A new antibiotic combination developed by Venatorx Pharmaceuticals Inc. "may represent a significant improvement over the standard of care" for adults with complicated urinary tract infections, said Christopher Burns, the company's president and CEO. The beta-lactam/beta-lactamase inhibitor combo surpassed noninferiority to standard meropenem in the phase III trial Certain-1, demonstrating statistical superiority for the trial's composite endpoint of microbiologic and clinical response. The company plans to file an NDA for the candidate, combining cefepime and taniborbactam, with the U.S. FDA later this year.

Huge ADC deals, but cancer index down 35% on company disappointments

Despite three mammoth deals signed for antibody-drug conjugates, the BioWorld Cancer Index (BCI), which ended last year down 36%, has fallen another 35% in the early months of 2022. It is a much sharper decline than that seen with the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are down 18% and 7.5%, respectively.

Scenic viewing clinical start ahead for lead QPCTL program with $31M series A

Scenic Biotech BV has raised $31 million in a series A round, as it moves to translate its high-throughput platform for identifying genetic modifier genes that suppress or block the effects of disease-causing mutated genes into small-molecule hits and on to the clinic. The new money will be used to complete preclinical research and start a trial in 2023 of the lead program targeting QPCTL (glutaminyl peptide cyclotransferase-like protein). Scenic has shown this enzyme to be a druggable modifier of one of the major mechanisms by which cancer cells evade detection by the immune system via the CD47 checkpoint.

Bridge Biotherapeutics secures second IPF candidate, targets US FDA IND by late 2022

Bridge Biotherapeutics Inc. has signed an exclusive option-to-license agreement for Cellionbiomed Inc.’s preclinical ion channel modulator, BBT-301, thus adding a second idiopathic pulmonary fibrosis (IPF) candidate to its fibrotic diseases portfolio. The company hopes to enter the clinic with the drug in the U.S. by the end of 2022. “We will receive an option payment of ₩500 million (US$404,950), as well as milestones for each stage of clinical trials and licensing in the future. The total deal size could be up to around ₩29 billion,” Seong Jin Kim, CEO at Cellionbiomed, told BioWorld. The company could also receive net sales royalties if the drug is successfully commercialized.

US spending package, minus extra pandemic funds, in Senate hands

Disagreement over offsets for an additional $15.6 billion in COVID-19 funding resulted in the proposed pandemic funds being cut from the $1.5 trillion fiscal 2022 spending bill the U.S. House passed late last night. Now it’s up to the Senate to pass the spending bill to avoid a government shutdown. Currently, the government is funded through tomorrow, but, along with the appropriations package, the House passed a four-day stopgap measure that would keep the government running through Tuesday, should the Senate need a little more time to push through the nearly 3,000-page spending package. Meanwhile, the House is expected to vote next week on a hastily assembled bill for the extra COVID-19 funds.

Quoin asks EMA for regulatory feedback to advance Netherton syndrome drug

Quoin Pharmaceuticals Ltd. submitted a scientific advice briefing document to the EMA for lead asset QRX-003, an investigational therapy for Netherton syndrome, a rare skin disorder. The document seeks feedback and guidance on the clinical and regulatory path in the EU for the compound, described as a competitive broad-spectrum serine protease inhibitor whose mechanism of action is to target kallikreins. Shares of Ashburn, Va.-based Quoin (NASDAQ:QRNX) were trading midday at $1.16, down 5 cents.

Nec acquires Vaximm AG’s neoantigen program assets

Nec Corp. has acquired all of Vaximm AG’s neoantigen program assets. Tokyo-based Nec will conduct the acquisition via its subsidiary, Nec Oncoimmunity AS (NOI). “Under the agreement, NOI will acquire Vaximm’s neoantigen vaccine-related patents and know-how, license manufacturing patents, and will take over several existing contracts with partners to bring the NECVAX NEO-1 neoantigen program into the clinic as trial sponsor,” an Nec spokesperson told BioWorld. The spokesperson added that NOI will be responsible for initiating the clinical trial.

Also in the news

Abbvie, Abivax, Adiso, Aeterna Zentaris, Allogene, Amarin, Antengene, Astellas, Atyr, Biogen, Brooklyn, Calcimedica, Caris, Cellevolve, Cerveau, Cipher, Cocrystal, Confo, Depymed, Domain, Erasca, Excellthera, Explicyte, Gan & Lee, Genetic Leap, Geovax, GT, Immutep, In3bio, Incannex, Inomagen, Insilico, Intellia, Iqai, KBI, Moderna, Morningside, Nevakar, Oragenics, Passage, Pharmazz, Pipeline, Puma, Pyramid, Quoin, Redx, Regen, Samsung Bioepis, Scisparc, Selecta, Servier, Sunshine, TG, Tiziana, Tracon, Transcenta, Venatorx, Xeris