News briefing: Four biotechs announce IPO terms, setting the pace to round out a busy year; FDA sets PDUFA date for Kadmon's graft-versus-host drug
Four more biotechs set the terms for their IPOs, lining up yet another busy week on Wall Street.
Silverback Therapeutics, which initially filed for a $100 million raise, is now shooting for $125 million from 7 million shares at a range of $17 to $19. About $70 million is tagged for the company’s lead Phase I/Ib antibody-drug conjugate, SBT6050, for advanced or metastatic HER2-expressing solid tumors. Interim data from the Phase I dose-escalation cohorts are expected in the second half of 2021. Another $55 million is set aside for Silverback’s two other candidates, which have yet to reach the clinic.
Kinnate Biopharma is looking for a $170 million raise, and set a $16 to $18 range for its 10 million share offering. About $105 is earmarked for its RAF inhibitors, including its lead preclinical candidate KIN002787 for patients with lung cancer, melanoma and other solid tumors. An IND is coming in the first half of 2021, the company says. Back in August, it hooked a $98 million Series C.
Seer also set its shares at a $16 to $18 range. The company, which is working on next-gen proteome analysis tests, is offering 8.8 million shares, going for a $150 raise. About $65.0 million would go to its Proteograph Product Suite, which already has one collaborator and could have a second by the end of the year.
Sigilon Therapeutics is seeking $101 million from 5.6 million shares at a $17 to $19 range. Between $30 to $35 million will be set aside for its lead candidate, SIG-001, which is in a Phase I/II trial to prevent bleeding episodes in patients with hemophilia A. Another $30 to $35 million would fund a scale-up of the company’s GMP manufacturing processes SIG-001 and SIG-005, its preclinical candidate for patients with mucopolysaccharidosis type 1, or MPS-1.
More than 72 biotech and biopharma companies and counting have hit Nasdaq so far this year, and head of healthcare listings Jordan Saxe predicted rounding out the year with just under $14 billion in proceeds.
FDA sets PDUFA date for Kadmon’s graft-versus-host drug
Kadmon’s chronic graft-versus-host drug belumosudil is in the FDA’s hands.
The agency accepted the biotech’s NDA under its real-time oncology review (RTOR) pilot program, and set the PDUFA date for May 30, 2021. The submission was based on positive results from a pivotal, open-label trial dubbed ROCKstar, which enrolled 132 patients who had received at least two prior lines of therapy.
Belumosudil is designed to tamp down the inflammatory response seen after hematopoietic stem cell transplant by blocking Rho-associated coiled-coil kinase 2 (ROCK2). Instead of a comparator arm, Kadmon set the bar at a 30% overall response rate, based on conversations with the FDA. Patients were given 200 mg of the drug either once or twice daily. At six months after the completion of enrollment, Kadmon saw an ORR of 73% and 75% in the respective arms.
That’s it for data, until the full report is read out at ASH in December. The company’s stock $KDMN was up 6.68% on Monday, at $4.39 per share. Kadmon was founded by Sam Waksal, the biotech exec who was sentenced to prison for his insider trading conviction involving Martha Stewart.
Hookipa Pharma reads out interim results from Phase II CMV vaccine trial
Hookipa Pharma said no one from a small group of Phase II participants treated with its prophylactic cytomegalovirus vaccine came down with the disease, according to interim results.
The analysis was based on 41 participants — 8 of whom received 3 doses, 19 of whom received 2 doses, and 14 of whom received a placebo. Compared to the placebo, researchers saw a 48% reduction in CMV viremia, and a 42% reduction in the use of antiviral therapy. There were no cases of CMV disease in the treatment arm, compared to 2 in the placebo group.
“While these interim data are from a small group of patients, they offer early insight into the potential of a three-dose schedule of HB-101 to help protect kidney transplant recipients against CMV disease,” CEO Joern Aldag said in a statement.
The candidate is going head-to-head with Moderna’s mRNA-1647, which produced positive results from a proof-of-concept study back in January. Researchers said they saw an increasing level of neutralizing antibody titers in those who had received a third vaccination.
“This could really be a company builder,” CEO Stéphane Bancel said at the time, adding that the candidate could turn into a $2 billion to $5 billion annual franchise.