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Ahab, I think if we get no news until Oct./Nov. that could be possible, though I suspect things will hold at or near a buck.
OncoSec Presents Update from Triple Negative Breast Cancer Program at 3rd Global Insight Conference on Breast Cancer
PR Newswire PR Newswire July 17, 2018
Ongoing Phase 1 TNBC Study Now Fully Enrolled
Preliminary Data Expected Later this Year
SAN DIEGO and PENNINGTON, N.J., July 17, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (ONCS), a company developing intratumoral cancer immunotherapies, today announced that Sharron Gargosky, PhD, Chief Clinical and Regulatory Officer, presented a clinical update of the Company's intratumoral therapy, ImmunoPulse™ tavokinogene telseplasmid (TAVO), as well as an overview of the ongoing and anticipated clinical programs involving TAVO in triple-negative breast cancer (TNBC). The presentation, titled "Intra-tumoral delivery of tavokinogene telseplasmid (pIL-12) by electroporation: immunomodulation in melanoma and triple negative breast cancer," took place at the 3rd Global Insight Conference on Breast Cancer in Valencia, Spain.
"We were grateful for the opportunity to present at the 3rd Global Insight Conference on Breast Cancer and share progress from our TAVO clinical programs with the clinicians, biotechnology executives, and industry opinion leaders in attendance. Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," said Dr. Gargosky. "The marked synergy shown in these patients strongly suggest that IL-12 may have primed the tumor microenvironment, impacting the clinical result. The combination of TAVO and checkpoint inhibition represents a highly promising new therapeutic approach for TNBC and warrants a formal evaluation given the extremely low response rate in women who have failed multiple prior therapies."
The ongoing Phase 1 TNBC study, OMS-140 (NCT02531425), is designed to determine whether TAVO as a single cycle of monotherapy can elicit a pro-inflammatory molecular and histological signature in treated as well untreated tumors. The study has reached its target enrollment of 10 patients. Several of these patients were subsequently treated with an anti-PD-1 checkpoint inhibitor treatment(s) as their next therapy. As previously reported at the American Association for Cancer Research (AACR) Annual Meeting, immunological signals were observed on an individual patient basis, and clinically meaningful objective tumor responses have been observed in both TAVO treated and untreated lesions following the anti-PD-1 checkpoint inhibitor treatment. A detailed case study of one such patient, along with information regarding clinical observations and safety data, were presented at this conference.
Following these observations, the Company entered a clinical collaboration with Merck to evaluate the combination of TAVO with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase 2 clinical trial, KEYNOTE-890 (NCT03567720). KEYNOTE-890 is a study of TAVO in combination with KEYTRUDA® in TNBC patients with inoperable locally advanced or metastatic TNBC who have progressed on more than one line of prior therapy. Patients will be treated with the combination of TAVO with pembrolizumab. The proposed primary endpoint is to assess efficacy as measured by objective response rate (ORR) by independent central review (ICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. KEYNOTE-890 is expected to initiate in the third quarter of 2018.
Dr. Gargosky's update is available on the OncoSec website, www.oncosec.com.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or "TAVO"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to TAVO, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
A Look At Biotech In 2018 And The Biggest Catalysts Coming Up In The Second Half Of The Year
7/5/18, 11:25 AM
July 5, 2018 12:25 PM ET (BZ Newswire) -- Biotech
Biotech stocks carved out modest gains in the first half of 2018 and outperformed the broader market, although their gains paled before those of the tech-weighted Nasdaq Composite Index. From the fundamental perspective, there was no lack of catalytic events such as FDA decisions, clinical trial results announcements and mergers and acquisitions.
Here's a listing of some individual biotechs that moved notably in either direction in the first half of the year.
Stocks That More Than Doubled
Innovate Biopharmaceuticals Inc (NASDAQ:INNT)
Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR)
ArQule, Inc. (NASDAQ:ARQL)
Xenon Pharmaceuticals Inc (NASDAQ:XENE)
Endocyte, Inc. (NASDAQ:ECYT)
Madrigal Pharmaceuticals Inc (NASDAQ:MDGL)
The 5 Worst Declines
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV)
OHR Pharmaceutical Inc (NASDAQ:OHRP)
Edge Therapeutics Inc (NASDAQ:EDGE)
Aytu Bioscience Inc (NASDAQ:AYTU)
Auris Medical Holding AG (NASDAQ:EARS)
IBB Vs. S&P 500 Vs Nasdaq Composite Index
IBB Chart
Source: YCharts
NME Approvals
New molecular entities are products that contain active moieties that haven't been previously approved by the FDA, either as a single ingredient drug or as part of a combination product. The number of NME approvals are usually considered a measure of innovation in drug research. So far in 2018, the number of NME approvals totaled 17 — a big number, though smaller than the 23 approvals made in the same period last year. Click here to learn about FDA's NME approvals for the first half.
