On March 13, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah (Press release, OS Therapies, MAR 13, 2025, View Source [SID1234651143]). Key data will be presented from the Company’s Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma. This data will be compared with a newly created regulatorily compliant synthetic control group comprised of case matched controls that will be used for the Company’s US Food & Drug Administration (FDA) OST-HER2 Biologics License Application (BLA) submission. Equivalent submissions with international regulatory authorities will be made in order to gain commercial marketing authorization. MIB Agents FACTOR is the most important annual osteosarcoma conference bringing together the leading osteosarcoma researchers, clinicians, patient families, osteosarcoma survivors, patients, and bereaved parents to "Make It Better" (MIB) for those battling this deadly cancer.

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The Company reiterates its intention to submit a BLA with FDA for OST-HER2 in osteosarcoma in the second quarter of 2025, positioning it to receive approval in the fourth quarter of 2025. OST-HER2 has received Rare & Pediatric Disease Designation (RPDD) from the FDA and Fast Track and Orphan Drug Designations from the FDA and European Medicines Agency (EMA). If OST-HER2’s BLA submission is approved by the FDA before September 30, 2026, the Company will be granted a Priority Review Voucher (PRV) that it will be able to sell to a third party. The most recent PRV transaction occurred last month when Zevra sold its PRV to an undisclosed third party for $150 million.

On March 13, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported it will be exercising its option, under its license and option agreement with Synaffix B.V. ("Synaffix"), a Lonza company (SWX: LONN), to obtain a license to Synaffix’s technology to develop two bispecific antibody-drug conjugate (ADC) programs (Press release, SOTIO, MAR 13, 2025, View Source [SID1234651142]).

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The exercised option will enable SOTIO to advance two bispecific candidates, designed by its in-house research team, that have the potential to become first-in-class and/or best-in-class treatments for solid tumors. SOT112 is a bispecific ADC with potential applicability in several major cancer indications, while SOT113 demonstrates promise for precision targeting of prostate cancer. Both programs leverage the selection of highly attractive target pairs and are now in the lead nomination stage.

The bispecific antibody candidates were identified by SOTIO’s research team and will now be developed under SOTIO’s license and option agreement with Synaffix, which enables SOTIO to combine its proprietary antibodies with Synaffix’s GlycoConnect, HydraSpace, and potent linker-payloads of the toxSYN platform to research, develop, manufacture, and commercialize ADC products.

"The promising preclinical data on SOT112 and SOT113 have reinforced our confidence in their potential, and we are excited to advance these candidates within our first-in-class and best-in-class ADC portfolio," said Martin Steegmaier, Ph.D., chief scientific officer of SOTIO. "Bispecific ADCs represent a groundbreaking frontier in oncology, offering enhanced tumor-targeting precision and the potential to overcome the challenges of heterogeneity in solid tumor target expression. Both advancements align with our mission to develop safer and more effective treatments for solid tumors."

Peter van de Sande, head of Synaffix, commented: "We are pleased that SOTIO, recognizing the versatility and robustness of our clinically validated platform, has chosen to expand its use of our ADC technology to two additional targets. ADCs are a key part of our offering, and our technology is primed to support this next stage of innovation in targeted cancer therapeutics. We look forward to seeing these promising candidates advance toward the clinic."

Under the terms of the agreement, Synaffix is eligible to receive an upfront payment with the potential for milestone payments, plus single-digit royalties on net sales. SOTIO will be responsible for research, development, manufacturing, and commercialization of the ADC products, and Synaffix will closely support SOTIO’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect, HydraSpace, and linker-payloads of the toxSYN technologies.

On March 13, 2025 BioCity Biopharmaceutics Co., Ltd., a clinical-stage biopharmaceutical company, reported that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate the combination of BioCity’s BC3195 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a global phase 1/2 trial in patients with locally advanced or metastatic solid tumors (Press release, Biocity Biopharmaceutics, MAR 13, 2025, View Source [SID1234651141]).

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Under the terms of the agreement, BioCity will conduct a phase 1/2 clinical trial to evaluate the safety and efficacy of BC3195 in combination with KEYTRUDA. BioCity and MSD each retain all commercial rights to their respective compounds. The recruitment in the clinical study is expected in Q4 2025.

