On February 6, 2023 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson’s Disease, PDAC, DIPG, and COVID-19, reported the initiation of its second investigator initiated studies (IIS) in a series of planned clinical studies (Press release, Oncotelic, FEB 6, 2023, View Source [SID1234626891]).
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We have submitted to US FDA a protocol for the study with approximately 30 patients with non-small cell lung cancer in collaboration with the Fred Hutchinson Cancer Center and a large pharmaceutical company in the field of immuno-oncology (IO). The study will be combining our oligodeoxynucleotide OT-101 and a US FDA approved anti-PD-L1 checkpoint inhibitor.
Near term, the Company is planning to initiate up to 7 clinical studies in various oncology indications along with ‘Centers of Excellence’ and major pharmaceutical companies. The first trial as noted in a prior press release is planned to be in patients with metastatic pleural mesothelioma.
All studies will be assessing the tumor response to various combination studies assessing pre and post therapeutic biopsies measuring close to 800 genes, changes in phenotype and functionality, cytokines, suppressive immune cells; and their spatial distribution within the tumor.
"These studies are the result of careful planning with our collaborators in order to ensure the rigor and thorough assessment of changes within the tumor microenvironment resulting from combination immune-therapy and immune-oncology modalities" said Dr. Anthony Maida, Chief Clinical Officer – Translational Medicine.
For more information on the Fred Hutchinson Cancer Center and how you or someone you know can enroll in a trial, please visit: View Source
About OT-101
OT-101, is a first-in-class anti-TGF-β2 RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. HGGs are characterized by a T-cell exhaustion signature and pronounced T-cell hypo responsiveness of their tumor microenvironment ("TME"). TGF-β2 has been implicated as a key contributor to the immunosuppressive landscape of the TME in HGG. OT-101 is designed to abrogate the immunosuppressive actions of TGF- β2. In a completed Phase 2 clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult HGG patients, including young adults with Glioblastoma Multiforme or Amyloidosis.
OT-101 has been granted orphan designation by the FDA under the Orphan Drug Act ("ODA"). ODA provides for granting special status to a drug to treat a rare disease or condition upon request of a drug company. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. OT-101 also been granted Rare Pediatric Designation for DIPG. The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred.
As previously reported, on March 31, 2022, we entered into a joint venture, or JV, with Dragon Overseas Capital Ltd. (Dragon Overseas) and GMP Biotechnology Ltd. (GMP Bio). The JV and Oncotelic will develop and ultimately market OT-101, individually and/or in combination with other products. Oncotelic would receive up to $50 million on sale of the RPD voucher, following marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG, by the US Food and Drug Administration.