In a massive deal that is one of the year’s biggest, Akeso Inc. signed a collaboration and license deal with Summit Therapeutics Inc. to out-license its bispecific antibody, ivonescimab (AK-112), for development and commercialization in the U.S., Canada, Europe and Japan.

All gains made throughout the summer have vanished as the BioWorld Cancer Index (BCI) has hit its lowest point in 2022. Down 41.9% this year, BCI diverged in October from the path taken by both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA), both of which are moving upward. Still, NBI is down 7.8% and DJIA is down 5.4% for the year.

Rigel Pharmaceuticals Inc.’s ahead-of-deadline approval from the U.S. FDA of Rezlidhia (olutasidenib) twice-daily capsules for adults with relapsed/refractory (r/r) acute myeloid leukemia (AML) came as a surprise to the company, but followed encouraging interactions, “including a very positive midcycle review meeting,” said CEO Raul Rodriguez, adding that the firm will “redouble our efforts to make sure we're able to convey the information supporting this product” to the marketplace. Regulators had assigned the compound a Feb. 15, 2023, PDUFA date.

Rgenta Therapeutics Inc.’s $52 million in a series A money will let the RNA-focused firm pursue its small-molecule drug efforts “for the next two or three years,” as candidates in cancer and neurology make their ways toward the clinic, said co-founder and CEO Simon Xi. “We’ll go where the science leads us,” he told BioWorld, adding that the cash on hand is sufficient to complete a phase I study.

Astrazeneca plc is beefing up its cell therapy capabilities in immuno-oncology by acquiring Neogene Therapeutics BV for an initial outlay of $200 million. There’s up to $120 million more on the table for undisclosed milestones and what the companies called a “non-contingent consideration.” Even without the additional earnouts, the deal represents a profitable return for Neogene’s shareholders. The Amsterdam-based firm had raised $110 million in a series A round in 2020, which represented the largest A round in Europe that year. Since then, it has started to move its first program, an autologous engineered T-cell receptor (TCR) T-cell therapy directed against up to five neoantigens, toward a phase I trial in patients with solid tumors.

Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval.

A combination of radiation therapy and CD47 blockade induced an abscopal effect in animal studies even in animals that lacked T cells, researchers reported in the Nov. 21, 2022, online issue of Nature Cancer. The findings are “the first demonstration of T-cell-independent abscopal response,” co-corresponding author Edward Graves told BioWorld. “We’re not trying to say that all abscopal responses are macrophage-mediated. There are plenty that require T cells,” Graves clarified. But “there is another avenue of abscopal responses that has not been reported. ... All the abscopal literature is about stimulating an adaptive response.”

Swiss-American startup Opna Bio SA launched this week with a $38 million series A, a Science paper on one of its targets and a pipeline stretching from preclinical to phase II.