On September 16, 2025 K36 Therapeutics, Inc. ("K36"), a privately held clinical-stage biotechnology company developing novel, targeted therapies for cancers with unmet medical need, reported a clinical update on its lead asset, KTX-1001 for multiple myeloma (MM) (Press release, K36 Therapeutics, SEP 16, 2025, View Source [SID1234656007]).

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The company has initiated patient dosing in an expansion cohort evaluating KTX-1001, its first-in-class NSD2/MMSET inhibitor, in combination with carfilzomib and dexamethasone (NCT05651932). NSD2 (also known as MMSET) is overexpressed in MM patients with the t(4;14) chromosomal translocation, one of the highest-risk genetic subtypes of the disease.

In addition, K36 has begun dosing patients in a separate cohort evaluating KTX-1001 in combination with mezigdomide, a novel investigational therapy from Bristol Myers Squibb (BMS) currently completing enrollment in two pivotal late-stage trials. To enable this study, the companies have entered into a clinical trial supply agreement, under which K36 will sponsor and run the trial to evaluate the novel triplet of KTX-1001, mezigdomide and dexamethasone in patients with relapsed and refractory MM (EUCTR: 2022-500801-41-00). K36 retains all development and commercial rights to KTX-1001 and is free to expand its use in other agents.

"We are excited to see the dose expansion cohorts open in the U.S. and EU and to see continued momentum for KTX-1001, an oral therapy we believe holds great promise to transform outcomes in multiple myeloma," said Terry Connolly, Ph.D., President and Chief Executive Officer of K36. "Despite advances that have extended survival for people living with MM, this challenging blood cancer remains incurable, and most patients eventually relapse. There is an urgent need for therapies that are both effective and convenient, enabling patients to receive care in community settings while also maintaining quality of life. We are deeply grateful to the patients, investigators, and their care teams for their commitment to advancing this important research. The favorable tolerability profile of KTX-1001, together with promising early signs of clinical activity, underscores its potential as a first-in-class targeted therapy for patients with t(4;14) multiple myeloma, and our agreement with BMS enables us to further explore its potential benefit in novel combinations."

"The combination of KTX-1001 with mezigdomide represents an exciting therapeutic opportunity for patients with high-risk t(4;14) multiple myeloma," said Dr. María-Victoria Mateos, MD, PhD, Director of the Myeloma Program and the Clinical Trials Unit in Salamanca’s University Hospital and Associate Professor of Medicine at the University of Salamanca, Spain. "This cohort builds on compelling preclinical evidence showing that KTX-1001 works synergistically with mezigdomide. With the first patient now dosed in this novel-novel cohort, we are encouraged by the potential of this approach to improve outcomes."

K36-MMSET Phase 1 Clinical Trial Details

K36 has opened all U.S. sites for its Phase 1 trial evaluating the safety and tolerability of KTX-1001 in combination with standard of care agents, as well as a novel combination with mezigdomide in Spain and France. The trial’s primary objectives are to determine the provisional recommended Phase 2 dose (RP2D) for these combinations, with additional objectives including assessment of efficacy and further safety characterization. The company anticipates reporting initial data in mid-2026.

KTX-1001 is designed to selectively inhibit NSD2 and reduce levels of the epigenetic mark H3K36me2, restoring balance to gene expression and re-sensitizing tumor cells to therapy. In preclinical models, KTX-1001 reduced H3K36me2 levels in t(4;14) multiple myeloma, suppressed tumor growth and triggered cancer cell death in NSD2-high cell lines, and showed strong synergy when combined with proteasome inhibitors and immunomodulatory drugs. Early clinical data demonstrate clear evidence of target engagement through H3K36me2 suppression in patient samples and emerging signs of clinical activity in heavily pretreated patients, with a safety profile that supports ongoing evaluation of this novel epigenetic approach.

"Given the favorable safety profile we have already seen with KTX-1001, we are pleased to be able to participate in this next cohort evaluating KTX-1001 in combination with carfilzomib," said Edward Stadtmauer, MD, and principal investigator at Abramson Cancer Center at the University of Pennsylvania Perelman School of Medicine. "The emerging efficacy signals from this combination are encouraging. As an oral agent, KTX-1001 holds potential for use in earlier lines of therapy, both as a monotherapy and in combination with standard of care regimens."

About KTX-1001
KTX-1001 is a novel, first-in-class, potent, and selective methyltransferase inhibitor of the catalytic activity of MMSET/NSD2. It is an orally administered small molecule developed initially for the treatment of relapsed and refractory multiple myeloma, with a focus on patients with the t(4;14) translocation. This inhibitor offers a promising avenue for addressing this challenging high risk patient population.