Launches With Blockbuster Potential
A handful of drugs with blockbuster potential were launched in the first half:
Gilead Sciences, Inc. (NASDAQ:GILD)'s AIDS cocktail Biktarvy, a concoction of bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg. A once-daily single tablet regimen for HIV-1 infection was approved by the FDA Feb. 7. Biktarvy's sales could touch $6.1 billion by 2024, Evaluate Pharma said in its World Preview 2018.
Novo Nordisk A/S (ADR) (NYSE:NVO) launched its Ozempic injection, chemically semaglutide, 0.5 mg or 1 mg as well as Fiasp 100 Units/mL across the U.S. in February. The FDA had approved Ozempic, a glucagon-like peptide 1 agonist, in December. EvaluatePharma estimates Ozempic sales of about $4.41 billion by 2024.
Major Heartaches
On the flipside, some biotechs did experience setbacks in the first half of the year.
Incyte Corporation (NASDAQ:INCY) had to halt trials of its lead immunotherapy candidate epacadostat — which was evaluated in combination with Merck & Co., Inc. (NYSE:MRK)'s Keytruda for melanoma — after it failed to meet the primary endpoint in a pivotal Phase 3 study. The news triggered a 23-percent downward move in Incyte shares in a single day on April 6.
AbbVie Inc (NYSE:ABBV) had its share of bad news, as its rovalpituzumab tesirine, or Rova-T, produced disappointing results. The therapy was evaluated in a Phase 2 trial dubbed TRINITY as a third-line treatment for patients with relapsed or refractory small-cell lung cancer demonstrating high DLL3 expression. The company said it would not pursue accelerated approval for Rova-T. The stock fell about 13 percent on the March 22 announcement and is still off from levels reached before the announcement.
Celgene Corporation (NASDAQ:CELG) was in for a shock after the FDA issued a "refuse-to-file" letter in response to its NDA filing for ozanimod in patients with relapsing forms of multiple sclerosis.
See also: Achieve Life Sciences Shares Rip Higher On Positive Data For Smoking Cessation Drug
It's Raining Deals
M&A in the biotech space picked up momentum after a lull in 2017, with a few multibillion-dollar deals announced in the space. Tax reform freed up free cash flow, and the urge to bolster pipelines prompted companies to explore the M&A route in a bid to reinvigorate sagging top and bottom lines. Some of the noteworthy deals that were announced include:
Japan's Takeda agreeing to buy Shire PLC (ADR) (NASDAQ:SHPG) for $62 billion.
Sanofi SA (ADR) (NYSE:SNY) acquiring Bioverativ, which develops hemophilia and blood disorder drugs, for $11.6 billion, as well as Belgian biotech company Ablnyx for $4.8 billion.
Celgene buying Juno Therapeutics for $9 billion — and in the process gaining a foothold in the immuno-oncology market through its access to JCAR071, a CD-19 targeted CAR-T therapy in pivotal late-stage trials for relapsed and/or refractory diffuse large B-cell lymphoma. Celgene also bought Impact Biomedicines for up to $7 billion, including potential milestone payments.
A Second Half Preview
Here's a sneak peek into potential biotech catalysts coming in the second half of 2018.
FDA Approvals
Johnson & Johnson (NYSE:JNJ)'s sNDA for its Xarelto vascular dose to reduce the risk of major cardiovascular events in patients with chronic coronary and/or peripheral artery disease, as well as for reducing the risk of acute limb ischemia in patients with peripheral artery disease, is pending before the FDA. The application was submitted in mid-December.
Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE:TEVA)'s BLA for its migraine treatment candidate fremanezumab will come before the FDA, with the agency scheduled to rule on the drug Sept. 16.
Abbvie and Neurocrine Biosciences, Inc. (NASDAQ:NBIX) are awaiting the FDA verdict on their NDA for elagolix in endometriosis-associated pain. The PDUFA date is set for the third quarter following a three-month extension of the review period.
Insys Therapeutics Inc (NASDAQ:INSY) has a July 28 FDA date and is set to receive the verdict on the company's sublingual spray formulation of buprenorphine to treat moderate-to-severe acute pain.
DURECT Corporation (NASDAQ:DRRX), which has licensed its schizophrenia candidate RBP-7000 to U.K.-based Indivior, comes under the FDA scanner, with the agency set to rule July 28 on the pipeline candidate. DURECT will yet again be in the spotlight, as Remoxy ER, a drug it licensed to Pain Therapeutics, Inc. (NASDAQ:PTIE) has a PDUFA action date of Aug. 7. The odds of the drug clearing the FDA hurdle have worsened after a FDA panel voted against the approval.
SIGA Technologies, Inc. (NASDAQ:SIGA)'s small pox antiviral therapy Tpoxx in an oral formulation faces an FDA decision Aug. 8.
AstraZeneca plc (ADR) (NYSE:AZN)'s BLA for moxetumomab pasudotox for treating hairy cell leukemia has a PDUFA date in the third quarter.
