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Monte Rosa Therapeutics Announces Collaboration with Novartis for Degraders to Treat Immune-mediated Diseases

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.

Limula Announces Collaboration with Leading Cancer Centre to Improve Blood Products Processing for Stem Cell Transplantation

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]).

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."

Champions Oncology Reports Quarterly Revenue of $14.0 Million

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]).

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".

Phrontline Biopharma Announces First Patient Dosed in Phase 1 Clinical Trial of TJ101

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]).

"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.

New Drug Application for KN026 (Anbenitamab Injection) Has Been Accepted by the National Medical Products Administration

On September 12, 2025 Alphamab Oncology (Stock Code: 9966.HK) reported that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), has been accepted by the National Medical Products Administration (NMPA). KN026 has been applied for as a Class 1 therapeutic biological product and the indication is for use in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).

This NDA for KN026 is primarily based on a pivotal Phase II/III clinical trial (Study ID: KN026-001). Results from the first interim analysis of the Phase III clinical study demonstrated that, compared to the current standard of care, KN026 combined with chemotherapy significantly improved clinical efficacy, by prolonging progression-free survival (PFS) and overall survival (OS). Furthermore, the combination showed no new safety signals, with a low incidence of cardiotoxicity and low immunogenicity in terms of safety profile. Previously, results from the Phase II clinical study, presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, showed that KN026 in combination with chemotherapy achieved an objective response rate (ORR) of 40.0%, with a median PFS of 8.6 months as assessed by the independent review committee (IRC). KN026 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA on November 4, 2023, and received Priority Review status on August 28, 2025.

Currently, there are no approved anti-HER2 therapies for the second-line treatment of HER2-positive gastric cancer. KN026 is the first HER2 bispecific antibody to demonstrate positive results in the second-line treatment of gastric cancer in China. Meanwhile, multiple pivotal Phase III clinical studies of KN026 in gastric cancer and breast cancer are undergoing smoothly, with the aim of benefiting more patients.

About KN026

KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. KN026 has demonstrated better tumor inhibition in HER2-positive tumor cell lines compared with trastuzumab and pertuzumab in combination. Additionally, KN026 has also shown inhibitory effect on tumor cells with trastuzumab-resistant cell lines.

The results of multiple clinical studies in different stages showed that KN026 has significant anti-tumor activities, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC), including those with prior anti-HER2 treatment. Currently, several pivotal clinical trials of KN026 for the second-line or above treatment of HER2-positive GC/gastroesophageal junction cancer (GEJ), the first-line treatment of HER2-positive BC, neoadjuvant treatment for HER2-positive BC are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China, pursuant to which, JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

(Press release, Alphamab, SEP 12, 2025, View Source [SID1234656998])