On October 3, 2023 PharmaEssentia Corporation, (TPEx:6446), a global biopharmaceutical innovator headquartered in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that it has entered into a license agreement with WuXi Biologics Ireland Limited to obtain the global exclusive rights to research, develop, manufacture and commercialize a myeloid immune checkpoint antibody candidate (Press release, PharmaEssentia, OCT 3, 2023, View Source [SID1234635619]). PharmaEssentia will take over responsibility for the subsequent preclinical and clinical development efforts.

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"We are excited to expand our pipeline, which reflects our dedication to growing our research capabilities and delivering transformative healthcare solutions," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer, PharmaEssentia. "Entering into this agreement with WuXi Biologics perfectly aligns with our commitment to accelerate priority development programs across oncology, hematology and immunology. We’re poised to pioneer breakthrough therapies and bring renewed hope to patients worldwide."

"PharmaEssentia’s mission is to create best-in-class or first-in-class therapies by expanding our expertise to new drug modalities where we can have the greatest impact on patient lives," said Lih-Ling Lin, Ph.D., Chief Scientific Officer, PharmaEssentia. "As one of the first programs that will be advanced by our global research and business development team, we are eager to apply our deep biopharmaceutical capabilities to better understand the clinical potential of this novel approach. We are committed to working urgently to advance this candidate, which has the potential to apply a new scientific breakthrough to create a treatment that helps alleviate the incredible medical burdens faced by patients living with solid tumors."

As part of the agreement, PharmaEssentia will pay license fees to WuXi Biologics, including an upfront payment upon signing, future research, development, regulatory and sales milestones payments, and sales royalties.

On October 3, 2023 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that it has completed its previously announced merger with Morphimmune (Press release, Immunome, OCT 3, 2023, View Source [SID1234635618]).

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"This merger is an essential step in establishing a preeminent oncology company," said Dr. Siegall. "We believe that we are well positioned to advance our current oncology pipeline into the clinic, build upon the pipeline through our technology platform and proprietary toolbox, and expand our portfolio through strategic transactions focused on clinical and preclinical assets."

Dr. Siegall previously served as the CEO and President of Seagen, Inc., which he co-founded in July 1997. Under his nearly 25 years of leadership, Seagen became an industry leader in antibody drug conjugate (ADC) therapeutics, a field he innovated, earned FDA approvals for four cancer therapies, and grew to over $2 billion in annual revenue. During his tenure, he raised well over $1 billion of equity financing for Seagen from public and private markets and oversaw the company’s acquisition of Cascadian Therapeutics. In March of 2023, Pfizer, Inc. agreed to purchase Seagen for $43 billion.

The oversubscribed private placement investment of $125 million includes participation from Enavate Sciences, EcoR1 Capital, Redmile Group, Janus Henderson Investors, Avidity Partners, Woodline Partners LP, and other leading institutional investors.

On October 3, 2023 Akamis Bio, a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene (T-SIGn) therapy platform to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors, reported data from a Phase 1 study of its adenovirus vector technology in combination with radiotherapy that showed improved response rates relative to expectations for radiation alone in patients with locally advanced rectal cancer (Press release, Akamis Bio, OCT 3, 2023, View Source [SID1234635617]).

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The CEDAR study, sponsored by Cancer Research UK and Akamis Bio, found that Enadenotucirev (EnAd), a tumor selective, I.V.-administered oncolytic adenovirus (on which T-SIGn therapeutics are based), in combination with chemoradiotherapy, showed significantly higher response rates by MRI assessed tumor regression grade (mrTRG – 41.6%) and pCR/cCR (41.6%) than expected rates (~20%) for standard chemoradiation. In the two dose schedules with administration pre-CRT and post-CRT, mrTRG of 1 or 2 was observed in 5 out of 10 (50%) of the treated patients. Further, hexon staining of patient samples suggested EnAd localization in both the primary tumor and in metastatic sites. The combined therapy was well tolerated with an acceptable safety profile.

"These data are compelling given the higher-than-expected pCR/cCR rate, and the low adverse event rate highlights the ability to deliver the oncolytic virus concurrently with chemoradiation. This demonstrates the potential of a more reliable systemic administration compared to intratumoral injection," said Dr. Maria A. Hawkins, Chair of Radiation Oncology at University College in London and the principal investigator of the study. "We are further encouraged by the potential of this systemic treatment to reach micro-metastatic cancer sites and we believe this approach should be pursued in additional studies as we look to improve the efficacy of chemoradiation for a wide range of solid tumors."

EnAd is a group B adenovirus designed for the systemic treatment of metastatic or advanced epithelial tumors. It is a precursor to Akamis Bio’s clinical-stage Tumor-Specific Immuno-Gene (T-SIGn) therapeutics platform, which selectively delivers multiple transgene combinations, such as cytokines, chemokines, and antibodies for expression by tumor cells.

