On February 7, 2024 Certis Oncology Solutions, a precision oncology and translational science company, reported its latest advancements in AI/ML at the Precision World Medicine Conference in Santa Clara, California (Press release, Certis Oncology Solutions, FEB 7, 2025, View Source [SID1234650099]).

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Certis President and CEO, Peter Ellman, presented "Predictive Oncology Intelligence: Revolutionizing Cancer Research with AI-Enabled Precision Oncology," as part of the event’s coverage of the rapidly expanding role of artificial intelligence in precision medicine. Ellman discussed the various ways the company’s patent-pending predictive AI/ML platform, CertisAI, helps close the translation gap in cancer therapeutics development via AI-enabled drug response predictions, better informed biomarker strategy, and data-driven decision-making.

"We’ve been talking about personalized medicine for decades now, but we’ve made little progress for patients. Nine out of ten investigational cancer therapies still fail in clinical trials. And despite all that we now know about cancer at a molecular level, fewer than 10% of patients derive meaningful clinical benefit from even the most advanced genomics-informed treatment," said Ellman. "In 2025, we have tools to change that. Multivariate computational algorithms, together with faster, lower-cost computing power, are quickly transforming the way we approach drug development and how we think about individualizing care."

During Ellman’s presentation, conference attendees were treated to an interactive demonstration of CertisOI Assistant, a recently launched generative AI tool that accelerates research workflows and democratizes the evaluation of complex datasets. The CertisOI Assistant works as a natural language intermediary for analyzing the genomic and drug sensitivity characterization data associated with thousands of cancer research models, including Certis’ patient-derived xenograft (PDX) models as well as public cancer cell lines from the Cancer Cell Line Encycolopedia (CCLE).

About CertisAI

CertisAI is a patent-pending predictive artificial intelligence/machine learning (AI/ML) platform developed by Certis Oncology Solutions. It is the first and only commercially available, validated AI/ML platform that predicts therapeutic efficacy by identifying complex gene expression signatures that correlate with drug response. The platform is designed to assist pharmaceutical researchers to develop and clinicians to identify new treatment options for specific cancers based on a tumor’s unique gene expression profile.

On February 7, 2025 Nusano, a physics company transforming the production of radioisotopes, reported the company’s CFO Pushkar Bedekar will present at Oppenheimer’s 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025 (Press release, Nusano, FEB 7, 2025, View Source [SID1234650098]). The presentation will highlight Nusano’s 2025 commercialization plans and provide an overview of how the company will leverage its proprietary technologies to make new supplies of rare and hard-to-produce radioisotopes available for medical and commercial markets.

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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

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WHO:
Nusano CFO Pushkar Bedekar

WHAT:
Company Presentation

WHEN:
Tuesday, Feb. 11, 2025
1:20 – 1:50 PM Eastern

WHERE:
Virtual Event – Oppenheimer 35th Annual Healthcare Life Sciences Conference

To listen to the webcast, please contact your representative at Oppenheimer and request a link.

On February 7, 2025 Kura Oncology, Inc. (the "Company") (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that on February 3, 2025, the Compensation Committee of the Company’s Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 164,000 shares of common stock to nine (9) new employees under the Company’s 2023 Inducement Option Plan, as amended (Press release, Kura Oncology, FEB 7, 2025, View Source [SID1234650097]). The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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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

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Each stock option has an exercise price equal to $8.25 per share, the Company’s closing sales price on February 3, 2025, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2023 Inducement Option Plan, as amended, and the terms and conditions of an applicable stock option agreement covering the grant.

On February 7, 2025 Amgen (NASDAQ: AMGN) reported that it will present at the 35th Annual Oppenheimer Healthcare Life Sciences Conference at 11:20 a.m. ET on Wednesday, Feb. 12, 2025 (Press release, Amgen, FEB 7, 2025, View Source [SID1234650096]). Narimon Honarpour, senior vice president of global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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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

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On February 6, 2025 Alphamab Oncology (Stock Code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) reported that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (Study ID: JSKN003-301). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer. This marks the third Phase III clinical study initiated for JSKN003, following the trials in HER2 low-expressing breast cancer and platinum-resistant ovarian cancer.

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Breast cancer is one of the most common malignant tumors among women worldwide and the most prevalent cancer in women in China. HER2-positive breast cancer accounts for 20% to 25% of all breast cancer cases in China, and it is the most aggressive and highly malignant subtype, prone to recurrence, metastasis, and worse prognosis. In recent years, targeted therapies and combination treatments have emerged and significantly improved the diagnosis and treatment of HER2-positive breast cancer. However, recurrent and metastatic breast cancer still poses a severe threat to patients’ health, with a significant unmet clinical need.

JSKN003 is an anti-HER2 bispecific ADC developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. The antibody molecule KN026 is site-specifically modified via enzyme catalytic reaction and click chemistry to achieve a drug-to-antibody ratio (DAR) of approximately 4. It can bind HER2 on the surface of tumor cells, and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Multiple clinical studies at various stages of JSKN003 conducted in China and Australia have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC), or high HER2-expressing solid tumors.

JSKN003-301 is a randomized, controlled, open-label, multicenter, Phase III clinical study aimed at evaluating the efficacy and safety of JSKN003 compared to emtansine (T-DM1) in the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab or taxane-based therapies. The primary endpoint of the study is progression-free survival (PFS) as assessed by the Blinded Independent Review Committee (BIRC).

About JSKN003

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC), or high HER2-expressing solid tumors.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, FEB 6, 2025, View Source [SID1234657006])