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 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2024, and provided a corporate update (Press release, Cellectar Biosciences, MAR 13, 2025, View Source [SID1234651125]).

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"In 2024 the company showcased the efficacy and safety of iopofosine I 131 for the treatment of relapsed/refractory Waldenström macroglobulinemia. We recently completed a productive meeting with the FDA that established a clear regulatory pathway for the accelerated approval of this promising drug. Based upon this regulatory clarity, the quality of the CLOVER-WaM data, and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations for iopofosine I 131, which we view as an attractive, non-dilutive funding approach." said James Caruso, president and CEO of Cellectar. "In addition, the company received clearance for an IND for our Auger-emitting radioconjugate and will be submitting an IND application for our alpha-emitting radioconjugate. By the middle of 2025 we will be prepared to advance into phase 1 clinical studies for both compounds, in triple negative breast cancer and pancreatic cancer indications, respectively."

2024 and Recent Corporate Highlights

· Finalized confirmatory study design and regulatory pathway for potential FDA accelerated approval of iopofosine I 131, the Company’s targeted radiotherapeutic candidate for the treatment of relapsed/refractory WM.

o The study will be a randomized, controlled trial of iopofosine I 131 versus a comparator arm, with 100 patients per arm.

o Two-stage approval process includes conditional accelerated approval based on a major response rate (MRR) endpoint with full approval based upon achieving a progression-free survival endpoint.

o Company expects to complete full patient enrollment within 24 months of the first patient admitted to the study.

o Total study cost is expected to be between $40M-$45M, with approximately $30M to full enrollment.

· Presented data from the Phase 2 CLOVER-WaM study in an oral session at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2024) in December. The oral presentation highlighted that treatment with iopofosine I 131 in patients suffering from relapsed/refractory WM demonstrated:

o overall Response Rate (ORR) was 83.6%;

o major Response Rate (MRR) was 58.2%, which exceeded the FDA agreed-upon primary endpoint of 20% MRR;

o durable efficacy in previously treated WM patients, with no current standard of care therapy;

o well tolerated with a manageable toxicity profile across broad biologic and clinical subgroups.

· An article published in the journal eBioMedicine, volume 111, 2025, 105496, ISSN 2352-3964 from a SPORE Grant-supported, investigator-led study utilizing iopofosine I 131 (also known as CLR 131) in combination with external beam radiation, reported the best overall response from 11 evaluable patients included seven participants with a complete response (63.6%), one with a partial response (9%), one with stable disease (9%), and two with disease progression (18%), further supporting iopofosine I 131’s therapeutic benefit in solid tumors.

· Continued development of CLR 121225 and CLR 121125, the Company’s pre-clinical radioconjugate assets, to support Phase 1 solid tumor studies:

o The company is prepared to initiate a Phase 1b/2a dose-finding study with CLR 121125 in triple-negative breast cancer. CLR 121125 is the company’s lead Auger-emitting (iodine-125) Phospholipid Radioconjugate (PRC) that provides the greatest precision in targeted radiotherapy as emissions only travel a few nanometers.

o The company plans to file an IND application in the first half of 2025 for CLR 121225. CLR 121225 is Cellectar’ s lead alpha-emitting (actinium-225) PRC, which has demonstrated activity in multiple solid tumor animal models, including pancreatic and colorectal cancer.

2024 Financial Highlights

· Cash and Cash Equivalents: As of December 31, 2024, the company had cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023. In 2024, Cellectar executed multiple financial transactions, including investors’ exercise of warrants in January 2024 that generated $44.1 million, and an inducement financing in July 2024, which included the exercise of existing warrants and the purchase of new warrants for an additional $19.4 million. The company believes its cash balance as of December 31, 2024, is adequate to fund its basic budgeted operations into the fourth quarter of 2025.

· Research and Development Expenses: R&D expenses for the year ended December 31, 2024, were approximately $26.1 million, compared to approximately $27.3 million for the year ended December 31, 2023. The decrease was primarily a result of the timing of expenditures for our WM Phase 2 study to support final patient visits, partially offset by the extensive analytic work necessary to prepare for a planned regulatory submission, product sourcing, manufacturing, and logistics infrastructure costs to support multi sourcing for each aspect of iopofosine I 131 production.

· General and Administrative Expenses: G&A expenses for the year ended December 31, 2024, were approximately $25.6 million, compared to approximately $11.7 million for the same period in 2023. The increase was primarily driven by costs associated with the development of infrastructure necessary to support potential commercialization, including the related marketing and personnel costs.

· Other income and expense: Other income and expense, net, was approximately $7.3 million of income in 2024, as compared to approximately $3.9 million of expense in the prior year. These amounts are almost exclusively non-cash and driven by the issuance and valuation of equity securities in conjunction with financing activities. The only cash impact was interest income, which for 2024 improved to approximately $1.2 million from $0.4 million in the prior year.

