Extensive Demand for T-Cell Adoptive Immunotherapy Rising with Growing Prevalence of Cancer

Palm Beach, FL –February 23, 2021 – In the breast cancer therapy market, the rise in the prevalence of cancer, has propelled the T-cell therapy market over the last few years and it is projected to continue to do so for several years to come. T-cell therapy includes using genetically engineered T-cells to produce an artificial T-cell receptor for applications in immunotherapy. Growing prevalence of cancer across the world and increase in cancer research & development drive the market. According to the WHO, the number of global cancer deaths is projected to increase by 45% between 2008 and 2030. It is also estimated that by 2030, approximately 10 to 11 million cases of cancers would be diagnosed each year in low- and middle-income countries. The increase in investment in adoptive T-cell transfer approaches of disease treatment drives and the increasing number of clinical trials the market. Furthermore, technological advancements in manufacturing processes and developments in CAR T-cell therapy for solid tumors fuel the revenue generation. A report from ReportsAndData projected that T-Cell Therapy Market To Reach USD 8.37 Billion By 2027.    Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Vaccinex, Inc. (NASDAQ: VCNX), PDS Biotechnology Corporation (NASDAQ: PDSB), Citius Pharmaceuticals, Inc.  (NASDAQ: CTXR), Clovis Oncology, Inc. (NASDAQ: CLVS).


The report added:The T-cell therapy involves isolating the T-cells from the body and equipping them with new T-cell receptors; once the T-cells are activated and expanded, they are infused back into the body to fight off the cancerous cells. In the most common form of T-cell therapy, T-cells are hijacked from the body and the natural functions of those t-cells are augmented in the laboratory to steer them towards the tumorous or the cancerous cells particularly. The Global T-Cell Therapy market is growing at a substantial pace as the number of cancerous diseases and the implementation of T-cell therapeutic immunity system are drastically being propelled. An increased awareness about healthcare & wellness, changing disease patterns, government supports, and escalating volumes of implementation of the T-Cell therapies in various cancer research centers is expected to accelerate the further rapid growth of this market.”


Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Reports Preclinical Data Demonstrating the Synergistic Anti-cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors – Oncolytics Biotech® announced publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors.


Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell (“CAR/Pela”) therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep (“pelareorep boost”), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:


Therapy Survival Rate at End of Study
PBS (vehicle) 0% (0/7)
CAR T 14% (1/7)
Pelareorep 0% (0/7)
Pelareorep + Pelareorep boost 0% (0/7)
CAR/Pela 57% (4/7)
CAR/Pela + pelareorep boost 100% (7/7)
CAR/Pela + VSV boost 42% (3/7)


“These very exciting data demonstrate pelareorep’s ability to overcome major shortcomings of CAR T cells,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep’s ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications.”


Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, “While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep’s business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors.”    Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/    


Other recent developments in the biotech industry of note include:


Vaccinex, Inc. (NASDAQ: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, recently announced that Surface Oncology will be exercising its option to license the anti-CCR8 antibody discovered via Vaccinex’s ActivMAb® antibody discovery and novel viral display platform. The antibody, SRF114, is a fully human IgG1 anti-CCR8 antibody that selectively depletes immuno-suppressive tumor T regulatory cells (Tregs) while sparing peripheral Tregs. The terms of agreement with Surface Oncology provided that Surface Oncology pay technology access and licensing fees in addition to research funding, and that Vaccinex will qualify for development milestone payments and royalties.


“We are thrilled to continue building on the recent success of our ActivMAb platform with the announcement of our licensing deal with Surface Oncology,” said Ernest Smith, chief scientific officer of Vaccinex. “The presence of Treg in human tumors is associated with resistance to immunotherapy and blocking CCR8 has been demonstrated to potentiate inhibition of tumor growth in animal studies. Data presented at SITC 2020 demonstrated that SRF114 specifically binds to human CCR8 and induces Treg destruction through antibody-dependent cellular cytotoxicity. We are pleased to have played a part in the development of this promising drug candidate and look forward to following continuing development of SRF114 and further interactions with Surface Oncology.”


PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, and Farmacore Biotechnology recently announced that Blanver Farmoquímica e Farmacêutica S.A. has joined their consortium to develop and commercialize a novel COVID-19 vaccine in Latin America.


Blanver is a leading Brazilian Pharmaceutical Company focused on the development, manufacture, and commercialization of innovative pharmaceutical products. Under the terms of the agreement, São Paulo-based Blanver will manufacture, promote, distribute, and commercialize the Versamune®-based COVID-19 vaccine in Latin America. As the license holder of Versamune-CoV2-FC (PDS0203) in Latin America, Farmacore will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research organization to conduct clinical trials in Brazil. PDS Biotech will continue to contribute scientific expertise and operational support.


Citius Pharmaceuticals, Inc.  (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, recently issued a shareholder letter providing a corporate update on the Company’s recent achievements and anticipated milestones for 2021.


“Our important achievements against the COVID headwinds last year give us great confidence that 2021 will be a banner year for advancing our three product platforms in the clinic, and our corporate decision to commence the development of NoveCite next-generation cellular therapies further expands our goal as a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for significant unmet medical needs” said Myron Holubiak, President and CEO of Citius Pharmaceuticals. “Our advanced clinical program for Mino-Lok is moving forward with expected full enrollment for the Phase 3 pivotal trial this year. For Halo-Lido, we expect to file an Investigational New Drug Application (IND) for the combination by the second quarter and initiate our Phase 2b trial by year-end. We also plan to start pre-clinical pharmacology and toxicology studies for Mino-Wrap within the next few months along with chemistry, manufacturing and controls (CMC) development, and we target filing an IND by the end of 2021. In addition to the plans described above for our NoveCite i-MSCs Program, we plan to submit an IND to the FDA and initiate our Phase 1 first-in-human clinical trial in COVID-19 ARDS by the end of the second quarter of 2022. Our recent $20 million private round of financing and investors’ exercise of warrants for net proceeds of approximately $4.5 millionprovides significant financial runway to move forward with our three programs in the clinic, as well as manufacturing development for our unique induced-mesenchymal stem cell therapy for ARDS associated with COVID-19. We are excited about the road ahead and thankful as always for the ongoing support of our shareholders.”


Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced Rubraca data being presented at the American Society for Clinical Oncology (ASCO) Genitourinary Cancers Virtual Symposium 2021. These include data from the Phase 1b RAMP study evaluating Rubraca in combination with Xtandi, exploratory analyses from the pivotal TRITON2 study, and an analysis evaluating the rates of adverse events for different metastatic castration-resistant prostate cancer (mCRPC) treatments in a population of insured patients in the United States.


“We are pleased to share these data with the medical and scientific community to inform choices related to mCRPC treatment. The research into co-occurring alterations in mCRPC patients with a mutation of BRCA underscores the importance of genomic testing in men with mCRPC,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Additionally, we are encouraged by the results from the RAMP study, which lay the groundwork for the Phase 3 CASPAR clinical trial sponsored by the Alliance for Clinical Trials in Oncology evaluating Rubraca and Xtandi as a novel combination therapy in men with first-line metastatic castration-resistant prostate cancer.”


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