Shares of the thinly traded, nano-cap biotech PDS Biotechnology Corp PDSB were rallying strongly Thursday on above-average volume.
What Happened
PDS, which engages in the development of multifunctional immunotherapic products, announced a modified clinical trial collaboration agreement with Merck & Co., Inc. MRK.
PDS' lead Versamune-based immunotherapy PDS0101 will be evaluated in a Phase 2 trial in combination with the latter's anti-PD-1 therapy Keytruda as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16, or HPV16, infection.
The modification follows the recent FDA approval for Merck's Keytruda as a monotherapy in patients whose tumors express PD-L1, or in combination with platinum and fluorouracil for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.
PDS0101 is PDS' proprietary clinical-stage immunotherapeutic administered by subcutaneous injection to treat HPV-associated cancers.
Why It's Important
"We are honored to collaborate with Merck, a proven leader in the field of immuno-oncology to evaluate novel investigational combination therapies that have the potential to further improve the lives of cancer patients," said Dr. Lauren Wood, chief medical officer at PDS, said in a statement.
Recently released Phase 1 data that evaluated the PDS0101 monotherapy demonstrated unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses in a majority of evaluable patients, according to PDS.
A lack of dose-limiting toxicities at all tested doses was observed, the company said.
The companies did not disclose the details of the collaboration.
What's Next
PDS is the portfolio company of London-listed Netscientific Plc. On the collaboration news, Netscientific shares were rallying over 75% on the London Stock Exchange.
At last check, PDS shares were adding 23% to $3.69.
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