On December 19, 2023 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 a new licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property that was the result of collaborative research conducted at the University of Wisconsin-Madison (UW) with iopofosine I 131 in pediatric cancers (Press release, Cellectar Biosciences, DEC 19, 2023, View Source [SID1234638719]).

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Under the terms of the agreement, Cellectar has an exclusive license to develop and commercialize iopofosine in various pediatric solid cancers, such as high-grade glioma, neuroblastoma and sarcoma.

"This licensing agreement further strengthens our iopofosine I 131 patent portfolio and our industry-leading position in radiopharmaceutical patent grants and applications. It also expands our long-standing relationship with the University of Wisconsin. WARF, the intellectual property management arm of the UW, is highly respected for its history of successfully protecting intellectual property associated with its license agreements." said James Caruso, president and CEO of Cellectar. "Based on the encouraging performance of iopofosine in our pediatric Phase 1a study, we were awarded a $2 million NCI grant to further evaluate the activity of iopofosine in pediatric high-grade gliomas with anticipation of first patient enrollment in the near term."

On December 19, 2023 MBrace Therapeutics, Inc. ("MBrace"), a clinical-stage biopharmaceutical company devoted to improving the lives of patients with cancer by developing novel antibody-drug conjugates (ADCs), reported the successful initiation of patient dosing in its Phase 1/1b study evaluating MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment (Press release, MBrace Therapeutics, DEC 19, 2023, View Source [SID1234638682]).

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This first-in-human Phase 1/1b clinical trial (NCT06014658) is a multicenter, open-label, dose-escalation and dose-expansion study of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study are to determine the following parameters for MBRC-101: potential optimal biologically relevant doses (OBRD), maximum tolerated dose (MTD), safety profile, and anti-tumor activity.

"Developed using our proprietary SPARTA platform, MBRC-101 is our first drug candidate and has the potential to treat a variety of very commonly occurring cancers," said Isan Chen, M.D., president and chief executive officer at MBrace. "SPARTA is a robust antibody and target discovery platform which, by overcoming several limitations of previous approaches, accelerates translation into clinical applications. The dosing of the first four patients in our first clinical trial marks an important milestone as MBrace works to deliver new and effective ADCs to patients facing difficult-to-treat cancers."

MBRC-101 is a novel, targeted ADC in development for the treatment of several cancers. In preclinical studies, it has demonstrated robust anti-tumor activity in several patient models of non-small cell lung cancer (NSCLC), breast cancer and squamous cell carcinoma of the head and neck. MBRC-101 targets the EphA5 receptor tyrosine kinase, which is present in multiple cancers (including, but not limited to, NSCLC, breast, colorectal, gastric, pancreatic and hepatocellular) but is not observed in corresponding normal, non-malignant tissues.

"Despite the availability of newer cancer therapies, many patients with advanced cancer develop tumors that become non-responsive to these treatments," said Shiraj Sen, M.D., Ph.D., director of clinical research at NEXT Oncology-Dallas and an investigator in the Phase 1/1b study of MBRC-101. "We need novel efficacious therapies, including new ADCs, to benefit patients with advanced cancer resistant to prior treatments. I believe that MBRC-101 has the potential to bridge these current treatment gaps for patients with solid tumor cancers and look forward to our involvement in this clinical trial."

"At MBrace, as we move into this next exciting phase of clinical development, we remain dedicated to improving outcomes for patients who are living with difficult-to-treat cancers," said Wadih Arap, M.D., Ph.D., director of Rutgers Cancer Institute of New Jersey at University Hospital and chief of hematology/oncology, and founder and scientific advisor at MBrace. "MBRC-101 is a proof point of our emerging pipeline and broader vision."

On December 19, 2023 InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies against drug resistance, and Escugen, a clinical-stage antibody–drug conjugate (ADC) company, reported that InxMed licensed EZWi-Fit linker-payload platform from Escugen for the development of the next generation tumor-associated antigens (TAAs) targeting ADCs (Press release, InxMed, DEC 19, 2023, View Source [SID1234638698]).

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The license agreement provides InxMed with right to use EZWi-Fit platform on the several novel ADC candidate molecules. InxMed will have the right for development, manufacturing, and commercialization of these ADC candidate molecules.

InxMed is developing next generation TAAs targeting ADCs with significant improvement of efficacy and therapeutic window. Meanwhile, the company is developing solutions to boost ADC’s efficacy including enhancing ADC penetration via FAK inhibitor and developing stroma targeting ADC to create synergy.

InxMed is positioned to invent next generation ADCs, with the attributes to be more tumor selective and potent, and broad combination potential. The novel antibodies discovered by InxMed to be equipped with payload from EZWi-Fitplatform will be one of key differentiations.

