CYT-1853

Cyteir Therapeutics ended 2022 with $147 million in cash and equivalents, although the redundancies are likely to skim off up to $3 million in the coming weeks. Back in the summer, Cyteir Therapeutics announced that it was pressing pause on plans to get one of its cancer meds into the clinic. But it’s only now that we’re seeing the fallout of the decision to focus on its lead ovarian cancer asset—in the form of laying off 70% of its workforce. The biotech reaffirmed the prioritization of CYT-0851 in a postmarket release yesterday. The monocarboxylate transporter inhibitor in combination with capecitabine chemotherapy had produced “encouraging preliminary clinical activity” in a small number of patients with advanced ovarian cancer in a phase 1 dose-escalation study, the company noted. Cyteir now plans to enroll more patients in the first half of the year to see whether the clinical results are sustained. The aim is to identify a maximum tolerated dose for the capecitabine combo in the next three months and push through to development and market as an oral treatment for platinum-resistant ovarian cancer. The biotech also has a separate phase 1 trial running of CYT-0851 in combination with gemcitabine chemotherapy in solid tumors, for which 10 patients have so far been treated. Dosing data from this trial may be used as part of Cyteir’s development plans for the therapy. But going all-in on CYT-0851 as a combo treatment for ovarian cancer comes at a price. To extend the biotech’s cash runway into 2026, Cyteir is reducing its head count to just 15 employees as well as halting R&D work on identifying inhibitors of DNA damage repair. “We are encouraged by these early signals and believe that an initial focus on the combination of CYT-0851 and capecitabine represents the greatest likelihood of success and an opportunity to serve patients with advanced ovarian cancer that have a high unmet medical need,” CEO Markus Renschler, M.D., said in the release. “This strategic prioritization and the difficult decision to reduce our workforce is expected to extend our cash runway into 2026 and, if supported by the data and regulatory feedback, allows us to advance CYT-0851 into a potentially registrational trial as early as the second half of 2024.” Also left by the wayside are plans to develop CYT-0851 as a monotherapy in solid tumors. The biotech is suspending a phase 2 trial due to insufficient activity, it said in the same release. Change was already in the air at Cyteir last August when the company announced it would halt work on CYT-1853. The biotech had originally laid out plans to get the monocarboxylate transporter inhibitor into the clinic by the end of 2022, but the candidate was sacrificed to save cash. After raising $29 million in early 2018, Cyteir joined the public biotech boom just as it was beginning to slide, closing a $133.2 million IPO in June 2021. Since then, the company’s shares have crumbled, falling from $17.40 to $1.53. Cyteir ended 2022 with $147 million in cash and equivalents, although the redundancies are likely to skim off up to $3 million in the coming weeks.

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) 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 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