17 Mar 5 Companies Redefining Therapeutic Options for Cervical Cancer
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.
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.
We take a look at some companies that are using advances in science and technology to address the unmet needs in the cervical cancer market.
Agenus Inc (NASDAQ: AGEN)
Market Cap: $306.36M; Current Share Price: 2.23 USD
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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.
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.
Genocea Biosciences (NASDAQ: GNCA)
Market Cap: $40.91M; Current Share Price: 1.48 USD
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Genocea Biosciences, a clinical-stage biotechnology company develops personalized cancer immunotherapies, using its proprietary ATLAS™ technology platform, which identifies the right antigen-specific T cell responses based on an individual’s own cells.
The Company’s lead immuno-oncology program is GEN-009, a neoantigen vaccine that is currently undergoing a Phase 1/2a clinical trial across a variety of solid tumor types. It is also developing GEN-011, a neoantigen-specific adoptive T cell therapy for which it intends to file for an IND in 2020. It was founded in 2006 and is headquartered in Cambridge, Massachusetts. Additionally the Company’s Tumor infiltrating lymphocyte (TIL) therapy has demonstrated a 44 percent objective response rate (ORR) in cervical cancer patients
Genocea’s proprietary ATLAS technology platform uses a patient’s own T cell immune response machinery, to identify optimal antigens, thereby eliminating the guesswork as to which antigen can have an optimal impact on T-Cells. It can create a per-patient tumor-specific immune response profile to narrow down the most pertinent antigens.
Atlas works by delivering polypeptides that relate to a specific mutation from a patient’s tumor, to their antigen presenting cells (APCs), which then process and present the cell peptides on the cell’s surface, to be recognized by T Cells. The cytokine reaction, resulting from the T Cells binding to the peptide are then measured and monitored to determine the most appropriate antigen. GEN-009 is essentially a customized vaccine that delivers synthetic long peptides paired with the adjuvant Poly-ICLC to an individual’s immune system.
ATLAS was developed based on the work of the Company’s scientific founder, Dr. Darren Higgins from Harvard University. Scientists at Genocea have been relentlessly working to develop a pipeline of targeted cancer immunotherapy candidates such as GEN-009, a neoantigen cancer vaccine and its lead candidate, which is currently undergoing phase 1 / 2 clinical trials.
Additionally, it is developing GEN-011, a neoantigen T cell therapy for which the Company plans to file for an IND in the first half of 2020. It has also discovered certain unique antigens for Epstein-Barr virus.
Neon Therapeutics (NASDAQ: NTGN)
Market Cap: $52.81M; Current Share Price: 1.83 USD
Data by YCharts
The company aims to offer personalized immuno-oncology therapies consisting of both T cell therapies and vaccines using neoantigen biology. Neon uses mutational fingerprint to create a treatment strategy composed of neoantigen-targeted therapies to combat cancer. Neoantigens help enhance and generate new immune responses by providing them with a specific target, broad immunogenicity and extensive applicability.
Dr. James Allison, co-founder of the company is credited with some pioneering research which has resulted in a new class of immunotherapy known as checkpoint inhibitors. The company’s proprietary neoantigen platform uses a combination of RECONTMBioinformatics Engine, peptide chemistry and NEON-STIMTM T cell biology and immune-monitoring expertise to develop neoantigen-targeted therapies.
The company in collaboration with Bristol Myers Squibb (NYSE: BMY) is developing NEO-PV-01 as a combination therapy for melanoma, NSCLC and Bladder cancer. The drug candidate is currently in clinical trials to study the efficacy of NEO-PV-01 dosed in combination with nivolumab (marketed as opdivo), an anti PD-1 checkpoint therapy. NT-003, a clinical study designed to study the efficacy of NEO-PV-01 and nivolumab dosed in combination with Apexigen’s APX005M, a CD40 agonist or ipilimumab, a CTLA-4 antibody for advanced metastatic melanoma is currently underway.
In addition the company’s pipeline includes NEO-PTC-01, a personal neoantigen T cell therapy in solid tumor setting.
