Seaport Therapeutics Inc. has followed up its recent fundraiser with an oversubscribed $225 million series B financing that will help set it on the path to a phase IIb study of major depressive disorder. The company’s lead candidate is allopregnanolone, an endogenous neurosteroid, that is taken orally. Investors were led by General Atlantic in a group that included T. Rowe Price Associates Inc., Foresite Capital, Invus, Goldman Sachs Alternatives and CPP Investments. Seaport’s founding investors, Arch Venture Partners, Sofinnova Investments, Third Rock Ventures and Puretech Health plc also participated. The company launched with a $100 million oversubscribed series A financing in April. 

US FDA issues first-in-class and first-line approval for Astellas’ Vyloy 

Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin (CLDN) 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. The treatment is to be used in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of adults whose tumors are CLDN18.2-positive as determined by an FDA-approved test, VENTANA CLDN18 (43-14A) RxDx Assay, from Roche Holding AG, of Basel, Switzerland. The approval follows a complete response letter for zolbetuximab issued in January in which the FDA cited unresolved deficiencies following an inspection of a third-party manufacturing facility. 

CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib

The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP) at its monthly meeting Oct. 14 to 17. Also meeting with CHMP’s approval was Novo Nordisk A/S’ Alhemo (concizumab), a once daily subcutaneous treatment for hemophilia A and B in people with inhibitors against replacement clotting factors. The committee’s previous negative opinions on PTC Therapeutics Inc.’s Translarna (ataluren) for Duchenne muscular dystrophy and on AB Science SA’s masitinib for amyotrophic lateral sclerosis, remained unchanged

US effort to claim share of big pharma profits resurfaces

Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in 2014 and every Congress since then, the Medical Innovation Act was reintroduced Friday as a way to tap into the profits of large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and support for early career scientists. Under the bill, qualifying companies that settle with the federal government to resolve allegations of wrongdoing would be assessed a portion of their profits, ranging from at least 0.75% to 1.5%, regardless of whether they acknowledge guilt. While the bill has little chance of being passed by the 118^th Congress at this late date, it is gathering support.

Lanova raises $42M series C round to advance lead programs

After raising $42 million in a series C1 round, Lanova Medicines Ltd. is advancing its lead phase III antibody-drug conjugate (ADC) LM-302 that targets Claudin 18.2, as well as LM-299, an anti-PD-1/VEGF bispecific antibody and LM-108, an anti-CCR8 monoclonal antibody. “Proceeds from this financing will allow us to expedite the development of our late-stage clinical programs, LM-302 and LM-108, moving us closer to market approval. We will also accelerate the clinical development of LM-299, which is currently in phase I clinical trials with best-in-class potential,” Lanova founder and CEO Crystal Qin said. As previously reported by BioWorld, Shanghai-based Lanova out-licensed global rights to LM-305, its ADC targeting GPRC5D for multiple myeloma to Astrazeneca plc in a deal worth up to $600 million.

Japan mulls ways to boost cell, gene therapy approvals

The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals. “Japanese stem cell researcher Shinya Yamanaka [who won the 2012 Nobel Prize] discovered induced pluripotent stem cells [iPSC] nearly 20 years ago, but there are still not many [regenerative medicine] products,” Japan’s Forum for Innovative Regenerative Medicine’s steering committee chair Kanoh Hiroyuki said Oct. 11 at the Pacifico Yokohama. “We need to support the industry and academia now [for the future].”

The BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Quantum computing could lead to more efficient drug discovery by identifying promising compounds faster, understanding their effects at the molecular level, and then reducing the need for costly or time-consuming lab experiments. Lipinska is one of the more than 100 experts who will evaluate the future of health care at the upcoming 2024 Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a sponsor of the Oct. 28-30 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Lipinska.

Also in the news

Aavantgarde, Adjuvance, Alzamend, Amivas, Amylyx, Anavex, Arcutis, Astrazeneca, Aura, Avadel, Biodexa, Bright Minds, Clearb, Curevo Vaccine, Emergex Vaccines, George Medicines, Innovent, Jaguar Health, Kezar, Kiji, Lanova Medicines, Merck, Nektar, Neuvivo, Nordic, Novartis, Novo Nordisk, Oncozenge, OSE Immunotherapeutics, Pacira, Pharmanovia, PTC, Regimmune, Roche, Supernus, Theratechnologies, Treeline, Vianautis