Big Pharma Gaining Increased Interest in Fighting Cancer with Oncolytic Virus Therapies

FN Media Group Presents USA New Group Market Commentary

 

Los Angeles, CA – November 11, 2019 – USA News Group – As the global oncology drug market is projected to grow at a rate of 7.6% CAGR to hit $176.5 billion by 2025, there’s a growing interest within the big pharma sector to tap into the power of viruses to fight cancer. It’s estimated that the therapeutic cancer vaccine market alone will reach more than $15 billion by 2025. Dubbed ‘oncolytic viruses’ these treatments utilize all types of viruses to encourage the patient’s immune system to respond and attack cancer cells with heightened efficacy. It’s been seen that a variety of majors including Amgen Inc. (NASDAQ:AMGN), Merck & Co. (NYSE:MRK), AbbVie Inc. (NYSE:ABBV), and Bristol-Myers Squibb (NYSE:BMY) are looking at a variety of oncolytic virus developers, such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC).

 

Innovators like development stage Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) are drawing interest from major partners for developing their own immuno-oncology virus. The companuy’s proprietary reovirus, marketed as pelareorep, is currently being studied for potential combination with Opdivo from Bristol-Myers Squibb Company  and Keytruda from Merck & Co., Inc.

 

In 2018, both Opdivo and Keytruda are multi-billion dollar products—Opdivo sales were $6.7 billion, while Keytruda sales were $7.2 billion. Pelareorep is also being studied for potential combinations with Merck/Pfizer’s paclitaxel and Bavencio (which sold $75.5 million in 2018), and Roche’s Tecentriq (which had sales of $766 million in 2018).

 

Now with the Opdivo and Keytruda developments, it’s worth noting that Bristol-Myers Squibb and Merck are no strangers to the oncolytic virus scene. Both companies have made significant investments in the oncolytics virus sector in recent years.

 

MAJORS MAKING 9-DIGIT ONCOLYTIC VIRUS INVESTMENTS

 

In 2015, Amgen Inc. became the first company to win approval for such a treatment, when the FDA approved the therapy T-VEC (or Imlygic) to treat metastatic melanoma that cannot be surgically removed. The approval was based on the results of a multicenter phase 3 clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes.

 

Bristol-Myers Squibb followed up this approval, by entering a partnership in 2016 with PsiOxus involving its lead asset Adenovirus, which was in phase 1. The transaction involved a $50 million payment up front, with up to $886 million in milestone payments and royalties at stake. The first milestone payment was earned the following year when it achieved approval for its Clinical Trial Application.

 

Merck has also been active, including the acquisition of Viralytics for its lead asset Coxsackievirus which was in phase 1b at the time of acquisition, and another immunotherapy partnership with Vyriad (and lab partner Pfizer), involving its lead drug candidate Voyager-V1.

 

Merck acquired the virus-based cancer drug firm Viralytics for $394 million in 2018, at a premium price of 160% to the average stock price over the previous month. Viralytics’s leading experimental product at the time of acquisition was Cavatak, which uses a proprietary formulation of a common cold virus, and was in the process of being studied in multiple Phase I and Phase II clinical trials.

 

In 2017, AbbVie Inc.  partnered with another Canadian drug developer Turnstone Biologics. The deal gives AbbVie the exclusive right to license up to three of Turnstone Biologics’ immunotherapy treatments for commercial purposes. Terms of the deal, however, are not publicly available.

 

PELAREOREP’S ONGOING PROGRESS

 

Pelareorep from Oncolytics Biotech Inc. (ONCY – ONC.TO) selectively infects tumor cells, leading to the creation of inflamed tumors. The body’s ability to target the inflamed tumors is heightened, leading to the creation of tumor reactive T cells. In turn, pelareorep expands existing T cell clones priming the immune system for checkpoint blockade. To date, the drug has synergized with all checkpoint inhibitor combinations tested.

 

So far, based on the final advice from the FDA following their EOP2 meeting, the company’s been granted Special Protocol Assessment (SPA). It’s been recommended that identification of biomarker should be done before Phase III. Confirmation of a single phase 3 study is required for approval.

 

Through a partnership with Northwestern Medicine’s Feinberg School of Medicine, and Merck & Co., Oncolytics is studying pelareorep’s potential with Merck’s Keytruda in targeting metastatic pancreatic cancer. The phase 2 study incorporates up to 30 patients.

