Partner Therapeutics, Inc.

Today, a brief rundown of news involving Daiichi Sankyo, Agenus and Amgen, as well as updates from the U.S. PTO, Bluebird bio and Merus that you may have missed.AstraZeneca and Daiichi Sankyo on Friday revealed new study results supporting their revised approval plans for the closely watched cancer drug datopotamab deruxtecan, or dato-dxd. A pooled analysis from two clinical trials showed dato-dxd kept tumors in check for a median of about six months in people whose non-small cell lung tumors were driven to growth by mutations in the EGFR gene. Among 117 people, median survival was 15.6 months, according to a statement. The findings underpin an accelerated approval filing the partners submitted last month in EGFR-mutated lung cancer a much narrower request than theyd originally anticipated. Ben FidlerAgenus will cut yearly spending by 60% to focus resources around a cancer immunotherapy combination thats approaching late-stage testing in colorectal cancer, the company said Thursday. The company will implement significant cost-cutting measures, including layoffs and other unspecified adjustments, to lower its cash burn to $100 million for the 2025 fiscal year. Agenus has been streamlining costs since last year, when it laid off 25% of its workforce, and has said its restructuring initiatives are a bridge to a forthcoming strategic transaction designed to deliver substantial resources. Ben FidlerAmgen said Thursday it will invest another $1 billion to expand its manufacturing footprint in Holly Springs, North Carolina. The new investment builds on a previously announced $550 million commitment and will add a second drug substance manufacturing facility that will employ about 370 people. Amgen has already boosted its drug production capabilities this year, having opened a production plant in Ohio in February. It didnt say when the new Holly Springs facility will begin operating. Delilah AlvaradoThe U.S. Patent and Trademark Office is withdrawing a controversial proposed rule that aimed to prevent so-called patent thickets around pharmaceutical products that can deter price competition from generic and biosimilar drugs. A notice published Wednesday cited resource constraints as a reason for pulling the rule after it received 349 comments. In the proposed rule, the PTO sought to reduce the legal burden on companies challenging intellectual property by narrowing the case to just the original inventions and not obvious variations on which the patent owner may have also claimed legal exclusivity. Jonathan GardnerNext Thursday, every 20 shares of Bluebird biowill be merged into one single share as the gene therapy developer moves ahead with a reverse stock split to regain compliance with Nasdaq listing rules. Shares in Bluebird have steadily declined this year and, since August, traded below $1 apiece. The company had to work to secure sufficient investor support for the move, which will give it more financing options. While Bluebird sells three approved gene therapies, its still struggling to break even on cash flows. Ned PagliaruloThe Food and Drug Administration granted an accelerated approval to Merus drug zenocutuzumabin adults with either non-small cell lung or pancreatic cancers that harbor a certain alteration to a gene called NRG1. The clearance is the FDAs first of a systemic therapy for these specific tumors. Merusrecently agreed to license U.S. rights to the drug, which will be sold as Bizengri, to Partner Therapeutics for an undisclosed sum. Bizengri is Merus first approved product. Ned Pagliarulo '

The Dutch biotech Merus received the first-ever FDA accelerated approval for a systemic treatment targeting a specific genetic fusion in patients with either non-small cell lung cancer or pancreatic cancer. The approval, disclosed Wednesday evening , is Merus’ first, and the drug will be sold as Bizengri. It’s a bispecific antibody targeting HER2 and HER3, and is approved for patients with advanced, unresectable, or metastatic non-small cell lung cancer or pancreatic adenocarcinoma who have an NRG1 gene fusion. Bizengri, also known as zenocutuzumab, was tested in an open label trial among 64 patients with NSCLC and 30 with pancreatic cancer. The overall response rate in the lung cancer cohort was 33%, and 40% in the pancreatic cancer group. The label includes a black box warning for pregnant women. Merus won’t actually spearhead commercialization of the drug in the US, after selling off rights earlier this week to Partner Therapeutics in exchange for an undisclosed upfront fee and $130 million in potential milestone payments. Merus’ development efforts have centered on another late-stage bispecific, petosemtamab, with new data giving the company optimism that it could be the standard-of-care in second-line head and neck cancer. Phase 2 results for petosemtamab released Sunday found that among 12 evaluable patients receiving the 1,500 mg dose of petosemtamab, one had a complete response, three had a partial response and another had an unconfirmed partial response. The data came from a dose comparison cohort that has so far randomized 42 patients to receive the 1,500 mg dose or the 1,100 mg dose.

20mg/ml injections of Bizengri will be available to patients in coming weeks. Credit: aslysun / Shutterstock. Merus ’ Bizengri (zenocutuzumab-zbco) has received accelerated approval from the US Food and Drug Administration (FDA), marking “an important milestone” in the treatment of cancers with a neuregulin 1 (NRG1) gene fusion, according to the principal investigator of the company’s ongoing trial. The drug is the first systemic therapy approved by the FDA for the treatment of advanced, unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are NRG1-positive (NRG1+) for patients who have disease progression on or after prior systemic therapy. Bizengri’s accelerated approval follows results from the eNRGy trial (NCT02912949), a multicentre, open-label clinical trial that included 30 patients with NRG1+ pancreatic adenocarcinoma and 64 with NRG1+ NSCLC. The former demonstrated an average overall response rate (ORR) of 40% while the latter experienced an average ORR of 33%. Continued approval for the use of Bizengri in treating NRG1+ lung and pancreatic cancers will be contingent upon verification and description of clinical benefit in confirmatory trials. Principal investigator of Merus’ eNRGy trial Alison Schram said: “The FDA approval of Bizengri marks an important milestone for patients with pancreatic adenocarcinoma or NSCLC that is advanced unresectable or metastatic and harbours the NRG1 gene fusion. “I have seen firsthand how treatment with Bizengri can deliver clinically meaningful outcomes for patients.” The drug will become available in the coming weeks, in the form of a 20mg/ml injection for intravenous use. It holds a boxed warning for risks of embryo-fetal toxicity, as well as infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD) or pneumonitis and left ventricular dysfunction. The FDA’s approval of Bizengri for pancreatic and lung cancers follows Merus’ success in finding a commercialisation partner for the drug earlier this week. It announced on 2 December that it would exclusively license Bizengri to Partner Therapeutics for its commercialisation in the US. Merus’ chief commercial officer Shannon Campbell said: “This approval is a testament to both our technology and strong execution as we continue to develop our multispecific platforms and pipeline, including our lead asset petosemtamab.” The company shared updated clinical data from its Phase II trial for the use of petosemtamab for the treatment of head and neck squamous cell carcinoma on 1 December, ahead of its presentation at the European Society for Medical Oncology (ESMO) Asia Congress, on 7 December.