In March 2020, the Company announced a merger agreement with Endor Lights, Inc., a Delaware corporation and a direct, wholly-owned subsidiary of BioNTech SE (NASDAQ: BNTX), which is expected to close during Q2,2020 subject to shareholder approval.
Iovance Biotherapeutics (NASDAQ: IOVA)
Market Cap: $2.47B; Current Share Price: 19.54 USD
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Iovance is developing innovative cancer immunotherapies using tumor infiltrating lymphocytes (TIL), an adoptive T-Cell therapy approach, developed by Dr. Steven A. Rosenberg at the National Cancer Institute (NCI). The Company aims to establish TIL therapy as a mainline cancer treatment in numerous cancer indications such as ovarian, breast, bladder, colorectal besides its current focus on metastatic melanoma, carcinoma of the head and neck and cervical cancer.
The Company’s proprietary technology harnesses the natural power of special immune cells namely lymphocytes, by expanding them into billions by replicating them ex vivo (in tissue culture) with IL-2. In addition, it helps eliminate the immune-suppressive environment responsible for neutralizing the natural anti-tumor immune response. These cells are then re-administered into the patient and are capable of anti-tumor responses.
The technology offers numerous benefits such as improved potency and persistence, shorter manufacturing process and lower costs, enhanced modulation of PD-1and CTLA-4 ( Immune-suppressing protein) and stronger intellectual property protection as per the Company.
The company is currently engaged in a phase 2 clinical trial namely C-145-04, in patients with recurrent, metastatic or persistent cervical carcinoma who are unlikely to be cured by surgery and/or radiation and have received at least one prior treatment with systemic immunotherapy or chemotherapeutic treatment for cervical cancer. The study aims to evaluate if LN-145, its lead candidate, is able to reduce or slow the progression of cervical carcinoma, eliminate all detectable cervical carcinoma and extend the life of the patient.
Advaxis, Inc (NASDAQ: ADXS)
Market Cap: $30.11M; Current Share Price: 0.50 USD
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The Company’s proprietary Lm technology offers immune stimulation and priming, by mounting a defense against cancer by using the body’s own immune system. Its vector is capable of stimulating multiple immunotherapy mechanisms, with minimal side effects, when compared to conventional treatment options. It can also be combined with other immunotherapy products such as checkpoint inhibitors, radiation therapy, co-stimulatory agents to name a few.
Advaxis lead candidate for the treatment of cervical Cancer is Axalimogene filolisbac , a cancer immunotherapy agent that has demonstrated the ability to stimulate the body’s immune defense, weaken cancer’s natural defense mechanism and encourage killer T cells to attack the cancer in preclinical studies. AXAL has shown to anti-tumor activity, safety and tolerability in multiple clinical trials. The Candidate has received a fast track designation from the FDA and adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients as per a Company statement. The FDA lifted a partial hold on the candidate in May 2019, after the Company provided satisfactory answers to its hold questions.
Its proprietary formulation of attenuated Lm is licensed from the University of Pennsylvania. ADXS-HOT, its program that targets common or mutation tumor driver genes focuses on somatic mutations, cancer testis antigens and oncofetal antigens. It intends to develop “off the shelf” and ready to administer products through its program. The Company has already received an investigational new drug approval for ADXS-503, indicated for the treatment of Non Small Cell Lung Cancer in February 2019. It is in preparation for filing an IND for Prostate and Bladder cancer as well.
The Company has developed strategic collaborations with major biopharmaceutical companies such as Bristol-Myers Squibb and MedImmune, the research and development arm of AstraZeneca (NYSE: AZN), in addition to Merck (NYSE: MRK). It is currently testing Advaxis’ axalimogene filolisbac and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab) for developing a treatment of Cervical Cancer.
Furthermore it is also testing MedImmune’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in combination with Advaxis’ axalimogene filolisbac for advanced cervical cancer and HPV-associated head and neck cancer. It has also licensed parts of the Lm Technology™ proprietary immunotherapies to other companies such as OS therapies, SELLAS Life Sciences Group (NASDAQ: SLS), Biocon (NSE: BIOCON) and Knight Therapeutics to name a few.
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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