Dantari

Pictured: 3D rendering of antibody-drug conjugate/ Antibody-drug conjugates are a breakthrough in targeted cancer therapy and will continue to attract big pharma investment over the next few years, finds a new report from market intelligence firm Evaluate. Pictured: 3D rendering of antibody-drug conjugate/iStock, Love Employee The antibody-drug conjugate market has been one of the hottest sectors in the biopharma industry as of late. Big players such as Pfizer, AbbVie, AstraZeneca, Merck and others are shelling out billions of dollars to acquire or license the breakthrough technology in targeted cancer therapy. This trend will continue over the next few years with the category worth nearly $30 billion by 2028, according to a new report from market intelligence firm Evaluate . The report calls the antibody-drug conjugate (ADC) market the “hottest real estate in oncology” that will continue to attract big pharma investment over the next few years. In 2023, ADC-focused M&A and partnership activity totaled almost $100 billion in total in 2023, more than three times the value of similar deals in 2022 and nine times more than in 2019, Evaluate said. Among the recent big deals: Pfizer acquired Seagen for $43 billion, AbbVie invested over $10 billion in ImmunoGen and Merck committed $4 billion upfront, with a potential total of $22 billion, for a stake in three of Daiichi Sankyo’s ADCs. “ADCs combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs to create what is in effect precision chemotherapy” and “the scientific and commercial promise are real,” the report concludes, while noting that big pharma is paying attention to Chinese companies that have become major players in ADC development in recent years. Mark Landsell, practice lead at Evaluate and the director of asset and portfolio strategy, told BioSpace that several of the companies involved in the ADC space have seen “substantial” growth with their products on the market and he sees that number growing significantly. Last year, Roche’s breast cancer ADC Kadcyla topped the leaderboard with $3 billion in sales but Evaluate predicts that Daiichi Sankyo will rule the roost in 2028. Daiichi Sankyo is expected to pull in over $9.9 billion in sales due to a combination of Enhertu and datopotamab deruxtecan , if approved. Datopotamab deruxtecan has already shown some good results and the FDA has accepted its BLA. Landsell noted that ADCs are “finally realizing their full potential” and while the technologies are not new, it sometimes takes time to come to fruition, especially because they represent a paradigm shift in cancer therapy with a potentially more precise and effective treatment approach. At the same time, he said there are significant challenges for the sector given that the design of ADCs is not as “predictable” as initially thought and that there is still trial and error involved in their development. Evaluate’s report shows that there are over 150 clinical-stage programs in the ADC field, with a dozen or so in Phase III, lending to the continued progress the market will make in the coming years. Evaluate named ImmunoGen as one of the key players in the ADC market. AbbVie acquired the company and its ADC Elahere in November 2023 for $10 billion . The report also named Daiichi Sankyo and ADC Therapeutics among those in the key player category. Seattle-based ProfoundBio was among the companies Evaluate determined was one to watch in the ADC space. This month, the biotech raised a $112 Million Series B to push four ADC candidates forward. The report also listed California-based biotech Dantari, Netherlands-based Tag Works and German biotech Tubulis as other companies to watch. Looking ahead, Landsell said there will be “continued growth” as there is a significant pipeline in the ADC market. And even if some ADCs eventually fall out by the wayside, a “plentiful supply” of candidates will make it through as companies keep forging on with research and development in the space. “Despite a chock-full ADC pipeline, accessing even early-stage assets is now tricky for all but the biggest and richest,” the report states, noting that one biotech CEO in September 2023 “declared being ‘priced out’ of ADC licensing negotiations despite having raised close to $200 million.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com . Follow him on LinkedIn .

