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It has the potential, but we do not know untill it is fully tested on humans
Orphan drug requires no resources except filing some paperwork with the FDA. It is obvious that 3-71 is not the first priority butt will be when income goes up.
Too optimistic. Previous enrolment was slower then expected here. Do not expect data before 2018w
Inovio’s SynCon® WT1 Cancer Antigen Breaks Tolerance, Highlights Potential for Universal Cancer Immunotherapy
SynCon WT1 and PSMA antigens join hTERT in INO-5401, Inovio’s cancer product planned for immuno-oncology combination study
PLYMOUTH MEETING, Pa. – February 27, 2017 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that its SynCon® WT1 cancer immunotherapy was capable of breaking immune tolerance and inducing neo-antigen-like T cell responses to cause tumor regression in pre-clinical studies. Breaking tolerance has been a major challenge for developing a potent cancer therapy; researchers have tried many other methods and been unsuccessful for decades. Notably, the WT1 antigen is over-expressed in multiple cancer types but not found in most normal tissue, giving it potential to be used as part of a universal cancer vaccine against multiple tumor types.
Results of these pre-clinical studies appear in the online edition of Molecular Therapy in a paper entitled, “A novel DNA vaccine platform enhances neo-antigen-like T-cell responses against WT1 to break tolerance and induce anti-tumor immunity,” authored by Inovio and its collaborators at The Wistar Institute.
Study results revealed that while mice did not mount an immune response to native mouse WT1 antigens, mice immunized with Inovio’s SynCon WT1 antigen broke tolerance and generated robust neo-antigen-like T cells. Furthermore, the immunized mice exhibited smaller tumors and prolonged survival in a tumor challenge study. SynCon WT1 DNA vaccination also broke tolerance and generated neo-antigen-like T cell immune responses in Rhesus monkeys, a species whose immune system closely resembles that of humans. Inovio’s ability to overcome the immune system’s usual tolerance of WT1 antigen suggests the potential of its SynCon WT1 antigen to tackle any WT1-expressing cancer in humans, which include pancreatic, brain, lung, thyroid, breast, testicular, ovarian, and melanoma.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "Our SynCon antigens’ ability to overcome the immune system’s inability to recognize tumor self-antigens is unique and powerful. While we systematically and synthetically mimic the body’s natural process of creating tumor neo-antigens, which possess differentiated but individualized genetic sequences that may then induce an immune response, our ability to break tolerance with broadly prevalent antigens makes our approach more universal across populations. We are pleased to again show such results with an important cancer antigen – in this case, WT1 – and continue to add to our array of promising universal cancer antigens in Inovio’s product development strategy.
“To expand on our capabilities and strategy, the power of our differentiated antigens dovetails with our ability to turn cancer tumors from cold to hot by creating a significant presence of antigen-specific CD8+ killer T cells in a target lesion or tumor microenvironment, which we have shown via biopsies in two human studies. These are critical outcomes: although checkpoint inhibitors have raised the bar for treating cancers by neutralizing cancer cells’ inherent ability to switch off T cells that are hunting them, they do not actually generate the antigen-specific killer T cells required to destroy cancer cells. We believe our DNA-based SynCon immunotherapies are the missing link to take immuno-oncology to the next level.”
“With these accomplishments we could not be more enthusiastic about two immuno-oncology combination human studies to start in the first half of 2017. MedImmune will combine INO-3112 (also named MEDI0457) with their checkpoint inhibitor molecule in an upcoming clinical study. Inovio is also planning to conduct a combination study for INO-5401 with a checkpoint inhibitor in cancer patients. We previously noted that INO-5401 will include our hTERT SynCon antigen. I am pleased to say that INO-5401 will also include our SynCon antigens for WT1 and PSMA. We believe this product has the potential to be a very powerful universal cancer immunotherapy in combination with different checkpoint inhibitors.”
The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85% of cancers and WT1 and PSMA antigens are also widely prevalent in many cancers.
Inovio’s synthetically designed antigens use a consensus of human and multiple animal genetic sequences for the same antigen to create a differentiated SynCon® antigen that can be more readily recognized as “foreign” by immune sentries in the patients. This recognition may help overcome the immune system’s tolerance of tumor cells displaying the native or self-antigens generated by the body. Once a significant antigen-specific T cell response is activated, these T cells may then also seek throughout the body and destroy cancer cells expressing the pre-existing natural or native tumor antigens.