 

In another partnership involving Keytruda, Oncolytics is pairing with Merck and Keck Medicine of USC to study a combination efficacy involving multiple myeloma. The phase 2 study involves 22 patients, and will incorporate existing safety data in combination with Keytruda.

 

For a combination with Opdivo, Oncolytics is also targeting multiple myeloma, by collaborating with Bristol-Myers Squibb and Emory University, in a phase 1 study. The study involves 40 to 50 patients, and so far at the top dose, there has been a 100% response rate.

 

“Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study,” said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. “Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing.”

 

To date, pelareorep has been involved with 1,100 patients treated, of which over 900 were administered intravenously. To date, no maximum tolerated dose (MTD) has been reached.

 

In terms of manufacturing the product, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has established cost-effective contract manufacturing. The final formulation was produced at 100 liter-scale under cGMP—which is more than 50,000 standard doses per production run.

 

Oncolytics has established a commercial scale manufacturing agreement with SAFC (part of Merck Millipore Sigma). When stored frozen, the liquid formulation is stable for at least five years (with stability testing ongoing).

 

Pelareorep has been given biosafety level 2 classification, thus requiring no specialized handling requirements. Cost of Goods (COGS) are in line with those of other products made via vaccine manufacturing process.

 

Oncolytics has 398 patents issued worldwide, including 48 US and 21 Canadian, with over 21 more pending applications worldwide. The reovirus issued patent claims cover compositions of matter comprising reovirus (through 2028 and extendable to 2033), and all pharmaceutical uses of it.

 

THE ONCOLYTIC VIRUS SCENE AHEAD

 

Merck & Co. (NYSE:MRK) made a big splash in the oncolytic virus scene when it bought the Australian biotech firm Viralytics for $394 million. The massive price paid signaled that Viralytics was an asset that Merck just had to own.

 

This was similar to the size of payment that Amgen Inc. (NASDAQ:AMGN) made, when it paid $424 million for Biovex in 2011. Given that Amgen’s T-VEC was the first oncolytic virus to receive FDA approval, it’s realistic to believe that they’re not done solidifying their position in the space. T-VEC is a genetically engineered oncolytic herpes virus, that’s injected into skin tumors, resulting in shrinkage or complete remission of tumors.

 

AbbVie Inc. (NYSE:ABBV) tipped its hand towards an interest in oncolytics viruses, when it secured an option on three oncolytic viral immunotherapies from Turnstone Biologics. The deal gives AbbVie the chance to add Turnstone’s lead MAGEA3 candidate to its pipeline once data from the two ongoing phase 1/2 trials are available.

 

While Bristol-Myers Squibb (NYSE:BMY) continues to work with Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) for a combination with Opdivo, the major invested heavily in a partnership with PsiOxus for roughly $900 million. Together, they are developing an oncolytic adenovirus, which has already earned a $15 million milestone payment for PsiOxus.

 

For more information on Oncolytics Biotech Inc., please go to:  https://usanewsgroup.com/2019/10/06/what-if-you-could-teach-your-body-to-fight-cancer/

 

 Article Source:

USA News Group

USA News Group

info@usanewsgroup.com

 

Legal Disclaimer/Disclosure:

 

This piece is an advertorial and has been paid for. This document is not and should not be construed as an offer to sell or the solicitation of an offer to purchase or subscribe for any investment. No information in this Report should be construed as individualized investment advice. A licensed financial advisor should be consulted prior to making any investment decision. We make no guarantee, representation or warranty and accept no responsibility or liability as to its accuracy or completeness. Expressions of opinion are those of USA News Group only and are subject to change without notice. USA News Group assumes no warranty, liability or guarantee for the current relevance, correctness or completeness of any information provided within this Report and will not be held liable for the consequence of reliance upon any opinion or statement contained herein or any omission. Furthermore, we assume no liability for any direct or indirect loss or damage or, in particular, for lost profit, which you may incur as a result of the use and existence of the information, provided within this Report.

 

DISCLAIMER:  USA News Group is Source of all content listed above.  FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein.  The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM.  FNM is not liable for any investment decisions by its readers or subscribers.  FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  FNM was not compensated by any public company mentioned herein to disseminate this press release.

 

FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

 

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

Media Contact Information:
FN Media Group, LLC
Media Contact e-mail:
editor@financialnewsmedia.com
U.S. Phone: +1(954)345-0611

 

SOURCE USA News Group

Sign Up & Get FREE News Alerts From FNM Today!