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Agenus Inc. Positive Cervical Cancer Provides Impetus to its Robust Cancer Pipeline

19 Mar Agenus Inc. Positive Cervical Cancer Provides Impetus to its Robust Cancer Pipeline

Agenus Inc (NASDAQ: AGEN), a clinical-stage immune-oncology company developing innovative therapies for treatment of cancer, announced the grant of a Fast Track designation for investigation of balstilimab [PD-1] in combination with zalifrelimab [CTLA-4] for the treatment of patients with relapsed or refractory metastatic cervical cancer.

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The Company is currently enrolling patients in a phase 2 multicenter study namely, C-145-04, to evaluate the safety and efficacy of LN-145, using autologous tumor infiltrating lymphocytes (LN-145) in patients with Recurrent, Metastatic or Persistent Cervical Carcinoma.

Dr. Jennifer Buell, President and COO, Agenus, commented,

“We are pleased that balstilimab and zalifrelimab have been granted Fast Track designation by FDA in recognition of the high unmet medical need in second line cervical cancer. The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review. We are excited about the prospect of making these novel agents available to women who suffer from metastatic cervical cancer. We look forward to continuing to work with FDA as we advance new treatment options for patients with cancer.” 

Furthermore the Company’s pipeline consists of AGEN1181, a modified antibody that can enhance antitumor immunity and has shown to significantly improve the interaction between antigen presenting cells (APCs) and T cells in preclinical studies. AGEN1307, another candidate in the pipeline inhibits the interaction between TIGIT, a negative regulator of immune responses and its binding partner CD155.

Agenus Inc (NASDAQ: AGEN)

Market Cap: $342.57M; Current Share Price: 2.12 USDChart
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Industry
Cancer is the second leading cause of death in the U.S, next only to heart diseases. An estimated 1.7 million new cancer cases are likely to be diagnosed in 2019 in the U.S alone, with 606,880 Americans eventually succumbing to the disease, according to the American Cancer Society. The Agency for Healthcare Research and Quality estimates, that the direct medical costs for cancer in the US in 2015 were $80.2 billion. Therefore it is imperative that there are treatments and therapeutics that can prevent the occurrence of this malady.

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Cervical cancer begins in the cervix, which connects the Vagina to the upper part of the uterus, and occurs mostly in women over the age of 30. Human papilloma virus (HPV) infections, one of the causes of cervical cancer, contributed to over 42,700 new cases of cancer from 2011 to 2015 in the U.S alone. Cervical cancer is the most common HPV-associated cancer among women, followed by oropharyngeal cancers in men. Therefore HPV vaccinations are now recommended for girls and boys in the age group of 11 to 12 years old. In case of those who were not administered a vaccination, it is recommended for females through age 26 and males through age 21.

The Global Cancer Vaccine market which was valued at over $4 billion in 2016 is expected to grow at a CAGR of 17.7% from 2017 to 2023, to reach an estimated 12.81 billion according to a report by Allied Market Research. Scientific and Technological advancements will propel the growth in the market, with development of vaccines with antigenic components that can boost the body’s natural immunity. Furthermore, the rise in incidences of Human papilloma virus (HPV) infections increased spending on research and development efforts and launch of novel therapeutics will help the market grow at a steady pace in the coming years.

Over 70% of cervical cancers are caused due to HPV infections. There is also a growing demand for prostate cancer and breast cancer vaccination especially of the recombinant variety. Currently there are various vaccines being developed using this technology such as Cervarix, Gardasil, and Recombivax HB. Also there is a gradual shift being witnessed from prophylactic cancer vaccines to therapeutic cancer vaccines. However, development of a vaccine takes an inordinate amount of time and effort and monetary resources.

Company
Agenus is developing immuno-oncology solutions, through its portfolio of antibodies, cell therapies, adjuvants and vaccines that aim to combat cancer by delivering innovation and optimal drug combinations. The Company is leveraging its world-class scientific team, unique technology platform, research and GMP manufacturing capabilities to understand patient requirements and create curative treatments.

The company is working on both single agent and combination therapies to target multiple mechanisms such as stimulating immune system through cancer vaccines, mobilizing immune cells by using priming agents, blocking immune resistance using immune checkpoints and developing bispecifics that can condition tumor microenvironment.

