GSK's Shingrix containing Agenus' QS-21 Stimulon® adjuvant receives Unanimous FDA Advisory Committee recommendation for approval

LEXINGTON, Mass., Sept. 13, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that GlaxoSmithKline's (GSK) shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®, was unanimously recommended for approval by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee.

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"The Advisory Committee's recommendation for the approval of Shingrix marks the first for a product that includes Agenus' proprietary immune adjuvant, QS-21 Stimulon, and serves as a significant validation," said Garo Armen, Ph.D., Agenus (AGEN) CEO and Chairman of the Board. "In addition to being studied in diverse development stage vaccines, QS-21 Stimulon is also a critical component of our neoantigen vaccine formulations. We believe QS-21 provides Agenus with a competitive advantage due to its demonstrated ability to bolster immunogenicity in diverse vaccine formulations offering potential benefit to patients."

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A Biologics License Applications (BLA) filed with the FDA by GSK for Shingrix for the prevention of herpes zoster (also known as shingles) in people aged 50 years and older is under regulatory review. The FDA will consider the Advisory Committee vote as it reviews the BLA, although it is not required to follow the recommendation.

GSK's shingles vaccine candidate is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway

QS-21 Stimulon is being evaluated in various GSK development candidates in addition to being studied in Agenus' neoantigen vaccine, AutoSynVax™, now in a Phase 1 clinical trial.

About Agenus 
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing a number of combination approaches that leverage a broad repertoire of antibody therapeutics and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support early phase clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com; information that may be important to investors will be routinely posted on our website.

Forward-Looking Statements 
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the FDA's pending review of GSK's BLA for Shingrix, as well as statements regarding Agenus' product candidates and clinical trial plans and activities. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contact:

Agenus Inc. 
Michael Plater 
781-674-4504
michael.plater@agenusbio.com

View original content: http://investor.agenusbio.com/2017-09-13-GSKs-Shingrix-containing-Agenus-QS-21-Stimulon-R-adjuvant-receives-Unanimous-FDA-Advisory-Committee-recommendation-for-approval

SOURCE Agenus Inc.

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AGEN Agenus Inc. up 12% on New Buy Rating

Nice jump today for Agenus Inc. (NASDAQ: AGEN)  on this news:

Jefferies Starts Agenus Inc. (AGEN) at Buy; Sees 100% Upside
December 16, 2015 7:54 AM EST 

Jefferies initiates coverage on Agenus Inc. with a Buy rating and a price target of $8.00.

Analyst Biren Amin commented, 

"Agenus is developing a comprehensive Immuno-Oncology (IO) platform consisting of multiple checkpoints both fully owned and through partnerships and could be a leader in cancer vaccine development through the deployment of its QS-21 adjuvant which could increase the efficacy of cancer vaccines. AGEN is also partnered with Merck and Incyte across 9 novel IO programs totaling >$450M in milestones. Therefore, AGEN's $130M EV offers significant upside, in our view."

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AGEN: Agenus Announces Positive Phase 2 Brain Cancer Vaccine Results

Positive Phase 2 Results from Agenus’ Brain Cancer Vaccine Published in Neuro-Oncology

Results Show Improved Survival Against Aggressive Brain Cancer; More Than 90% of Patients Alive After Six Months.  

AGEN's stock surged over 20% this morning on the news

From Business Wire press release:

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. 2 hours ago

Agenus Inc. (AGEN), a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, today announced results published from a Phase 2 study demonstrated that more than 90% of the patients treated with Prophage Series G-200 were alive at six months after surgery and 30% were alive at twelve months. Additionally, the median overall survival was approximately eleven months. This compares favorably to the expected median survival for recurrent Glioblastoma multiforme (GBM) patients of three to nine months1-7. The primary objective of this multi-center, single arm Phase 2 trial was to assess the survival rate at six months.

The data was published in a manuscript in Neuro-Oncology, the official journal of the Society of Neuro-Oncology. GBM is the most common and most aggressive form of primary brain cancer. Despite approved therapy patients with GBM face a poor prognosis. Prophage Series vaccines are currently being studied in both newly diagnosed and recurrent GBM.