About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic malignancy, driven by the uncontrolled proliferation of plasma cells in the bone marrow. According to the American Cancer Society, approximately 36,000 new cases are diagnosed each year. While recent therapeutic advances have extended survival, MM remains incurable, and most patients eventually relapse. High-risk MM, defined by genetic abnormalities such as t(4;14) and other adverse prognostic markers, is associated with aggressive disease biology, shorter survival, and limited benefit from standard-of-care regimens. Addressing this high-risk population represents one of the greatest unmet needs in myeloma research and treatment.

About the KTX-1001 Phase 1 MMSET Clinical Trial
The Phase 1 clinical trial is a single-arm, open-label study in participants with relapsed and refractory multiple myeloma. It is a multi-part study with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001 in combination with standard of care and mezigdomide. For more information and participating centers, visit NCT05651932 and EUCTR: 2022-500801-41-00.

On September 16, 2025 Researchers at Children’s Hospital of Philadelphia (CHOP) reported a novel antibody-drug conjugate (ADC) that shows striking efficacy against cancers that express the anaplastic lymphoma kinase (ALK) protein on the cancer cell surface (Press release, CHOP, SEP 16, 2025, View Source [SID1234656009]). The therapy, named CDX0239-PBD, achieved complete and lasting tumor responses in preclinical models of neuroblastoma, rhabdomyosarcoma and colorectal carcinoma, according to findings published in Nature Communications. The breakthrough could unlock a new class of precision medicine treatments for both childhood and adult cancers, potentially improving short- and long-term patient outcomes and minimizing the harmful side effects of many current treatments.

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Yael P. Mossé, MD, Professor of Pediatrics and leader of the Neuroblastoma Developmental Therapeutics Program at CHOP’s Cancer Center, and her team are renowned for the groundbreaking discovery of gain-of-function mutations in the ALK gene, which are the primary cause of hereditary neuroblastoma and the most common mutations in its sporadic forms. This discovery was pivotal as it identifies ALK as the only mutated oncogene in neuroblastoma that can be targeted for therapy, reducing the likelihood of toxic side effects. The new research, an outgrowth of Mossé’s work, was led by Alberto D. Guerra, MD, PhD, a fellow within the Division of Oncology at CHOP.

In the study, researchers combined CDX0239, a humanized antibody targeting ALK, with a potent chemotherapy agent called pyrrolobenzodiazepine (PBD) dimer. This innovative approach directs the antibody to cancer cells, delivering the chemotherapy inside to kill cancerous cells while mostly sparing healthy ones that do not express ALK. The ADC remained stable in the bloodstream, an essential step for moving the research into human trials.

"Our findings represent an important advance in the field of antibody-drug conjugates for pediatric solid tumors, an area where progress has lagged," said Guerra. "By combining tumor selectivity with potent drug delivery, CDX0239-PBD offers a potential blueprint for future pediatric solid tumor therapies."

The therapy’s effectiveness is closely linked to ALK levels on the surface of cancer cells. Those with a range of ALK surface expression responded well, even when expression was modest. This is particularly exciting as these findings credential the opportunity to leverage an ADC approach for a broad population of patients. In preclinical studies with human tumor models, three total weekly doses of CDX0239-PBD successfully eliminated tumors, resulting in 100% survival across several highly drug-resistant preclinical models. The effects were seen not only in pediatric cancers like neuroblastoma and rhabdomyosarcoma but also in colorectal carcinoma, underscoring the treatment’s potential versatility.

The therapy also achieved success where others did not. For example, in models resistant to lorlatinib, an FDA-approved ALK inhibitor, and those with TP53 mutations and MYCN amplification, treatment with CDX0239-PBD led to lasting positive effects and complete survival. Molecular analyses confirmed that the treatment caused DNA damage and activated cell-death pathways inside tumors, validating its mechanism of action to be selective delivery of a potent chemotherapy drug to cancer cells expressing ALK, and likely also to neighboring tumor cells which may not necessarily express ALK, a phenomenon referred to as the "bystander effect."

Moving forward, the research team is working on refining the technology to meet strict regulatory requirements for developing a first-in-class ALK-directed ADC, aiming for first-in-human/first-in-children early phase clinical trial testing within the next two years. The team is also exploring alternative antibodies with features that would allow for better penetration into the solid tumor microenvironment.

"Precision medicine is transforming our approach to cancer treatment by moving beyond one-size-fits-all therapies," said Mossé. "By tailoring treatments to the unique characteristics of each tumor, we can specifically target cancer cells, thereby increasing the potency and reducing harmful side effects on healthy cells. Our hope is to significantly boost survival rates for patients fighting aggressive cancers while also enhancing their quality-of-life post-treatment."