On December 19, 2023 NanOlogy LLC, a clinical-stage oncology company, reported data presented as posters during recent oncology conferences (Press release, NanOlogy, DEC 19, 2023, View Source;utm_medium=rss&utm_campaign=nanology-clinical-and-preclinical-immune-data-presented-at-naclc-and-sitc [SID1234638683]).

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A poster entitled Phase 2a Intratumoral Large Surface Area Microparticle Paclitaxel in Stage 3/4 Lung Cancer was presented during IASLC’s North American Conference on Lung Cancer in Chicago on December 2, 2023. The poster was authored by clinical investigators Hiren Mehta, Abhishek Biswas, Sarah Wang, Jason Akulian, Christine Argento, et.al. It was one of only about 10% of posters selected for discussion during the poster discussion session. Summarizing presented data:

The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies including systemic immunotherapy.
Disease Control Rate for evaluable subjects at 3- and 6-months was 80% (8/10) and 86% (6/7), respectively.
Flow cytometry and safety data suggest IT LSAM-PTX may cause immunomodulation, including increases in immune effectors cells and decreases in Tregs and immune suppressor cells, and complement systemic therapy without significantly increasing adverse events.
A poster entitled Local administration of large surface area microparticle docetaxel is associated with antitumor immunomodulation across multiple tumor types was presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 4, 2023. The poster was authored by Holly Maulhardt, Alyson Marin, et.al. Summarizing presented data:

Immunophenotyping in 3 diverse tumor settings found commonalities in antitumor immunomodulation following local LSAM-DTX including changes in T cells and MDSCs.
NMIBC clinical subjects demonstrated infiltrations of CD4+T, CD8+ T, and NK cells.
Mice administered IT LSAM-DTX into renal tumor xenografts had increased circulating T cells and reduced M2-macrophage levels in the blood and spleen when compared to IV docetaxel.
IT LSAM-DTX in a metastatic breast cancer model increased T cells in the TME and reduced thoracic metastasis when combined with systemic immunotherapy.
Preclinical/clinical antitumor immunomodulation suggests that IT LSAM-DTX may be amenable to combination with immunotherapy.

On December 19, 2023 ImpriMed, a leading precision medicine startup focused on leveraging artificial intelligence to improve cancer treatment, reported the close of a $23 million Series A funding round, led by SBVA. HRZ Han River Partners, SK Telecom, KDB Silicon Valley, Ignite Innovation Fund, Samyang Chemical Group, Murex Partners, and Byucksan also participated in this round (Press release, ImpriMed, DEC 19, 2023, View Source [SID1234638700]). The funding will enable ImpriMed to expand its revolutionary drug response prediction technology beyond veterinary medicine into human oncology, increase headcount, and broaden its business development and research and development pipeline.

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The only precision medicine company using AI and comprehensive analysis of canine and feline cancer cells to make personalized drug response predictions, ImpriMed is delivering real-world results at scale. To date, 250+ veterinary hospitals in more than 40 states have deployed ImpriMed’s technology, with more than 15,000 canine and feline blood cancer tests completed. The company is challenging the status quo for treatment in animal cancer patients, building and validating its AI models for clinical outcomes, and enabling veterinary professionals to deliver more successful results. Moving forward, ImpriMed aims to address the overall cancer precision medicine space, which is estimated to reach $100.5 billion by the end of 2028 (source: Research and Markets). Its work will arm hospitals with drug treatment response predictions, ensure stronger prognosis evaluations, and more effectively stratify treatment risks.

"As the importance of precision medicine in conquering cancer continues to grow, ImpriMed has been producing significant results in the treatment of canine cancer, based on an abundance of clinical data," remarked Jay Choi, Principal at SBVA, which led this investment round. "We highly value ImpriMed’s potential to commercialize customized medical services for a variety of cancer diseases."

According to Sungwon Lim, CEO of ImpriMed, "This significant funding, secured in a challenging global investment landscape, is a strong endorsement of our technological innovation and growth trajectory. We are eager to transfer our expertise from veterinary to human cancer care, aspiring to become a pioneer in the precision medicine arena." Additionally, ImpriMed intends to broaden its CRO services to assist pharmaceutical companies in clinical trial designs and drug combination strategies, leveraging its unique technology that evaluates drug sensitivity in patients’ live cancer cells.

ImpriMed, which was co-founded in 2017 by Sungwon Lim, CEO, and Jamin Koo, CTO—both distinguished alumni of Stanford University and KAIST (The Korea Advanced Institute of Science and Technology)—specialized in utilizing artificial intelligence to enhance the efficacy of personalized cancer treatments. Its AI algorithms are used in combination with a patient’s live cancer cell analytics, the results of which are far more accurate predictions of how a specific patient will respond to a particular cancer therapy before administration. The company’s multiple myeloma prognosis and drug response prediction software is an innovative medical device already recognized by the Korea Food and Drug Administration and is targeted for commercialization in the United States in 2025.