Clinical-stage immuno-oncology company PDS Biotechnology Corp. (PDSB:NASDAQ), which states that it is pioneering the development of multi-functional immunotherapeutic products, today announced a modification of the clinical trial collaboration agreement with a subsidiary of Merck & Co. Inc. (MRK:NYSE) to evaluate the combination of the firm's lead Versamune-based immunotherapy, PDS0101, with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 2 clinical trial. The company noted that the "planned clinical trial will now evaluate the efficacy and safety of the combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection and is expected to be initiated in Q1/20." The exact details of the collaboration were not disclosed.
The company explains that the "modification to the clinical trial design now allowing evaluation of PDS0101 in combination with KEYTRUDA as first-line treatment comes as a result of Merck's recent approval by the FDA on June 10, 2019, for KEYTRUDA as monotherapy in patients whose tumors express PD-L1 (CPS ≥1) or in combination with platinum and fluorouracil (FU) for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma."
Dr. Lauren V. Wood, PDS's chief medical officer, commented, "We are honored to collaborate with Merck, a proven leader in the field of immuno-oncology to evaluate novel investigational combination therapies that have the potential to further improve the lives of cancer patients...The recently updated clinical outcome findings of the PDS0101 phase 1 human clinical trial demonstrate unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses (regression/elimination of pre-cancerous lesions) in the majority of evaluable patients treated with PDS0101 monotherapy, and a lack of dose limiting toxicities at all tested doses as reported in PDS's September 19, 2019, press release."
PDS Biotechnology's lead product candidate, PDS0101 (Versamune-HPV) is a "proprietary clinical stage immunotherapeutic administered by subcutaneous injection being developed to treat HPV-associated cancers. These include cancers such as head and neck cancers and anal cancers, both of which are widely reported to be increasing in frequency over the last decade, and cervical cancer."
PDS Biotech's Versamune platform is a proprietary, synthetic lipid-based T-cell activating platform. PDS Biotechnology's pipeline of Versamune-based products, which are administered by subcutaneous injection, provides strong activation of type I interferon genes. The Versamune mechanism of action also involves effective presentation of tumor antigens via the MHC Class I and Class II pathways. These mechanisms together promote strong in-vivo induction of polyfunctional tumor-targeting CD8+ T-cells. Versamune-based immunotherapies have been demonstrated to alter the tumor micro-environment in preclinical mechanism of action studies, thus further enhancing the ability of Versamune-induced T-cells to effectively kill tumor cells.
Just a few days ago PDS Biotechnology announced that it will "prioritize clinical development of PDS0101 in advanced cancers following its recent reporting of promising Phase 1 clinical trial outcome data" from a Phase 1 study of PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). The firm advised that the study demonstrated "robust treatment-induced HPV16-specific killer T-cell (CD8+) responses as well as clearance of the disease and regression of lesions in 60% of patients. These in-vivo PDS0101-induced T-cells were demonstrated to induce granzyme-b thus confirming their cytolytic/killing potency." The company states that this clinical data supports the superior CD8+ T-cell induction and anti-tumor efficacy of its Versamune platform, as published based on the results of preceding preclinical studies in the June 2019 issue of the Journal of Immunology.
Dr. Frank Bedu-Addo, CEO of PDS stated, "Our intent is to continue to advance our previously announced combination studies with PDS0101 in various advanced HPV-associated cancers. These phase 2 clinical studies are partnered with top leaders in the field. We also intend to rapidly progress PDS0102 (targeting prostate and breast cancers), PDS0103 (targeting colon, lung, ovarian cancers) and PDS0104 (targeting melanoma) into human clinical trials in combination with checkpoint inhibitors. This approach has been recently supported by promising Phase 1 clinical outcome data...The unique ability of PDS0101 to promote in-vivo induction of high levels of CD8+ T-cells overcomes a significant limitation of many current immunotherapy approaches such as checkpoint inhibitors."
The report indicated that as a result of the recent data showing strong CD8+ T-cell induction and the subsequent decision to prioritize the platform's application in combination therapies addressing advanced cancer, the company no longer anticipates starting a Phase 2 study to evaluate PDS0101 monotherapy in CIN2/3 as previously reported.
PDS Biotechnology describes itself as a clinical stage immuno-oncology company with a growing pipeline of clinical-stage immunotherapies to treat various HPV-associated cancers, including head and neck cancer, cervical and anal cancers. All of PDS's products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells. The firm's PDS0101 includes the Versamune immune-activating platform and a mixture of HPV16 E6 and E7 peptide antigens designed to induce cytolytic T-cell responses against HPV expressed in patients with HPV-associated cancers.
PDS Biotechnology started the day with a market capitalization of about $15.8M. The company has 5.279 million shares outstanding. The stock has a 52-week price range of $3.00–23.60/share. This morning, PDSB shares opened at $3.50 (+$0.50, +16.67%) over yesterday's $3.00 closing price. The stock has traded today between $3.41 and $5.11/share and is currently trading at $4.14 (+$1.14, +38.00%).[NLINSERT]
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