Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema (HAE) attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists. A humanized anti-factor XIIa monoclonal antibody, garadacimab is self-administered by subcutaneous administration once monthly, offering a huge convenience for patients, Andrew Nash, CSL’s chief scientific officer and senior vice president for research, told BioWorld. The TGA has approved garadacimab for routine prevention of recurrent HAE attacks in patients 12 and older with C1-esterase inhibitor deficiency or dysfunction.
Plans to forge ahead with sirexatamab in CRC, but Leap says gastric phase II data less impressive
Shares of Leap Therapeutics Inc. (NASDAQ:LPTX) were trading at 67 cents, down $1.58, or 70%, on word of data from part B of the phase II Defiance study evaluating anti-DKK1 antibody sirexatamab (also known as DKN-01) in combination with Avastin (bevacizumab, Roche AG) and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC), along with initial data from part C of the phase II Distinguish study evaluating sirexatamab in combination with Tevimbra (tislelizumab, Beigene Ltd.) and chemo in first-line patients with advanced gastroesophageal junction and gastric cancer. The drug did better in CRC than in gastric cancer, and Leap said preparations will begin for a registrational phase III effort in second-line CRC patients. In the other indication, biomarker data proved encouraging, but the signal was not strong enough to merit phase III investigation, the company said.
Lantheus lights up market with Evergreen acquisition of up to $1.025B
Lantheus Holdings Inc. is making waves in M&A with its second big deal of the month, and year, the acquisition of Evergreen Theragnostics Inc. for $250 million up front and up to an additional $752.5 million in contingent payments. The transaction follows announcement of a definitive agreement to acquire Life Molecular Imaging Ltd. on Jan. 13 for $350 up front and a further $400 million in milestone payments. The deals consolidate Lantheus’s position as a leader in radiopharmaceuticals and its strategy of adding late-stage tuck-ins to build its capabilities.
ITM marks a milestone in radiotherapeutic tumor therapy
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care. “This marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved progression-free survival compared to a targeted molecular therapy, everolimus, in patients with grade 1 and grade 2 gastroenteropancreatic neuroendocrine tumors in a phase III study,” said Jaume Capdevila, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona.
Harness going after new target, FAN-1, in Huntington’s disease
Harness Therapeutics Ltd. has raised fresh financing to further develop its technology for upregulating the translation of mRNA into proteins, and in particular to take on a previously undruggable target in Huntington’s disease .The new money arrives some 3.5 years after the company raised $12.9 million in a seed round to optimize the technology platform and assess how best to apply it. The conclusion was that the ability to modulate protein production in a precise way would open up a large number of currently undruggable targets of relevance to neurodegenerative diseases.
Insider trades on sales data result in US SEC settlement
A former regional sales director at Lantheus Holdings Inc. is the latest biopharma official to settle insider trading charges with the U.S. SEC. As part of the settlement, John Heropoulos agreed to disgorge nearly $61,000, an equal amount in civil penalties and more than $10,000 in prejudgment interest, according to the SEC. The settlement stems from trades Heropoulos made between Feb. 11-23, 2022, based on nonpublic information about Lantheus’ upcoming financial results.
US Supreme Court to hear case on litigation for the uninjured
Companies in the life sciences for years have had to deal with litigation that included both those who were and were not injured by the product in question, but that consideration has taken a new twist in a case involving Burlington, N.C.-based Labcorp Inc. The U.S. Supreme Court has accepted a petition from Labcorp to address a case involving whether the provision of pad computers for check-ins at the company’s clinical labs violates the Americans with Disabilities Act, a case that might not exist if the courts appropriately handled the question of whether uninjured members of the public are entitled to compensation from manufacturers.
Also in the news
Adagene, Allakos, Averna, Bicara, Corundum, CSL Behring, Elevar, Exelixis, Freya, Immunomet, Immunoprecise Antibodies, Maze, Sapience, Totus, Triumvira, Umoja, Vaxart, Vect-Horus, Walden