Rutherrin® Increases Efficacy of Immunotherapy Preclinically

On June 18, 2024 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that in preclinical research, it’s lead drug formulation, Rutherrin, has demonstrated an ability to increase the efficacy of immunotherapy (Press release, Theralase, JUN 18, 2024, View Source [SID1234644440]).

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Immunotherapy, the latest technology in the war on cancer, can come in various forms; including: checkpoint inhibitors, Chimeric Antigen Receptor ("CAR") T-Cell therapy, cytokines, immunomodulators, cancer vaccines, monoclonal antibodies and oncolytic viruses, but the fundamental Mechanism Of Action ("MOA") of all of these immunogenic drugs is to stimulate the immune system to destroy cancer cells.

Cancer cells hide from the immune system by overexpressing proteins on their cellular surface, known as checkpoint proteins, that prevent the immune system from recognizing and subsequently destroying them. They thus remain incognito to the one failsafe that can protect the human body, the immune system.

The MOA of checkpoint inhibitors is to block the PD-L1 (checkpoint protein) on the cancer cell surface, allowing the immune system to detect and destroy the cancer cell; however, resistance to immunotherapy remains one of the major challenges in this form of treatment. In an attempt to overcome this resistance, multiple immunotherapy treatments are delivered to the patient, which may ultimately lead to a diminishing return in efficacy and a corresponding increase in patient serious adverse events and even treatment-related death.

Theralase’s latest research demonstrates that Rutherrin enhances the MOA of immunotherapy by not only killing cancer cells directly, but also significantly reducing the amount of PD-L1 proteins expressed by cancer cells; hence, reducing the number of target checkpoint proteins that need to be blocked by checkpoint inhibitors.

This results in an elegant one-two-three punch on the destruction of cancer cells; where, Rutherrin delivers the first punch, targeting and destroying cancer cells directly, as well as the second punch, by reducing the number of PD-L1 proteins expressed. This allows immunotherapeutic drugs to deliver the third and final punch, blocking the PD-L1 proteins remaining, allowing the immune system to significantly increase their recognition of cancer cells and hence their destruction. As a result, this technological advance increases both the safety and efficacy of immunotherapy, as less treatments would be required to induce the same clinical effect.

As a primary MOA, Rutherrin, has been demonstrated clinically to destroy NMIBC, when activated by light, and preclinically to destroy GBM and Non-Small Cell Lung Cancer ("NSCLC"), when activated by x-ray radiation.

As a secondary MOA, Rutherrin, has been demonstrated preclinically to unmask cancer cells through dual immunogenic check points; specifically, CD47 (previously reported by Theralase) and now PD-L1 inhibition. This down regulation of immunogenic check points allows the cancer cell to be detected and destroyed by the immune system, resulting in a process known as Immunogenic Cell Death ("ICD"). ICD is characterized by the secretion of Damage-Associated Molecular Patterns ("DAMPs"), which are transported to the cell surface during ICD.

Calreticulin ("CRT"), one of the DAMPs found in the lumen of the endoplasmic reticulum, is translocated to the surface of dying cells, after the induction of ICD, where it functions as an "eat me" signal for the immune system.

Dr. Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase stated, "It is one of humanity’s greatest health challenges in the 21st century, that cancer of various forms, affects and kills millions of people each and every year, without discrimination. Immunotherapy is the latest technology that attempts to harness the power of the immune system to detect and destroy cancer cells; however, these same cancer cells, treated with immunotherapy, develop mechanisms to avoid detection by the immune system, which consequently has an adverse effect on how effectively they react to therapy. In that regard, in a clinical setting, the term "resistance to immunotherapy" is applied; primary resistance denoting a failure to respond to the treatment from day one, while secondary resistance denoting a relapse following the initial response to immunotherapy. Despite remarkable scientific progress in this field, attempts to develop new strategies against cancer resistance to immunotherapy have proven difficult. We are very pleased with the results of our latest research, demonstrating that our lead drug formulation, Rutherrin, is able to maintain a therapeutic balance between various "accelerators" and "brakes" of our immune system to ensure that it is sufficiently engaged in attack against malignant cells, while avoiding destruction of healthy cells and tissues."

