Tessa gets RMAT designation for new CAR-T; FDA adcomm narrowly votes to expand Eli Lilly NSCLC label
→ Tessa Therapeutics has received a Regenerative Medicine Advanced Therapy designation for its experimental CAR-T therapy. The therapy, which showed a 67% complete response rate in two trials covering 27 patients, is being developed for relapsed and refractory Hodgkin’s lymphoma. A pivotal Phase II trial is expected for fall of this year.
→ Jim Wilson’s preclinical biotech — focused on developing gene therapies for rare CNS disorders — has expanded its proposed share offering for its upcoming IPO. It now plans to raise $170 million by offering 10 million shares at a price range of $16 to $18. Previously it had set the goal at $126 million by offering 7.4 million shares within the same price range. At the midpoint, the Philadelphia, PA-based company could command a fully diluted market value of $757 million, according to Renaissance Capital. Founded in 2017, Passage Bio will make its debut on the Nasdaq under the symbol $PASG.
→ Six weeks after posting disappointing results from a Phase II cystic fibrosis trial, Eloxx Pharma is cutting staff to save cash and hiring a new chief executive. Thirteen staffers will lose their jobs, although it’s not clear from which levels. Gregory Williams, a former Medicines Company executive, has been promoted to CEO as part of the shakeup, as longtime biotech executive Rob Ward sees the exit. The company’s stock has tumbled precipitously over the last 2 years, but they’re hoping another CF Phase II readout expected for the first half of this year will boost their sails.
→ Of the $2.5 billion that the Trump administration has requested from Congress to battle the coronavirus in the US, more than $1 billion will be dedicated to creating a vaccine, Bloomberg reported. Therapeutic programs were also among the priorities.
→ Puma Biotechnologies has received a supplemental approval for its tyrosine kinase inhibitor neratinib. The drug, which had been approved under the brand name Nerlynx as an adjuvant treatment for early-stage HER2 positive breast cancer, can now be used on advanced and metastatic HER2 positive patients who have received at least 2 prior anti-HER2 therapies in the metastatic setting.
→ An FDA advisory committee narrowly voted 6-5 in favor of expanding the approval of Eli Lilly‘s cancer drug Cyramza. Already approved as a therapy for several cancers, including certain forms of non-small cell lung cancer, the drug is up for review as part of a combination treatment for metastatic EGFR-mutated NSCLC. The committee considered results from a 449-person Phase III trial in which patients on the drug lived 7 months longer than those on placebo. The FDA generally follows committee decisions but is not obligated to do so.
→ Ascletis Pharma announced it is advancing on a clinical trial testing a combination of Ganovo, a hepatitis drug, and ritonavir, an HIV drug, against novel coronavirus pneumonia after 3 patients were discharged from the hospital following treatment. Ritonavir is one of several HIV protease inhibitors being tested against the virus, known as SARS-CoV2. An article in Nature Reviews Drug Discovery in early February noted these drugs were potentially effective, but it’s not yet clear how well they will inhibit the proteases in coronaviruses, which belong to a different family than HIV proteases. The article also mentioned hepatitis C drugs as potential treatments.