On April 10, 2025 Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), reported that its independently developed antibody-drug conjugate (ADC), SIM0686, which targets FGFR2b (Fibroblast Growth Factor Receptor 2b), has received clinical trial approval from the China National Medical Products Administration (Press release, Jiangsu Simcere Pharmaceutical Company, APR 10, 2025, View Source [SID1234654314]). This achievement permits the company to initiate clinical trials involving Chinese patients with FGFR2b-positive, locally advanced, or metastatic solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FGFR2b is a transmembrane tyrosine kinase receptor expressed in epithelial tissues. Its overexpression or gene fusion has been associated with various solid tumors. SIM0686 is a clinical-stage ADC developed using Simcere Zaiming’s proprietary technology platform. The molecule combines the tumor-specific targeting capabilities of antibodies with the anti-cancer properties of topoisomerase inhibitors. Preclinical studies indicate that it demonstrates significant anti-tumor activity, not only in FGFR2b-positive tumor cells but also in FGFR2b-negative tumor cells via a bystander effect. The preclinical findings will be presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Abstract No. 2964.

On April 10, 2025, Cue Biopharma, Inc. (the "Company") reported to have entered into a Collaboration and License Agreement (the "Collaboration and License Agreement") with Boehringer Ingelheim International GmbH ("BI") to research, develop and commercialize differentiated B cell depletion molecules, including the Company’s CUE-501 product candidate, which the Company is developing as a B cell depletion therapy for autoimmune diseases (Filing, Cue Biopharma, APR 10, 2025, View Source [SID1234651913]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the Collaboration and License Agreement, BI and the Company will conduct collaborative research focused on CUE-501 during a four year period or, if earlier, the completion of activities under the research plans (the "Research Term"). In addition to, or instead of, CUE-501, BI may elect, at its sole discretion, to include additional or alternative compounds targeted at B cell depletion. BI will have an exclusive, royalty-bearing, worldwide, sublicensable license, under the Company’s applicable patents and know-how, to develop, manufacture and commercialize such compounds and their derivatives ("Licensed Products") for all uses, and BI shall be responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of Licensed Products at its expense. During the Research Term, the Company is prohibited from developing or commercializing any molecule for applications in B cell depletion.

Pursuant to the terms of the Collaboration and License Agreement, the Company will receive an upfront payment of $12.0 million and will be eligible to receive up to an aggregate of approximately $345.0 million in success-based research, development and commercial milestone payments, beginning with two preclinical development milestones, as well as royalty payments on net sales. The royalty payments will be subject to reduction due to patent expiration, payments made under certain licenses for third-party intellectual property and generic competition. During the Research Term, BI will also make research support payments to the Company.

The Collaboration and License Agreement will continue, on a product-by-product and country-by-country basis, until the expiration of the applicable royalty term, unless earlier terminated. BI has the right to terminate the Collaboration and License Agreement for any reason after a specified notice period. Each party has the right to terminate the Collaboration and License Agreement on account of the other party’s bankruptcy or material, uncured breach.

The foregoing description of the Collaboration and License Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by reference to, the complete text of the Collaboration and License Agreement, which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

Amendment to Einstein License Agreement

On April 10, 2025, the Company entered into an amendment (the "Amendment") to its Amended and Restated License Agreement, dated July 31, 2017, with Albert Einstein College of Medicine ("Einstein"), as amended by the First Amendment to the Amended and Restated License Agreement with Einstein, dated October 30, 2018, and the Second Amendment to the Amended and Restated License Agreement with Einstein, dated January 13, 2024 (as so amended, the "Einstein License"). Pursuant to the Amendment, Einstein consented to the Company’s entry into the Collaboration and License Agreement and granted the Company the right to sublicense to BI. In addition, Einstein and the Company agreed to amend specified upstream payment obligations that may be owed to Einstein by the Company, solely in connection with the sublicense to BI.

The foregoing description of the Amendment does not purport to be complete and is subject to, and qualified in its entirety by reference to, the complete text of the Amendment, which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

On April 10, 2025 Arima Genomics, Inc. (Arima), a company leveraging 3D genomics to reveal actionable insights that will empower researchers and clinicians to improve human health, reported the publication of a study in The Journal of Molecular Diagnostics showing its proprietary technology detected clinical structural variants missed by conventional clinical tests (Press release, Arima Genomics, APR 10, 2025, View Source [SID1234651881]). Conducted in collaboration with researchers from NYU Langone Health, Weill Cornell School of Medicine, Scripps Cancer Center, Moores Cancer Center at the University of California, San Diego, and the University of Colorado School of Medicine, the retrospective study found that Arima’s technology identified gene fusions or rearrangements in 71% of cases where standard molecular techniques failed. Importantly, in 14% of these cases where no driver had been found by other techniques, a clinically actionable variant was identified.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Structural variants like gene fusions are central to cancer diagnostics, but current clinical tests miss many events that are crucial to diagnostic and therapeutic decision-making," said Matija Snuderl, MD, Professor of Pathology and Director of Molecular Pathology and Diagnostics at NYU Langone Health and corresponding author of the study. "Arima’s technology allowed us to detect hidden variants — many of them clinically actionable — in cases where standard tests came up empty. This provided important information to our understanding of the cancers and directly impacted patient care in some cases, confirming diagnoses and improving treatment options."

