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PDS Biotech (PDSB) Up 32% on Interim Data From HPV Cancer Study

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PDS Biotech (PDSB - Free Report) stock surged almost 32% as it announced promising interim data from its phase II VERSATILE-002 clinical study, aimed at treating patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.

The mid-stage study, VERSATILE-002, is an open-label study being conducted across multiple centers. It aims to evaluate the efficacy and safety of its lead candidate PDS0101, which is administered in combination with Merck’s (MRK - Free Report) anti-PD-1 therapy — Keytruda (pembrolizumab). The therapy helps immune cells kill cancer cells better for different cancer indications.

VERSATILE-002 includes two patient populations — Immune checkpoint inhibitor (ICI)-naïve patients and those with previously failed treatments, including ICI therapy.

The majority of the 48 patients enrolled in the ICI-naïve cohort were males aged 62.5 years, who received at least one cycle of the combination treatment. The estimated 12-month overall survival rate was 87.1%, significantly higher than the published results of 36-50% when using approved ICIs alone.

The median progression-free survival for patients treated with the combination therapy was 10.4 months. The disease control rate, which includes disease stabilization or tumor shrinkage, was 70.6% among those who participated in the study.

Results from the study were presented at the 2023 American Society of Clinical Oncology Annual Meeting in Chicago.

Shares of PDS Biotech have fallen 49.1% year to date compared with the industry’s 7.5% decline. 

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Last week, the company completed enrollment in the ICI-naïve group. The same in the ICI refractory group was completed in December 2022. PDS0101, in combination with Keytruda, was granted Fast Track designation in June 2022.

This designation is designed to aid in the development and acceleration of the review of drug candidate applications that could potentially treat serious or life-threatening conditions.

Keytruda is already approved for the treatment of many cancers globally. The drug is continuously growing and expanding into new indications and markets. In the first quarter of 2023, Merck recorded $5.8 billion from Keytruda product sales.

Based on this encouraging data, PDSB plans to initiate the phase III study (VERSATILE-003) by the end of this year. 

PDS0101 is also being evaluated in triple combination with M9241 (now PDS0301) and bintrafusp alfa for HPV-16 patients with head and neck squamous cell carcinoma. The study is being led by National Cancer Institute. 

PDS Biotech is advancing its development candidates — PDS0102, PDS0103 and PDS0104 — targeting different cancer indications.

Zacks Rank and Stocks to Consider

Currently, PDSB carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the same sector are ADMA Biologics (ADMA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

Loss per estimates for ADMA have narrowed from 19 cents to 9 cents for 2023 in the past 60 days. Shares of ADMA have risen 1.6% in the year-to-date period.

ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the mark in one, delivering an average surprise of 19.3%. 

Loss per share estimates for Allogene have narrowed from $2.45 to $2.31 for 2023 and from $2.48 to $2.21 for 2024 in the past 60 days. Shares of ALLO have plunged 13.1% in the year-to-date period. 

Allogene’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 5.08%.

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