PDS Biotechnology Amends VERSATILE-003 Clinical Trial Protocol
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 13 hours ago
0mins
Should l Buy PDSB?
PDS Biotechnology announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the trial's primary endpoint for full approval, consistent with the Company's prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration. Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug Application, without objection, the Company is proceeding with the amended protocol.
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Analyst Views on PDSB
Wall Street analysts forecast PDSB stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.658
Low
3.00
Averages
9.00
High
15.00
Current: 0.658
Low
3.00
Averages
9.00
High
15.00
About PDSB
PDS Biotechnology Corporation is a clinical-stage immunotherapy company. The Company is developing a pipeline of targeted cancer immunotherapies based on its Versamune T cell-activator and Versamune in combination with its interleukin 12 (IL-12) fused antibody drug conjugate (ADC), PDS01ADC, a tumor targeting immunocytokine. PDS0101 is its lead Versamune based immunotherapy. PDS0101 combines Versamune with a mixture of short proteins (peptides) derived from the cancer-causing HPV16 viral protein. Versamune is a proprietary lipid nanoparticle and T cell activating platform. PDS0301 is an investigational tumor-targeting antibody conjugate of Interleukin 12 (IL-12) that enhances the proliferation, potency, infiltration, and longevity of T cells in the tumor microenvironment. Its Versamune immunotherapies and Versamune in combination with PDS01ADC, are utilized for treatments in oncology, and Infectimune is utilized for preventive vaccines against infectious agents.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
PDS Biotechnology Amends Phase 3 Trial Protocol for Accelerated Approval
- Protocol Amendment: PDS Biotechnology Corporation announced an amendment to its Phase 3 VERSATILE-003 clinical trial protocol, adding progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer.
- Survival Endpoint Maintained: While PFS is added as an interim endpoint, the median overall survival (mOS) remains the primary endpoint, ensuring consistency with prior regulatory dialogues with the FDA, thereby enhancing the company's confidence in the regulatory approval process.
- Accelerated Approval Potential: By including PFS as an interim primary endpoint, the trial duration is expected to shorten, accelerating the timeline for regulatory submission while improving cost efficiency, further advancing the company's strategic positioning in cancer immunotherapy.
- Optimistic Market Outlook: PDS0101, as a targeted immunotherapy for HPV16-positive recurrent and/or metastatic head and neck cancer, developed in combination with standard immune checkpoint inhibitors, demonstrates strong market potential, aligning with the growing patient demand.
See More
Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer during the GOBLET Cohort 4, significantly exceeding the historical benchmark of 10%, indicating its crucial clinical value in a setting with no FDA-approved treatment options.
- Duration of Response: Among 14 evaluable patients, the median duration of response for pelareorep reached approximately 17 months, far surpassing the standard treatment's 9.5 months, showcasing the drug's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for potential accelerated approval if the data is validated.
- Strategic Investment and Expert Support: The company expanded its Scientific Advisory Board by adding three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, further strengthening its strategic positioning in the gastrointestinal oncology field.
See More
Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer patients during the GOBLET Cohort 4 study, significantly surpassing the historical benchmark of 10%, indicating the therapy's substantial potential in a patient population with no FDA-approved options.
- Duration of Response: The study also revealed a median duration of response of approximately 17 months, far exceeding the standard treatment's 9.5 months, suggesting that pelareorep offers durable efficacy in heavily pretreated patients, addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for accelerated approval if the observed data can be replicated.
- Strategic Investment and Expansion: The company is enhancing its strategic positioning in gastrointestinal oncology by expanding its Scientific Advisory Board, further solidifying its market presence in anal cancer and other indications.
See More
PDS Biotech Submits Amended Protocol for VERSATILE-003 Trial, Potentially Accelerating PDS0101 Approval
- Clinical Trial Advancement: PDS Biotech has submitted an amended protocol to the FDA for the VERSATILE-003 trial, aiming to change the progression-free survival (PFS) endpoint to a primary measure, potentially accelerating the approval process for PDS0101 and enhancing the company's competitive position in cancer immunotherapy.
