On September 15, 2025 Merck reported that raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab (Press release, Merck & Co, SEP 15, 2025, View Source [SID1234655977]).

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Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines.

The FDA granted this BTD based on data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 trial. A subgroup analysis of the phase 1 trial was presented at the 2023 European Society for Medical Oncology meeting (#ESMO23). Subsequent subgroup analyses of the phase 1 trial were presented at the 2024 Society for Gynecologic Oncology Annual Meeting on Women’s Cancer and the 2025 European Society for Medical Oncology Gynaecological Cancers Congress. This is the first BTD for raludotatug deruxtecan and represents the second BTD since the start of the Daiichi Sankyo and Merck collaboration.

"Patients have limited treatment options once ovarian cancer becomes resistant to platinum-based chemotherapy, highlighting the urgent need for new medicines that can improve patient outcomes," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "The receipt of Breakthrough Therapy Designation represents an important step forward in our efforts to advance raludotatug deruxtecan as a novel medicine for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab."

"The FDA’s Breakthrough Designation is a reflection of our commitment to advancing research for patients impacted by women’s cancers," said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. "Raludotatug deruxtecan has the potential to one day become an important option for the treatment of patients with CDH6-expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab, and we are excited to share data from REJOICE-Ovarian01 with the scientific community at an upcoming medical meeting and to continue working closely with the FDA."

About the Phase 1 Trial

The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of investigational raludotatug deruxtecan in adult patients with advanced ovarian cancer previously treated with platinum-based chemotherapy and a taxane. Patients with renal cell carcinoma resistant or refractory to standard of care therapy were originally included, but that component of the study was discontinued.

The primary objective of the first part of the study (dose escalation) was to assess the safety and tolerability of increasing doses of raludotatug deruxtecan to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The primary objective of the second part of the study (dose expansion) is to further evaluate the safety and efficacy of raludotatug deruxtecan in patients with advanced ovarian cancer and in patients with advanced renal cell carcinoma.

The study will evaluate safety endpoints, including dose-limiting toxicities and adverse events and efficacy endpoints, including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), clinical benefit rate, time to response and progression free survival (PFS). Pharmacokinetic and exploratory biomarker endpoints also will be assessed.

The phase 1 trial enrolled 179 patients in Asia and North America. For more information, please visit ClinicalTrials.gov.

About REJOICE-Ovarian01

REJOICE-Ovarian01 is a global, multicenter, randomized, open-label phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan in patients with platinum-resistant, high-grade ovarian primary peritoneal or fallopian tube cancer, with disease progression following at least one but no more than three prior systemic lines of therapy, including prior treatment with mirvetuximab soravtansine for those with documented high-folate receptor alpha expression. Maintenance therapy (e.g., bevacizumab, poly ADP-ribose polymerase [PARP] inhibitors) is considered part of the preceding line of therapy.

The phase 2 part of REJOICE-Ovarian01 is assessing the safety and tolerability of three doses of raludotatug deruxtecan (4.8 mg/kg, 5.6 mg/kg, or 6.4 mg/kg) to identify the recommended dose for the phase 3 part of the trial. The primary endpoint of the phase 2 part of the trial is ORR as assessed by blinded independent central review (BICR). Secondary endpoints include ORR as assessed by investigator, DoR, PFS and DCR – all assessed by both BICR and investigator – and overall survival (OS).

The phase 3 part of REJOICE-Ovarian01 is assessing the efficacy and safety of raludotatug deruxtecan at the selected dose (5.6 mg/kg) compared to investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine or topotecan). The dual primary endpoints of the phase 3 part of the trial are ORR and PFS as assessed by BICR. Secondary endpoints include PFS and ORR as assessed by investigator, DoR and DCR as assessed by both BICR and investigator, and OS. Pharmacokinetic and biomarker endpoints also will be assessed in both parts of the trial.

REJOICE-Ovarian01 is expected to enroll approximately 710 patients across Asia, Europe, North America, and Oceania. For more information, please visit ClinicalTrials.gov.

