16 Jul Targeted Immunotherapy – Revigorating The Treatment Of Prostate Cancer
Prostate Cancer is the second leading cause of death in men in the U.S, with over 1 in 41 men likely to succumb to the disease. According to an estimate by the American Cancer Society there would be 174,650 new cases of prostate cancer and 31,620 deaths from prostate cancer in 2019.
The current treatment options for the disease, which primarily affects the prostate gland, is removal of the gland surgically (Radical prostatectomy), Brachy Therapy (Implanting Radioactive Seeds into the prostate) and Conformal Radiation therapy in combination with hormonal therapy. In addition, Chemotherapy and Androgen Suppression Therapy are used in cases of advanced cases of prostate cancer. The stage and grade of the disease along with the state of the patient with respect to age, existing illnesses and certain genetic factors determine the course of treatment.
A report by Datamonitor Healthcare estimates that the total prostate cancer drug market will reach $13.5bn in 2024, growing at a CAGR of 8.6% from $6.4bn in 2015. The introduction of novel therapeutics and treatment methodologies, a rise in geriatric population and increased awareness will drive the growth in the market. However prohibitive treatment costs, adverse side-effects that include infertility may act as a deterrent for growth.
The prostate cancer market is a subject of extensive research and development that aim at treating the disease without causing adverse affects. We take a look at few emerging therapeutics that have the potential to transform the treatment landscape.
Advaxis, Inc, (NASDAQ: ADXS)
Market Cap: $11.45M; Current Share Price: 1.5750 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 prostate cancer is ADXS-PSA, which is currently being evaluated in Phase I/2 clinical trials for metastatic castration-resistant prostate cancer (mCRPC), both as a monotherapy and in combination with Merck’s PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab).
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 (NYSE: BMY) and MedImmune, the research and development arm of Astra Zeneca (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 Inc. (TSK: GUD) to name a few.
Sophiris Bio, Inc. (NASDAQ: SPHS)
Market Cap: $32.90M; Current Share Price: 1.0300 USD
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The company is developing PRX302 (topsalysin), a first-in-class transmembrane pore-forming protein, which has been genetically altered to be activated only in the presence of enzymatically-active PSA, that is characteristic in men with prostate cancer. This clinical-stage biotechnology company is focused on delivering solutions to urological diseases.
Its lead product candidate Topsalysin is a powerful ablative agent that is currently being evaluated in Phase 2 Clinical trials for the focal treatment of localized prostate cancer. In addition, it is also undergoing Phase 3 trials for the treatment of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). It acts by binding to the GPI-anchored receptors on the cell surface of prostate cells and creating stable transmembrane pores that cause cell death.
The company’s efforts recently received an impetus as the European Medicines Agency provided scientific inputs for the design of Topsalysin’s Phase 3 clinical trials based on safety profile and efficacy data from its phase 2 studies comprising 451 patients.
Sotio Biotech (Private)
Sotio’s lead product candidate DCVAC/PCa, is an autologous immunotherapy, indicated for patients with metastatic castrate resistant prostate cancer, which is currently undergoing phase III clinical trials named “VIABLE” globally. It is based on an innovative active cellular immunotherapy (ACI) platform, named DCVAV, that can regulate the body’s natural immune response and targets prostate, ovarian and lung cancer.
VIABLE is a randomized double-blind, multicenter, parallel-group Phase III study, which is testing the efficacy and safety of DCVAC/PCa in patients with metastatic castration-resistant prostate cancer (mCRPC) who are already undergoing chemotherapy. It is being conducted in over 200 clinical sites in 21 European countries and the United States and has enrolled 1182 patients; the data on the overall survival rates from the study is expected to be presented in 2020.
DCVAC uses SOTIO’s proprietary ACI-MAP® technology, which activates a patient’s own dendritic cells to create a complex immune response. The company intends to extend its application to other autoimmune diseases as well.
In addition it is also developing SO-C101, a super agonist fusion protein of interleukin IL-15 aimed at the treatment of patients with selected advanced/metastatic solid tumors that is currently undergoing phase I/Ib study. SO-C101 was developed by Cytune Pharma, which was later acquired by SOTIO in September 2018.
As Radek Spisek, Chief Scientific Officer of SOTIO states
“This pivotal clinical trial is building on many years of scientific research at Charles University and University Hospital in Motol in Prague and intensive development efforts of SOTIO. Completing the enrollment underlines the significant progress SOTIO has made in the assessment of the innovative, dendritic cell-based active cellular immunotherapy for late stage prostate cancer and other cancer indications. We believe that adding DCVAC/PCa to standard chemotherapy can prolong patients’ lives and slow down disease progression.”
Progenics Pharmaceuticals (NASDAQ: PGNX)
Market Cap: $492.76M; Current Share Price: 5.68 USD
Data by YCharts
Progenics is developing multiple candidates that target prostate cancer such as PyL (also known as [18F] DCFPyL), a clinical-stage fluorinated PSMA (prostate specific membrane antigen) targeted PET/CT imaging agent, for prostate cancer, that was originally discovered and developed at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine. It is also developing 1095, a PSMA-targeted Iodine-131 labeled small molecule indicated for the treatment of metastatic castration-resistant prostate cancer.
The company primarily develops small molecules that are radiolabeled and can bind to specific receptors, enzymes and proteins, thereby acting as a beacon that aids in deciphering the disease location by using nuclear medicine cameras, known as single-photon emission computerized tomography (SPECT) or positron emission tomography (PET) cameras.
Furthermore, 1095, its small molecule candidate, is currently under development and offers precision therapy by delivering radioactive therapy to the diseased cancer cell, while leaving the peripheral tissue and organs untouched.
It already markets AZEDRA® (iobenguane I 131), a radiotherapeutic for unresectable, locally advanced or metastatic pheochromocytoma and paragangliom and RELISTOR® subcutaneous injection, and a small-molecule mu-opioid receptor antagonist for the treatment of opioid induced constipation in adult patients with chronic non-cancer pain.
Progenics is collaborating with Bayer for developing PSMA-targeted Thorium Conjugate (PSMA-TTC) in exchange for milestone payments and royalties. It has licensed PyL to Curium for development and commercialization in Europe, in exchange for double – digit royalties.
Veru Inc (NASDAQ: VERU)
Market Cap: $148.08M; Current Share Price: 2.3584 USD
Data by YCharts
An oncology and urology focused biopharmaceutical company; Veru is developing VERU-111, a first-in-class oral selective antitubulin, targeted at refractory metastatic prostate cancer. It works by inhibiting the microtubule assembly by selective binding and targeting of α and β subunits of microtubules. It is currently undergoing an open label l Phase 1b/2 clinical study at Johns Hopkins Cancer Center and 4 other centers.
Veru has been issued 7 compositions of matter patents that offer it protection until 2034 in the U.S along with 63 foreign granted or pending patents worldwide. It is also developing Zuclomiphene, which if approved, will be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy.
Its VERU-100 is a biologic and a proprietary GnRH antagonist for the treatment of advanced prostate cancer. It has completed a preIND meeting with the FDA in April 2019, followed by scaling up its manufacturing capacity by using contract manufacturing facilities. The company intends to submit an IND in Q1 of 2020.
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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