- FDA Meeting Outcomes: The submission follows a constructive meeting with the FDA in December 2025, where the accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer was discussed, reflecting strong communication with regulators and boosting investor confidence.
- Clinical Data Support: Positive final results from the VERSATILE-002 trial provide data backing for this amendment, demonstrating promising median overall survival (mOS) and durable PFS, which may attract additional investment by validating the therapeutic potential of PDS0101.
- Clear Strategic Goals: CEO Frank Bedu-Addo, PhD, stated that the amendment retains mOS and safety as requirements for full FDA approval while offering a significant opportunity to shorten the duration of VERSATILE-003, highlighting the company's long-term strategic positioning in cancer treatment.
See More
PDS Biotechnology (PDSB) Receives Upgrade to Buy: Reasons Explained
Zacks Rank Upgrade: PDS Biotechnology (PDSB) has been upgraded to a Zacks Rank #2 (Buy), indicating a positive outlook on its earnings estimates, which are crucial for stock price movements.
Earnings Estimate Revisions: The Zacks Consensus Estimate for PDSB has increased by 9.4% over the past three months, reflecting analysts' growing confidence in the company's earnings potential.
Correlation with Stock Performance: There is a strong correlation between earnings estimate revisions and near-term stock movements, suggesting that PDSB's upgrade could lead to higher stock prices.
Zacks Rating System: The Zacks rating system maintains a balanced approach to stock ratings, with only the top 20% of stocks receiving a "Strong Buy" or "Buy" rating, positioning PDSB favorably for potential market-beating returns.
See More
PDS Biotechnology Secures FDA Meeting to Discuss Accelerated Approval for PDS0101
- FDA Meeting Approval: PDS Biotechnology's request for a Type C meeting with the FDA has been accepted, scheduled for this month to discuss the accelerated approval pathway for PDS0101 in HPV16-positive recurrent head and neck cancer, marking a significant advancement in the company's cancer immunotherapy efforts.
- Clinical Trial Results: The final results from the VERSATILE-002 trial demonstrated promising median overall survival and durable progression-free survival, providing data support for the accelerated approval of PDS0101, potentially shortening the regulatory approval timeline.
- Trial Design Change: The company plans to amend the VERSATILE-003 Phase 3 trial to change the progression-free survival endpoint to a surrogate primary endpoint that can be evaluated earlier, enhancing statistical power and laying the groundwork for accelerated approval, thereby increasing market competitiveness.
- Strategic Outlook: PDS Biotechnology's CEO stated that the positive progression-free survival data offers a crucial opportunity to shorten the duration to a primary endpoint, which is expected to expedite treatment availability, meet patient needs, and enhance the company's position in the cancer treatment market.
See More
PDS Biotechnology Amends Phase 3 Trial Protocol for Accelerated Approval
- Protocol Amendment: PDS Biotechnology Corporation announced an amendment to its Phase 3 VERSATILE-003 clinical trial protocol, adding progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer.
- Survival Endpoint Maintained: While PFS is added as an interim endpoint, the median overall survival (mOS) remains the primary endpoint, ensuring consistency with prior regulatory dialogues with the FDA, thereby enhancing the company's confidence in the regulatory approval process.
- Accelerated Approval Potential: By including PFS as an interim primary endpoint, the trial duration is expected to shorten, accelerating the timeline for regulatory submission while improving cost efficiency, further advancing the company's strategic positioning in cancer immunotherapy.
- Optimistic Market Outlook: PDS0101, as a targeted immunotherapy for HPV16-positive recurrent and/or metastatic head and neck cancer, developed in combination with standard immune checkpoint inhibitors, demonstrates strong market potential, aligning with the growing patient demand.
See More
Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer during the GOBLET Cohort 4, significantly exceeding the historical benchmark of 10%, indicating its crucial clinical value in a setting with no FDA-approved treatment options.
- Duration of Response: Among 14 evaluable patients, the median duration of response for pelareorep reached approximately 17 months, far surpassing the standard treatment's 9.5 months, showcasing the drug's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for potential accelerated approval if the data is validated.
