Disclosure: We neither own AGEN nor have any financial relationship with the company.
Our body’s amazing protection mechanism – the immune system - is complex, intricate and interesting. Our immune system works around the clock in thousands of different ways, yet each individual immune system is different and will react differently once being exposed to various substances. Agenus, thus, takes upon this notion forward in confidence and committed to the principle of “we believe the best path for treating disease is through activating our own body’s natural mechanism.”
Agenus Inc. (NASDAQ:AGEN), headquartered in Lexington, Massachusetts, is an immune-oncology biopharmaceutical company focused on the development of innovative technologies and products aimed at treating cancers and infectious disease by helping the body’s immune system target diseased cells with precision.
As immunotherapy becomes a fast-moving field, Agenus embraces its business model around its three central, imperative and promising platforms – Checkpoint Antibody Program, Heat Shock Protein and Saponin Platforms – to construct innovative development of checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants that can be used in wide spectrum of vaccines and, ultimately, revolutionize vaccines of tomorrow.
Expansion of Innovative, Robust Pipeline to Advance Groundbreaking Technologies and Products
Agenus focuses on immunotherapeutic products based on its core platform technologies with multiple product candidates advancing through the clinic, including several product candidates that have advanced into late-stage clinical trails through corporate partners. The expansion of these platforms is a huge breakthrough for the company as well as aids in the transformation of cancer treatment.
Source: Agenus Inc.
The company’s core technology portfolio consists of the following platforms:
(1) Checkpoint Antibody Platform
The checkpoint antibody program holds an interesting position in the company as well as its innovative development in immunotherapeutic products as it enables to turn off a cancer’s defense mechanism or turn on a patient’s immune response.
The platform was recently added to the platform via the acquisition of 4-Antibody AG, a private European-based biopharmaceutical company. This program enables Agenus the technology to rapidly discover and optimize fully-human antibodies against a wide array of molecular targets.
With this platform, the company enables to collaborate with world-class researchers and clinicians, including the Ludwig Institute and MSKCC, to rapidly evolving cancer treatment paradigms. The platform, thus, has been applied to six immune checkpoint targets seeking therapeutic antibody CMPs to regulate immune response to cancers and other diseases - GITR, OX40, CTLA-4, PB-1 TIM-3, and LAG-3. The company, thus, is filing INDs for both GITR agonists and CTLA-4 antagonist.
Via this platform, Agenus successfully discovered its proprietary antibody engine, Retrocyte Display, to generate high quality therapeutic antibody drug candidates quickly using a high-throughput approach incorporating human antibody libraries expressed in mammalian B-lineage cells.
(2) Heat Shock Protein (HSP) Platform: Prophage Series and HerpV
With this new autologous therapy derived from cells extracted from the patient’s tumor, Agenus uses its HSP platform to develop its Prophage Series cancer vaccines.
The vaccines contain a precise antigenic “fingerprint” of a patient’s particular cancer and are designed to reprogram the body’s immune system to target only cells bearing this fingerprint, reducing the risk that powerful anti-cancer agents will target healthy tissue and cause debilitating side effects often associated with chemotherapy and radiation therapy.
The Prophage Series G-100 and G-200 vaccines, championed by a neurosurgeon, Dr. Parsa, are currently being studied in different setting of glioblastoma multiform (GBM). The study, thus, demonstrated promising results as well as doubled in survival rate in both newly diagnosed and recurrent GBM patients.
Within the HSP platform, Agenus also tapped into the genital herpes market with the development of HerpV – a recombinant, synthetic vaccine containing multiple antigens derived from the herpes simplex 2 viruses. Genital herpes is the most prevalent viral STD with at least 60M Americans/Europeans affected annually and more than 80% of patients suffer symptomatic recurrences. Genital herpes’ market cap is predicted to be more than $1B.
Combining the heat shock protein technology and the QS-21 Stimulon adjuvant, HerpV represents a potential new approach to the treatment of genital herpes. Rather than attempting to suppress the virus, which is what antivirals do, HerpV has the potential to enable the individual’s own immune system to stop the virus from causing and transmitting disease without chronic treatment. HerpV surpassed phase 1 study with 100% patients receiving HerpV+QS-21 had CD4+ T-cell response and 75% had CD8+ T-cell response. HerpV’s phase 2 study also recently showed statistically significant 75% reduction in viral load (P<0.001; CI 46.2 – 88.6%). This level of reduction in viral load represented the potential in reduced incidence and severity of herpetic outbreaks and reduction in viral transmission.
