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PDS Biotechnology Corporation - $PDSB STOCK NEWS

Welcome to our dedicated page for PDS Biotechnology Corporation news (Ticker: $PDSB), a resource for investors and traders seeking the latest updates and insights on PDS Biotechnology Corporation stock.

PDS Biotechnology Corporation (Nasdaq: PDSB) is a clinical stage biopharmaceutical company focused on developing next-generation immunotherapies for cancer and infectious diseases. The company's proprietary Versamune® platform leverages synthetic and biodegradable lipids to form nanoparticles that are readily taken up by the immune system. These nanoparticles are designed to activate and direct the immune system to target and eliminate disease-causing cells.

PDS Biotech's lead product candidates include PDS0101, targeting HPV-related cancers, and PDS01ADC, an IL-12 fused antibody drug conjugate. These candidates are part of the company's broader strategy to treat a range of cancers, including head and neck, prostate, breast, cervical, and anal cancers.

Recent achievements include the completion of a Phase 1 clinical trial for PDS0101 and ongoing Phase 2 trials demonstrating positive survival results and tumor shrinkage. The company is preparing to initiate a pivotal clinical trial in advanced head and neck cancers in 2024.

Financially, PDS Biotech reported a net loss of $10.8 million for Q3 2023, primarily due to increased R&D and administrative expenses. Despite this, the company remains focused on advancing its pipeline and has several key partnerships to support its research and development efforts.

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PDS Biotechnology provided a data update from its VERSATILE-002 Phase 2 clinical trial in head and neck cancer as of May 17, 2024. The trial focuses on the combination of Versamune® HPV and KEYTRUDA® in HPV16-positive HNSCC patients. Median Overall Survival (mOS) remains at 30 months, consistent with previous data. Out of 53 enrolled patients, 27 remain alive, 6 withdrew consent, 2 were lost to follow-up, and 18 have died. The lower limit of the 95% confidence interval is 19.7 months, while the upper limit is not yet estimable. Full data are expected in Q3 2024. PDS Biotech plans a three-arm Phase 3 trial to further evaluate treatment efficacy.

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PDS Biotech (Nasdaq: PDSB) has released its Q1 2024 financial results and business updates. Key highlights include positive data from the Phase 2 VERSATILE-002 trial for HPV16-positive head and neck cancer, showing improved survival rates with Versamune® HPV and KEYTRUDA®. The company also announced a new two-part clinical trial strategy for Versamune® in combination with PDS01ADC and pembrolizumab. Financials show a net loss of $10.6 million, up from $9.7 million in Q1 2023, mainly due to increased R&D and interest expenses. Cash reserves stand at $66.6 million.

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PDS Biotech's VERSATILE-002 Phase 2 clinical trial for first-line recurrent/metastatic HPV16-positive head and neck cancer met primary study endpoints with a 30-month median overall survival, impressive response rates, and a planned Phase 3 trial in 2024. The trial evaluated the combination of Versamune® HPV + KEYTRUDA® (pembrolizumab) and showed promising results. The Company also announced a two-part registrational trial focusing on a triple combination therapy.

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PDS Biotechnology (Nasdaq: PDSB) will participate in two investor conferences in May 2024. The first is the Citizens JMP Life Sciences Conference on May 13 in New York, where the company will present and hold 1:1 meetings. The second event is the A.G.P.'s Virtual Healthcare Company Showcase on May 21, featuring a fireside chat with A.G.P.’s Jim Molloy and Scott Henry.

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PDS Biotech, a late-stage immunotherapy company, will announce its first quarter 2024 financial results on May 15, 2024. They will also discuss positive data from their VERSATILE-002 Phase 2 clinical trial during a Key Opinion Leader Event on May 8, 2024.

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PDS Biotechnology announced details of a virtual Key Opinion Leader (KOL) event focusing on updated Phase 2 trial results and unmet needs in advanced head and neck cancer. The event will discuss the positive data from the VERSATILE-002 trial and plans for a triple combination trial. Panel participants include renowned experts in the field.

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PDS Biotech appointed Stephan Toutain as Chief Operating Officer, bringing over 30 years of operational experience in the pharmaceutical industry. Mr. Toutain's expertise in drug development, commercialization, and oncology will be important as PDS Biotech advances its lead program into a pivotal clinical trial. In addition to his appointment, PDS Biotech granted Mr. Toutain a nonstatutory stock option to purchase 200,000 shares of PDS Biotech common stock as an inducement to his employment.

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PDS Biotech announces a Key Opinion Leader event to discuss positive, updated data from Phase 2 VERSATILE-002 clinical trial with Versamune® HPV in combination with KEYTRUDA® in recurrent or metastatic head and neck cancer. The event will focus on the trial results, unmet treatment needs in advanced head and neck cancer, and planned triple combination trial. The VERSATILE-002 trial evaluates Versamune® HPV with pembrolizumab in patients with unresectable, recurrent, or metastatic HPV16-positive HNSCC.
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PDS Biotechnology announces successful clinical trials with a 3-year survival rate of 75% in advanced head and neck cancer, leading to a focus on a triple combination treatment. The company reports strong safety profiles of its drugs and plans to start a pivotal randomized trial. Financially, PDS Biotech saw a net loss increase due to higher operating costs and interest expenses, despite a decrease in research and development expenses.
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PDS Biotechnology (PDSB) will release financial results for the year ended December 31, 2023, and provide a business update on March 27, 2024. The company focuses on developing targeted cancer immunotherapies and infectious disease vaccines.
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FAQ

What is PDS Biotechnology Corporation's main area of focus?

PDS Biotechnology focuses on developing next-generation immunotherapies for cancer and infectious diseases using its proprietary Versamune® platform.

What is the Versamune® platform?

The Versamune® platform uses synthetic and biodegradable lipids to form nanoparticles that activate and direct the immune system to target disease-causing cells.

Which cancers are targeted by PDS Biotechnology's therapies?

PDS Biotechnology's therapies target various cancers including head and neck, prostate, breast, cervical, and anal cancers.

What are the recent achievements of PDS Biotechnology?

Recent achievements include completing a Phase 1 clinical trial for PDS0101 and ongoing successful Phase 2 trials showing positive results.

How did PDS Biotechnology perform financially in Q3 2023?

PDS Biotechnology reported a net loss of $10.8 million for Q3 2023, mainly due to higher research and development and administrative expenses.

What is PDS01ADC?

PDS01ADC is an IL-12 fused antibody drug conjugate in development for use in PDS Biotechnology's cancer immunotherapy treatments.

What upcoming events should investors watch?

Investors should watch for the pivotal clinical trial in advanced head and neck cancers planned for 2024.

What are the unique features of PDS Biotechnology's vaccines?

PDS Biotechnology's vaccines induce robust neutralizing antibodies and powerful T-cell responses, including long-lasting memory T-cells.

Where can investors find more information about PDS Biotechnology?

Investors can find more information on the company's official website at www.pdsbiotech.com.

How can the media contact PDS Biotechnology?

Media can contact PDS Biotechnology through Gina Mangiaracina at 6 Degrees via phone at +1 (917) 797-7904 or email at gmangiaracina@6degreespr.com.

PDS Biotechnology Corporation

Nasdaq:PDSB

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