Rinatabart Sesutecan

Nadzeya Haroshka/Getty Images AbbVie claims that Genmab turned a blind eye to trade secret theft allegedly used to support the development of ProfoundBio’s investigational antibody-drug conjugates. Genmab acquired ProfoundBio in May 2024. AbbVie has sued long-time partner Genmab, claiming that the Danish biotech “misappropriated” trade secrets related to antibody-drug conjugate technology developed at the Chicago-based company, according to Genmab’s press announcement of the matter. The complaint, filed late last week in the U.S. District Court for the Western District of Washington, focuses on certain techniques to improve antibody-drug conjugates (ADCs). According to Genmab’s statement, AbbVie’s claims pertain to rinatabart sesutecan (Rina-S), an investigational FRα-targeting ADC being developed by Washington-based ProfoundBio, which Genmab acquired in May 2024 . AbbVie’s allegations also cover other ADC candidates from ProfoundBio. “AbbVie is not asserting or enforcing any patent rights against the defendants,” Genmab noted in its press announcement. “To Genmab’s knowledge, AbbVie has not pursued any development of products incorporating their alleged trade secrets.” According to reporting from Fierce Biotech , AbbVie is accusing Genmab of turning a blind eye to trade secret theft that occurred at ProfoundBio related to technology involved in building ADCs, ahead of Genmab’s acquisition of the company. The lawsuit names several former AbbVie employees as well as Tae Han, the founder of ProfoundBio. The suit claims that Han “knowingly and intentionally encouraged and enticed” the disclosure of trade secrets related to ADC technology developed at AbbVie. Genmab “categorically refutes” AbbVie’s allegations and intends to “vigorously defend” against the claims. Rina-S is currently in late-stage development for ovarian cancer and other solid tumors that express the FRα protein. Its toxic payload is exatecan, a second-generation topoisomerase I inhibitor that can damage DNA in cancer cells, triggering their death. According to Genmab, Rina-S “has the potential to address a broader patient population in ovarian cancer than is served by current standard of care, including AbbVie’s Elahere.” The trade secret complaint, the biotech continued, “is yet another lawsuit among multiple recent lawsuits filed by AbbVie against competitors alleging misappropriation of its trade secrets by former AbbVie employees.” In September 2024, the pharma sued BeiGene, claiming it “enticed and encouraged” a former AbbVie employee to share protected information, according to Fierce Biotech . Both companies are advancing next-generation BTK inhibitors for cancer. Meanwhile, in December 2023, AbbVie slapped Adcentrx Therapeutics with a lawsuit, alleging that the biotech hired a former AbbVie scientist to extract information regarding a certain antibody cancer program at the pharma, as per Reuters . Genmab and AbbVie are long-time oncology partners, joining hands in June 2020 to advance and commercialize three bispecific therapies. The star of this collaboration is Epkinly, which won the FDA’s approval in June 2024 for relapsed or refractory follicular lymphoma. Under their 2020 agreement, the companies are jointly commercializing Epkinly in U.S. and Japan, while AbbVie will take charge in other territories. In its news release over the weekend, Genmab said AbbVie’s trade secret lawsuit will not affect the Epkinly partnership. “We remain fully committed to the epcoritamab broad clinical development program and our commercialization efforts,” the biotech noted.