(3) Saponin Platform: QS-21 Stimulon Adjuvant
QS-21 Stimulon is a unique adjuvant extracted from the bark of the Quillaja saponaria tree or Soapbark. The adjuvant is added to a vaccine or other immunotherapy that is intended to enhance immune response. QS-21 Stimulon, thus, has become a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, including several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. QS-21 Stimulon exceeded extensive clinical experience.
The key licensees of QS-21 Stimulon are GlaxoSmithKline (GSK) and JANSSEN Alzheimer Immunotherapy (JANSSEN AI).
QS-21 Stimulon is currently being studied in 21 vaccine indications, which include GSK's Phase 3 vaccine programs for RTS,S for malaria,MAGE-A3 cancer immunotherapeutic for non-small cell lung cancer and melanoma and HZ/su for shingles. In addition, JANSSEN AI’s QS-21 Stimulon adjuvant-containing vaccine candidate is in Phase 2 trials for the treatment of Alzheimer’s disease.
If any of the partners’ products containing QS-21 Stimulon successfully completes clinical development and receives approval for commercial sale, Agenus is generally entitled to receive royalties for 10 years after commercial launch.
Source: Agenus Inc.
Huge Phenomenal Acquisition, Partnership and Agreement Opportunities
At its core, Agenus is focused primarily on two goals: (1) discover, develop and commercialize immunotherapeutics, and (2) partner and collaborate with leading institutions and companies to realize the full potential of cutting edge immunotherapies. The company’s innovative immunotherapy, thus, attracts more than one huge key partners and deals.
Starting from February 2000, after the company became public, Agenus acquired Aquila Biopharmaceuticals and further acquired Aronex Pharmaceuticals a year after.
In March 2012, GlaxoSmithKline (GSK) (NYSE:GSK) paid $9M to include additional rights to two firms’ agreement of Agenus’ QS-21 Stimulon adjuvant. The deal amended license and manufacturing terms as well as royalty payments to Agenus for an undisclosed indication upon commercialization of a vaccine. This “call-us-first-if-you-want-to-sell-something” agreement showed that GSK is fully confident and eagerly crave for Agenus’ innovative technologies and products.
In February 2014, Agenus acquired the European biotechnology firm, 4-Antibody, along with its Retrocyte Display technology and a portfolio of checkpoint modulator antibody candidates. These agents constitute to Agenus’ expanding portfolio in rapidly and efficiently discover new antibodies.
Recently, in April 2014, Agenus entered into a collaboration and license agreement worth potentially $100M with Merck & Co., Inc. (NYSE:MRK). The deal involves the development of fully human therapeutic antibodies against two undisclosed MRK checkpoint targets using the Retrocyte Display platform to discover and optimize antibodies against the targets. No money upfront upon agreement, Agenus, however, is eligible to receive the cash in potential milestone payments as well as worldwide royalties on product sales.
Source: Agenus Inc.
Shares and Financial Snapshot
Agenus’ shares gained 6.89 percent today to trade at $3.26 after the companyreleased its earnings data of second quarter 2014. The company reported revenue of $3.07M as well as $7.7M or $0.12 PS, basic and diluted, which beat the analysts’ consensus estimate of $0.17 by $0.05 PS.
Shares of Agenus are recently traded in a range of $3.17 to $3.35. The 52-week range is $2.27 to $5.27 Ps. The company has a market cap of $202.89M.
The Bottom Line for Investors
The immunotherapies (checkpoint agents, vaccine and cell therapy) market is predicted to become increasingly huge with > $35B over the next decade and anticipate to become the backbone treatment of more than 60% of cancers and infectious disease. Though difficult to develop, Agenus ingeniously tapped into the body own immune system to deliver potential therapeutic benefits. With diverse pipeline and many catalysts, Agenus show promises as a prudent investment because the company only needs to post positive data on few trials to make Agenus a worthwhile investment. Nonetheless, investors need to research what characteristics make Agenus drugs to post positive trials data and to assess the risk versus reward necessitating prudent investment. As a final note, it's impossible to forecast biopharmaceutical-investing thesis with 100 percent accuracy; therefore, we do not make such promises. Investors should use our research as starting points to facilitate their own due diligence.