- Strategic Investment and Expert Support: The company expanded its Scientific Advisory Board by adding three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, further strengthening its strategic positioning in the gastrointestinal oncology field.
See More
Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer patients during the GOBLET Cohort 4 study, significantly surpassing the historical benchmark of 10%, indicating the therapy's substantial potential in a patient population with no FDA-approved options.
- Duration of Response: The study also revealed a median duration of response of approximately 17 months, far exceeding the standard treatment's 9.5 months, suggesting that pelareorep offers durable efficacy in heavily pretreated patients, addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for accelerated approval if the observed data can be replicated.
- Strategic Investment and Expansion: The company is enhancing its strategic positioning in gastrointestinal oncology by expanding its Scientific Advisory Board, further solidifying its market presence in anal cancer and other indications.
See More
PDS Biotech Submits Amended Protocol for VERSATILE-003 Trial, Potentially Accelerating PDS0101 Approval
- Clinical Trial Advancement: PDS Biotech has submitted an amended protocol to the FDA for the VERSATILE-003 trial, aiming to change the progression-free survival (PFS) endpoint to a primary measure, potentially accelerating the approval process for PDS0101 and enhancing the company's competitive position in cancer immunotherapy.
- FDA Meeting Outcomes: The submission follows a constructive meeting with the FDA in December 2025, where the accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer was discussed, reflecting strong communication with regulators and boosting investor confidence.
- Clinical Data Support: Positive final results from the VERSATILE-002 trial provide data backing for this amendment, demonstrating promising median overall survival (mOS) and durable PFS, which may attract additional investment by validating the therapeutic potential of PDS0101.
- Clear Strategic Goals: CEO Frank Bedu-Addo, PhD, stated that the amendment retains mOS and safety as requirements for full FDA approval while offering a significant opportunity to shorten the duration of VERSATILE-003, highlighting the company's long-term strategic positioning in cancer treatment.
See More
PDS Biotechnology (PDSB) Receives Upgrade to Buy: Reasons Explained
Zacks Rank Upgrade: PDS Biotechnology (PDSB) has been upgraded to a Zacks Rank #2 (Buy), indicating a positive outlook on its earnings estimates, which are crucial for stock price movements.
Earnings Estimate Revisions: The Zacks Consensus Estimate for PDSB has increased by 9.4% over the past three months, reflecting analysts' growing confidence in the company's earnings potential.
Correlation with Stock Performance: There is a strong correlation between earnings estimate revisions and near-term stock movements, suggesting that PDSB's upgrade could lead to higher stock prices.
Zacks Rating System: The Zacks rating system maintains a balanced approach to stock ratings, with only the top 20% of stocks receiving a "Strong Buy" or "Buy" rating, positioning PDSB favorably for potential market-beating returns.
See More
PDS Biotechnology Secures FDA Meeting to Discuss Accelerated Approval for PDS0101
- FDA Meeting Approval: PDS Biotechnology's request for a Type C meeting with the FDA has been accepted, scheduled for this month to discuss the accelerated approval pathway for PDS0101 in HPV16-positive recurrent head and neck cancer, marking a significant advancement in the company's cancer immunotherapy efforts.
- Clinical Trial Results: The final results from the VERSATILE-002 trial demonstrated promising median overall survival and durable progression-free survival, providing data support for the accelerated approval of PDS0101, potentially shortening the regulatory approval timeline.
- Trial Design Change: The company plans to amend the VERSATILE-003 Phase 3 trial to change the progression-free survival endpoint to a surrogate primary endpoint that can be evaluated earlier, enhancing statistical power and laying the groundwork for accelerated approval, thereby increasing market competitiveness.
- Strategic Outlook: PDS Biotechnology's CEO stated that the positive progression-free survival data offers a crucial opportunity to shorten the duration to a primary endpoint, which is expected to expedite treatment availability, meet patient needs, and enhance the company's position in the cancer treatment market.
See More
