Pyramid Biosciences Inc. has in-licensed Genequantum Healthcare Co. Ltd.’s preclinical trophoblast cell surface antigen 2 (TROP2)-targeting antibody-drug conjugate (ADC), GQ-1010, in a deal worth up to $1 billion in potential milestones. Under the terms, Pyramid gains exclusive rights to develop and commercialize GQ-1010 globally, excluding greater China (mainland China, Hong Kong, Macau and Taiwan). In exchange, privately held Genequantum, of Suzhou, China, will receive an up-front payment of $20 million and up to an additional $1 billion in milestone payments. Genequantum will also be eligible to receive tiered-based sales royalties.

Torl closes $158M series B to advance anti-Claudin candidates

Torl Biotherapeutics LLC has raised $158 million in a series B round as it seeks to nudge its anti-Claudin-6 antibody-drug conjugate candidates, TORL-123 and TORL-2307, beyond phase I trials for the treatment of ovarian and gastric cancers, respectively. Claudin-6, or CLDN6, is a molecule that forms tight junctions around cells. It is highly expressed in a range of solid tumor types, so is a popular target for drug development. TORL-123, the firm’s lead candidate, is currently in a phase I study in 90 patients with several advanced cancer types, including ovarian cancer, endometrial cancer and non-small-cell lung cancer.

Cytomed squeaks out $9.6M in a near-frozen IPO market

On what has become one of the slowest IPO years in recent memory, cancer immunotherapy company Cytomed Therapeutics Ltd. debuted on Nasdaq April 14, raising $9.65 million, while another biopharma firm, Acelyrin Inc., filed to list its stock for a potential $100 million. Up to this point, there were only six biopharma IPOs completed this year – the fewest since 2013. Cytomed, which priced 2.4 million shares at $4 apiece, is now the seventh for 2023, and the fifth on Nasdaq. Two other IPOs have closed on Chinese markets. Cytomed’s shares (NASDAQ:GDTC) dropped more than 9% by midday and were trading at $3.63.

Alebund nets $29M in pre-C round to develop drugs for kidney disease

Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. The company also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization.

CRLs for Lilly and Alvotech cite manufacturing problems

Manufacturing deficiencies are standing in the way of two BLAs. The U.S. FDA issued a complete response letter (CRL) regarding Eli Lilly and Co.’s BLA for mirikizumab, a humanized IgG4 monoclonal antibody to treat ulcerative colitis, specifically citing manufacturing concerns. With approval, Clarivate’s 2023 Drugs to Watch anticipates sales of $595 million in 2027. Lilly said the CRL contained no concerns about clinical data, safety or the label. There’s a similar problem with Alvotech Holdings SA’s biosimilar candidate for Humira (adalimumab). The FDA issued a CRL for AVT-02’s BLA, citing problems needing resolution at its Reykjavik manufacturing facility before it could approve the application. Alvotech’s stock (NASDAQ:ALVO) had sunk 24% at midday to about $10.50 per share.

FDA’s dual adcom mulls Otsuka/Lundbeck’s Rexulti in AD agitation

A joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee is taking up the matter of serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd./Lundbeck A/S) for agitation in Alzheimer’s disease dementia. Rexulti, already cleared for schizophrenia and for the adjunctive treatment of major depressive disorder, gained its first approval in the summer of 2015. The FDA has assigned a PDUFA date for AD agitation of May 10, 2023.

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Aldeyra, Allegro, Amylyx, Atai, Atma, Aviceda, Bridge, Evofem, Fusion, Immunis, Karolinska, Merck, Pfizer, Regenerx, Regulus, Sab, Sinopharm, Synaptixbio, Tonix, Totus, Transcode, Zura