From Yahoo!'s Briefing.com newsfeed:

7:01 am Agenus: Positive Phase 2 Results from Agenus' Brain Cancer Vaccine Published in Neuro-Oncology; Results Show Improved Survival Against Aggressive Brain Cancer; More Than 90% of Patients Alive After Six Months (AGEN) : Co announces results published from a Phase 2 study demonstrated that more than 90% of the patients treated with Prophage Series G-200 were alive at six months after surgery and 30% were alive at twelve months. Additionally, the median overall survival was approximately eleven months. This compares favorably to the expected median survival for recurrent Glioblastoma multiforme patients of three to nine months 1-7. The primary objective of this multi-center, single arm Phase 2 trial was to assess the survival rate at six months.

Here is a copy of an October 31, 2013 special email alert where I added significant shares of AGEN to the Explore Portfolio in my newsletter.

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End of Day Update for AGEN.  This chart show AGEN tested its Oct/Nov $2.40 low on Friday just before the news today that surged it 31¢.  (Posted 1:55PM PST)

Antigenics Surges on Oncophage Kidney Cancer Survival Data

One of my "explore portfolio" stocks, Antigenics Inc., (AGEN Charts) surged recently on positive survival data for its cancer drug Oncophage® (vitespen).

As of today's close at $1.53, AGEN is up 219% YTD.
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Interim survival data showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage® compared to the control group. Press Release

Adding to the good news, survival comes without significant "toxicities"

“Demonstration of an overall survival benefit remains the gold standard, and these interim results show that Oncophage has a real promise of improving survival in patients with earlier-stage disease for whom current prognosis remains poor,” said Dr. Wood. “Based on these results, Oncophage offers these patients a potential treatment that extends survival without significant toxicities.”

About Oncophage:

In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Pre-commercial launch activities are ongoing. In October 2008, Antigenics submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma.

Derived from each individual’s tumor, Oncophage contains the ‘antigenic fingerprint’ of the patient’s particular cancer and is designed to reprogram the body’s immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a Phase 2 trial in recurrent glioma.

Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.

In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.

Even if you do not own the stock, you have to hope the company is successful as the treatment has the potential to work with almost all cancers.

Disclaimer: I own and cover AGEN in "Kirk Lindstrom's Investment Letter" with my last buy below the current price as of this writing. I may sell or buy more shares without notice here but I will update my subscribers of any changes.

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Antigenics Oncophage Cancer Treatment Approved in Russia

Today Antigenics Inc. (NASDAQ: AGEN ) announced that the Russian Ministry of Public Health has issued a registration certificate for the use of Oncophage® (vitespen) in the treatment of kidney cancer patients at intermediate risk for disease recurrence. Antigenics expects to launch Oncophage in Russia in the second half of 2008.

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Oncophage is a personalized vaccine made from cells taken from a patient's malignant cancer tumor. It contains the "antigenic fingerprint" of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint.

“The registration of Oncophage in Russia represents an important treatment advancement for patients with intermediate-risk kidney cancer,” said Garo H. Armen, PhD, chairman and CEO of Antigenics. “We are very pleased that Oncophage is the first personalized cancer vaccine that will be available in any major country. Additionally we hope to file for the conditional approval of Oncophage in Europe this year.”

To comply with US regulations for exporting biologics, Antigenics applied for an export license from the US Food and Drug Administration (FDA). The company expects the FDA to take action on the license application within approximately 60 days of submission.

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Last year I reported (Insider Buying at AGEN by Chairman and CEO Garo H. Armen) insiders bought AGEN at $1.93 a share in February 2007 . I also disclosed I owned AGEN in my personal portfolio and I bought 1,000 shares on the Feb 9, 2007 news.

The stock rallied soon after to over $5 a share then returned to the area of our purchase at $1.95 in late 2007 before the latest news has it jumping again.

About today's news, CNBC's Mike Huckman reported:

• ... a test showed that a subset of patients on Oncophage lived 1.7 years longer without the cancer coming back. But because the clinical trial didn't meet its main goal and the aforementioned benefit was only discovered in a re-analysis of the data, the drug didn't pass muster with the Food and Drug Administration.
• The agency wanted AGEN to do a bigger, longer and expensive study. But like most baby biotechs, Antigenics didn't have that kind of cash. So, the company turned to Russia where it had enrolled 125 patients in the same clinical trial. And after a 10-month process, AGEN won approval of the drug there making Russia the first country in the world to allow a therapeutic cancer vaccine onto the market.
• The lead clinical trial investigator, Dr. Christopher Wood at the MD Anderson Cancer Center, says the company has given him verbal assurances that it will use the Russian revenue to pay for another study here that might eventually satisfy the FDA. Dr. Wood, an associate professor of urology and cancer biology, says he doesn't own AGEN stock--he just consults for Antigenics and ran the clinical trial.
• Over the phone he told me, "Absolutely no question about it (that the drug works). I've looked at the data," he said, "and there's clear activity in the intermediate risk subgroup."

