The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
Five months after the first anti-CD20xCD3 T-cell engaging bispecific antibody, Roche Holding AG’s Lunsumio (mosunetuzumab), cleared U.S. FDA approval for follicular lymphoma, partners Genmab A/S and Abbvie Inc. won the agency’s approval for epcoritamab as the first subcutaneous CD20xCD3 bispecific antibody for treating diffuse large B-cell lymphoma.
The advent of bispecific antibodies bridging two different cell types has enabled a new level of cell specificity in cancer biology that has only recently begun to be realized in the clinic.
After more than two decades of working together, Genmab A/S has entered a new licensing agreement with Scancell Holdings plc to gain the exclusive rights to develop and commercialize an anti-glycan monoclonal antibody. All potential disease areas except cell therapy applications are on the table in the deal. Genmab will make an up-front payment of an undisclosed amount to Scancell as well as covering milestone payments of up to $208 million for each candidate that’s developed and commercialized. The amount is capped at $624 million to Scancell if Genmab manages to develop and commercialize products across all modalities the companies have defined. Scancell could also receive single-digit royalties on the net sales of products.
Genmab A/S, of Copenhagen, Denmark, said it intends to file a BLA with the U.S. FDA for its subcutaneous bispecific antibody epcoritamab, for patients with relapsed/refractory large B-cell lymphoma in the second half of 2022.
LONDON - Synaffix BV’s third-generation linker and payloads have attracted therapeutic antibody veteran Genmab A/S in a potential S415 million licensing deal.
Little more than six months after filing a BLA for the antibody-drug conjugate (ADC) tisotumab vedotin in recurrent or metastatic cervical cancer, Seagen Inc. and Genmab A/S have secured an accelerated approval for the medicine. The green light for the co-developed product marks Seagen's third approved ADC and Genmab's first marketed therapy, though another medicine based on its Duobody technology platform recently won approval, too. The new cervical cancer drug, to be marketed as Tivdak, was approved for the treatment of adults experiencing disease progression on or after chemotherapy.
The always-busy American Society of Hematology meeting in December promises to include some especially intriguing datasets from the bispecific antibody space, as multiple players are likely to unveil findings related to their CD20xCD3 prospects.
DUBLIN – Shares in Genmab A/S gained 5% during trading on Nasdaq June 10 on news of an oncology alliance with Abbvie Inc., in which it is banking $750 million up front and up to $3.15 billion in development, regulatory and commercial milestones for up to seven next-generation antibody-based therapeutics.
Significant progress is being made in the development of next-generation treatments for multiple myeloma. For that reason, investors and industry analysts alike will be anxiously awaiting the abstracts for the upcoming American Society of Hematology (ASH) annual meeting.
