Securities and Exchange Commission ("SEC") on Forms 20-F and 6-K, in its annual report to shareholders, in press releases, and other written materials, and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Several factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company's goals and strategies; the Company's future business development, financial condition, and results of operations; the expected growth of the AR holographic industry; and the Company's expectations regarding demand for and market acceptance of its products and services.
Further information regarding these and other risks is included in the Company's annual report on Form 20-F and the current report on Form 6-K and other documents filed with the SEC. All information provided in this press release is as of the date of this press release. The Company does not undertake any obligation to update any forward-looking statement except as required under applicable laws.
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SOURCE WiMi Hologram Cloud Inc.
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On December 1, 2023, the Company repaid all amounts due and owing under the Note in full, in an aggregate amount, including accrued interest, equal to $650,180.56. In connection with the repayment of the Note, the Company agreed that the Purchaser would be permitted to retain all of the Commitment Fee Shares. Under the SPA, the Company originally had the right to repurchase half of the Commitment Fee Shares if the Note was repaid in full prior to maturity. As a result of the repayment of the Note, the Company will have no further payment or other obligations to the Purchaser in connection with the Note or any agreements or instruments entered into in connection with the Note. The Company obtained the funds necessary to repay the Note through the financial obligations entered into as described in Item 2.03.
Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine
– Antigen-specific T cell responses were observed at all dose levels –
– IFN? and IL-17, immune-mediated biomarkers of T cell activation, increased over time from baseline –
– Vaccine was safe and well tolerated –
– Conference call to commence today at 6:30 p.m. ET –
SAN JOSE, Calif., Dec. 6, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense.
The data were presented at the 2023 San Antonio Breast Cancer Symposium by G. Thomas Budd, M.D., staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study, in a poster entitled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC."
Patients who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFN? and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect. Data from the 16 patients treated to date showed that:
The majority of patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.
12 (75%) of the women had antigen-specific IFN? and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA antibody responses were observed at Dose Level 2 and higher.
A statistically significant (P = 0.03) increase in IFN? over baseline (Day 0) was observed by Day 56; while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.
Among the doses studied, Dose Level 1 (10 mcg a-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well as the maximum tolerated dose (MTD).
No significant side effects were observed, at the MTD, besides irritation at the sites of injection. No myalgias, flu-like symptoms, or aberrant laboratory values were noted.
Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine's safety and immunologic effects in two additional patient cohorts.
The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.
The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation positive and are planning prophylactic risk-reducing mastectomies.
"The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine. Our goal is to initially evaluate the vaccine's ability to prevent recurrence of cancer in survivors, and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC."
"There is a large unmet need for preventing TNBC, an aggressive form of breast cancer with few targeted treatment options available," said Dr. Budd, Cleveland Clinic. "We are encouraged by the data gathered to date and look forward to determining the optimal vaccine dose in additional patient cohorts. Our hope is that future studies will demonstrate that the antigen-specific T cell responses we observed translate to the prevention of breast cancer recurrence."
Anixa is the exclusive worldwide licensee to the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase 1 trial. The grant from the U.S. Department of Defense was made directly to Cleveland Clinic.
Conference Call Information
Anixa is pleased to invite all interested parties to participate in a conference call, during which this new data will be discussed.
Conference Call Details:
Presentation host:
Anixa management, with special guest speakers
Date and time:
Today, December 6, 2023, at 6:30 p.m. ET
Phone access:
Registration Link to receive your dial-in number and unique PIN
Webcast:
Available at www.anixa.com under "Events & Presentations"
About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
About Anixa Bioscience's Breast Cancer Vaccine
Anixa's breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, a-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express a-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute. Dr. Tuohy was inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. He was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.
About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR- T, known as chimeric endocrine receptor T-cell (CER-T) technology. The Company's vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10- Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward- looking statements when evaluating the information presented in this press release.
Contacts:
Stephen KilmerInvestor Relations
skilmer@anixa.com
646-274-3580
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.
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$10.49 Won't Get Fooled Again
Out @ $6.00
Out @ $6.00
That dip yesterday to $11.69 sure looks great today!
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