"We are encouraged by the clinical data we have seen thus far for BC3195 as monotherapy, which have demonstrated improved anti-tumour activity in patients with certain non-small cell lung and breast cancers. We now look forward to exploring the potential of BC3195 in combination with KEYTRUDA through this collaboration, as we continue to advance our clinical program and seek to further validate our differentiated drug discovery and development approach." Said by Ivy Wang, Co-founder and Executive President of BioCity.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About BC3195

BC3195 is currently the only ADC targeting CDH3 (P-Cadherin) in clinical development globally. In preclinical studies, BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells, as well as surrounding cells, which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers.

BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in China and in US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics, significant antitumor activity with confirmed PRs observed across multiple tumor types.

On March 13, 2025 Third Arc Bio Inc., a clinical stage biotech company developing novel multifunctional antibodies for a range of oncology and immunology & inflammation (I&I) indications, reported the first patient has been dosed in its first-in-human study evaluating ARC101, a potential best-in-class T cell engager targeting Claudin 6 (CLDN6) (Press release, Third Arc Bio, MAR 13, 2025, View Source [SID1234651140]).

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This Phase 1 study will evaluate the optimal dosing, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor efficacy of ARC101 as monotherapy in patients with locally advanced or metastatic solid tumors expressing CLDN6.

"ARC101 is the first program from our growing pipeline to reach the clinic – signifying Third Arc Bio’s transition into a clinical stage company," said Peter F. Lebowitz, MD, PhD, Chief Executive Officer and Chief Medical Officer of Third Arc Bio. "Given ARC101’s remarkable specificity for CLDN6 over other Claudin proteins, we believe ARC101 has the potential to achieve a superior therapeutic index in the clinic. As we advance the ARC101 clinical program, we are also rapidly progressing our next programs towards the clinic with the execution of critical IND-enabling studies."

ARC101 represents the company’s first clinical effort to evaluate in humans its immune cell engaging antibodies that modulate the immune system in precise ways to target specific disease states. Building upon ARC101 as a foundation, Third Arc Bio continues to invest in its Synergy Platform to develop a pipeline of novel CD3 and CD28 targeting multispecifics to create transformational drugs against solid tumors.

Third Arc Bio will present a poster highlighting preclinical results for ARC101 at the upcoming 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data will highlight ARC101’s best-in-class specificity for CLDN6 versus other closely related Claudin proteins.

On March 13, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that the Safety Review Committee (SRC) monitoring its Phase I clinical trial has unanimously approved opening of the fourth cohort of patients based on the SRC’s favorable review of Cohort 3 safety data (Press release, TransCode Therapeutics, MAR 13, 2025, View Source [SID1234651139]). The therapeutic candidate being evaluated, TTX-MC138, is a first-in-class therapeutic designed to treat multiple metastatic cancers using antisense technology. The dose administered to the fourth cohort, as originally planned in the clinical protocol, will be approximately fifty percent higher than the dose administered in the third cohort.

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Under the clinical protocol, patients may remain on study absent safety events or disease progression. Out of 9 patients treated with TTX-MC138 in the first three cohorts, 6 remain on study for continued treatment since there have been no dose limiting toxicities or disease progression with these patients. The patient that has remained on study the longest has, to date, received 7 doses each approximately 28 days apart over the approximately 7 months that this patient has been on study. In addition to approving opening the fourth cohort, the SRC approved enrollment of additional patients in Cohort 3 to build upon the safety profile of TTX-MC138. Further, Cohort 1 and 2 data analysis for both pharmacokinetic (PK) and pharmacodynamic (PD) activity is ongoing and suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode’s Phase 0 clinical trial. Preliminary results from Cohort 2 confirmed observations from the Phase 0 trial and from Cohort 1 that the drug candidate shows evidence of activity in patient blood. Preliminary PK analysis suggests that dose levels 0.8-1.6 mg/kg, the levels administered to Cohorts 1 and 2, could represent an efficacious range.

"SRC approval to open the fourth cohort and expand enrollment in Cohort 3 is an important advancement for the clinical trial. It will provide an opportunity to obtain additional safety and PK/PD data, inform the dose expansion stage of the clinical trial and may allow us to obtain initial evidence of clinical activity" commented Sue Duggan, TransCode’s Senior Vice President of Operations. Duggan added, "Enrollment into the study continues based on the cumulative safety data review. Eligible subjects may now be screened and scheduled in Cohort 4 for treatment with the next dose level of TTX-MC138 while preliminary data analysis continues."

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate that targets microRNA-10b, a micro-RNA widely believed to be a driver of metastatic disease. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

About the Trial

TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study, designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation stage followed by a dose-expansion stage. The primary objective of the dose-escalation stage is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion stage, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation stage.

Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).