Bristol-Myers Squibb Co (NYSE:BMY)'s sBLA for Opdivo for treating small-cell lung cancer that has progressed following two or more lines of therapy was granted priority review in mid-April. The application was submitted based on the CheckMate-032 trial.
Eli Lilly And Co (NYSE:LLY) and Merck await the FDA's decision on the Keytruda-Alimta combo along with platinum chemotherapy as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer. The PUDFA action date is set for Sept. 23.
Pfizer Inc. (NYSE:PFE)'s dacomitinib, evaluated as a first-line treatment for squamous non-small cell lung cancer with epidermal growth factor receptor-activating mutations, awaits the FDA's verdict in September.
The FDA is set to rule on Verastem Inc (NASDAQ:VSTM)'s lead product candidate duvelisib Oct. 5. The pipeline candidate is being tested for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
Clinical Trials
Alkermes Plc (NASDAQ:ALKS) expects to release top-line results from the ENLIGHTEN-2 study, the second of two key Phase 3 studies for ALKS 3831 for schizophrenia, in the fourth quarter. The company plans to use clinical data from the study for the NDA submission if the study is successful, along with the previously reported data for the ENLIGHTEN-1 study.
Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) plans to release top-line results from two Phase 3 pivotal studies for its FMX103 trial of 1.5-percent topical minocycline foam in rosacea early in the fourth quarter. The company will also release top-line data for its FMX-101 Phase 3 acne study in the third quarter.
FibroGen Inc (NASDAQ:FGEN) expects to release top-line results from Phase 3 studies supporting its NDA submission for roxadustat in anemia-associated with chronic kidney disease by the end of 2018. The company expects to submit the NDA in the first half of 2019.
Regulus Therapeutics Inc (NASDAQ:RGLS) plans to release data from the Phase 1 renal biopsy study of RG-012 to treat Alport syndrome by the end of the year.
OncoSec Medical Inc (NASDAQ:ONCS) will complete enrollment of 23 patients in the first stage of the PISCES/KEYNOTE-695 study evaluating its intratumoral Tavo plus electroporation in combination with intravenous Keytruda in patients with stage III/IV melanoma who are progressing on either Keytruda or Opdivo in the third quarter. The company expects to present top-line results from this study before the end of the year.
Regulatory Submissions
AbbVie announced positive Phase 3 top-line results for its oral JAK1-selective inhibitor upadacitinib in early June. The candidate is being evaluated as a monotherapy in adults with moderate-to-severe rheumatoid arthritis. The company expects the SECLECT-EARLY study, the fifth pivotal study, to -produce results supporting a regulatory filing in the second half of 2018.
Intra-Cellular Therapies Inc (NASDAQ:ITCI), which initiated a rolling submission of its NDA for lumateperone for treating schizophrenia in June, expects to complete the NDA submission by mid-2018. Rolling submission allows a company to submit sections of the NDA when they are complete, rather than waiting until the entire application is finalized.
Copyright © 2018 Benzinga (BZ Newswire, http://www.benzinga.com/licensing). Benzinga does not provide investmentadvice. All rights reserved. Write to editorial@benzinga.com with any questions about this content. Subscribe to Benzinga Pro (http://pro.benzinga.com).
© 2018 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Hey ZB, I agree with TJ about the tutes, And I have been forced to move my expected time schedule for Oncosec From January/June to July/December. The Pisces trail his plan to be fully enrolled by September with patient data to be released within 3 to 6 months. The intriguing part about that data is that it’s regarding technology that is already slipping into outdated relevancy. With the polycistronic interleukin 12 immune modulator coming to the forefront in 2019. They also have the tech for their new Electroporation device that can reach tumors subcutaneously– – The trace technology to include multigene cocktail which is going to leave the Pisces data in the dust – – but that’s years out in development.
The question I put to myself is what am I waiting for At this point in oncosec’s development, It used to be a Buy out; but at this point with up-and-coming advancements with their technology, if I were big Pharma I would wait For their latest tech development performance before considering a purchase. But I do think positive Pisces trial Data should put the stock value at or near $5. If we get there I’m going to hold while looking for the new stuff to perform. That might be 2 more years, but hell – I’ve been here since 2012 what’s two more years?
David, it's a map ahead, not data or partnership announcement. And when you think about it, following PIECES data, all clinicals will be in early development with new tech such as the Polycistronic Interleukin-12 Immune Modulator (PIIM) which is in mouse trials, and the TRACE tech (the only IN VIVO electroporation device) which O'Connor told me is at 80% development--which he added, "is mainly paperwork," without being able to say when that will be completed. So for me, I get why Institutes are pulling up front row seats to watch what has the potential to be a Great Show; but as for now, we were just handed the program to read--not really newsworthy material to trade on.