COPENHAGEN, Denmark I March 17, 2025 I Genmab A/S (Nasdaq: GMAB) announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S ® ), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m 2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels. With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). The data are from the dose expansion cohort of the multi-part study evaluating the safety and efficacy of Rina-S as a single agent in solid tumors that are known to express FRα and were presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer ® (SGO) in Seattle, Washington. “The antitumor activity observed in the dose expansion cohort continues to demonstrate the potential for a much-needed treatment option for patients with PROC, who have historically had poor prognosis. I am hopeful that further exploration of Rina-Swill lead to advancements in the treatment landscape.” said Elizabeth Lee, M.D., a medical oncologist in the gynecologic oncology program at Dana-Farber. The B1 cohort is a dose expansion study in patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer). Rina-S 120 mg/m 2 Q3W at a median on-study follow-up of 48 weeks showed encouraging antitumor activity; the confirmed ORR was 55.6% (95% CI: 30.8-78.5), the disease control rate (DCR) was 88.9% (95% CI: 65.3-98.6), and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). In the 18 patients evaluable for response treated with 120 mg/m 2 Q3W, complete responses were observed in 4 patients (2 confirmed; 2 unconfirmed) and 8 patients experienced confirmed partial responses (44.4%). Most responses with Rina-S 120 mg/m 2 were observed early (at week 6). Only one patient in the 120 mg/m 2 treatment arm was not evaluable. In the Rina-S 100 mg/m 2 Q3W treatment arm (N=22), at a median on study follow-up of 46 weeks, the confirmed ORR was 22.7% (95% CI: 7.8-45.4), the DCR was 86.4% (95% CI: 65.1-97.1), and the mDOR was not reached (95% CI, 16.3-NR). Partial responses were observed in 4 patients (18.2%) and 1 patient (4.5%) experienced a complete response. Rina-S 120 mg/m 2 has been selected for further evaluation in the RAINFOL-01 and Phase 3 RAINFOL-02 trials for patients with platinum resistant ovarian cancer (PROC). In this Phase 1/2 study, common treatment-emergent adverse events (TEAEs) included anemia, nausea, neutropenia, leukopenia, fatigue, thrombocytopenia, vomiting, diarrhea, alopecia, and hypokalemia. Dose reductions and treatment discontinuations were infrequent and no new safety signals were observed. “The updated results reinforce the potential of Rina-S and further validate our development approach in advanced ovarian cancer,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. “We are excited to keep moving forward with the ongoing Phase 3 trial, to evaluate the potential of Rina-S as a treatment option for patients facing this challenging disease.” The safety and efficacy of rinatabart sesutecan has not been established for these investigational uses. About the RAINFOL TM -01 Trial RAINFOL-01 ( NCT05579366 ) is an open-label, multicenter Phase 1/2 study, designed to evaluate the safety and efficacy of rinatabart sesutecan (Rina-S) as a single agent Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part A dose-escalation cohorts; Part B tumor-specific monotherapy dose-expansion cohorts; Part C platinum-resistant ovarian cancer (PROC) cohort; and Part D combination therapy cohorts. Part B of the trial includes the B1 cohort, a dose expansion study in patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Patients were randomized 1:1 to 100 mg/m 2 and 120 mg/m 2 dose cohorts. Median age was 62.5 and 64.5 years in the 100 mg/m 2 and 120 mg/m 2 cohorts, respectively. Study participants were previously treated with a median of 3 prior lines of therapy (range 1-4). Patients received prior treatment with bevacizumab (90.9% in the 100 mg/m 2 group and 90.0% in the 120 mg/m 2 group respectively), PARP inhibitors (68.2%; 65%), and mirvetuximab soravtansin (18.2%; 19%). Initial results from Part B of this trial were presented during a mini-oral session at the European Society of Medical Oncology Congress 2024 (ESMO). About Ovarian Cancer Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide. i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally. ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating. iii Standard of care for platinum resistant ovarian cancer typically involves single agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel). iv Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment. v Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%. vi,vii About Rinatabart Sesutecan (Rina-S ® ; GEN1184) Rinatabart sesutecan (Rina-S; GEN1184) is a FRα-targeted, TOPO1 ADC, currently being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. A Phase 3 trial (RAINFOL-02, NCT06619236 ) evaluating Rina-S in patients with platinum resistant ovarian cancer compared to treatment of investigator’s choice is ongoing. In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. Please visit www.clinicaltrials.gov for more information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines ® . Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . i World Cancer Research Fund International. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/ . Accessed August 2024. ii World Ovarian Cancer Coalition. https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/ . Accessed August 2024. iii Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival – Population cohort study in the ‘no screen’ arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002. iv Eskander RN, Moore KN, Monk BJ, Herzog TJ, Annunziata CM, O’Malley DM and Coleman RL (2023) Overcoming the challenges of drug development in platinum-resistant ovarian cancer. Front. Oncol. 13:1258228 Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/ . v Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/ . vi European Institute of Women’s Health. https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/ . Accessed August 2024. vii American Cancer Society. Stages of Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html. Accessed August 2024 . SOURCE: Genmab