PDS Biotechnology

Versamune® HPV Shows Promising ctDNA Clearance and Survival Rates in Advanced Cervical Cancer Trial

3 months ago

• Clinical trial data reveals 100% HPV16 ctDNA clearance in patients receiving Versamune® HPV plus chemoradiotherapy, compared to 50% in standard therapy group at 3-4 months follow-up. • HPV ctDNA clearance strongly correlates with improved 2-year recurrence-free survival, achieving a significant 92.9% versus 30% rate (P = 0.0067). • Patients receiving five doses of Versamune® HPV with chemoradiotherapy demonstrated impressive 36-month overall survival rate of 100%, highlighting potential therapeutic value.

PDS Biotech's VERSATILE-003 Phase 3 Trial for HPV16-Positive Head and Neck Cancer to Start Q1 2025

4 months ago

• PDS Biotech reaffirms the initiation of the VERSATILE-003 Phase 3 clinical trial in Q1 2025 for HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma. • The VERSATILE-003 trial will evaluate Versamune® HPV in combination with pembrolizumab as a first-line treatment option. • The FDA has cleared the amended trial design, paving the way for the trial's commencement at the beginning of 2025. • PDS Biotech presented rationale for combining PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone for recurrent prostate cancer.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Adicet Bio's ADI-001 Receives FDA Fast Track for Refractory SLE, Expands Autoimmune Pipeline

6 months ago

• Adicet Bio's ADI-001 receives FDA Fast Track designation for refractory systemic lupus erythematosus (SLE) with extrarenal involvement, expediting its development. • A Phase 1 trial is underway, evaluating ADI-001 across six autoimmune indications, including lupus nephritis (LN), SLE, systemic sclerosis (SSc), and others, with preliminary data expected in 2025. • ADI-001, an allogeneic gamma delta CAR T-cell therapy targeting CD20, has shown promising B-cell depletion in preclinical studies, suggesting potential as an off-the-shelf treatment. • Adicet Bio is also advancing ADI-270, a CAR T-cell therapy for metastatic clear cell renal cell carcinoma (ccRCC), with Phase 1 data anticipated in the first half of 2025.

PDS Biotech's VERSATILE-003 Phase 3 Trial for HPV16-Positive Head and Neck Cancer to Initiate Q1 2025

6 months ago

• PDS Biotech reaffirms its plan to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating Versamune HPV plus pembrolizumab for recurrent/metastatic HPV16-positive head and neck cancer. • The FDA has cleared the updated clinical protocol for the trial, which maintains statistical power with approximately 350 patients and a 2:1 randomization. • VERSATILE-002 study data showed a median overall survival of 30 months, an objective response rate improvement to 36%, and a disease control rate of 77%. • The VERSATILE-003 trial will utilize a companion diagnostic to confirm HPV16-positive HNSCC, ensuring targeted therapy for suitable patients.

PDS Biotech's Versamune HPV Shows Promise in HPV16-Positive Cancers, Phase III Trial Planned

6 months ago

• PDS Biotechnology's VERSATILE-003 Phase III trial, evaluating Versamune HPV with pembrolizumab, is set to begin in early 2025, with interim data expected six months after enrollment completion. • Encouraging VERSATILE-002 data reveals improved overall survival and objective response rates with Versamune HPV compared to pembrolizumab alone in HPV16-positive cancers. • IMMUNOCERV trial data supports further development of Versamune HPV for cervical cancer, demonstrating high overall and progression-free survival rates. • PDS Biotech maintains a solid financial position with approximately $50 million in cash reserves, supporting ongoing clinical trials and research initiatives.

PDS Biotech's PDS0101 and Keytruda Combination Therapy to Enter Phase 3 Trial for HPV16-Positive Cancers

6 months ago

• PDS Biotechnology is set to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating the combination of PDS0101 and Keytruda. • The trial will focus on patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC). • The analysts believe Merck's Keytruda success in KEYNOTE-689 study is unlikely to affect the Versamune double combination since KEYNOTE-689 enrolled very few HIV16+ patients. • Alliance Global Partners maintains a Buy rating on PDSB, though lowered the price target to $4.50 from $7.

PDS Biotech Reports Q3 2024 Results, Highlights VERSATILE-003 Trial Progress

6 months ago

• PDS Biotechnology Corp reported a net loss of $10.7 million in Q3 2024, slightly better than the $10.8 million loss in Q3 2023, with revenue in line with expectations. • R&D expenses increased to $6.8 million due to higher manufacturing costs, while general and administrative expenses decreased to $3.4 million. • The company is advancing its VERSATILE-003 Phase 3 trial, combining Versamune® HPV with pembrolizumab for HPV16-positive head and neck squamous cell cancer. • Modifications to the VERSATILE-003 trial design aim to reduce costs and expedite data readouts, with $49.8 million in cash and cash equivalents as of September 30, 2024.

PDS Biotech Presents Trial Design of PDS01ADC Plus Enzalutamide for Recurrent Prostate Cancer

7 months ago

• PDS Biotech presented the rationale and design for a clinical trial evaluating PDS01ADC in combination with enzalutamide for recurrent prostate cancer. • The trial aims to assess the efficacy of this combination without testosterone-lowering therapy in biochemically recurrent prostate cancer patients. • The presentation took place at the 12th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2024) in Seoul, South Korea. • PDS01ADC, an IL-12 fused antibody-drug conjugate, is being developed as part of a triple combination therapy for HPV16-positive cancers.

PDS Biotech's PDS0101 Shows Promising Survival Data in Advanced Cervical Cancer Trial

8 months ago

• PDS Biotechnology's IMMUNOCERV trial shows an 84.4% overall survival rate at 36 months for advanced cervical cancer patients treated with PDS0101 and chemoradiation. • Patients receiving all five doses of Versamune HPV in the trial achieved a 100% overall survival rate at 36 months, significantly surpassing historical rates. • The combination therapy of PDS0101 and chemoradiation demonstrates a favorable safety profile with minimal toxicity in treating HPV-related cervical cancer. • H.C. Wainwright maintains a Buy rating for PDS Biotechnology, highlighting the potential of PDS0101 as a novel immunotherapy for HPV-driven tumors.

PDS Biotech's Versamune® HPV Plus Pembrolizumab Shows Promising Results in Head and Neck Cancer

8 months ago

• PDS Biotech announced Phase 2 trial results of Versamune® HPV with pembrolizumab for HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). • The combination therapy demonstrated a median overall survival of 30 months, significantly higher than pembrolizumab alone. • The trial also showed a 36% objective response rate and a 77% disease control rate, outperforming historical data for pembrolizumab monotherapy. • PDS Biotech plans to initiate a Phase 3 clinical trial (VERSATILE-003) this year to further evaluate the combination therapy.

PDS Biotech's Versamune-HPV and Keytruda Combo Shows Promising Survival in Head and Neck Cancer

8 months ago

• PDS Biotechnology's Versamune-HPV, combined with Keytruda, demonstrated a median overall survival of 30 months in HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). • The combination therapy achieved an objective response rate of 36%, surpassing the published rates of 19-25% for pembrolizumab alone in similar patient populations. • A disease control rate of 77% was observed, with 21% of patients experiencing significant tumor shrinkage (90-100%) and 9% achieving a complete response. • Treatment-related adverse events of Grade 3 or higher were reported in 9 patients, suggesting a manageable safety profile for the combination regimen.