Oncosec Medical (ONCS) Provides Outlook for Second Half
Article
June 28, 2018 8:04 AM EDT
OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, provided an update of key value-creating milestones for the second half of 2018 and a review of its year-to-date accomplishments.
"We believe we can unlock the larger checkpoint market across multiple cancer types by turning 'cold tumors' to 'hot tumors' with our intratumoral IL-12 immunotherapy or 'TAVO.' Our data have demonstrated TAVO's ability to do so by recruiting more tumor infiltrating lymphocytes (TILs) into the tumors. In doing so, TAVO can pave the way for checkpoints to be effective in the largest, but still unresponsive, segment of the checkpoint market," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec.
ANTICIPATED 2018 MILESTONES
OncoSec anticipates to achieve the following clinical and operational milestones during the second half of 2018:
Clinical Milestones for TAVO
TAVO for Metastatic Melanoma
Complete enrollment of 23 patients in Stage 1 of PISCES/KEYNOTE-695 in the third quarter
Provide topline data update from Stage 1 PISCES/KEYNOTE-695
Meet with European regulatory authorities to seek the classification of TAVO as an Advanced-Therapy Medicinal Product (ATMP)
Submit for publication the complete results from the TAVO monotherapy (OMS-100) and TAVO / KEYTRUDA® combination (OMS-102) studies to peer-reviewed medical journals
Present final TAVO monotherapy data (OMS-100) at a medical meeting
Initiate a Phase 2 neoadjuvant clinical trial of TAVO in combination with standard of care Opdivo® (nivolumab) in operable melanoma
TAVO for Triple Negative Breast Cancer (TNBC)
Initiate KEYNOTE-890, a Phase 2 study of TAVO in combination with KEYTRUDA® in TNBC patients who have progressed on more than one line of prior therapy
Complete patient enrollment and provide topline data update from TAVO monotherapy (OMS-140) in late-stage TNBC
TAVO for Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Initiate a Phase 2 investigator-sponsored clinical study of TAVO in combination with standard of care KEYTRUDA® (pembrolizumab) and another immunotherapy in the recurrent and/or metastatic SCCHN
New Product Candidate
Expanding Clinical Pipeline beyond TAVO
Conduct pre-IND (Investigational New Drug) meeting with FDA for our new proprietary product candidate by adding additional immune stimulating targets to complement our IL-12 foundation
Commercially Ready Generator
Prepare to replace the MedPulserTM generator, currently being used in clinical trials, with the new commercially ready generator, GenPulseTM generator
Business Development
Advance ongoing discussions with several global biopharmaceutical companies in order to achieve transformational collaborations for our cancer immunotherapy platform
FIRST HALF 2018 HIGHLIGHTS
OncoSec achieved important clinical, operational and business-development milestones during the first half of 2018, highlighted by the following accomplishments:
Presented on PISCES/KEYNOTE-695 Phase 2b Registration-Directed Clinical Trial in Combination with Merck's KEYTRUDA® (pembrolizumab) for Metastatic Melanoma at the ASCO 2018 Annual MeetingOn June 4, 2018, OncoSec announced the presentation of a Trials-in-Progress poster at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The poster detailed OncoSec's global, multi-center, registration-directed open-label Phase 2b clinical trial, assessing the Company's investigational therapy, (intratumoral pIL-12 [tavokinogene telseplasmid] delivered with electroporation) ("TAVO" or "ImmunoPulse® IL-12"), and the approved anti-PD-1 therapy pembrolizumab, in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.
Announced Expanded Relationship with Merck; Clinical Collaboration to Evaluate Combination of TAVO and KEYTRUDA® (pembrolizumab) for TNBCOn May 8, 2018, OncoSec entered into a second clinical trial collaboration and supply agreement with Merck to evaluate the combination of OncoSec's TAVO with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase2 clinical trial. The planned clinical trial will evaluate the safety and efficacy of the combination in patients with inoperable locally advanced or metastatic TNBC who have previously failed at least one systemic chemotherapy or immunotherapy.
Hosted Research Reception at AACR Annual Meeting 2018On April 15, 2018, OncoSec held a research reception at the AACR Annual Meeting 2018. The Research Reception was organized to provide industry experts gathered at AACR with a comprehensive overview of OncoSec's ongoing and anticipated clinical programs involving TAVO (ImmunoPulse® IL-12) in metastatic melanoma and TNBC, including an overview of a poster presented at AACR regarding a Phase 1 pilot study of TAVO in TNBC.
Announced Strategic Relocation of Office and LaboratoriesOn March 20, 2018, OncoSec announced a strategic relocation of its office and lab in San Diego that is expected to provide immediate and significant cost-savings of approximately $65,000 per month.