About Ovarian Cancer

More than 324,000 women were diagnosed with ovarian cancer worldwide in 20221. The median overall survival for advanced ovarian cancer following recurrence can be as little as two years, with a five-year survival rate of 31.8% for those with distant stage disease.2,3

The introduction of targeted therapies has expanded treatment options and improved survival outcomes for some patients with ovarian cancer, but additional options are needed for patients with tumors that progress on available medicines4. Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens5. For patients who develop platinum-resistant ovarian cancer, defined as disease progression less than six months after completion of last platinum-based chemotherapy, prognosis is particularly poor and treatment options are limited.6,7

About CDH6

CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, including ovarian tumors.8 An estimated 65% of patients with ovarian cancer have tumors that express CDH6. In addition, CDH6 expression is observed more frequently in high-grade serous carcinomas.8,9 There is currently no CDH6 directed medicine approved for treatment of any cancer.

About Raludotatug Deruxtecan

Raludotatug deruxtecan is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

On September 15, 2025 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported an agreement to collaborate with Novartis to develop novel degraders for immune- mediated diseases (Press release, Monte Rosa Therapeutics, SEP 15, 2025, View Source [SID1234655976]). The agreement is the Company’s second with Novartis, in addition to the global exclusive license agreement for Monte Rosa’s VAV1 degraders including MRT-6160, announced in October 2024.

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The agreement announced today was uniquely structured by the companies to collaborate on accelerating development of degraders for important immune-mediated diseases driven by highly credentialed and difficult-to-drug targets. Under the agreement, Monte Rosa’s scientists will apply their proprietary AI/ML-enabled QuEEN product engine for the discovery and development of degraders to be further developed and commercialized by Novartis.

"We are extremely excited to extend our relationship with Novartis beyond our previously announced VAV1 agreement given the strong progress made to advance MRT-6160 toward initiation of multiple Phase 2 studies in immune-mediated diseases," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "We believe this new agreement further strengthens our relationship with Novartis, a recognized global leader in immune-mediated diseases, and reflects the expansive opportunity in the space for our highly selective and potent MGDs. Our AI/ML-enabled QuEEN product engine continues to generate new insights and opportunities, delivering an expanding pipeline of programs directed against a breadth of historically undruggable immunology targets. This new collaboration allows us to expedite the development of certain of those programs with Novartis, leveraging their recognized development and commercialization capabilities. The agreement further strengthens our financial position, which allows us to progress our wholly owned programs, including multiple undisclosed targets in Th1, Th2, and Th17-driven autoimmune conditions, and provides runway beyond multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359."

"We are pleased to expand our collaboration with Monte Rosa Therapeutics, building on the strong foundation and progress established through the VAV1 program," said Fiona Marshall, Ph.D., President of Biomedical Research at Novartis. "This new agreement underscores our commitment to advancing targeted protein degradation as a promising approach to address immune-mediated diseases with high unmet need. We believe Monte Rosa’s QuEEN platform has the potential to uncover new insights in this field. We look forward to working together to translate these insights into transformative therapies for patients."

Agreement Details and Financial Terms

Under the terms of the agreement, Monte Rosa will receive an upfront payment of $120 million. Monte Rosa will also receive payments to maintain the options. In total deal value, Monte Rosa is eligible to receive up to $5.7 billion, including upfront, option maintenance, preclinical milestone, option exercise, and development, regulatory, and sales milestone payments across programs, as well as tiered royalties on global net sales in the high single to low double-digit range.

Monte Rosa’s publicly disclosed pipeline programs are outside the scope of this agreement.

Monte Rosa plans to provide further information regarding its updated cash position and runway in its third quarter 2025 earnings update.

Lazard served as the exclusive financial advisor to Monte Rosa for this agreement.

