Penny stock biotech misses on its sole clinical trial; Caladrius teams up with Roche for pancreatic cancer collaboration

10 Aug 2022
endpts.com
ImmunotherapyAcquisition
Vyne Therapeutics had put all its clinical focus on one drug: FMX114 for mild-to-moderate atopic dermatitis. However, that trial, VYNE’s only ongoing clinical trial, has now sunk. The New Jersey biotech put out word Wednesday that the trial failed to meet its primary endpoint, listed as the change in an atopic dermatitis measure (known as ADSI) over one month. The Phase IIa trial enrolled 21 patients. The biotech’s share price went down more than a third after the announcement, with $VYNE now trading on the Nasdaq at 26 cents a share. “As a result of this outcome, our management team and our board of directors will evaluate the Company’s pipeline and prioritization of activities,” Vyne CEO David Domzalski said in a statement. — Paul Schloesser Caladrius Biosciences and its merger partner Cend Therapeutics will be collaborating with Roche to look at Cend’s lead drug, dubbed CEND-1, in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab)PD-L1 inhibitor Tecentriq (atezolizumab) for the treatment of metastatic pancreatic ductal adenocarcinoma. The agreement has Roche in charge of managing the trial, while Cend and Roche share equally in the costs of the CEND-1 treatment arms in the study. “We are committed to exploring applications of CEND-1 to improve clinical outcomes for patients with this deadly disease. This collaboration represents a desire to explore a novel combination that may enable immunotherapy to benefit pancreatic cancer patients, who, to date, have not benefited broadly from this important emerging class of anti-cancer treatments,” said Cend CEO David Slack. The drug has gone through a Phase Ib clinical trial with the results posted in The Lancet . Additionally, a Phase IIb trial of CEND-1 in combination with chemotherapy has also kicked off. — Tyler Patchen A biotech developing oral chelators to treat radiation and heavy metal poisoning is now going to Nasdaq through a SPAC merger. Captura Biopharma and SPAC OceanTech Acquisitions I Corp jointly announced Wednesday that the pair had reached a deal after approval by the board of directors at each company. OceanTech is already on Nasdaq and trading under the ticker $OTEC . The combined company is expected to stay on Nasdaq sometime after the deal closes, which the companies said is expected to happen in Q4 this year. The combined company, which will be named Captura Biopharma Holdings, will have an approximate market capitalization at around $224 million, assuming a share price of $10 each. “We believe the merger with OceanTech will provide us with greater opportunity to take advantage of improved access to capital markets and to finance our growth,” Captura CEO Michael Geranen said in a statement. — Paul Schloesser The Massachusetts biotech Cyteir Therapeutics is rethinking some aspects of its pipeline. According to Cyteir CEO Markus Renschler in the company’s Q2 report, it has made the strategic decision to postpone the IND for its RAD51 inhibitorRAD51 inhibitor CYT-1853. The company will put all of its financial focus on its lead asset CYT-0851, which it is testing in a variety of cancers. The company said data on CYT-0851 in solid tumor studies will be coming later this year, followed by an initial readout in blood cancers next year. The report also detailed that Cyteir has stopped further enrollment for its Phase II multiple myeloma trials for CYT-0851 alone and in combination. The company said this decision was based on the “evolving treatment landscapes” for multiple myeloma and diffuse large B-cell lymphoma, as well as the viability of development as more competition is present. This move will see Cyteir operate through the second half of 2024, it reported. — T yler Patchen
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