Announced Publication In Nature Gene Therapy Demonstrating Efficacy Of IL-12 Intratumoral Gene ElectrotransferOn March 12, 2018, OncoSec announced that its manuscript, "Improving therapeutic efficacy of IL-12 intratumoral gene electrotransfer," was published in Nature Gene Therapy. The research, led by a team of OncoSec scientists, evolves the company's current clinical EP platform to improve the therapeutic efficacy of IL-12 intratumoral gene electrotransfer through novel plasmid design and modified parameters. Findings demonstrated that modifications to the electroporation parameters, including lowering the electric field strength (low voltage) combined with a longer pulse length, significantly increase the transfection efficiency of intratumoral electroporation.
Closed $23.0 Million Public Offering of Common StockOn February 6, 2018, OncoSec announced the closing of its underwritten public offering of 15,333,334 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 2,000,000 additional shares, at the public offering price of $1.50 per share. The gross proceeds from the offering, including the exercise of the option to purchase additional shares, were approximately $23 million, before deducting underwriting discounts and commissions and estimated offering expenses paid by OncoSec.
Appointed Veteran Biopharma Executive Gregory T. Mayes to Board of DirectorsOn January 16, 2018, OncoSec announced the appointment of Gregory T. Mayes to its board of directors. Mr. Mayes is President, Chief Executive Officer and Founder of Engage Therapeutics, and brings more than 20 years of experience as a biopharmaceutical executive with an extensive network in the life sciences field to OncoSec.
https://www.streetinsider.com/Corporate+News/Oncosec+Medical+%28ONCS%29+Provides+Outlook+for+Second+Half/14352450.html
OncoSec Added to the Russell Microcap® Index
OncoSec Medical Incorporated logo (PRNewsfoto/OncoSec Medical Incorporated)
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SAN DIEGO and PENNINGTON, N.J., June 25, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, announced today that it has been added to the Russell Microcap® Index, effective Friday, June 22, 2018, after market close.
Russell US Indexes are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell US Indexes. Russell US Indexes are part of FTSE Russell, a leading global index provider. OncoSec's addition to this index will increase the Company's already growing visibility and presence with institutional investors and greater financial community.
Annual Russell US Indexes reconstitution captures the 4,000 largest US stocks as of May 11, 2018, ranking them by total market capitalization. FTSE Russell determines membership for its Russell US Indexes primarily by objective, market-capitalization rankings and style attributes.
About FTSE Russell
FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world. For more information, visit www.ftserussell.com.
OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "can," "may," "will," "suggest," "look forward to," "potential," "understand," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.
Thanks Hsch, I passed your DD along to Dan O'Connor--asked for his feedback.
Only because of the # of Clinical trials seeking stage III/IV melanoma patients are increasing due to so many recent Phase 3 trials failing and those upstarts are vying for that melanoma space.
Talked with Dan O'connor last Saturday in response to a call I put in last week. He stated they are having to open 1 site per patient needed, for a total of 23 sites, because they need to cast a broader net to find patients that fit their criteria--in which there is a lot of clinical competition. He said, a site requires a 4 month start-up time frame to get it up and running to begin evaluating potential clinical qualifiers. At present clinicaltrials.gov shows OncoSec with 17 sites presently, needing just six more. They do not open sites near a city where a clinical trial is already utilizing similar patient populations.
He used the simile of a hockey stick that, it looks relatively flat, then a quick, angle upwards--which means patient enrollment reaching completion could happen quickly at any time. He would not say # of patients enrolled, but that they are on coarse as they expected.
He was clear that they wanted to release data base upon a significant data base at medical conference in the future.
I do too, since they can do what they want with their data, just not at asco--that is if they have the data scrubbed enough to provide anything to talk about. Think as far as OncoSec is concerned. ASCO is a side show to proving themselves to Merck and by now there is plenty of data to show if they want to to Merck for decision making purposes, not to mention accelerated applications, etc.
2018 Healthcare And Biotech Outlook: Seeking Alpha
Jan. 5, 2018 8:33 AM ET | Includes: ABBV, ABT, AGN, AMGN, AZN, BBC, BBH, BBP, FBT, GILD, HQL, IBB, LABD, LABS, LABU, LLY, NVS, PBE, PFE, RHHBY, SHPG, UBIO, XBI, ZBIO
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Summary
2017 will undoubtedly go down as one of the most fabulous years for the stock market.
While we continue to warn of the dangers associated with the market continuing to trade at lofty valuations, we are intrigued by the outlook for big-cap pharma and biotech.
Changes in the US tax laws will likely have a profound impact on the industry.
By Alexader J. Poulos
Big Cap Pharma
We view the big-cap pharma sector as ripe for a change in its operating structure as the current environment may pave the way for a wholesale shift. We're not ignoring the frothy existing prices of the equity markets these days, but the big-cap pharma industry still offers opportunities.
One key issue plaguing pharma heavyweights such as Novartis (NVS) is a large concentration in slower growth lines of business outside of the core biotech/pharmaceutical products we have come to expect. For example, Novartis derives nearly a third of its quarterly earnings from the Alcon eye care division, and Sandoz, its generic drug division. The lack of meaningful growth from these businesses masks the stellar growth of Novartis' oncology portfolio and new star-molecule Cosentyx for inflammatory diseases.