There are multiple lines of evidence pointing to the potential of INO-5401 in immuno-oncology. Inovio previously reported preclinical data indicating the ability of its PSMA and hTERT tumor-associated SynCon antigens to generate significant antigen-specific killer T cell responses. Inovio is also running an ongoing phase I study of its SynCon hTERT antigen (INO-1400) to assess safety and immunogenicity in over fifty patients with at least one of nine different hTERT-expressing cancers. Our SynCon PSMA antigen is one of two components (along with SynCon PSA) making up INO-5150, which is currently in a phase I study of sixty biochemical-relapse prostate cancer patients. Interim immune responses and safety data from both INO-1400 and INO-5150 studies will be presented at cancer conferences in 2017.
Importantly, Inovio has already reported human data characterizing the activation of significant antigen-specific CD8+ killer T cells in patients and their infiltration into lesions and tumors displaying target antigens. These studies of HPV-related precancer (VGX-3100) and cancer (INO-3112) showed a significant presence of activated T cells based on pre and post immunization biopsies. In a controlled phase 2b study for VGX-3100, Inovio also showed statistically significant efficacy in regressing HPV-related cervical dysplasia.
back in the good old days of JBEM you were singing a completly different song!
OncoSec Granted FDA Fast Track Designation for ImmunoPulse® IL-12 for the Treatment of Metastatic Melanoma Following Progression on Pembrolizumab or Nivolumab
Provides Opportunities for Upcoming Phase 2b PISCES Clinical Trial and Future Clinical Development
SAN DIEGO, Feb. 27, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its ImmunoPulse® IL-12, a potentially first-in-class, Intratumoral anti-cancer gene therapy that expresses interleukin-12 (IL-12) for the treatment of metastatic melanoma, following progression on pembrolizumab or nivolumab.
"With the number of melanoma patients now being treated with either pembrolizumab or nivolumab in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy. Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies," said Punit Dhillon, OncoSec President and CEO. "With the recent presentation of our interim data from our ongoing combination study with pembrolizumab in patients predicted not to respond to single-agent anti-PD-1 therapy, we are increasingly confident in ImmunoPulse® IL-12 to potentially convert 'cold' tumors to 'hot' tumors to effectively and safely improve the response rates of these patients."
"This Fast Track designation by the FDA serves as an additional validation for OncoSec's clinical development program," said Sharron Gargosky, Ph.D., Chief Clinical and Regulatory Officer. "As we launch our upcoming Phase 2b PISCES clinical trial, we look forward to collaborating closely with the FDA at this important stage of our clinical program."
The PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a Phase 2b, Simon 2-stage, non-comparative, open-label, single-arm, multicenter study of ImmunoPulse® IL-12 (intratumoral pIL-12 plus electroporation) in combination with an intravenous anti-PD-1 antibody in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. Eligible patients will be those with Stage III/IV metastatic melanoma who are progressing or have progressed according to RECIST v1.1 guidelines on, or within, 24 weeks of receiving approved anti-PD-1 antibodies on either pembrolizumab or nivolumab treatment (either as monotherapy or in combination with another approved checkpoint inhibitor). The primary endpoint for this registration-directed trial will be overall response rate (ORR) at 24 weeks with secondary endpoints of best overall response rate (BORR), duration of response (DOR), median progression-free survival (PFS) and overall survival (OS). This clinical trial is planned to initiate in the first half of 2017.
The FDA established the Fast Track program to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent communications and meetings with the FDA, to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers, and the extent of data needed for approval. Fast Track designated drugs may qualify for expedited FDA review, and a rolling Biologics License Application (BLA), if certain criteria are met.
Where do you get the average 13k/patient from?
Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases
Significant immune responses observed in 100% of Zika-vaccinated subjects and 98% of MERS-vaccinated human subjects in separate phase I studies
PLYMOUTH MEETING, Pa. – February 23, 2017 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that Dr. David B. Weiner, Inovio’s co-founder, presented positive clinical data on Inovio’s DNA-based vaccines against MERS (Middle East Respiratory Syndrome) (GLS-5300) and Zika (GLS-5700) at the Coalition for Epidemic Preparedness Innovation (CEPI)’s 1st Scientific Meeting on “Vaccines Against Emerging Infections - A Global Insurance” in Paris, France.