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Agenus recently received a fast track designation for balstilimab [PD-1] in combination with zalifrelimab [CTLA-4] for the treatment of patients with relapsed or refractory metastatic cervical cancer. The approval was based on clinical data that demonstrates 26.5% objective response rates (ORR) (4 CRs, 5 PRs, 8 SD) which are durable (median not yet reached) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizuma, as per a Company statement.

The Company intends to file for 2 BLA’s in 2020 for the accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.

Agenus’s proprietary QS-21 Stimulon™, a key component of GlaxoSmithKline’s (GSK’s) Shingrix, recently received $15.1M milestone payment from HealthCare Royalty Partners (HCR) based on net sales of vaccine exceeding $2.0B in 2019. The Company is also eligible for another milestone payment of $25.5M, if Shingrix net sales exceed $2.75B over four consecutive quarters before 2026.

Furthermore the Company is developing AGEN2373 is a fully human monoclonal antibody in collaboration with Gilead (NASDAQ: GILD), besides two more programs namely AGEN1223, a bispecific designed to selectively deplete immunosuppressive T regulatory cells from the tumor microenvironment and AGEN1423, a TME conditioning Anti-CD73/TGFβ TRAP Bifunctional Fusion Proteinβ TRAP Bifunctional Fusion Protein.

Agenus has a global alliance with INCAGN1876, through which it is developing INCAGN1876, a GITR (glucocorticoid-induced TNFR-related protein) agonist; other programs include TIM3, a checkpoint inhibitor, LAG-3 (lymphocyte-activation gene 3) a checkpoint protein and an undisclosed target.

The Company has developed unparalleled capabilities in research, development and manufacturing and has expertise in areas such as immunology, structural biology and computational biology. Agenus also has an in-house cell line development that is capable of delivering monoclonal, stable and have commercial grade yields for conducting preclinical and commercial supply.

Agenus is also working on creating personalized vaccines namely Prophage and AutoSynVax that contain cancer neoantigens, using its proprietary Agenus Immunogenic Mutation (AIM™) algorithms  and Next Generation Sequencing (NGS) technologies, cloud computing and our cutting-edge proprietary bioinformatics capabilities.

The Company has two state-of-the-art in-house GMP manufacturing facilities located in Berkeley, CA (Agenus West) and Lexington, MA.

Risk Assessment

  • The Company has numerous strategic partnerships with Companies such as Gilead, Urogen Pharma (NASDAQ: URGN), Incyte (NASDAQ: INCY), Merck (NYSE: MRK), GSK (NYSE: GSK) that offer $2.5B in potential milestones and royalties, out of which the company has already received $540M and is expecting further$60M in milestones from existing partnerships during 2020. This not only acts as a validation of its technology and platform but also provides crucial funds for the development of its pipeline.
  • Agenus is expecting readouts from 6 different clinical programs in 2020, providing significant catalysts. The data from its phase I AGEN1181 clinical trial showed new partial responses when used in combination with balstilimab.
  • The Company intends to file 2 BLA’s for balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4), in addition to 3 Investigational New Drug Applications for myeloid & macrophage biology and allogeneic iNKT cell therapy which are significant milestones for the Company.
  • Agenus has two potential game-changers in its kitty, GS-1423 and its next generation CTLA-4 agent, which has the potential to be a class leader. Most importantly it has a diverse pipeline of candidates that focus on immunotherapies for cancer holding immense future potential.
  • Clinical trials are fraught with risk and uncertainty. However the Company’s diverse pipeline will help mitigate risks and make optimal use of its resources.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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    Source

    https://investor.agenusbio.com/presentation-webcasts

    https://investor.agenusbio.com/2020-03-12-Agenus-Reports-Fourth-Quarter-and-Full-Year-2019-Financial-Results-and-Provides-Corporate-Update

    https://www.prnewswire.com/news-releases/agenus-receives-fast-track-designation-for-balstilimab–zalifrelimab-in-advanced-cervical-cancer-301022144.html

    https://www.prnewswire.com/news-releases/agenus-receives-fast-track-designation-for-balstilimab–zalifrelimab-in-advanced-cervical-cancer-301022144.html

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