· Net Loss: Net loss for the full year ending December 31, 2024, was $44.6 million or $1.22 per basic share and $1.40 per diluted share, compared with $42.8 million or $3.50 per basic and diluted share during 2023.

Conference Call & Webcast Details

Cellectar management will host a conference call and webcast today, March 13, 2024, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

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 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported U.S. Urology Partners, one of the nation’s largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio’s Expanded Access Program (EAP) for recombinant Bacillus Calmette-Guérin (rBCG) to address the current shortage of TICE BCG in the U.S (Press release, ImmunityBio, MAR 13, 2025, View Source [SID1234651127]).

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"The shortage of BCG has real consequences, especially in many rural communities across the country where supply shortages have impacted the treatment of patients with bladder cancer," said Christopher M. Pieczonka, M.D., Chief Executive Officer and Director of Clinical Research, Associated Medical Professionals, an affiliate of U.S. Urology Partners. "I’m pleased U.S. Urology is at the forefront of offering rBCG and would like to thank ImmunityBio for their initiative to seek and secure authorization from the FDA for expanded access to this vital BCG alternative."

Supply shortages of TICE BCG in the U.S. have become a significant impediment to the treatment of bladder cancer patients. In a recent Sermo survey of 100 U.S. urologists, 57 percent indicated they were unable to treat patients in the last 12 months due to a lack of access to TICE BCG. Providers who are unable to source TICE BCG are able to access rBCG through the ImmunityBio EAP.

"It is gratifying to see the rapid uptake and interest in the rBCG Expanded Access Program, which was authorized by the FDA just recently," added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "Participation by a major national provider like U.S. Urology Partners is a testament to the critical importance of rBCG and the need for an alternative supply of this essential medicine."

"This is an incredibly exciting opportunity to expand the BCG supply to allow more patients to receive the full course of their cancer treatment, saving bladders and extending lives," said Dr. Eugene B. Cone, Co-Director of Clinical Research, Urology of Indiana, an affiliate of U.S. Urology.

The Serum Institute of India, ImmunityBio’s collaboration partner, is the world’s largest manufacturer of vaccines by volume. In bladder cancer clinical trials in Europe, the recombinant BCG vaccine has demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains and formulations. Clinical research organization, Anova Enterprises, Inc. (Anova) is helping ImmunityBio manage the rBCG EAP.

"Constrained BCG supply has improved stewardship of a limited resource but has come at a high cost to our patients," said Dr. Chad Reichard, Co-Director of Clinical Research, Urology of Indiana. "rBCG represents a long overdue potential alternative but does not abrogate responsibility to ongoing diligence and discipline in BCG delivery."

About Recombinant BCG (rBCG)

BCG is a benign bacterium originally developed as a live vaccine against tuberculosis (TB). It is based on the well-known Mycobacterium bovis (M. bovis) Bacillus Calmette-Guérin (BCG) strain. It has been in use since 1921 and administered to more than 4 billion individuals worldwide. BCG given via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with non-muscle invasive bladder cancer (NMIBC) since 1977. BCG induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients.

Two gene modifications have been implemented in rBCG to improve its immunogenicity and safety in comparison to earlier strains and formulations of BCG. Recombinant rBCG has completed Phase 1/2 human clinical studies in Europe as an immunotherapy in patients with NMIBC. The findings from those studies demonstrate rBCG is well-tolerated when administered intravesically with a safety profile similar to placebo, and reduced rates of adverse events observed in earlier strains and formulations of BCG.

Supportive clinical data of rBCG as a TB vaccine are available from four clinical trials. Two studies in healthy adult volunteers and one Phase IIa study in healthy newborn infants were performed with rBCG. Additionally, a Phase II clinical trial was conducted with rBCG in HIV-unexposed and HIV-exposed, BCG-naïve newborn infants for clinical bridging. Clinical trials have also been conducted to assess the effect of rBCG vaccination on TB recurrence and on the susceptibility or severity of respiratory diseases during the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic.

BCG is one of the most widely used vaccines worldwide. However, because BCG is a biologic drug that uses benign bacteria, it is more complicated to manufacture than many other types of drugs. Serum Institute of India is the largest manufacturer of BCG vaccines in the world, while Merck & Co., based in New Jersey, currently is the only manufacturer of BCG (TICE BCG) in the U.S.

ImmunityBio has been awarded multiple patents covering the composition and methods of use for the combination of BCG plus ANKTIVA in bladder cancer (US 11,173,191 Β2; US 11,679,144 Β2; US 11,890,323 B2).

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com.

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.