PDS develops cancer immunotherapies
T-cells vs. Tumors
Established in 2005, PDS Biotechnology Corporation -- a clinical-stage immunotherapy company --attempts to address some of the shortcomings of cancer immunotherapy. They include the ability to train the immune system to induce enough powerful disease-attacking killer T-cells and to overcome the tumor’s ability to avoid or suppress T-cell attack.
After the discovery that certain positively charged cationic lipids can activate the immune system, PDS scientists engineered the proprietary cationic, lipid-based Versamune® nanoparticle platform technology. In preclinical studies, when combined with cancer-specific proteins called antigens, Versamune® induced the body to produce targeted killer T-cells against cancer for rapid and sustained tumor eradication. PDS0101, PDS Biotech’s lead Versamune®-based product, is being studied in proof-of-concept phase 2 human clinical trials in multiple HPV-associated cancers.
Versamune®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Its immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers.
PDS Biotech aims to develop novel and effective therapies based on the Versamune® platform to save and improve the lives of cancer patients worldwide. The company is also committed to developing safer and more powerful infectious disease vaccines to prevent deadly infectious diseases.
Recently, PDS Biotech and the Head and Neck Cancer Alliance (HNCA) announced a partnership to raise awareness of new and developing treatment options, including available clinical trials, for patients with HPV-attributed head and neck cancer diagnoses. The incidence of head and neck cancer -- cancer that arises in the mouth, voice box, throat, sinuses, nasal cavity or salivary glands -- is increasing in the United States, primarily because of the rates of infection with human papillomavirus (HPV). Because these cancers are often diagnosed at later stages, treatment can be more difficult and more invasive. PDS is trying to change the landscape of HPV-attributed head and neck cancer treatment with its lead candidate, PDS0101, which uses Versamune® to activate the immune system to recognize HPV-associated cancer cells and respond by inducing T-cells to attack and destroy them.
Such partnerships are becoming more common in the patient advocacy and biotechnology spaces. By combining their efforts, partners can more efficiently spread the word about emerging treatments, clinical trials and additional options for patients not responding to traditional therapies.
According to Dr. Lauren V. Wood, chief medical officer of PDS Biotech, “Raising awareness of treatment options for patients and their families who are dealing with head and neck cancer that has returned or spread is critical. Treatment options for these patients can be limited and the search often expands to include investigational therapies being studied in clinical research. We’re excited to partner with the HNCA to raise awareness of these options for patients and physicians.”
“There are exciting things happening in clinical research for head and neck cancer therapies,” added Amanda Hollinger, executive director of HNCA. “Partnering with companies like PDS Biotech who are leading the way forward and working together to raise awareness of new and developing treatment options brings hope to patients, survivors, and families of those battling cancer, as well as offering new avenues of treatment for clinicians.”
PDS Biotech also announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation after participating in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.
“We are pleased to receive an allocation from the New Jersey NOL program,” said Frank Bedu-Addo, chief executive officer of PDS Biotech. “The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development.”
The NOL program allows qualified, unprofitable New Jerseyy-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This enable qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.
PDS Biotech will have an oral presentation at the 2021 ASCO Annual Meeting. The presentation, scheduled for June 7, will include results from the National Cancer Institute (NCI)-led phase 2 clinical study of PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.
Objective responses (tumor reduction) were observed in 83 percent (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve patients and 63 percent (5 of 8) of HPV16-positive relapsed or refractory advanced cancer patients who have also failed checkpoint inhibitor therapy. Additional data highlights include: an overall objective response rate of 71 percent (10/14) in patients with refractory HPV16-associated cancers, one complete response (anal cancer), nine partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer) and 90 percent of these of these responses ongoing after a median 5 months of follow up (9/10).
The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial (NCT04287868). The trial is evaluating the treatment combination in both checkpoint inhibitor naïve and refractory patients with advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment. Objective response is measured by radiographic tumor responses according to RECIST 1.1. These reported data validate the preclinical studies published by the NCI demonstrating that the complementary mechanisms of action of the three immunotherapies which involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration, blocking of immune checkpoints as well as targeting of TGF-β resulted in superior tumor regression.
“The achievement of a 71% objective response rate in a difficult to treat patient population continues to strengthen the evidence of our novel Versamune® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus leading to effective tumor regression,” commented Dr. Wood. “The initial data solidifies our belief that PDS0101’s published preclinical efficacy, when combined with these two immune-modulating agents, demonstrates the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV-associated cancers who have limited treatment options.”