Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
U.S. Health and Human Services Secretary Xavier Becerra is getting more pressure to take the unprecedented step of marching in on the patent rights protecting Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. Referencing the provision under the Bayh-Dole Act that allows federal agencies to march in on licensed patents stemming from federally funded research when the products are not available to the public on “reasonable terms,” a dozen Democratic congressional members wrote to Becerra Feb. 8 urging him to move forward on the Xtandi patents.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
Wall Street nicked shares of Karyopharm Therapeutics Inc. after the firm offered top-line results from the 263-subject phase III study with Xpovio (selinexor) in advanced or recurrent endometrial cancer (EC). Shares (NASDAQ:KPTI) closed at $8.19, down $2.05, or 20%, having dropped as low as $7.66.
Endeavor Biomedicines Inc.’s $101 million series B round will let the firm forge ahead with ENV-101 (taladegib), a small-molecule inhibitor of the PTCH1 receptor in the Hedgehog signaling pathway, for cancer and idiopathic pulmonary fibrosis (IPF), as well as ENV-201, described as a potentially best-in-class small-molecule inhibitor of ULK1/2 in KRAS-driven cancers.
“The premise of our whole company is that we target molecular machines, but we don’t target the engine,” Adrian Schomburg told BioWorld. Instead, “we interfere with the throttle and other highly specific controls of these machines.” “We,” in this case, is Eisbach Bio GmbH, a German startup that is developing anticancer programs aimed at exploiting synthetic lethality by targeting helicases. Founded in 2019, the company has three programs, a recently announced collaboration with MD Anderson Cancer Center in oncology, and another program in COVID-19.
The dosing by Vincerx Pharma Inc., in mid-December of last year, of the first patient in the phase I study with VIP-152 marked the second experiment begun by the company in 2021, and added oomph to the already-growing renewal of interest in CDK9 as a therapeutic target.
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.
Mersana Therapeutics Inc. has signed a potential billion-dollar agreement with Johnson & Johnson’s Janssen Biotech Inc. to research and develop antibody-drug conjugates (ADCs) for three cancer targets. Janssen will pay $40 million up front as well as more than $1 billion in potential milestone payments in a big day for ADCs, which saw Mersana’s other development partner, Synaffix BV, announce a tie-up with Macrogenics, Inc. in a deal worth up to $586 million.
LONDON – “I really believe we can start using the word cure,” said the pioneer of chimeric antigen receptor T-cell (CAR T) therapy Carl June, as he revealed two leukemia patients he treated in a phase I trial have now been in remission for 10 years. Both patients with chronic lymphocytic leukemia achieved complete remission shortly after treatment in 2010. The genetic modification has remained detectable in their CAR T cells for more than 10 years of follow-up, June said, describing details of the case studies published in Nature Feb. 2.
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