Regenerative medicine company Mesoblast Ltd. plans to raise AU$97 million (US$64.5 million) to conduct additional phase III registration trials for its allogeneic stem cell treatment for steroid-refractory acute graft-vs.-host disease and for chronic back pain, as required by the U.S. FDA.
Acelyrin Inc. said a vendor used by Fortrea Inc., a CRO the company used for its phase IIb/III study testing interleukin-17A inhibitor izokibep in psoriatic arthritis, incorrectly programmed the study’s protocol and created a dose sequencing error, resulting in some patients in two of the four dosing arms to randomly receive placebo and active treatment instead of the intended alternating pattern. The discovery has prompted a review of other studies involving the CRO, including a study that failed to reach statistical significance in September.
Newco T-Therapeutics Ltd. has raised £48 million (US$59 million) in a series A to advance development of T-cell receptors generated by its transgenic mouse platform for the treatment of solid tumors, autoimmune diseases and infections.
The blowup in phase II with Aclaris Pharmaceuticals Inc.’s oral MK2 inhibitor zunsemetinib (ATI-450) for moderate to severe rheumatoid arthritis (RA) sent shares (NASDAQ:ACRS) into a tailspin and sparked Wall Street speculation about the firm’s other mid-stage prospect. Wayne, Pa.-based Aclaris’ stock ended Nov. 13 at 64 cents, down $4.11, or 86%, after investors learned that ATI-450 missed the study’s primary and secondary endpoints. Development of the candidate, which was also under phase IIa investigation in psoriatic arthritis, will be stopped.
Nearly a year and a half after an interim analysis cast doubt on the future of Atara Biotherapeutics Inc.’s phase II study of ATA-188 in treating non-active progressive multiple sclerosis (PMS), the newly released primary analysis didn’t change much.
Top-line results from Moonlake Immunotherapeutics AG’s phase II study of sonelokimab treating active psoriatic arthritis encouraged the company but discouraged investors.
A new deal between privately held Hummingbird Bioscience Pte. Ltd. and Endeavor Biomedicines Inc. is just one of three antibody-drug conjugate (ADC) agreements reached in the past week, marking a fourth-quarter surge for the therapy. Endeavor has acquired the exclusive, worldwide rights to Hummingbird’s HMBD-501, a HER3-targeted ADC with an exatecan payload. Hummingbird could receive up-front and milestone payments of up to $430 million, along with royalties from net sales.
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news.
Nkarta Inc. is looking to return to the heady heights it hit three years ago when its shares were going for around $70 each. The company is reinventing itself as a cancer fighter and branching out as an autoimmune specialist. Nkarta joins at least four other companies looking at expanding their cell therapies into other autoimmune indications.
Astria Therapeutics Inc.’s potential $320 million deal with Ichnos Sciences Inc. to bring aboard an OX40 portfolio for atopic dermatitis puts the firm in line to compete with big pharma, which is trying – at a much later stage – the same mechanism of action.
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