The primary objective of the Phase 1 CEDAR study was to determine the optimal dose and frequency that EnAd can be administered with chemoradiation for rectal cancer, with secondary objectives focused on demonstrating the ability to deliver EnAd with chemoradiation and to measure the local response rate to combined therapy compared to pre-treatment status.

"These results are very encouraging as they demonstrate the acceptable safety profile and potent efficacy achievable with our first-generation adenovirus vector, EnAd," said Dr. Oliver Rosen, Akamis Bio’s Chief Medical Officer. "As our T-SIGn therapeutics combine the EnAd backbone with an ability to selectively deliver transgenes to solid tumors, we look forward to building upon the clinical insights from the CEDAR study and demonstrating the potential of T-SIGn in conjunction with chemoradiation to positively impact the lives of patients living with rectal cancer and other solid tumors."

Data from the CEDAR study will be presented today at the 2023 American Society for Radiation Oncology Annual Meeting in San Diego, CA. Details of the presentation are as follows:

Poster Presentation Title: A Phase 1 Trial of the Safety, Tolerability, and Biological Effects of Intravenous Enadenotucirev (EnAd), a Novel Oncolytic Virus, in Combination with Chemoradiotherapy in Locally Advanced Rectal Cancer (CEDAR)
Poster Session: Gastrointestinal Cancer and Sarcoma
Date and Time: October 3 at 12:45 – 2:00 p.m. ET
Presenter: Dr Séan M. O’Cathail, MSc DPhil MRCPI FRCP FRCR, Senior Research Fellow, School of Cancer Sciences, University of Glasgow

About T-SIGn

Akamis Bio’s T-SIGn therapeutics are based on a replication competent, chimeric group B adenovirus backbone which has been adapted via directed evolution to home specifically to both primary and metastatic epithelial-derived solid tumor tissue following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive the intratumoral expression of multiple transgene payloads, turning solid tumor cells into "drug factories" while leaving healthy tissue unaltered and intact. The intratumoral expression of immunologically active biomolecules and therapeutic proteins can result in the remodeling of the solid tumor microenvironment, triggering robust antitumor immune responses. T-SIGn therapeutics have the potential to be used in the monotherapy setting, as well as in combination with other immuno-oncology agents to target the key mechanisms that tumors use to evade the immune system.

On October 3, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, OCT 3, 2023, View Source [SID1234635616]). THIO is being tested in sequential combination with Regeneron’s anti PD-1 monoclonal antibody cemiplimab (Libtayo) to evaluate anti-tumor activity and immune response in NSCLC patients.

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"We are extremely pleased to obtain clearance to extend our go-to-market THIO-101 trial to the U.S. and further develop THIO’s global reach," said Vlad Vitoc, MAIA’s Chief Executive Officer.

"The FDA IND clearance represents an essential milestone in the clinical development of THIO, as a first-in-class telomere targeting agent in clinical development for patients with advanced NSCLC," said Mihail Obrocea, M.D., MAIA’s Chief Medical Officer.

"We worked diligently with the FDA throughout the pre-IND/IND process to successfully align with their regulatory guidance and recommendations and we remain committed to developing novel, safe and effective treatments for patients with cancer," added K. Robinson Lewis, MAIA’s Head of Regulatory and Quality.

About Investigational New Drug Application

An Investigational New Drug (IND) application is a request for authorization from the U.S. Food and Drug Administration to administer an investigational drug or biological product to humans in the United States. Organizations can initiate a clinical trial in the U.S. with IND clearance from the FDA.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to Regeneron’s anti-PD1 cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator and (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On October 3, 2023 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, reported a master agreement with Johns Hopkins University School of Medicine (JHUSOM) to collaborate on multiple clinical research projects (Press release, BostonGene, OCT 3, 2023, View Source [SID1234635615]). The agreement allows BostonGene and JHUSOM to further identify and validate novel precision medicine approaches.

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JHUSOM will work with BostonGene on the molecular characterization study of the patient’s tumor, microenvironment and immune system and its predictive value in response to treatment. BostonGene’s solution will provide JHUSOM with detailed analysis, interpretation and visualization of big data obtained from cancer patient’s genomic, transcriptomic, proteomic and imaging studies. This work hopes to identify significant somatic alterations, evaluate protein expression, compute tumor clonality, tumor heterogeneity, tumor microenvironment cell type composition, hereditary predisposition, viral infestation and pharmacogenomics and predict neoantigens for personalized vaccine development, among other molecular features. BostonGene will perform comprehensive bioinformatics to validate hypothesis-driven research to identify targetable molecular alterations.

"We’re honored to collaborate with JHUSOM to provide our AI-based molecular and immune profiling techniques that comprehensively analyze the tumor, microenvironment, and immune system to uncover treatable targets to personalize therapy for patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "This collaboration supports our mission to support doctors in finding the most effective strategy for personalized treatment options for their patients."