Data from Phase 1 clinical trial in heavily pretreated patients with metastatic breast cancer showed DAN-222 was safe and well tolerated and demonstrated clinical activity as monotherapy and in combination with a PARP inhibitor DAN-222 is the first topoisomerase 1 inhibitor able to be combined with a PARP inhibitor at clinically relevant doses for extended time Phase 1 data in metastatic HER2-negative breast cancer to be presented today at San Antonio Breast Cancer Symposium THOUSAND OAKS, Calif., Dec. 7, 2023 /PRNewswire/ -- Dantari, Inc. ("Dantari") today announced that data from the completed dose-escalation Phase 1 clinical trial showed that DAN-222 was safe, well tolerated, and demonstrated promising antitumor activity in patients with metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Results showed stable disease (SD) in 38% of participants receiving DAN-222 as monotherapy and SD in 67% of participants receiving DAN-222 in combination with a PARP inhibitor (niraparib) across all dose levels. These data will be presented today in a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS). DAN-222 is a novel high-capacity drug conjugate with a topoisomerase 1 inhibitor (TOPO1) payload. The main risk of TOPO1 products in general is bone marrow toxicity. Because of its low bone marrow exposure in preclinical models and complementary mechanism of action with PARP inhibitors, DAN-222 has the potential for broad application and provide new utility as a combination therapy with PARP inhibitors and other agents. Importantly, the complementary enhanced efficacy is independent of BRCA status and broadly homologous repair deficiency status. "These data on DAN-222 are encouraging as they show this novel platform with high chemotherapy capability was safe and well tolerated in heavily pretreated patients with advanced breast cancer," said Sara A. Hurvitz, M.D., FACP, senior vice president and director, Clinical Research Division, Fred Hutchinson Cancer Center, head, Division of Hematology and Oncology, University of Washington Department of Medicine, and clinical consultant and principal investigator of the study. "We believe these data support continued clinical development of DAN-222 and in combinations such as with PARP inhibitors." "What is especially exciting about these results is that they show DAN-222 can be safely given as a monotherapy or in combination with a PARP inhibitor, a highly desired combination due to the known complementary mechanisms of action," said Richard A. Markus, M.D., Ph.D., president and CEO of Dantari. "We look forward to advancing the Phase 2 clinical trial of DAN-222 which will also help fulfill our vision to deliver groundbreaking next-generation targeted high-capacity drug conjugate therapeutics to a broad range of patients who are in need of new treatment options." DAN-222 Phase 1 dose-escalation data at 2023 San Antonio Breast Cancer Symposium This was an open-label, multicenter, Phase 1 dose-escalation clinical trial designed to assess the safety, tolerability, pharmacokinetics (PK), and initial clinical activity of intravenously (IV) administered DAN-222 as monotherapy or in combination with niraparib in patients with metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The initial clinical activity of DAN-222 is based on RECIST v1.1 criteria to determine the recommended Phase 2 dose. Thirty adult women with metastatic HER2-negative breast cancer that progressed on standard therapies were enrolled, without restriction on BRCA or homologous repair deficiency status. The median age was 61.5 years old (range, 36-75) and the median number of prior treatment lines was six. All patients were PARP inhibitor naïve and BRCA wild type. Results showed: DAN-222 was safe and well tolerated and did not require pre-medication with steroids, H1-blockers, or H2-blockers. Adverse events (AEs) were generally equivalent in frequency and severity for DAN-222 monotherapy and DAN-222 plus niraparib combination therapy. Grade 3-4 AEs observed were neutropenia (3/30; 10%), anemia (3/30; 10%), thrombocytopenia (1/30; 3%), and cystitis (1/30; 3%). All Grade 3-4 anemia were in the combination group and all Grade 3-4 neutropenia were at the highest monotherapy dose. No dose-limiting toxicities were observed in either the monotherapy or combination therapy cohorts. There were no Grade 5 events. Pharmacokinetics showed the designed control of DAN-222 payload was linear and dose-proportional. The mean half-life ranged from 25.2 to 33.5 hours across all cohorts. DAN-222 monotherapy and in combination with a PARP inhibitor showed encouraging clinical activity in highly pretreated patients that is consistent with Phase 1 results from other approved breast cancer products. Clinical activity during dose escalation was demonstrated with stable disease (SD) in 38% of patients receiving DAN-222 monotherapy and SD in 67% of patients receiving DAN-222 plus niraparib combination therapy across all dose levels. About Dantari Dantari, Inc. is a clinical-stage biotechnology company developing best-in-class targeted therapeutics for the treatment of cancers and other diseases. Dantari is advancing a pipeline of T-HDC (Targeted High-capacity Drug Conjugate) chemotherapeutic agents and next-generation antibody-drug conjugate (ADC) therapeutics T-HDC technology originating from Caltech. Dantari's HDC and T-HDC platform technology uses chemically defined polymers with a high drug-antibody ratio (DAR), and a high degree of control and flexibility to optimize performance of targeted drug conjugates that can leverage validated targets across a broad range of therapeutic payload options. Visit us at to learn more. SOURCE Dantari

Dantari’s drug conjugate asset has produced positive data as both a monotherapy and in combination with a PARP inhibitor in an early-stage breast cancer trial, paving the way for a Phase II test. The biotech’s Phase I dose escalation trial studied DAN-222 as a single agent and in combination with GSK’s Zejula in 30 metastatic HER2-negative breast cancer patients with a median of six prior lines of therapy. Results from the trial come one year after Dantari raised $47 million in a Series A round. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.