Founder and Chief Technology Officer Nello Mainolfi told BioWorld that Kymera Therapeutics Inc. will disclose more in the months ahead about its lead compound, which sits at "the juncture between oncology and inflammation" and has been widely implicated in hematological cancers as well as other conditions. Meanwhile, the Cambridge, Mass.-based firm's $65 million series B round will push that prospect into the clinic and advance the pipeline of other candidates in cancer and immunology. So far, the Pegasus protein degradation platform has yielded preclinical data packages that support drug-like properties of Kymera's assets as well as differentiated pharmacology, Kymera said.
Harpoon Therapeutics Inc.'s series C financing of $70 million plus cash on hand "basically enables all four of [our] development programs" to enter the clinic, CEO Gerald McMahon told BioWorld. "Near-term, we'll have clinical data on the first two in the 2019-2020 time frame."
Cabaletta Bio Inc. CEO Steven Nichtberger noted that his firm is "not the first to develop chimeric T cells as therapeutics, [but] we are the first to develop them in a way that leverages the potential of T cells to specifically eliminate only the B cells that cause autoimmune disease, thus sparing the healthy cells," and he told BioWorld that the lead indication – mucosal pemphigus vulgaris (PV) – represents a "hallmark for potential efficacy in a whole host of B-cell-mediated autoimmune diseases."
During a recent conference call by Oppenheimer & Co. to advise investors about what's ahead and point out valuable names in the sector, analyst Hartaj Singh took a high-altitude view, calling this "a weird time" for raising money when compared to trends in previous eras.
On the regulatory front Friday, one pain drug company, Trevena Inc., lost and another, Acelrx Pharmaceuticals Inc., won, as the FDA – just for good measure – also cleared a biosimilar product from Coherus Biosciences Inc. in a busy afternoon of notifications.
As expected, Dublin-based Alkermes plc encountered rough waters in the joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which deliberated over ALKS-5461 sublingual tablets for the adjunctive treatment of major depressive disorder (MDD).
Tango Therapeutics Inc.'s immuno-oncology (I-O) deal with Gilead Sciences Inc. brings "substantial preclinical milestone [payments], substantial enough that they move the needle for us on our financing timeline," CEO Barbara Weber told BioWorld.
Alkermes plc's decision – against the advice of the FDA – to use an abbreviated, six-item version of the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) in Study 207, one of the main trials with ALKS-5461 (buprenorphine/samidorphan), became a bone of contention in briefing documents made public ahead of Thursday's adcom meeting.
Although a few skeptics remain, Esperion Inc.'s top-line data from its pivotal phase III study known as Study 2, or 1002-047, with bempedoic acid (BA) for lowering LDL-C seemed to lay mostly to rest the worries brought on by five neoplasm (lung cancer) deaths in Study 1. "When we think back to May [when data from Study 1 with BA were disclosed], the issue was really: What is the perceived meaningfulness of what we called and still call the spurious result?" CEO Timothy Mayleben told BioWorld.
In the company's second program with UX-007 (triheptanoin, or trihep), Ultragenyx Pharmaceutical Inc.'s data are "much more robust" – enough so that the FDA recently said the firm could file an NDA based on phase II findings, spokesperson Danielle Keatley told BioWorld.