Dr. J. Joseph Kim, Inovio’s CEO, said: “Advancing DNA vaccine technology for broadly applicable, rapid response against infectious diseases of epidemic potential is one of Inovio’s priorities. We quickly designed and manufactured vaccines for two recent emerging infectious pathogens, MERS CoV and Zika, and these products join our Ebola program in generating significant immune responses with a favorable safety profile in phase I studies. We are pleased to see CEPI moving forward on its vision for proactive and accelerated vaccine development for epidemic threats and to contribute to their first scientific meeting.”
Officially launched at the World Economic Forum in Davos in January, 2017, CEPI received an initial $460 million from the governments of Germany, Japan and Norway, plus the Bill & Melinda Gates Foundation and Wellcome Trust, as part of a drive to bring together a total of $1 billion to fund and support its goal of stimulating, financing and coordinating the advancement of safe, effective and affordable vaccines.
MERS Vaccine Results
Dr. Weiner noted that in a phase I MERS study, after a three dose vaccine regimen with GLS-5300, high levels of binding antibodies were measured (ELISA) in 92% (57 of 62) of evaluated subjects. Even two doses or a single dose of vaccine generated a robust antibody response in 84% (52 of 62) or 44% (27 of 62) of evaluated subjects, respectively.
Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were also observed. Importantly, all but one evaluated vaccinated subject or 98% (61 of 62) generated an antibody and/or T cell response against the MERS vaccine. Generation of MERS antigen-specific antibody and T cell responses is believed to be important for generating immediate and long-lasting protection against the disease. The vaccine was well tolerated and no significant safety concerns were noted to date.
These interim data from the first set of evaluated subjects were from a fully enrolled phase I study of 75 healthy volunteers. Inovio and GeneOne Life Science Inc. (KSE: 011000) are co-developing Inovio’s GLS-5300 in partnership with the Walter Reed Army Institute of Research in Maryland, where the trial was conducted. This trial represents the first and still only MERS vaccine to be tested in humans for this disease that has no approved vaccines or treatments.
In preclinical studies of GLS-5300 (data published in the peer reviewed journal Science Translational Medicine, 2015), 100% of vaccinated Rhesus macaques were protected from symptoms of MERS when exposed to the live MERS virus. The animals also generated strong antibody and T-cell responses.
Since the virus was first identified in Saudi Arabia in 2012, the World Health Organization has reported almost 2,000 MERS infections and nearly 700 deaths worldwide. Twenty seven countries have reported cases, including Korea where an outbreak in the summer of 2015 resulted in 186 cases and 38 deaths. While the SARS epidemic in 2003 killed 10% of those infected, SARS-related MERS has killed about 36% of people who contracted this communicable virus.
Zika Vaccine Results
Dr. Weiner also highlighted that in a phase I Zika study, after a three dose vaccine regimen with GLS-5700, high levels of binding antibodies were measured (ELISA) in 100% (39 of 39) of evaluated subjects. Moreover, two doses or a single dose of vaccine generated a robust antibody response in 82% (32 of 39) or 40% (16 of 40) of evaluated subjects, respectively.
T cell immune responses are currently being evaluated. The vaccine was well tolerated and no significant safety concerns were noted. These preliminary data are from a fully enrolled phase I study of 40 healthy volunteers. Inovio and GeneOne are co-developing GLS-5700. This trial represents the first Zika vaccine to be tested in humans for this disease that has no approved vaccines or treatments and also the first human clinical data reported with a Zika vaccine documenting the induction of immune responses following vaccination.
Preclinical data published in the peer-reviewed journal npg Vaccines (2016) showed that GLS-5700 generated single-dose protection in 100% of animals against neurologic or testicular effects of the Zika virus.
Dr. Scott White, Inovio’s Vice President of Infectious Disease Clinical Development, will also present this Zika data on Friday, February 24th at the “First International Conference on Zika Virus,” a worldwide forum sponsored by the American Society of Tropical Medicine and Hygiene in Washington, D.C.
end close or weeks end close are binary events: they are either red or green.
50% this is a correct prediction.
Similiar MOA?
Relevance to TPIV?
• Soligenix (OTCQB:SNGX) is awarded a European patent covering its proprietary formulation of synthetic hypericin for the treatment of psoriasis. The patent complements the claims in a previously issued patent in the U.S.