On September 15, 2025 Limula, a Swiss life sciences tools company advancing automated solutions for cell and gene therapy (CGT) manufacturing reported the collaboration with the Institut Paoli-Calmettes (IPC) to characterise the cell processing capabilities of LimONE for haematopoietic stem cell (HSC) transplantation applications (Press release, Limula, SEP 15, 2025, View Source [SID1234655975]).

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IPC is internationally recognised as a leading treatment centre for cell therapies in haematological cancers and runs one of the most established autologous and allogeneic stem cell transplantation programmes in Europe. Performing more than 150 transplants each year, IPC is committed to advancing clinical innovation and broadening patient access to cutting-edge treatments.

The collaboration will leverage Limula’s automated and closed LimONE platform for autologous HSC transplantation, a procedure impacting nearly 50,000 patients annually in Europe. After promising preliminary results using an early prototype of Limula’s technology in 2022, and with strong confirmatory results earlier in 2025, IPC will further document the performance of LimONE. The goal of the collaboration is to advance automated cell product processing, with a focus on the removing of cryoprotectants and cell debris from thawed apheresis products. A fast and efficient wash is critical for maintaining the quality and consistency of the cell product and also significantly improves the patient experience.

"We are impressed with the improvements we saw during the development of LimONE and are eager to adopt the platform into our facility," said Boris Calmels, Head of the Cellular Manufacturing Unit at IPC. "I see strong potential for Limula’s technology to play a key role in improving both our cell processes and the patient’s experience during stem cell transplantation."

Luc Henry, CEO of Limula added: "This collaboration is a powerful demonstration of the versatility of our platform. We are proud to support IPC in their mission to deliver high-quality transplantation products to their patients."

On September 15, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its first quarter of fiscal 2026, ended July 31, 2025 (Press release, Champions Oncology, SEP 15, 2025, View Source [SID1234655973]).

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First Quarter and Recent Highlights:

•Total revenue of $14 million
•Adjusted EBITDA of $60,000
•Appointment of Rob Brainin as Chief Executive Officer to lead the next phase of growth

Rob Brainin, newly appointed CEO of Champions, commented, "It is great to be joining Champions at such an exciting inflection point. Our core services business—the backbone of our company—is strengthening and well positioned for sustained growth. At the same time, we are scaling our emerging data platform, which has already shown encouraging traction with leading biopharma partners. These complementary growth engines give us the opportunity to deepen our scientific impact, deliver innovative solutions to patients and customers, and create durable long-term value for shareholders. In parallel, our Corellia team continues to generate data demonstrating the potential of the compounds in our pipeline. Over the coming quarters, I look forward to working closely with our talented team to sharpen our strategy, invest in key capabilities, and build on Champions’ culture of collaboration and scientific excellence."

David Miller, CFO of Champions, added, "We opened the fiscal year with $14 million in revenue and adjusted EBITDA of $60,000. While revenue was slightly lower than the first quarter of last year, we achieved solid sequential growth that met our expectations and provides a strong foundation for the year. As we move forward, we anticipate continued topline expansion and margin improvement driven by a healthy services pipeline and growing demand for our proprietary data offerings. Our financial discipline and focus on profitable growth give us the flexibility to invest in strategic initiatives that will position Champions for long-term success."

First Fiscal Quarter Financial Results

Total oncology revenue for the first quarter of fiscal 2026 was $14.0 million compared to $14.1 million for the same period last year, consisting of a $400,000, or 3% decline in service revenue and a $300,000 increase in data license revenue. Total costs and operating expenses for the first quarter of fiscal 2026 were $14.5 million compared to $12.7 million for the first quarter of fiscal 2025, an increase of $1.8 million or 14.1%.

For the first quarter of fiscal 2026, Champions reported a loss from operations of $527,000, including $208,000 in stock-based compensation, $358,000 in depreciation and amortization expenses, and a $20,000 charge for the disposal of lab equipment, compared to income from operations of $1.3 million, inclusive of $258,000 in stock-based compensation and $448,500 in depreciation and amortization expenses, in the first quarter of fiscal 2025. Adjusted EBITDA, which is defined as income from operations excluding stock-based compensation, depreciation and amortization expenses, and equipment disposal charges, was $59,000 for the first quarter of fiscal 2026 compared to adjusted EBITDA of $2.0 million in the first quarter of fiscal 2025.