A similar phenomenon is playing out at Shire Plc (SHPG) as its equity price came under enormous pressure in 2017 as its key hemophilia division is being disrupted by a new entity in Roche's (OTCQX:RHHBY) Hemlibra, as detailed in a recent post, "Roche's Hemlibra Looks Very Promising." The drop in demand in its hemophilia unit coupled with the lack of growth in its ADHD unit has capped the upside for Shire while obscuring the strong growth from its rare drug platform.
The venerable Eli Lilly (LLY) is operating under similar constraints as the expected loss of patent coverage for Cialis, one of its top-selling products, will put a lid on growth, thus masking the promising suite of recently-approved molecules in Eli Lilly's product lineup. To combat the lack of top-line growth, the management team at Lilly has signaled a willingness to seek strategic alternatives for its animal health division.
These developments may seem independent and uncorrelated, but we have chosen to highlight them as they illustrate big pharma players' willingness to disrupt traditional business models in search of improved growth potential. Strong growth in the pharma/biotech area invariably comes from bringing forth a new or more successful treatment for various disease states, but the challenge is the difficulty in developing a string of multi-billion-dollar hits.
Bristol-Myers and AbbVie as a Template
We believe the recent willingness of big pharma management teams to dispose of non-core divisions is an attempt to emulate the uber-successful moves undertaken by Bristol-Myers (NYSE:BMY) and the original Abbott Laboratories (NYSE:ABT). Bristol-Myers was facing a relatively bleak product future as its top-selling product Plavix was facing the loss of patent protection thus blowing a massive hole in Bristol's annual revenue. The innovative management team decided to refocus the company into a "BioPharma" by spinning off its nutrition division Mead Johnson to shareholders. The transaction occurred in 2009 where existing Bristol shareholders could exchange $1 in BMY for $1.11 worth of Mead Johnson stock thus valuing Mead at ~$7.3 billion. Mead was recently acquired in 2017 by Reckitt Benckiser (OTCPK:RBGLY) for $16.7 billion - a return of over 200% for those who exchanged shares in 2009!
Abbott underwent a radical transformation in early 2013 as it split itself into two companies with Abbott remaining a medical device and nutrition company, while the drug discovery unit would become a stand-alone entity under the corporate structure currently known as AbbVie (NYSE:ABBV). AbbVie has thoroughly outperformed the market since its initial debut fueled by the continued growth of Humira, the top-selling inflammatory disease treatment.
We believe the results delivered by Bristol and Abbott are noted by big pharma management teams - dare we say they are looked upon with envy. The recent changes in the tax law structure have brought a degree of clarity that had been lacking regarding policy impacts on major investments, which may have prevented more aggressive M&A activity in 2017 as heavyweights such as serial acquirer Pfizer (NYSE:PFE) remained notoriously coy.
Pfizer has signaled it is willing to dispatch its consumer goods division with popular but slow growth products such as Advil. We view this as an incremental step towards a much more significant transformation - keep in mind Pfizer in recent years attempted to acquire AstraZeneca (NYSE:AZN) in a tax-inversion deal and more recently went after Allergan (NYSE:AGN). AbbVie was also very interested in a tax inversion with overtures towards Shire that fell through.
We believe a strong wind of change will rip through the traditional pharma sector with a dispatching of non-core assets to fund the acquisition of growth molecules in order to transform into the BioPharma model put forth by Bristol. In this scenario, a new blockbuster molecule will have an outsized impact on revenue and ultimately the share price.
Large-Cap Biotech
The biotech industry is poised to be a significant beneficiary of the tax law change as 2018 could shape up to become the "Year of the Takeout" as we suspect big pharma players will open up the checkbook to acquire recently-approved or promising phase 3 molecules to round out their product portfolios.
We have written many skeptical articles on the prospects of Amgen (NASDAQ:AMGN) as the decay in revenue from its top-selling products continues to plague top-line growth. This could change quickly should management deploy cash held overseas to fund the acquisition of promising molecules with meaningful sales potential, most notably in the area of oncology, where it has been lacking.
The prudent deployment of cash in M&A remains a core portion of our thesis in highlighting Gilead Sciences (NASDAQ:GILD). We were able to highlight Gilead in anticipation of a major splash - the takeout of Kite Pharma to gain the pole position in the revolutionary CAR-T treatment. It is not a coincidence that both Novartis and Gilead are listed among our top pharma ideas, as a primary criterion for addition is the strength of the forward-looking pipeline. In the case of Gilead, we expect additional M&A activity in 2018 as its overseas cash hoard is now largely unlocked.