• Synthetic hypericin is the active ingredient in SGX301, currently in Phase 3 development for the treatment of cutaneous T-cell lymphoma.
Correct, as per Missling roughly 1 million
Rett clinical to be partially funded by Rett Foundation
Excellent!
When is the FDA to lift this pre-clinical hold on the delivery mechanism?? Taking way too long to get the P3 up and running.
AVNX = Avanex?
You are missing Misslings couple million shares
Give it 12 months, untill we get interim data from the p2's
FDA guidelines to adaptive trial designs go back couple of years. Anavex did not guide them in writing the rules
2010: http://www.fda.gov/downloads/drugs/guidances/ucm201790.pdf
Oh boy, have been hearing this in every runup to data release. One day, presenting p3 data...
Seriously?
IR is outsourced to a 3d party. Probably they are not in charge of keeping the website up to date.
I guess We have to if we need funding for the Alzheimer trial
Another Cayman resident, perhaps a neighbour from Dart? ;)
The different phase 2's are just starting. When did you expect news?
Did not hear much news, but still good to hear.
My question on P1 data was not answered either...
Soligenix Announces SGX301 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency
Princeton, NJ – February 2, 2017 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today SGX301 (synthetic hypericin) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of cutaneous T-cell lymphoma (CTCL).
The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme (EAMS). Launched in April 2014, EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible.
PIM status, the first phase of EAMS, which is awarded following an assessment of early nonclinical and clinical data by the MHRA, has been created as an early signal to companies that the development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme, once further development work has been conducted. In this second phase, the product is made available to UK patients before a marketing authorization is approved. This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises.
The criteria products must meet to obtain the PIM designation are:
Criterion 1 – The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e., there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations).
Criterion 2 – The medicinal product is likely to offer major advantage over methods currently used in the UK.
Criterion 3 – The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be based on preliminary scientific evidence, as justified by the applicant, that the safety profile of the medicinal product is likely to be manageable and acceptable in relation to the estimated benefits.
“We are excited that the MHRA agrees that SGX301 meets the specified criteria for PIM designation,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “This is now the second of our programs to receive this important designation, with the first being SGX942 for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy. We look forward to working with the MHRA to advance both programs and leverage the potential benefits of the EAMS scheme to make these important products available to patients and physicians facing the challenges of CTCL and severe oral mucositis.”
Webcall today!
Chairman and CEO, Dr. Glynn Wilson, and COO, Dr John Bonfiglio, will speak with investors and advisors through an interactive real-time virtual conference on Thursday, February 2, 2017.
During the webinar, Dr. Bonfiglio and Dr. Wilson will focus on the company’s recent accomplishments and progress, especially surrounding its sponsored Phase 2 trial in triple-negative breast cancer now enrolling at nine sites and the status of the Phase 2 trial in triple negative breast cancer sponsored by the Mayo Clinic. They will also discuss their ongoing trial with Memorial Sloan Kettering and AstraZeneca in ovarian cancer.
Attendees are invited to ask them questions in real-time, both in the presentation hall as well as the association’s “virtual trade booth.” If attendees are not able to join the interactive online event live, an on-demand archive will be available for 90 days.
It is recommended that attendees pre-register and run the online system check to save time and receive event updates.
DATE: Thursday, February 2, 2017
TIME: 12:15 p.m. Eastern Time
LINK: http://tinyurl.com/201prepr
JACKSONVILLE, Fla., February 2, 2017 — TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, announced today it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, the company’s multi-epitope T-cell vaccine targeting folate receptor alpha. The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer.
“The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies,” said Dr. Glynn Wilson, Chairman and CEO of TapImmune. “Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization.”
“Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients,” said Dr. John Bonfiglio, President and COO of TapImmune. “The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense.”
I believe you are referring to this paragraph?
Ofcourse a CEO would never exagerate just a little...
Put out the PR!
For all we know Missling was thinking about LPC financing. It is a possibility.
Sure we can speculate. But show me a PR who will finance...
Have you written that article already?
Dr Wilson has in the past usually been very responsive to e-mails. No complaints about accessibility.
Back up this statement with facts:
"some of which have already been on the Prana trial with Professor Mc Farlane."
Thank you so much for investment guidance!