On June 18, 2024 Ability Biologics ("Ability") reported the final closing of its seed funding, raising a total of $18 million (US), a financing round led by founding investor Amplitude Ventures ("Amplitude") (Press release, Ability Biotherapeutics, JUN 18, 2024, View Source [SID1234653581]). Amplitude is joined by the Fonds de solidarité FTQ, Investissement Québec, Charles River Laboratories, Theodorus and Alexandria Venture Investments. Ability, a pioneer in the application of generative Artificial Intelligence (AI) to therapeutic discovery, focuses its platform on discovering and developing potent and selective antibody therapeutics for cancer and immune-related disorders. Ability Biologics, through its AbiLeap discovery engine, is generating novel, logic-enabled antibodies with the potential to become best-in-class or first-in-class therapeutics.

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Ability’s leadership team combines deep experience in immunology, antibody discovery, engineering and therapeutic development, from the bench to commercial stage, and is leveraging this experience to create next generation antibodies using powerful computational tools through its unique, proprietary AI platform. The AbiLeap discovery engine is an AI platform built on top of one of the largest databases of antibody-antigen interactions ever constructed, bringing together more than five years of discovery data and incorporating both public and private data sources. AbiLeap allows Ability to address a longstanding challenge by generating fully human antibodies that are logic-gated, enabling them to target specific tissues and cells based on the local microenvironment, including conditions such as secondary antigens, pH, temperature and/or the presence of specific metabolites.

"We’re seeing a need for a new generation of antibodies and modalities as simply binding, blocking or agonizing a single receptor is not enough to achieve therapeutic impact," said Giles Day, Co-founder and CEO of Ability. "At Ability, our platform overlays multiple approaches in a single molecule, enhancing specificity and selectivity to develop potent therapeutics with broad therapeutic windows. To do so, our antibodies employ tried and tested IgG formats that enable easier manufacturing, storage and administration, avoiding complex formats that introduce multiple risks from manufacturing to immunogenicity," concluded Giles Day.

"We are focused on solving the next set of complex biology challenges and one of them is to tackle the issue of on-target, off-tissue toxicity, which is limiting the utility of antibody therapy," said Dion Madsen, CFA, Co-founder and Partner at Amplitude Ventures. "Ability’s proprietary platform stands out as an intelligent way of rapidly developing selective and potent, ultra-targeted biotherapeutics to enhance potency and patient outcomes."

"The life science and biotech sector is in constant flux, and we are proud to provide financial backing for Ability’s ongoing innovations," said Bicha Ngo, President and CEO of Investissement Québec. "Harnessing the latest technologies, like artificial intelligence, in the development of antibodies will solidify Québec’s expertise in an area that is critical to the treatment of various types of cancer, and ultimately other diseases, that affect many Quebecers every year."

On June 18, 2024 Zentalis Pharmaceuticals, a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the following studies of azenosertib: the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC) (Press release, Zentalis Pharmaceuticals, JUN 18, 2024, View Source [SID1234646059]). This action follows two recent deaths due to presumed sepsis in the DENALI study.

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"Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate. We are working closely with the FDA to resolve this partial clinical hold as quickly as possible," said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "Over 500 patients have been treated with azenosertib monotherapy to date, and we believe that our data indicate a favorable therapeutic index that could potentially offer meaningful benefits to women facing PROC and USC. We have completed enrollment for Cohort 1b of the DENALI study, where we’ve enrolled more than a hundred patients, further demonstrating the support we’ve seen for having a novel oral therapy like azenosertib. We look forward to sharing these results along with overall efficacy and safety data from DENALI Cohort 1b later this year."

In addition to sharing topline results of Cohort 1b of DENALI, the Company remains on track to present results from the ZN-c3-001 and Phase 1/2 ZN-c3-006 (MAMMOTH) studies later this year. The Company will provide additional updates to the azenosertib clinical development and other data timelines following resolution of the partial clinical hold. Zentalis remains committed to the azenosertib development program and bringing this potentially practice-changing therapy to patients with gynecological malignancies.

Conference Call Details
Zentalis will host a live conference call and webcast today at 8:00 a.m. Eastern Time to provide a business update. To access the live conference call by telephone, please register at: https://register.vevent.com/register/BI24249bb9e5714044b9f4057f28565923. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source The webcast will also be made available on the Company’s website at www.zentalis.com under the Investors & Media section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On June 18, 2024 EUROAPI reported the implementation of a 5-year development and manufacturing agreement with Priothera, a biotechnology company specializing in molecules for the treatment of hematological malignancies and for the improvement of CAR-T cell therapies (Press release, Priothera, JUN 18, 2024, View Source [SID1234644446]). Priothera is headquartered in Dublin, Ireland, and has a subsidiary in Saint-Louis (Haut-Rhin), France.

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As part of this collaboration, EUROAPI will develop and industrialize the manufacturing process of mocravimod, an innovative oncology molecule, through its Contract Development and Manufacturing Organization (CDMO) activity. This project will be carried out at EUROAPI’s Budapest site, its center of excellence for complex chemistry.

"Oncology is a major segment for EUROAPI’s CDMO business. Signing this development and manufacturing agreement with Priothera demonstrates our ability to adapt to state-of-the-art innovation and quality requirements," said Cécile Maupas, Chief CDMO Officer of EUROAPI. "This contract is a true recognition of EUROAPI’s broad panel of technologies and capabilities to respond to the increasing demand across different modalities."

"Having EUROAPI as a commercial manufacturing partner brings a substantial value to Priothera who is accelerating its late development of mocravimod in a global phase 3 clinical study with a view of worldwide drug registration and commercialization by 2027," said Florent Gros, Co-Founder and Chief Executive Officer of Priothera.

Mocravimod is a S1P[1] receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers, with the objective to reduce relapses and increase survival of patients. It is being developed in a global phase 3 trial which is enrolling approximately 250 adult Acute Myeloid Leukemia patients, and is ongoing in the US, Europe, Asia and Latin America. It has been granted Orphan Drug designation by both EMA and US FDA. Oncology is a growing market worldwide: global spending on cancer medicines is expected to reach $375 billion by 2027, up from $196 billion in 2022[2]. According to the US National Cancer Institute, approximately 1.6 percent of men and women will be diagnosed with leukemia at some point during their lifetime[3].

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."

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.