Feeding Frenzy in Small-Cap Biotech
The small-cap biotech space remains one of the most exciting yet volatile sections of the entire stock market. Small-cap biotech will often consist of companies that are attempting to bring forth one or two molecules through the rigors of the clinical trial process - hence the heightened risk profile. In essence, if the primary molecule is a success, the share price will most likely leap accordingly. Unfortunately, a late-stage failure can torpedo the share price, often rendering the market value of shares nearly equal to the cash held on the books by the company as future free cash flow expectations are crushed.
The coming year may go down as one of the best in recent history for the small-cap biotech sector as a proverbial feeding frenzy will commence aided in large part by the increased willingness by big pharma to refocus the landscape into one with more pure play research-driven entities. The sweet spot of the sector for deals may be companies that can be had for less than $5 billion based on a plethora of comments from various big pharma CEOs. We will continue to monitor events as they transpire as we believe the ingredients are now in place to radically transform the industry. On that note, we would like to wish all of our readers a healthy and prosperous New Year!
This article or report and any links within are for information purposes only and should not be considered a solicitation to buy or sell any security. Valuentum is not responsible for any errors or omissions or for results obtained from the use of this article and accepts no liability for how readers may choose to utilize the content. Assumptions, opinions, and estimates are based on our judgment as of the date of the article and are subject to change without notice.
Disclosure: I am/we are long GILD, AGN.
Business relationship disclosure: Alexander J. Poulos is an independent contributor to Valuentum Securities.
Additional disclosure: Valuentum's healthcare and biotech contributor Alexander J. Poulos is long Gilead Sciences (GILD) and Allergan (AGN). Valuentum is a publisher and does not own any stocks or securities mentioned in this article.
Well, tomorrow night earning after the bell and Mon. 5/4, poster presentation--What will Tuesday look like?
Kykkern, perfectly succinct.
Just six trading days before poster
I'm only talking this way cuz I'm swing trading ONCS with a bit of my investment. This has formed a very symmetrical rounded bottom and technically speaking, yesterdays drop and pullback perfectly balances a similar move back on 4/16. Anyone else swing trading here and if so, what do you think. I got in a 1.56 for this ride up.
I'm guessing a move toward !.80 level with loading in the 1.70-75 range today.
Well Pazzo, aren’t I the copycat ;o)
I don't think they are restrained from giving data, but that ASCO will not be evaluating the abstract based on data.
Hey there Twiz, thought I'd post this:
ABSTRACT SELECTION PROCESS FOR TRIALS IN PROGRESS ABSTRACTS
Abstracts will be reviewed by the Scientific Program Committee and evaluated on the following criteria
Strength of Science: Does the trial address an important and novel question?
Trial Design: Are the eligibility criteria, study endpoints, and planned analysis well defined in this abstract?
Collaboration: Is there potential for investigator collaboration?
Relevance: Will the results be relevant and of interest to ASCO Annual Meeting community?
Requirements:
Trial is registered, open, and enrolling patients
Abstract does NOT contain preliminary data or results
POSTER SESSIONS
Selected abstracts are grouped by topic and displayed on poster boards for 3.5 hours. Abstracts that will be discussed in the Poster Discussion Sessions will be grouped together and flagged. The Poster Sessions will again include Trials in Progress abstracts within each track, designed to facilitate awareness of open, ongoing clinical trials of any phase. First authors should be available at their poster for a minimum of 2 hours to informally answer questions from Meeting attendees.
First authors of abstracts selected for either type of poster session will be invited to submit an electronic version of their posters in advance of or during the Annual Meeting to be posted on Meeting Videos.
Yeah Pazzo, with the market closed on Memorial Day (5/28), we only have 12 trading days left 'til June 4th poster session.
That’s not what they let on to me Pazzo, At the reception that is. One the scientists said to me and my wife, “you just wait shortly you’ll see,”. And then he gestured with a 45° upward thrust. He said this in response to my telling them that I am on an investor board and they were wondering how things are going – – and that was his response.
Remember this trail is the worst of the worst they’ve already demonstrated that they can reach that percentage of patients. So they consider “that greater than three out of 23 to be a very easy target to be reached”. Imagine a polevault bar being said it 10 feet and then have it cleared by an 8 foot gap up – – I think we’re going to see something like that at ASCO.
Blockchain will help ‘drive this next industrial revolution,’ Wall Street bull predicts
Quote:
One of Wall Street's biggest bulls sees blockchain playing a big role as an economic growth driver.
It still may be considered an emerging technology, but Federated Investors portfolio manager Steve Chiavarone is folding the electronic system, which records cryptocurrency transactions, into his stock market forecast.
"This is going to be one of five key technologies — along with automation, robotics, A.I. [artificial intelligence] and the Internet of things that drive this next industrial revolution," he said Friday on CNBC's "Trading Nation."
He's not letting the growing pains currently gripping the cryptocurrency market affect his bullish view.
Bitcoin, which has been referred to as the FANG stock of the crypto world, has been struggling to break $10,000 — just months after hitting a record price just shy of $20,000 last December.
