On January 5, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported that it has submitted a clinical study protocol to the United States Food and Drug Administration ("US FDA") for the initiation of a Phase 1 Clinical Trial for CA4P, the Company’s Vascular Disrupting Agent, in combination with Anti-PD-1 (pembrolizumab) as a treatment for patients with Melanoma (Press release, Oncotelic, JAN 5, 2022, View Source [SID1234598259]).

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The Phase 1 Clinical Trial is designated as S101: Phase 1, Prospective, Multicenter, Open-Label, Single Arm Study of Safety and Initial Efficacy of CA4P in Combination with anti-PD1 (pembrolizumab) in Patients with Recurrent Metastatic Cutaneous or Uveal Melanoma.

CA4P has been evaluated in over 500 patients and treated in 17 clinical studies to date. These included multiple Phase 1 dose escalation studies, with dose cohorts up to 114 mg/m2, when used as monotherapy, 63 mg/m2 when used in combination with paclitaxel, and 63 mg/m2 when used in combination with bevacizumab. Based on the early Phase 1 studies, CA4P was further studied in larger Phase 2 studies including:

• Ovarian cancer – 60 mg/m2 CA4P in combination with 15 mg/kg bevacizumab (n=54) in combination with physician’s choice chemotherapy;

• Anaplastic thyroid cancer – 60 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=51);

• Platinum resistant ovarian cancer – 63 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=44);

• Non-small cell lung cancer – 60 mg/m2 CA4P in combination with bevacizumab and with paclitaxel and carboplatin q3wk (n=31).

CA4P was generally well tolerated in these studies, and toxicity did not appear to be significantly related to dose frequency. The Company believes that the combination of CA4P together with checkpoint inhibitors, such as pembrolizumab, could be synergistic. Mechanistically, the trial is also designed to assess the impact of CA4P on tumoral TGF-β signature which would allow us to integrate CA4P into our TGF-β platform as combination with checkpoint inhibitors, CAR-T, and vaccine/oncolytic viruses.

"This is the first of a series of planned clinical trials in melanoma patients to ultimately obtain marketing approval for CA4P in a Rare Pediatric Disease. The US FDA has previously granted the Company a Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients." noted Dr. Vuong Trieu, Chairman and Chief Executive Office of Oncotelic.