Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one.
BEIJING – Suzhou, China-based Ascentage Pharma Group Inc. said on Monday that it is working with Astrazeneca plc’s hematology R&D unit, Acerta Pharma, to develop a combination therapy of its Bcl-2 inhibitor, APG-2575, with Acerta's BTK inhibitor, Calquence (acalabrutinib). The first patient has been dosed in the U.S.
On June 17, the FDA approved checkpoint blocker Keytruda (pembrolizumab, Merck & Co. Inc.) “for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.”
About six months after Epizyme Inc. won FDA clearance of Tazverik (tazemetostat) for epithelial sarcoma (ES), the firm scored accelerated approval in the larger indication of relapsed or refractory (r/r) follicular lymphoma (FL). Specifically, U.S. regulators cleared the methyltransferase inhibitor for adults whose tumors test positive for an EZH2 mutation who have received at least two prior systemic therapies and for those with no satisfactory alternative treatment options – language that “gives physicians a lot of flexibility to use their clinical judgement in how to best prescribe” the drug, CEO Robert Bazemore noted.
Orca Bio Inc.’s $192 million series D brings the company out of stealth and openly into the business of transforming allogeneic cell therapies. The new funding brings Orca’s total capital raised since 2016 to nearly $300 million.
DUBLIN – Lassen Therapeutics Inc. is following the Enleofen Bio Pte Ltd. playbook by targeting the interleukin-11 receptor (IL-11R) as a novel approach to combating both fibrosis and cancer. It’s a move that paid off handsomely earlier this year for Singapore-based Enleofen, which entered a broad alliance in fibrosis with Boehringer Ingelheim GmbH, which could generate up to $1 billion in milestones for each product emanating from the partnership. San Diego-based Lassen is now laying claim to that space as well and has just emerged from stealth mode, having closed but not previously disclosed a $31 million series A round.
C4 Therapeutics Inc., a company focused on destroying disease-causing proteins via degradation, has closed a $170 million financing intended to help move four cancer candidates into the clinic by the end of 2022.
Glaxosmithkline plc (GSK) will collaborate in three of Ideaya Biosciences Inc.’s synthetic lethality programs, MAT2A (methionine adenosyltransferase 2a), Pol Theta (polymerase theta) and Werner Helicase, in a deal that Ideaya estimated could be worth billions.
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