In fact, Chiavarone sees FANG stocks, which include top tech names Facebook, Amazon, Netflix and Google [Alphabet], as ultimately reaping benefits from blockchain's processing power — as well as areas from health care to financials.
"A lot of investors went to bitcoin first because it was the first way to access blockchain," added Chiavarone. "Look, big banks are investing in this heavily. Bank of America boasted at Davos earlier this year that they're investing the most."
Chiavarone believes blockchain technology is valuable because it could potentially transform reconciliation, the action of verifying account balances in corporate America.
"It has an ability to replace reconciliation, which is expensive and requires back office and time and paperwork with more instantaneous verification," he said.
"What that means is companies can have more efficient supply chains. They can cut their back and middle office costs," Chiavarone said. "And, that will allow business to flow more efficiently and it'll allow costs to be cut and net savings to be passed along."
Not to mention--Merck and OncoSec headquarters would be virtually nextdoor neighbors--just an hour apart from each other.
I would agree on the uptrend Ignatius, but that is only going back to May 4th. On a purely technical note, I see a rounded bottom (no, common now) pattern forming, dating back to April 9, extending down 19 days and the uptrend I think you're speaking of (May 4th?) is beginning the rising side of the bowl and could potentially complete near $2.20 level June 1st -- the beginning of ASCO.
I do understand News regarding TNBC detail could disrupt the pattern from potentially forming and just blow through the roof, but that wouldn't be so bad either.
Also, OncoSec earnings report is May 31st--not usually a big deal for an non-revenue company, but to traders it is.
Just FYI, The FDA reports that they will respond regarding to applications for breakthrough designation, fast track, accelerated approval within 60 days of submission.
I’m not exactly sure why they waited three weeks to announce the trail, but at the time of the reception on April 15, 2018, They were clear that they were already putting in the application process for all three. It’s possible that they could’ve submitted prior to that where they could hear about the TNBC trial by the ASCO conference.
I was told at the Reception April 15, that they were going to pursue up-front for Fast Track, Breakthrough Therapy, and Accelerated Approval.
Article: Too many cancer drugs? Crowded market gives investors pause
http://redirect.viglink.com/?format=go&jsonp=vglnk_152543913126513&key=bbb516d91daee20498798694a42dd559&libId=jgryry32010004m6000DAm6prjoq1f18t&loc=http%3A%2F%2Fthebiotechinvestor.freeforums.net%2Fthread%2F691%2Fdaily-discussion-oncs%3Fpage%3D147&v=1&out=https%3A%2F%2Fwww.reuters.com%2Farticle%2Fus-health-cancer-pharmaceuticals-insight%2Ftoo-many-cancer-drugs-crowded-market-gives-investors-pause-idUSKBN1I31EX&title=*%20Daily%20Discussion%3A%20ONCS%20*%20%7C%20The%20Biotech%20Investor&txt=www.reuters.com%2Farticle%2Fus-health-cancer-pharmaceuticals-insight%2Ftoo-many-cancer-drugs-crowded-market-gives-investors-pause-i...
Wing, $2.5 with no stop between
INTL, what do you mean by, "close to the 10k mark"?
Yeah....., but isn't that like happy hour and saying, "It's 5 o'clock somewhere!" But if your looking from an oversold position that it appears ONCS is...I would agree. Technically, Today's candle is wedged into touching Resistance angling down since April 5th and a solid support level of $1.45 buffered by the 200 SMA. Looks like a squeeze play for tomorrow with only about .05 cents before one or the other starts to be broke. And I'm with you Wing, I'm hoping for an actual happy hour tomorrow!
You don't know how right I hope your are!
My take is that it indicates they never had a partnership and they’re still looking for a partner in the TNBC trial
Despite what was told me at the "reception," TJ--I think your idea that OncoSec may have just decided to wait for ASCO for the release of TNBC partnership--who knows and could be anytime. I don't think it benefits them to wait myself.
On the downside for us who are already in, technically the PPS could to powerful dip to $1.35 level probably on high volume, candle.
On the upside, I would like to see your observation TJ of a double bottom at $1.46 going back 5 days which triggers a reversal rise back to higher levels leading up to ASCO 4 weeks from now.
Yep, we'll know if ONCS opens at or near $1.52
I think that spot on Pazzo
TJ, do you think they'll have data to show at ASCO, or will wait 'til the data is more complete and cleaned up?
Well this Someone thinks that that Someone should have kept his big mouth shut ;o) but I'll pass along your sentiments and see what happens...
I tell ya HC, there are several possibilities here regarding that: One is that the deal fell through; two, could be further negotiations were needed; but I hope for the third would be behind-the-scenes bidding based on their insider knowledge of data that is presently continuing to come forward that changes the relationship horizon.
Is it possible that big pharma is looking to combine an offer for both TNBC and melanoma or do they partner separately?
And whatever happened to that "Someone's" idea of a partnership that was to announced by now!?! ;o{