Final Topline Survival Data Announced: Nasdaq Profile (PDSB) Drops Breaking News!

PDS Biotechnology Corporation (Nasdaq: PDSB) just dropped major breaking news!

*Sponsored Final Topline Survival Data Announced: Nasdaq Profile (PDSB) Drops Breaking News! August 25th Dear Reader, PDS Biotechnology Corporation (Nasdaq: PDSB) just dropped major breaking news! Check it out: PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer Median Overall Survival (mOS) of 39.3 months in patients with CPS ≥ 1 – best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months* VERSATILE-003 Phase 3 trial in progress PRINCETON, N.J., Aug. 25, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune® HPV) + Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (“1L R/M HNSCC”). 53 patients were enrolled in the 1L R/M HNSCC arm of the trial. PDS0101 was administered by subcutaneous injection together with IV infusion of pembrolizumab during the first 4 treatment cycles. The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12. On every other cycle where PDS0101 was not administered, pembrolizumab monotherapy was administered. This continued until disease progression, death, or to cycle 35. The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable. Durable patient survival is promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 and was similar across patient demographics and clinical characteristics such as age, CPS status, and prior treatment. “We believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “We believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients. We look forward to publishing the full data set for this trial later this year.” “With these results, PDS Biotech is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated, and no patients discontinued the trial due to treatment-related adverse events,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. *No head-to-head studies have been performed comparing pembrolizumab and PDS0101 Read the full article here. With this huge news and PDSB trading above both its 5-Day Simple Moving Average (SMA) and its 5-Day Exponential Moving Average (EMA), this chart should be watched for any potential trends developing. There's a lot going on here. Take a moment review my initial (Nasdaq: PDSB) report below and consider this profile for your radar. ----- There is a late-stage biopharma company working at the intersection of immunotherapy and oncology that is beginning to capture attention for its innovative approach to harnessing the body’s own immune system. By advancing a unique platform designed to target multiple types of hard-to-treat cancers as well as infectious diseases, this company is progressing with clinical trials that could reshape future treatment standards. Early studies suggest the potential for meaningful improvements in patient outcomes compared to existing options. With an expanding pipeline and a science-driven foundation, this is a company worth learning more about in greater depth. And as their positive news announcements have flown below the radar for 2025, an analyst $13 target may bring buzz near term to this new Nasdaq profile: *PDS Biotechnology Corporation (Nasdaq: PDSB)* PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. And based on several potential catalysts, (Nasdaq: PDSB) has taken over control of the top spot on my watchlist. Take a look: #1. A $13 Analyst Target Suggests Triple-Digit Potential Upside! #2. PDS Biotech Gets FDA Clearance Of IND Application in Game-Changing Milestone. #3. Key Phase 2 Clinical Trial Meets Criteria For Stage 2 Expansion After Positive Results. #4. PDS Biotech Shares Updated Positive Data (Pleased with Overall Survival Results). But more on those in a second... About PDS Biotech Corporation (Nasdaq: PDSB) PDS Biotech was established with the goal of harnessing the power of T cells to address some of the most devastating illnesses of modern times. While many companies have attempted to leverage the body’s immune system to induce a strong T cell response, most have been unsuccessful in overcoming the tumor’s ability to defend itself against the immune system and in producing the right type and quantity of potent tumor-infiltrating T cells needed to execute a targeted attack. PDS Biotech’s proprietary targeted technologies are designed to deliver IL-12 into the tumor’s inner environment to suppress the tumor’s defenses against T cells while simultaneously generating a potent, targeted T cell attack on the cancer. When paired with proprietary tumor-associated proteins called antigens, PDS Biotech’s Versamune® platform has been shown to promote the induction of the right type and quantity of potent tumor-infiltrating killer and helper T cells that specifically recognize the tumor antigen. PDS01ADC, the company’s novel investigational tumor-targeting IL-12 fused antibody drug conjugate, when used with Versamune®, overcomes tumor-induced suppression of the immune system. This proprietary combination also promotes enhanced infiltration and expansion of T cells within the tumor, leading to more effective immunotherapy. In addition, PDS Biotech’s Infectimune® platform is being applied in the development of novel investigational T cell- and antibody-inducing preventive vaccines. PDS Biotech is committed to developing novel investigational immunotherapies based on its T cell-stimulating platforms to save and improve the lives of patients worldwide: Versamune®-based T-cell Stimulating Immunotherapies (TSI): Developed to provide a targeted attack against tumor-associated proteins called antigens. Versamune®-based T-cell Stimulating Immunotherapy (TSI) plus PDS01ADC: A novel investigational tumor-targeting IL-12 fused antibody drug conjugate that targets the tumor microenvironment to suppress the tumor’s defenses against the immune system and promotes enhanced infiltration and expansion of T cells within the tumor, with the goal of treating recurrent and/or metastatic (R/M) cancers with poor survival prognosis. Pipeline Overview PDS Biotech’s oncology pipeline leverages the Versamune® platform and Versamune® plus PDS01ADC in combination with proprietary tumor-specific proteins or peptides (antigens) in the development of targeted cancer immunotherapies. Targeting HPV16-positive Head and Neck Cancer with Versamune® HPV Addressing Growing Market with Compelling Clinical Results No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune®HPV. *Head and neck squamous cell carcinoma (HNSCC) Grab Sources And More Here: PDSB Website. PDSB Presentation. ----- And as I mentioned above, (Nasdaq: PDSB) has several potential catalysts to consider. Check them out: #1. PDSB Potential Catalyst - A $13 Analyst Target Suggests Triple-Digit Potential Upside! Check out what we found over at TipRanks: Last week, an analyst with at H.C. Wainwright suggested a $13 target. From Friday's closing valuation, that target provides PDSB with an upside potential of over 900%! Could this target suggest PDSB is severely undervalued from current chart levels? ----- #2. PDSB Potential Catalyst - PDS Biotech Gets FDA Clearance Of IND Application in Game-Changing Milestone. PDS Biotech Announces FDA Clearance of IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer PRINCETON, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (“IND”) application filed in January 2025 to evaluate a combination of Versamune® MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma (“mCRC”) in patients who failed previous treatment. “MUC1 is over-expressed in multiple solid tumors including colon, pancreatic, ovarian, breast, and NSCLC, and is associated with drug resistance and poor patient outcomes. This results in an unmet need for more effective, safer, better-tolerated targeted treatment options. Versamune® MUC1 targets mCRC tumors that are MUC1-positive and will be studied in Proficient Mismatch Repair/Microsatellite Stable mCRC, which accounts for 95% of patients with mCRC. These tumors are typically more resistant to current immunotherapy, such as immune checkpoint inhibitors, and second-line chemotherapy,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Targeting MUC1 with an immunotherapy that elicits a strong and durable tumor-infiltrating T-cell response could represent a major advancement in cancer treatment.” The National Cancer Institute (“NCI”), under its Cooperative Research and Development Agreement (“CRADA”) with PDS Biotech, will lead the Phase 1/2 clinical trial evaluating the combination of Versamune® MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer. “The IND clearance of Versamune® MUC1 marks progress for our Versamune® platform and its potential to expand beyond HPV-related cancers,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Though our focus remains on our recently initiated VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma, we are pleased to support the NCI investigation of a therapy that shows promise in driving strong, durable anti-tumor immune responses.” ... Read the full article here. ----- #3. PDSB Potential Catalyst - Key Phase 2 Clinical Trial Meets Criteria For Stage 2 Expansion After Positive Results. PDS Biotech Announces Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results Metastatic Colorectal Cancer Cohort in NCI-Led Multi-Cohort Study Demonstrates Promising Response Rate, Triggering Enrollment Expansion Under Simon Two-Stage Design PRINCETON, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced patient recruitment has been completed in Stage 1 of a clinical trial of the Company’s PDS01ADC therapeutic administered systemically in combination with floxuridine (FUDR) administered by hepatic artery infusion pump (HAIP) for patients with metastatic colorectal cancer (NCT05286814), led by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH). The study met the pre-set RECIST v1.1 criteria for expansion into Stage 2 of the study. ... “Colorectal cancer is among the most deadly and difficult to treat cancers. In 2020, it was estimated that more than 930,000 deaths were due to colorectal cancer worldwide according to the World Health Organization, and more effective treatments are desperately needed,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “This novel investigational approach to the targeting and use of IL-12 results in little, or no systemic exposure to IL-12, and may allow patients to reap the benefits of cytokine therapy without the typical treatment-limiting toxicities. We are delighted that the NCI has achieved this milestone and anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025.” ... Read the full article here. ----- #4. PDSB Potential Catalyst - PDS Biotech Shares Updated Positive Data (Pleased with Overall Survival Results). PDS Biotech Unveils Updated Positive Data From VERSATILE-002 Trial and Additional Trials Evaluating Versamune® HPV to Treat Head and Neck Cancers at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting Median overall survival data in first-line recurrent/metastatic (1L r/m) HNSCC remains durable at 30.0 months with additional follow-up of ~4.5 months beyond the initial abstract HPV16-positive is the most rapidly increasing HNSCC in the US VERSATILE-003 is the only ongoing Phase 3 clinical trial exclusively addressing 1L r/m HPV16-positive HNSCC PRINCETON, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced publication of three Versamune® HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website. These abstracts summarize Versamune® HPV (PDS0101) studies that were presented during the Head and Neck Cancer Poster Session taking place May 30-June 3, 2025, in Chicago, Illinois. ... Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, continued, “We are very pleased with the overall survival (OS) results. As stated in a 2023 Journal of Clinical Oncology article authored by the FDA, OS is considered the gold standard for oncology approvals. The article discussed the discordance between ORR, PFS and OS. In recently published registrational 1L r/m HNSCC studies, improved ORR and PFS have not translated to improved OS. We look forward to the two interim survival data readouts from the ongoing Phase 3 study as well as the final OS results.” Read the full article here. ----- (Nasdaq: PDSB) Recap - These Explosive Potential Catalysts Lead The Way #1. A $13 Analyst Target Suggests Triple-Digit Potential Upside! #2. PDS Biotech Gets FDA Clearance Of IND Application in Game-Changing Milestone. #3. Key Phase 2 Clinical Trial Meets Criteria For Stage 2 Expansion After Positive Results. #4. PDS Biotech Shares Updated Positive Data (Pleased with Overall Survival Results). ----- That's it! Coverage is now officially initiated on PDS Biotechnology Corporation (Nasdaq: PDSB). When updates are available, I'll get them out quickly. Talk soon. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) *FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. 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