On November 14, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, reported its financial results for the quarter ended September 30, 2023 (Press release, PDS Biotechnology, NOV 14, 2023, View Source [SID1234637636]). The Company will provide a business update on its conference call and webcast at 8:00 AM EST today.
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CEO Comments:
"We are pleased with the outcome of the National Cancer Institute (NCI)-led Phase 2 triple combination trial of PDS0101, PDS01ADC (formerly known as PDS0301) and an investigational immune checkpoint ihnibitor (ICI). The data show that 75% of immune checkpoint inhibitor (ICI)-naïve patients remain alive at three years, and the 12-month overall survival (OS) rate in the ICI-resistant patients is 72%," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Furthermore, the triple combination continues to be well tolerated, with only 4% of patients reported to have Grade 4 treatment-related adverse events."
He continued, "As the development of our IL12 fused antibody-drug conjugate or ADC, PDS01ADC, continues to progress, its potential to overcome key safety and efficacy limitations associated with existing cytokine therapy is reinforced. Data presented at Cytokines 2023 marked the first-in-human clinical trial evaluating the combination of docetaxel chemotherapy and PDS01ADC to treat advanced metastatic castration sensitive (mCSPC) and castration resistant prostate cancer (mCRPC). Decreases in prostate-specific antigen (PSA) levels were reported in all patients. In addition, with our lead candidate PDS0101, the interim Phase 2 VERSATILE-002 data presented during our Key Opinion Leader (KOL) roundtable showed a 2-year overall survival rate of 74% in ICI-naïve human papillomavirus (HPV)16- recurrent/metastatic head and neck cancer patients. We are excited about the strides we are making across our pipeline, fueled by our commitment to developing groundbreaking therapies that revolutionize cancer treatments."
Recent Business Highlights:
PDS0101 Lead Drug Candidate
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VERSATILE-003: Received feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase 3 clinical protocol for a randomized, controlled multicenter trial of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer. PDS Biotech anticipates initiation of VERSATILE-003 in Q1 2024.
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VERSATILE-002: Phase 2 open-label, multicenter clinical trial of PDS0101 in combination with KEYTRUDA in patients with HPV16-positive recurrent and/or metastatic head and neck cancer.
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Hosted KOL roundtable on interim VERSATILE-002 data and current and future treatments. Highlights from ICI-naïve patients:
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24-month OS rate of 74%; published 24-month OS less than 30% data with approved ICIs for head and neck cancer.2
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Well tolerated with no patients having Grade 4 or 5 combination treatment-related adverse events. Thirteen percent with Grade 3 combination treatment-related adverse events.
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Presented biomarker data at European Society for Medical Oncology Congress 2023, highlighting that the combination of PDS0101 and KEYTRUDA has the potential to promote a TH1 immune response which is known to promote a strong CD8 T cell response. Biomarker data demonstrated that the combination promotes the induction of HPV16-specific multifunctional CD8 T cells.
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IMMUNOCERV: Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) in the treatment of locally advanced cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.
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Data presented at American Society for Radiation Oncology 2023 Annual Meeting demonstrated PDS0101, in combination with SOC CRT, was associated with a rapid decline in HPV circulating cell-free DNA, a potential predictive biomarker of treatment response. Ninety-two percent reduction in ctDNA with PDS0101 and SOC and 53% reduction was seen with SOC at 5 weeks.
PDS01ADC (formerly known as PDS0301): IL12 Fused Antibody Drug Conjugate
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NCI-led Triple Combination: Phase 2 clinical trial for combination therapy of PDS0101, PDS01ADC and an investigational ICI for the treatment of recurrent/metastatic HPV-positive, ICInaïve and ICI-resistant HPV16-positive cancers including anal, cervical, head and neck, vaginal and vulvar cancers.
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ICI-naïve group:
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75% of patients remain alive at 36 months; published median OS data in similar patients is 7-11 months.1 The median OS has not yet been reached.
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ICI-resistant group:
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12-month OS rate of 72%.
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Median OS approximately 20 months; published median OS in HPV-positive ICI-resistant cancer is 3.4 months3.
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Responses were seen in all HPV-positive tumor types.
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NCI-led PDS01ADC + Docetaxel: Phase 1/2, open-label, single-arm trial of PDS01ADC in combination with docetaxel in advanced mCSPC and mCRPC.
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Presented interim safety and immune response data of the combination in the first clinical trial of an immunocytokine with docetaxel in prostate cancer patients at Cytokines 2023.
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Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.
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All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.
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Presented data from the NCI-led preclinical study evaluating PDS0101, PDS01ADC and an HDAC inhibitor at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting, (demonstrating antitumor activity against ICI-resistant cancers.
PDS0202 Universal Flu Candidate
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Presented data from the preclinical universal flu vaccine program at 9th European Scientific Working Group on Influenza, demonstrating the potential ability of PDS0202 to neutralize multiple influenza viruses. PDS0202 also demonstrated the ability to prevent viral replication in the lungs of ferrets and provide complete protection after challenge with lethal doses of the H1N1 influenza virus.
Third Quarter 2023 Financial Results
Net loss for the three months ended September 30, 2023 was approximately $10.8 million, or $0.35 per basic share and diluted share, compared to a net loss of approximately $7.4 million, or $0.26 per basic and diluted share, for the three months ended September 30, 2022. The higher net loss reported for the three months ended September 30, 2023 is primarily due to the increase in research and development expenses and general and administrative expenses.
Research and development expenses increased to $6.4 million for the three months ended September 30, 2023 from $4.4 million for the three months ended September 30, 2022. The increase of $2.0 million is primarily attributable to an increase of $1.3 million in clinical trials, and $0.7 million in personnel costs, including $0.3 million in non-cash stock-based compensation.
General and administrative expenses increased to $4.1 million for the three months ended September 30, 2023 from $2.9 million for the three months ended September 30, 2022. The increase of $1.2 million is primarily attributable to an increase of $0.7 million in personnel costs, including $0.5 million in non-cash stock-based compensation, and $0.5 million in investor relations costs.
PDS Biotech’s cash balance as of September 30, 2023 was approximately $54.3 million. PDS Biotech believes that, with initiating the VERSATILE-003 Phase 3 clinical trial in the first quarter of 2024, its available cash resources will sustain operational and research and development endeavors into the third quarter of 2024. PDS Biotech expects to execute its current operational and research and development endeavors by obtaining additional capital, principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or additional public or private debt and/or equity financings. The Company has had and continues to provide, what the Company believes to be favorable development milestones to the market and has upcoming development milestones.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EST today, November 14, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13741454. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.