In the current study, researchers analyzed 71 formalin-fixed, paraffin-embedded (FFPE) specimens across ten solid tumor types, comparing results using Arima’s technology to results from prior clinical testing via fluorescence in situ hybridization (FISH), RNA sequencing, and DNA sequencing. Arima’s technology demonstrated 98% concordance with positive cases detected by conventional methods. Among the 14 samples negative by standard techniques, structural variants in 71% (10/14) were uncovered. Among these:

14% (2/14) harbored gene fusions or rearrangements listed in current clinical guidelines, directly impacting patient care.
14% (2/14) involved rearrangements affecting therapeutically targetable genes, potentially expanding treatment options even though they are not currently classified as actionable in guidelines.
Several cases described in the paper highlight the utility of Arima’s technology in achieving proper diagnosis and enabling appropriate therapeutic intervention.

For example, one young patient experiencing seizures was initially believed to have a non-tumorous brain abnormality called focal cortical dysplasia. DNA methylation results hinted at a possible low-grade glioma but remained inconclusive following two commercial RNA sequencing panels, which did not identify a diagnostic fusion for low-grade glioma. Only when the patient’s sample was analyzed with Arima’s technology did doctors detect a MYBL1::MAML2 fusion, confirming a low-grade glioma diagnosis and allowing the patient to receive the proper treatment.

In another case involving a pediatric glioblastoma patient, Arima’s technology detected a complex rearrangement involving PD-L1 that standard RNA and DNA tests missed. Later confirmatory testing using immunohistochemistry showed that PD-L1 was overexpressed on the tumor cells and provided an opportunity for immunotherapy treatment based on PD-L1 expression—an option that would have been overlooked without the enhanced sensitivity of Arima’s technology.

Arima’s technology uses high-throughput chromosome conformation capture (Hi-C) sequencing to map the spatial architecture of the genome within FFPE tumor samples. By revealing how DNA is organized in 3D space, it detects gene fusions, rearrangements, and translocations with 100-1000 times higher signal compared to standard methods like RNA or DNA sequencing or FISH, resulting in superior sensitivity.

Beyond actionable findings, the study also described how Arima’s technology offers deep insights into tumor biology by detecting complex genomic rearrangements such chromothripsis and extrachromosomal DNA (ecDNA). Recent literature has suggested ecDNA may be involved in treatment resistance, but may also be targetable with on-market therapies.

"Our technology provides a unique method to amplify the signal of rearrangements," said Anthony Schmitt, PhD, Senior Vice President of Science at Arima Genomics. "This allows us to capture structural rearrangements with far greater sensitivity and detail in FFPE samples—bringing both immediate clinical benefit and new avenues for research."

This new publication adds to a growing body of clinical evidence supporting Arima’s technology, building on recent studies conducted in collaboration with institutions such as Yale School of Medicine, Harvard Medical School, and Seattle Children’s Hospital.

On April 10, 2025 Alterome Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering the development of next-generation, small molecule targeted therapies for the treatment of cancer, reported the appointment of Jung Choi as Chief Executive Officer (CEO) and Richard Heyman, Ph.D., as Chair of the Board of Directors (Press release, Alterome Therapeutics, APR 10, 2025, View Source [SID1234651880]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ms. Choi brings significant experience in growing companies from privately held, preclinical to publicly traded, commercial-stage organizations. Dr. Heyman is a scientist and entrepreneur with more than 25 years of experience in co-founding and building biotech and life science companies.

"Jung’s deep experience in building innovative portfolios and effectively scaling organizations will be invaluable to Alterome as we advance our two clinical-stage precision oncology programs from early clinical development towards commercialization. We are thrilled to welcome Jung to lead our next phase of growth and Rich to an expanded role as Chair. He has been instrumental in advising the company from our discovery phase to clinical development, and we look forward to his continued guidance," said Melissa McCracken, Partner at Nextech Ventures and member of the Board of Directors at Alterome Therapeutics. "The company thanks co-founder and former CEO Eric Murphy for his contributions to Alterome, and we are grateful for his service and leadership."

"I am honored to join the Alterome team at this important phase, as we work to advance two potential best-in-class and first-in-class treatment options for cancer patients and maximize the impact of our entire portfolio," said Ms. Choi. "My career has been driven by a passion to make transformative changes in people’s lives by delivering the best medicines science can create, and I see a great opportunity to bring this passion to life with the team at Alterome."

Ms. Choi is an expert in strategic deal making, having led or managed more than 50 transactions exceeding $17 billion in value. Her leadership experience includes serving most recently as Entrepreneur-in-Residence at Third Rock Ventures. Previously, she was Chief Business & Strategy Officer at Global Blood Therapeutics, where she was instrumental in building the company from preclinical stage to commercialization, establishing a portfolio of therapeutic hematology candidates, and leading the company’s $5.4 billion acquisition by Pfizer. She previously served as head of corporate development at InterMune (acquired by Roche), Chimerix, and Gilead Sciences, and began her career at Bay City Capital and McKinsey. She currently serves on the Boards of Annexon Biosciences and New York Blood Center.

