On June 18, 2024 CEL-SCI Corporation (NYSE American: CVM) reported the Company’s Chief Scientific Officer, Dr. Eyal Talor, delivered a presentation titled "Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression – IT-MATTERS – RCT" at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary on Tuesday, June 18, 2024 (Press release, Cel-Sci, JUN 18, 2024, View Source [SID1234644434]). Dr. Talor presented during the Cancers/Tumors session which he Chaired along with Dr. Elizabeth Tran of Purdue University.

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Multikine* (Leukocyte Interleukin, Injection) is the first investigational pre-surgical cancer drug intended for use in newly diagnosed locally advanced resectable head and neck cancer. There is extensive affirmative safety and efficacy data from 750 patients who have been treated with Multikine. A randomized, controlled, Phase 3 trial (RCT) in head and neck cancer revealed that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to checkpoint inhibitors (e.g. Keytruda, Opdivo) which show longer survival benefit in patients with a higher level of tumor cell PD-L1 expression. Tumor cell PD-L1, also known as Programmed Death-Ligand 1, is a protein that plays a crucial role in immune system regulation. It is the target pathway for immune checkpoint inhibitors, a major class of immune-oncology drugs which work by blocking the interaction between tumor cell PD-L1 and the PD-1 receptor on immune effector cells, thereby favoring immune evasion by the tumor.

"The survival benefit of Multikine we observed from previous data for the same study population is much higher than that which will be required to be successful in the confirmatory study," stated Dr. Talor.

The presentation may be accessed on CEL-SCI’s website at the following:

View Source

On June 18, 2024 Iambic Therapeutics, a clinical-stage biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, reported the closing of an oversubscribed $50 million extension to its Series B financing (Press release, Iambic Therapeutics, JUN 18, 2024, View Source [SID1234644435]). The Series B extension was led by new investors Mubadala Capital and Exor Ventures, with participation from Qatar Investment Authority (QIA), and existing investors Abingworth, Illumina Ventures, Nexus Venture Partners, Coatue, and Tao Capital Partners.

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The extension adds to an oversubscribed $100 million Series B that closed in October and was co-led by Ascenta Capital and Abingworth and joined by NVIDIA and others.

Proceeds from the latest financing will be used to further Iambic’s pipeline of clinical and pre-clinical programs. These include IAM1363, a highly selective, brain penetrant small molecule inhibitor of both wild-type and oncogenic HER2 mutants currently in a Phase 1/1b study, as well as a potential first-in-class selective dual CDK2/4 inhibitor designed to expand the therapeutic window and address treatment resistance in solid tumors in diseases such as breast cancer.

"We are delighted to build this strong team of investors around the company who share our conviction in the demonstrated power of the Iambic AI-driven technology platform to deliver highly differentiated drugs to the clinic," said Iambic’s Chief Executive Officer Thomas Miller, Ph.D.

Iambic’s pipeline candidates were discovered using its leading AI models for protein structure prediction and wholistic drug design. These technologies are integrated within a closed-loop, automated, high-throughput biology and chemistry experimental platform that provides new biological insights from thousands of molecular designs each week, which in turn directly inform its AI models.

"Iambic is a true innovator, both in the demonstrated accuracy and speed of its state-of-the art AI drug discovery models, and its ability to rapidly advance candidates from discovery and into human studies," said Ayman AlAbdallah, Partner at Mubadala Capital. "Iambic is a company purpose-built for AI and drug discovery and we are excited to see how their machine learning and drug hunting expertise will help deliver on the promise of AI to bring potential life-saving medicines to patients."

On June 18, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference on Tuesday, June 25, 2024, at 2:00 p.m. ET (Press release, CytomX Therapeutics, JUN 18, 2024, View Source [SID1234644420]).

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

On June 18, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported that it will participate in the hubXchange’s Immuno-Oncology Xchange – Boston 2024, taking place June 18 in Boston, Massachusetts (Press release, BostonGene, JUN 18, 2024, View Source [SID1234644436]). The event brings together executives from pharma and biotech to address and find solutions to the key issues that are currently faced in Immuno-Oncology.

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During the event, BostonGene will lead a roundtable discussion:
Multiomic immune biomarker selection for novel IO response and toxicity assessment: tissue, blood, plasma, or all of the above?

Tuesday, June 18 | 11:20 AM ET
Speaker: Michael Goldberg, PhD, VP, Research & Development, BostonGene
This session will explore the utilization of immune biomarker strategies to enhance drug development and improve patient outcomes. The focus will be on current applications, technological advancements, novel approaches and the necessary validation and regulatory processes. By addressing these aspects, the session aims to highlight how these strategies can significantly improve therapeutic results and personalize treatment plans.

"I’m excited to participate in the hubXchange’s Immuno-Oncology Xchange and discuss how immune biomarker strategies can revolutionize drug development and patient care. By leveraging advanced technologies and comprehensive biomarker profiles, we have the potential to drastically enhance therapeutic outcomes and tailor treatments to individual patients’ needs," said Michael Goldberg, PhD, VP, Research & Development at BostonGene.

On June 18, 2024 Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it has entered into an exclusive licensing agreement (the Agreement) with MabCare Therapeutics (MabCare) for MTX-13, a novel ADC targeting protein-tyrosine kinase 7 (PTK7) (Press release, Day One, JUN 18, 2024, View Source [SID1234644421]). Pursuant to the terms of the Agreement, Day One has exclusive rights to develop, manufacture, and commercialize MTX-13 worldwide, excluding Greater China.

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In April 2024, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for MTX-13, which going forward will be identified as DAY301. In pre-clinical studies, DAY301 showed antitumor activity in a wide range of solid tumors.

"Our priorities for 2024 are to successfully launch OJEMDATM (tovorafenib), to advance our existing programs and to expand our pipeline by in-licensing clinical-stage assets that have the potential to transform outcomes for patients of all ages living with cancers," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We are excited by the opportunity presented by DAY301, and we believe we have the right team in place to develop the program to its full potential."

DAY301 targets PTK7, a highly-conserved, catalytically inactive transmembrane protein that is overexpressed in multiple adult cancers, including esophageal, ovarian, lung, and endometrial cancer, as well as pediatric cancers such as neuroblastoma, rhabdomyosarcoma and osteosarcoma. PTK7 has limited expression in normal tissues or organs, making it an attractive target for therapeutic development.

"The addition of DAY301 to our pipeline strategically fits our mission of advancing both pediatric and adult medicines in areas of unmet need with equal urgency," said Dr. Samuel Blackman, co-founder and head of research and development at Day One. "We believe the linker-payload technology embodied in DAY301 will overcome the limitations of earlier PTK7-targeted ADCs, giving us a potential first-in-class drug against a clinically-validated target. We are excited to add this program to Day One and will look to enter the clinic in the coming months."

Under the terms of the licensing agreement, MabCare will receive $55 million upfront, and is eligible to receive an additional $1.152 billion in development, regulatory and commercial success-based milestones, plus low-to-mid single-digit royalties on net sales outside of Greater China. Day One expects the first patient to be dosed in the Phase I study in the fourth quarter of 2024 or first quarter of 2025.