Incyte Corp.’s retifanlimab-dlwr received its first regulatory nod on March 22, with the U.S. FDA granting accelerated approval for the PD-1 inhibitor to treat adults with a rare form of skin cancer, advanced Merkel cell carcinoma.
It’s been a rough year at Macrogenics Inc., but times may be changing. Having terminated a phase II study due to fatalities, dropped 15% of its workforce and closed research and manufacturing sites in the past year, the company has taken the helping hand of Gilead Sciences Inc. The pair have agreed to develop the bispecific MGD-024, which has a CD3 component for minimizing cytokine release syndrome, as an oncology candidate along with two additional bispecific research programs, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes.
Seven fatalities that could be related to hemorrhagic events in Macrogenics Inc.’s phase II trial of the monoclonal antibody enoblituzumab for treating head and neck cancer has led to the study’s closure.
Despite three mammoth deals signed for antibody-drug conjugates, the BioWorld Cancer Index (BCI), which ended last year down 36%, has fallen another 35% in the early months of 2022. It is a much sharper decline than that seen with the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are down 18% and 7.5%, respectively.
LONDON – Another month, another deal for antibody-drug conjugate (ADC) specialist Synaffix BV, which has sealed a $586 million, three-target agreement with Macrogenics Inc. No details of the targets or the indications were disclosed, but Synaffix CEO Peter van de Sande said this is “an important milestone” because it will be the first time the company’s linkers and payloads have been attached to a bispecific antibody.
With the July 25 PDUFA priority review date looming for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic anal cancer, the FDA has one voting question for its Oncologic Drugs Advisory Committee (ODAC): Should it hold off on its approval decision until more data are in from a phase III study?
Zai Lab Ltd. and Macrogenics Inc. have announced a collaboration and license agreement involving up to four immuno-oncology molecules in a deal potentially worth upward of $1.5 billion. The deal makes sense as both are upcoming companies at around the same stage in development – making progress in oncology with first products recently approved by regulators.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 May 27 that the benefits of Provention Bio Inc.’s teplizumab outweighed its risks, but the vote was not a ringing endorsement of the anti-CD3 monoclonal antibody biologic that could be the first disease-modifying treatment for people at risk of developing type 1 diabetes (T1D).
According to the BioWorld Cancer Financings Report, 2020 proved to be a record year in terms of capital raised by biopharmaceutical companies working on therapeutics for cancer indications.
Macrogenics Inc., which started the year with a pipeline prioritization, ends 2020 with its first FDA approval. The agency cleared its HER2-targeting Fc-engineered monoclonal antibody margetuximab in combination with chemotherapy for use in patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