Dr. Heyman takes the role of Chair of the Board of Directors after serving as a senior advisor to the company since 2022 and has more than 25 years of experience building oncology companies. Most recently, he served as Chair of Vividion Therapeutics, Rayze Bio and Amunix Pharma. Previously, Heyman was the Co-Founder and CEO of Aragon and Seragon Pharmaceuticals. Johnson & Johnson purchased Aragon in 2013, and Genentech purchased Seragon one year later. Dr. Heyman is the Co-Founder and Chair of ORIC Pharmaceuticals, a Venture Partner for Arch Ventures, and a Science Partner at Nextech Invest. He is also Chair of PMV Pharma and Enliven Therapeutics.

"I have had the privilege of experiencing up close Alterome’s progress since the inception of the company, as the team advanced from concept to discovery to clinical development in record time," said Dr. Heyman. "The collective experience and unwavering focus at Alterome, along with the strong support of investors, has enabled the development of two extremely promising clinical candidates with the potential to make a significant impact on the oncology therapeutic landscape."

On April 10, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported positive data in the prevention or delay of amputation during the treatment of primary osteosarcoma for OST-HER2 combined palliative radiation in dogs with unresected appendicular osteosarcoma (Press release, OS Therapies, APR 10, 2025, View Source [SID1234651879]). The treatment led to clinical and radiographic arrest of the primary tumor and prolonged time to metastasis in dogs without surgery or chemotherapy. The data opens the potential for OST-HER2 to be used in frontline therapy in human osteosarcoma prior to initiation of chemotherapy, and potentially reduce the need for chemotherapy altogether, for the purposes of preventing or delaying limb amputation or primary tumor resection surgeries, in addition to the prevention, delay and/or control of lung metastasis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Additionally, the Company announced the publication of positive data in the journal "Molecular Therapy" entitled "Immunological responses and clinical outcomes in dogs with osteosarcoma receiving standard therapy and a Listeria vaccine expressing HER2" demonstrated the correlation of innate and adaptive immune responses to OST-HER2, with prevention of metastasis and long-term survival benefit when used in the adjuvant setting, following standard of care amputation and chemotherapy.

Treatment with OST-HER2 was found to be safe and well tolerated in both studies. Taken together, the data support the potential of OST-HER2 to achieve progression free survival (PFS) of primary osteosarcoma, prevent or delay or metastatic disease, prolong progression free survival (PFS) in metastatic disease, and significantly improve long term survival in patients with osteosarcoma. The data on the use of OST-HER2 in unresected primary osteosarcoma in dogs is being prepared for peer-reviewed publication.

"We first published strong clinical data on the benefit of OST-HER2 in canine osteosarcoma in 2016, and that led to an initial conditional approval based on a prior manufacturing process that was suboptimal for widespread veterinary use," said Dr. Nicola Mason, the Paul A. James and Charles A. Gilmore Endowed Professor at the University of Pennsylvania, School of Veterinary Medical. "Based upon this initial research, OS Therapies conducted a successful translational Phase 2b clinical trial in the rare pediatric indication of prevention of recurrence of fully resected, osteosarcoma lung metastases. Our newly published canine data and unpublished radiation combination canine data expands the potential use of OST-HER2 into delay/prevention of metastasis and PFS following resected primary osteosarcoma and raises the intriguing possibility of combination radiation therapy and OST-HER2 in the treatment of unresectable osteosarcoma."

The Company is preparing to submit this data to USDA, along with new data generated on its newly patented, commercially superior manufacturing process, with the aim of gaining conditional approval for the new manufacturing process for OST-HER2 in the United States to begin sales in 2025. Thereafter, the Company intends to conduct a pivotal clinical study with the aim of gaining full approval in 2026. A link to the publication is available here: View Source(25)00113-3.

"It has been my dream since founding the Company that OST-HER2 could potentially change the standard of care in osteosarcoma, potentially limiting the need for amputation or surgical resection of the primary tumor," said Paul Romness, CEO of OS Therapies. "With today’s data, we believe we are taking the first steps towards this given that our Comparative Oncology approach, as a result of the 96% genetic homology between human and canine osteosarcoma, leads us to believe there is significant potential for this canine data to translate into humans in the treatment of frontline and primary metastatic osteosarcoma, similarly to how it has in recurrent, fully-resected, lung metastatic osteosarcoma."

Mr. Romness continued, "We are laser focused on getting an Accelerated Approval for OST-HER2 in recurrent, fully resected, lung metastatic human osteosarcoma via Accelerated Approval by year-end 2025 and then using funds obtained from the sale of our pending Priority Review Voucher to expand the potential clinical uses of OST-HER2 throughout the human osteosarcoma treatment paradigm. In parallel, we believe the data from these two studies support the use of OST-HER2 in all phases of canine osteosarcoma treatment and we are hopeful to obtain conditional approval with our newly improved, patented manufacturing for OST-HER2 later this year so that we can launch the product at specialized cancer centers and our four-legged patients can begin getting treatment very soon.