Cost of oncology revenue was $8.0 million, up $923,000, or 13.1%, from $7.1 million in the same period last year. The increase primarily reflects higher outsourced lab services for radiolabeling work, which will vary from quarter to quarter. Importantly, as we migrate this work into our own labs in the coming quarters, we anticipate a reduction in cost of sales and improvement in gross margins. Gross margin for the quarter was 43% compared to 50% in the prior year.

Research and development expense for the three-months ended July 31, 2025 was $2.1 million, an increase of $628,000 or 43.2%, compared to $1.5 million for the three-months ended July 31, 2024. The increase reflected greater investment in sequencing and related costs to develop our data licensing platform. Sales and marketing expense for the three-months ended July 31, 2025 was $1.9 million, an increase of $176,000, or 10.5%, compared to $1.7 million for the three-months ended July 31, 2024. The increase was related to compensation expense to support the growth of our data license business. General and administrative expense for the three-months ended July 31, 2025 was $2.6 million, an increase of $43,000, or 1.7%, compared to $2.5 million for the three-months ended July 31, 2024 driven primarily from an increase in IT related costs.

Net cash provided by operating activities was approximately $600,000 for the quarter, supported by receivables conversion and normal working capital activity, partially offset by a quarterly net loss. Net cash used in investing activities for the three-months ended July 31, 2025 was approximately $46,000 for lab and computer equipment. Net cash used in financing activities for the three-months ended July 31, 2025 was $14,000 resulting from financing lease payments slightly offset by proceeds from options exercises.

The Company ended the quarter with cash on hand of approximately 10.3 million and no debt, providing us with a strong balance sheet and financial flexibility.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 261008, or provide the verbal reference "Champions Oncology".

On September 14, 2025 Phrontline Biopharma, a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), reported that the first patient has been successfully dosed in its Phase 1 clinical trial of TJ101, the company’s lead asset targeting EGFR/B7-H3 with a proprietary linker-drug technology (Press release, Phrontline Biopharma, SEP 14, 2025, View Source [SID1234655968]).

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"This is a critical milestone for Phrontline as we advance our mission to deliver innovative ADC therapies that can meaningfully impact patients’ lives," said Zhaoyuan "Tony" Chen, Chief Executive Officer of Phrontline Biopharma. "The initiation of this study not only represents the progress of our lead candidate, TJ101, but also demonstrates the strength of our platform and the dedication of our team in advancing breakthrough science into the clinic. Running this trial in both China and the United States reflects our commitment to a truly global clinical development strategy and ensures early alignment with international regulatory standards."

The Phase 1 study of TJ101 will evaluate its safety, tolerability, pharmacokinetics, and preliminary antitumor activity across multiple solid tumor types. The study design includes dose escalation followed by expansion cohorts to further assess TJ101’s potential in a broad patient population.

"This first patient dosing is a major step forward in validating our ADC platform," said Martín Sebastian Olivo, MD, Chief Medical Officer of Phrontline Therapeutics. "Our team has worked tirelessly to design a program that explores the full clinical potential of TJ101 while also laying the groundwork for our broader pipeline of differentiated ADCs. Beyond TJ101, we are advancing a portfolio of next-generation bispecific dual payload ADCs, which aim to overcome resistance mechanisms seen with current therapies and broaden the scope of patients who may benefit."

Phrontline’s pipeline includes multiple early-stage ADC assets targeting high-value tumor antigens. The company’s dual payload platform leverages a modular design with optimized linker stability and distinct mechanisms of action, enabling improved tumor penetration and a stronger bystander effect.

"By combining scientific innovation with a clear clinical strategy, we are building a robust ADC pipeline that we believe can transform the standard of care in oncology," added Dr. Chen.