Roger DuMoulin-White, B.E.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase stated, "All cancer therapies, in their essence, attempt to destroy the disease, with minimal to no side effects and allow the patient a complete response with no recurrence; however, despite recent advances in the treatment of specific cancer types, many patients still struggle to respond to cancer treatments and are left with significant side effects. The PD-L1 (immune checkpoint protein) functions as a "brake" on the innate immune system, while Calreticulin ("eat me" signal) functions as an accelerator. We are very pleased to demonstrate that Rutherrin has the potential of releasing the "brake" and applying the "accelerator" to the immune system at the right time and thereby unleashing the power of our immune system to attack and destroy cancerous cells, while sparing healthy ones. By stimulating the inherent ability of our immune system to protect and defend our bodies against cancer, Rutherrin has the potential to establish an entirely new paradigm for cancer therapy."

BostonGene Highlights Its AI-Powered Multiomics Platform at hubXchange’s Immuno-Oncology Xchange Boston 2024

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.

Iambic Therapeutics Closes $50 million Series B Extension to Broaden its Pipeline of AI-Discovered Clinical Oncology Programs

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."

CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population

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

Reveal Genomics® to Evaluate Prospective Real-time Performance of HER2DX® Genomic Test in the United States

On June 18, 2024 REVEAL GENOMICS, S.L., a pioneering biotechnology start-up based in Barcelona set to revolutionize precision oncology through biomarker innovation, reported the start of a prospective study in collaboration with the Dana-Farber Cancer Institute (Dana-Farber) (Press release, REVEAL GENOMICS, JUN 18, 2024, View Source [SID1234644433]). This trial will evaluate the turnaround time of the HER2DX genomic test to determine its feasibility in clinical practice in the US.

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HER2DX test results are currently generated and managed in Barcelona, Spain, with an average turnaround time of 8.1 business days, according to data presented at the ESMO (Free ESMO Whitepaper) Breast Conference last May. This study at Dana-Farber aims to additionally evaluate the turnaround time of HER2DX conducted at Brigham and Women’s Center for Advanced Molecular Diagnostics (CAMD, Boston, MA, USA) in tumor samples of patients with newly diagnosed HER2+ early-stage breast cancer.

The study will also examine how the HER2DX test results influence therapeutic decisions by Dana-Farber physicians for patients with stage I-III HER2+ breast cancer, and the confidence levels of both patients and physicians before and after the test.

Patricia Villagrasa, REVEAL GENOMICS’ CEO, says, "We are excited to see the HER2DX test being used in the United States to improve clinical decision-making and patient outcomes. This collaboration with the Dana-Farber Cancer Institute is a significant milestone in our mission to enhance precision oncology through innovative biomarker solutions."

Sara M. Tolaney, MD, MPH, Chief of Division of Breast Oncology and Associate Director of the Susan F. Smith Center for Women’s Cancers at Dana-Farber, adds, "The HER2DX test has the potential to significantly influence therapeutic decisions for patients with HER2+ breast cancer. We are excited to be the first center in the United States to incorporate HER2DX and to explore its practical application in diverse clinical environments."

Adrienne G. Waks, MD, and Principal Investigator of the study at Dana-Farber, notes: "In addition to its potential incorporation into clinical practice, the fact that the study analyzes decision-making and collects information on physician and patient opinions makes the results of this study very powerful data for the routine use of the test."

The study will include patients with newly diagnosed stage I-III HER2+ breast cancer. In addition to assessing turnaround time, the study will provide questionnaires to patients to assess their basic understanding of their disease and the HER2DX assay, and to physicians to assess their pre-assay treatment choice and confidence in the results. The study team will record the physician researcher’s choice of treatment before and after the HER2DX results.

About HER2DX

HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About HER2+ breast cancer

HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically, and biologically heterogeneous, and standard clinical-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.