I like the idea of a cancer vaccine treatment that targets the cancer cells while leaving the rest of the body alone. If this treatment works for one cancer, then in theory it should work for other cancers. I saw Dr. Dean Edell do a story on KGO TV7 about a patient with deadly brain cancer who was given an experimental drug therapy that was keeping her alive long past her "due date." The drug mentioned on the news story was "Oncophage."

Antigenics Inc. is one of those stocks I like to have some shares in my portfolio for the very long term with the hope it is successful for more than just a financial reward.

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Discuss and ask questions about this article in our Biotechnology Stocks forum at facebook's "Investing for the long term" group.

Disclaimers:

• I still own AGEN in my personal portfolio including the 1,000 shares purchased on the Feb 9, 2007 news.
• I may trade the ups and downs of AGEN in either or both my personal and my newsletter explore portfolios without announcing it here or anywhere else unless I add it to my newsletter explore portfolio where I will announce trades to subscribers via email.

Insider Buying at AGEN by Chairman and CEO Garo H. Armen

On Feb 9, 2007 Garo H. Armen, CEO and Chairman of the Board, bought 50,000 shares to increase his direct holdings to 106,601 shares. I wrote about it and my buy on the news here. The stock soared shortly after this purchase and has recoverd to a seven month gain of 27% trading at $2.45. Details:

• OFCR/ CEO & Chair o/ Board = Classification of Insider
• $96k = Value of I-Buy trade(s)
• 50k = Number of Shares
• $1.93 = Average Price Paid
• $1.91 = Recent Stock Price (delayed)
• 132k = Average Daily Volume (composite timeframe)
• $88M = Company Market Capitalization
• 2007-02-09 = Purchase Date
• 2007-02-13 = Filing Date
• 13:21:59 = SEC Arrival TimeStamp
  

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Yesterday, September 14, 2007, Garo H. Armen bought another 50,000 shares of AGEN at an average price of $2.33. Details:

• OFCR/ Chair & CEO = Classification of Insider
• $117k = Value of I-Buy trade(s)
• 50k = Number of Shares
• 2.33 = Average Price Paid
• 2.45 = Recent Stock Price (delayed)
• 315k = Average Daily Volume (composite timeframe)
• 112M = Company Market Capitalization
• 2007-09-14 = Purchase Date
• 2007-09-14 = Filing Date
• 17:31:46 = SEC Arrival TimeStamp (Filing appears on SEC site 30-60 secs later)

SEC Form 4 shows Armen how holds 266,610 shares of common stock directly and holds another 11,489,274 via By Antigenics Holdings LLC and Armen Partners LP ( 3 ).

The last insider buy in Feb was a good time to buy as the stock soared from $1.93 to about $5.25 two months later. Even if you didn't sell at the top and held, a 27% gain in seven months is nice.

Disclaimers:

1. I first reported this purchase here on Feb 13, 2007.
2. I own AGEN in my personal portfolio and bought 1,000 shares on the Feb 9, 2007 news.
3. I may trade the ups and downs of AGEN in either or both my personal and my newsletter explore portfolios without announcing it here or anywhere else.
4. Dr. Armen is CEO, Chairman of the Board of Managers and a member of Antigenics Holdings LLC ("Holdings") which, as of the date of this report, owns 11,154,274 shares of Antigenics Inc. common stock. Dr. Armen has a pecuniary interest in only a portion of the shares held by Holdings and disclaims beneficial ownership except to the extent of his pecuniary interest therein. Dr. Armen is also General Partner of Armen Partners LP. Armen Partners LP owns a total of 335,000 shares of Antigenics Inc. common stock. Dr. Armen has a pecuniary interest in only a portion of the shares held by Armen Partners LP and disclaims beneficial ownership except to the extent of his pecuniary interest therein.