Summit Therapeutics has signed a clinical collaboration with AstraZeneca and its Japan-based partner Daiichi Sankyo to evaluate ivonescimab in combination with the antibody-drug conjugate Datroway, also known as datopotamab deruxtecan, across multiple solid tumors including breast and lung cancers. The collaboration is expected to initially focus on a phase III study in first-line triple-negative breast cancer, expanding ivonescimab's development into a new tumor type. Under the agreement, each company will supply its respective drug, AstraZeneca or Daiichi will sponsor the planned studies, and the companies will share study costs while retaining development and commercial rights to their own therapies. The Datroway collaboration builds on the larger deal between AstraZeneca and Summit announced in the last week, under which AstraZeneca agreed to invest $2 billion in Summit to accelerate development of ivonescimab, with the companies also set to evaluate ivonescimab alongside AstraZeneca's investigational Claudin-18.2-targeted ADC sonesitatug vedotin, or Sone-Ve, in gastrointestinal cancers. An FDA filing is under review seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment, with a final decision expected by Nov. 14, 2026.
Daiichi Sankyo's Datroway (datopotamab deruxtecan) will be evaluated in combination with ivonescimab across multiple solid tumors, including a phase III triple-negative breast cancer study
Genmab Reports Phase 3 Win for Epcoritamab and Phase 1/2 Data for Rina S
Genmab posted two fresh oncology trial readouts, including a Phase 3 win for epcoritamab in newly diagnosed diffuse large B cell lymphoma. The EPCORE DLBCL 2 trial, run with AbbVie, reported that epcoritamab plus R CHOP cut the risk of disease progression or death by 51% versus R CHOP alone in patients with higher risk DLBCL. Separately, the Phase 1/2 RAINFOL 01 study of rinatabartsesutecan, or Rina S, in platinum resistant ovarian cancer reported a 45.9% confirmed objective response rate in a heavily pretreated population, with a median duration of response of 12.1 months and no clear safety signals around eye toxicity, peripheral neuropathy, interstitial lung disease or stomatitis. The trial headlines arrive after a strong run in the shares, with the DKK2,482.0 price coming alongside a 31.18% 90 day share price return and a 23.67% year to date share price return, while the 5 year total shareholder return is down 8.75%.
Enliven and FDA Agree on Phase 3 Design for Relcobatinib in CML
Enliven Therapeutics and the US FDA have agreed on a design for the phase 3 trial of relcobatinib for chronic myeloid leukemia in patients who have failed on prior treatments. The trial, called ENABLE-2, plans to enroll 450 adults with CML who were previously on one or more tyrosine kinase inhibitors. Participants will be randomized to receive either relcobatinib 80 mg once daily or an investigator-selected second-generation TKI. The primary endpoint is major molecular response at week 24. Relcobatinib, also known as ELVN-001, is a kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, which promotes the development of CML.
Biotech & Genomic Medicine › Oncology Therapeutics Regulation
ELVN · Technology · Positive FDA agreement on the phase 3 ENABLE-2 design for relcobatinib (ELVN-001) advances the company's lead drug development in CML.
Multiply Labs Raises $75 Million Series B Led by Patrick Soon-Shiong
Multiply Labs announced a $75 million Series B round, bringing its total capital raised to over $100 million since its founding in 2016. The round was led by Dr. Patrick Soon-Shiong with NantWorks, joined by new investors AstraZeneca, Lingotto, Teradyne, and Strange Ventures, alongside returning investors Casdin Capital, Lux Capital, Fifty Years, Ora Global, and Founders Fund. The San Francisco-based physical AI company automates biologics manufacturing with robotic clusters that integrate into existing instruments and processes without requiring a new facility, delivering a 74% reduction in cost per dose and up to 100 times more throughput than manual manufacturing. Beginning with cell and gene therapy and now expanding to advanced biologics including antibodies, viral vectors, and mRNA, the platform is owned and operated directly by pharmaceutical and biologics companies rather than run as an outsourced service. Multiply Labs will use the capital to expand manufacturing capacity, accelerate its product roadmap, and scale its team across engineering, regulatory, and commercial functions as it moves from clinical-stage deployments toward commercial-scale production.
Genmab Shares Jump 10.7% on Positive Phase III EPCORE DLBCL-2 Data
Genmab A/S Sponsored ADR shares rallied 10.7% in the last trading session to close at $38.48, following positive top-line results from the phase III EPCORE DLBCL-2 study. Genmab and its partner AbbVie announced that epcoritamab in combination with R-CHOP demonstrated a statistically significant improvement in progression-free survival in patients with newly diagnosed diffuse large B-cell lymphoma. The company is expected to post quarterly earnings of $0.37 per share in its upcoming report, a year-over-year change of -43.1%, on revenues of $1.18 billion, up 15.7% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 8.7% higher over the last 30 days, and the stock currently carries a Zacks Rank #3 (Hold).
Orion Pharma signs European distribution deal with Qilu Pharma Europe for pembrolizumab biosimilar
Orion Corporation, known as Orion Pharma, has entered into an agreement with Qilu Pharma Europe to commercialise an intravenous pembrolizumab biosimilar in Europe. Under the terms, Orion Pharma gains the exclusive right to distribute, market and sell Qilu's IV pembrolizumab biosimilar across Europe, while Qilu will supply the product and receive a share of profits plus certain development, regulatory and sales milestone payments. Pembrolizumab is an immune checkpoint inhibitor used to treat various cancers, and Qilu is currently developing the IV version. Satu Ahomäki, EVP Generics and Consumer Health at Orion Pharma, said the deal expands the company's strategic partnership with Qilu and brings its division closer to its long-term targets and strategic goals. Orion Pharma reported net sales of EUR 1,890 million in 2025 and employs about 4,000 professionals worldwide.
AstraZeneca to invest over $1 billion in Massachusetts, boosting staff by more than 50%
British pharmaceutical giant AstraZeneca announced on the 5th that it will invest more than $1 billion in the eastern state of Massachusetts as part of a total $50 billion US investment plan. The company expects to increase its Massachusetts workforce by more than 50% over the next several years. It has already opened a new research and development center in Cambridge, Massachusetts, and at the 570,000-square-foot, 18-story facility built in Kendall Square, it will focus on developing treatments for cancer, chronic diseases and rare diseases, as well as research into cell therapies. Together with a nearby genomic medicine site, about 2,000 researchers and scientists will work there, and the new research center features 10 floors of laboratories equipped with robotics, automation and artificial intelligence. The Cambridge site joins the company's other major research center in Gaithersburg, Maryland. AstraZeneca operates 24 research, manufacturing, sales and headquarters sites in the United States and employs more than 25,000 people there.
AZN.LSE · Capital · Positive AstraZeneca will invest over $1 billion in Massachusetts and expand its workforce by more than 50% as part of a $50 billion US investment plan.
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