This work was supported in part by the National Cancer Institute grants (R01CA140198-11-1, R37CA282041 and K08CA230223), Patricia Brophy Endowed Chair in Neuroblastoma Research, DOD Award (W81XWH-12-1-0486), the National Institutes of Health grant (R013208130624), the National Institutes of Health grant (DP2HD108775), funding from Braden’s Hope Foundation, the Margaret Q Landenberger Foundation, NIH Grant (2T32CA009615) and the Howard Hughes Medical Institute (HHMI).

On September 16, 2025 Senhwa Biosciences, Inc. (TPEx: 6492, "Senhwa") reported its official entry into the fast-growing global immuno-oncology market (Press release, Senhwa Biosciences, SEP 16, 2025, View Source [SID1234656010]). The Company’s novel investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the approved PD-1 inhibitor Cemiplimab (Libtayo), provided by Sanofi and Regeneron Pharmaceuticals, in a Phase 1/2 clinical trial for patients with microsatellite-stable colorectal cancer (MSS CRC) who are refractory to immune checkpoint inhibitors.

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This strategic collaboration marks the third clinical trial under Senhwa’s NCI-sponsored five-year cancer research program with the U.S. National Cancer Institute (NCI). An Investigational New Drug (IND) application has been submitted to the U.S. FDA. The partnership underscores the unique mechanism of action of CX-5461 and the strong interest from leading global pharmaceutical companies in its potential to enhance the immunotherapy efficacy.

Dr. Pin-Yen Huang, Chief Medical Officer of Senhwa, stated:
"This is more than a clinical trial—it is a transformative opportunity to redefine the future of cancer therapy. The compelling synergy between CX-5461 and PD-1 inhibitors holds the promise of bringing renewed hope to countless patients, while also showcasing Taiwan’s spirit of innovation on the global stage."

Breaking Through Solid Tumor Immunotherapy Barriers

While immune checkpoint inhibitors have revolutionized cancer care, their response rates in solid tumors — other than melanoma — remain low at approximately 20–30%. The CX-5461 plus Cemiplimab combination aims to significantly improves these response rates, broaden the reach of PD-1 inhibitors, and potentially overcome treatment bottleneck in MSS CRC and other low-immunogenicity tumors.

Rising Momentum for Cross-Border Partnerships in Asia

According to recent data, cross-border licensing and M&A transactions in Asia’s pharmaceutical sector surged to US$66 billion in just the first seven months of 2025, already surpassing the total value for the entire previous year. Several blockbuster deals exceeding US$1 billion demonstrate how global pharma leaders are rapidly pivoting strategic investments toward Asia.

Amid this trend, Senhwa stands at the intersection of differentiated innovation, strong collaborations with the NCI, and partnerships with global pharmaceutical companies. As immunotherapy and precision medicine markets continue their robust expansion, Senhwa is well-positioned to become a pivotal partner for multinationals while emerging as a key innovator in Asia’s biotech landscape — creating a dual opportunity for growth and value for its stakeholders.

Unmet Need in MSS CRC and Young-Onset Colorectal Cancer

In metastatic CRC approximately 95% of metastatic colorectal cancer cases are MSS, for which effective immunotherapy options remain limited. Alarmingly, incidence among younger patients continues to rise, highlighting the urgent need for innovative approaches. Many patients either fail to respond or develop resistance to existing immunotherapies; and high treatment costs plus a lack of reliable biomarkers posing additional clinical challenges.

Through its innovative combination and precise design, this trial seeks to breakthrough current limitations, offering patients new hope by extending survival and improving quality of life.

Global Market Potential and Outlook for CX-5461

According to Coherent Market Insights, the global cancer immunotherapy market is projected to surpass US$150 billion by 2025, with sustained double-digit growth expected to push the market beyond US$300 billion by 2035. Combination therapies, in particular, have emerged as a central focus for industry R&D and investment.

As a first-in-class small molecule with a novel mechanism, preclinical data has shown CX-5461to have the ability to reprogram the tumor microenvironment, increase tumor mutational burden, and induce neoantigen presentation. Preclinical data also suggests the drug to enhance dendritic and cytotoxic T-cell infiltration while reducing immunosuppressive macrophages, thereby boosting sensitivity and efficacy of immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 therapies.

Crucially, CX-5461 has not shown marked bone‑marrow suppression at evaluated doses, in contrast to levels commonly seen with conventional chemotherapy. This advantage not only preserves cytotoxic immune cells but also creates a tumor microenvironment more favorable to immunotherapy and even cell-based therapies.

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 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.