Being in a crowded space doesn’t bother recently installed Arch Oncology Inc. CEO Laurence Blumberg. As a matter of fact, he’s reassured by it. “There’s a lot of competition in CD47, that’s correct,” Blumberg told BioWorld. “But having been in industry for a long time, competition and the magnitude of that competition in pursuit of a target usually means there’s a good reason for that interest and that there’s compelling evidence it has utility.”
As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
Twenty years after the first, exclusively white human genomes were fully sequenced, science finds itself in the same position as the rest of society: with the uncomfortable realization that old inequalities are often morphing, rather than disappearing.
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
DUBLIN – Isotopen Technologien München (ITM) AG raised €90 million (US$108 million) in debt financing to complete phase III development of its lead radiopharmaceutical, solucin, in gastroenteropancreatic-neuroendocrine tumors and to take forward several more preclinical pipeline projects.
The enzyme proprotein convertase subtilisin/kexin type 9 (PCSK9) plays a major role in the regulation of blood LDL cholesterol levels. Now, new research shows that targeting PCSK9 may also potentiate checkpoint blockade.
Another PD-1 antibody is about to hit the U.S. market, following the FDA’s accelerated approval of dostarlimab (TSR-042) from partners Anaptysbio Inc. and Glaxosmithkline plc. But dostarlimab, branded Jemperli, will be only one of two PD-1 drugs indicated for endometrial cancer, going up against Merck & Co. Inc.’s Keytruda (pembrolizumab).
HONG KONG – Qilu Pharmaceutical Ltd. has inked a deal for the global rights to Peptron Inc.’s antibody-drug conjugate (ADC) candidate PAb-001-ADC for the treatment of various cancers. Seoul, South Korea-based Peptron stands to receive an up-front payment of $3 million and $539 million in milestone payments, as well as royalties.
Genome editing startup Edigene Inc. closed a ¥400 million (US$62 million) series B+ round to expand its operation to more cities and advance its lead product ET-01 into clinical trials. The financing follows the $67 million series B that closed in October 2020.
OS Therapies LLC, the developer of a listeria-based cancer vaccine to prevent metastasis and increase overall survival in young people with osteosarcoma, has closed on a $6 million series A financing led by Noble Capital Markets and Tichenor Ventures. The funds will help the company advance its lead candidate, OST-HER2, into a phase IIb trial this year with hopes of a potential FDA filing by in 2022.
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