Novo Nordisk A/S presented clinical trial findings this morning for its once-weekly human insulin analogue, insulin icodec, for adults with type 1 diabetes (T1D) mellitus to the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. Patients currently receive insulin treatment at least once daily. One of the agency’s concerns is the amount of hypoglycemia found in participants in the single randomized, controlled, pivotal phase IIIa Onwards 6 study. After hearing from the agency and Novo, the committee will vote later in the day on whether the benefits of insulin icodec outweigh its risks for improving glycemic control. Bagsvaerd, Denmark-based Novo submitted the BLA in April 2023. The injectable has an estimated PDUFA date in the third quarter of 2024. The adcom’s vote is not binding upon the FDA.

Shares rocky as Verastem unveils phase I/II data in pancreatic, starts rolling NDA in ovarian

Verastem Oncology Inc. unveiled positive phase I/II data from the Ramp 205 study testing RAF/MEK clamp avutometinib plus focal adhesion kinase inhibitor defactinib in combination with gemcitabine and nab-paclitaxel as first-line therapy for metastatic pancreatic cancer. Shares of the Boston-based firm (NASDAQ:VSTM) were trading at $4.66, down $7.52, or 61%, having surged as high as $19.13 after hours May 23, when the data were disclosed. Separately, Verastem said it has begun the rolling submission of an NDA to the U.S. FDA seeking accelerated approval of the combination of avutometinib and defactinib for recurrent KRAS mutant low-grade serous ovarian cancer who have received at least one prior systemic therapy.

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar 

South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications. Omlyclo is now approved in the EU to treat allergic asthma, chronic spontaneous/idiopathic urticaria and chronic rhinosinusitis with nasal polyps, Incheon-headquartered Celltrion said on May 24. The EMA’s Committee for Medicinal Products for Human Use first greenlighted the path to Omlyclo’s approval with a positive opinion recommending the biosimilar on March 21, 2024. Celltrion submitted the marketing application to the EMA in April 2023.

US argues for drug, device companies in terrorism case

Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago. The complaint sought to hold the companies accountable, with treble damages, for doing business with the Jaysh al-Mahdi militia, which was operating through the Iraqi Ministry of Health while conducting attacks that injured or killed hundreds of U.S. troops and civilians during the Iraq war.

Astrazeneca in Asia: $604M Nona deal, $1.5B Singapore ADC plant 

Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAb) and cell therapies. On May 22, Natick, Mass.-based Nona Biosciences, a subsidiary of HBM Holdings Ltd., inked a potential $604 million deal with Astrazeneca to discover preclinical MAbs for development into targeted cancer therapies. Astrazeneca is also building a $1.5 billion manufacturing plant in Singapore as its first end-to-end production site for ADCs, to be fully operational by 2029.

Clinical trial updates in April record a 24% increase from March 

In April 2024, BioWorld reported on 323 updates on phase I-III clinical trials, marking a 24% increase from March’s 261 updates. This number also exceeds the counts of February (236) and January (252). April’s total reflects an uptick from April 2023’s count of 264 updates. The average monthly count of phase I-III updates in the first four months of 2024 stands at 268 per month, compared to a monthly average of 305 for all of 2023.

Holiday notice

BioWorld’s offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 27.

Also in the news

Abdera, Amphista, Astrazeneca, Biomica, Citius, Cogent, Connect, Cynata, Cytokinetics, Gamma, Icell, Laekna, Merck, Mirus, Monopar, Nona, Orna, Owkin, Pneumagen, Providence, Renagade, Royalty, Sinaptica, Sun, Tango, Taro, Theriva, UCB, Upstream, Virios