On September 22, 2021 BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a novel approach to develop next generation cancer therapies using insights derived from frontline clinical experience, reported the successful completion of two antibody discovery campaigns with IONTAS, aimed at supporting the optimisation of BiVictriX’s lead program, BVX001 (Press release, FairJourney Biologics, SEP 22, 2021, https://fjb.pt/collaboration/bivictrix-and-iontas-successfully-complete-two-antibody-discovery-campaigns/ [SID1234590246]).

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IONTAS, a leading clinical research organisation offering phage and next generation mammalian display antibody discovery services, has successfully identified novel human binders which target BiVictriX’s proprietary "twin cancer antigens", as part of an ongoing collaboration with BiVictriX. These binders cover a broad range of affinities including species cross-reactivity. They will be further assessed in-house by BiVictriX through in vitro characterisation and testing of all possible combinations of targets to validate the efficacy and selectivity in human cell models and further optimise lead program, BVX001.

BiVictriX is using a first-in-class approach to generate a proprietary pipeline of Bi-Cygni therapeutics which are designed to selectively target antigen co-expression fingerprints, or "twin antigens", on tumour cells, which are largely absent from healthy cells. BVX001, BiVictriX’s lead program, is in preclinical development for Acute Myeloid leukaemia, one of the most aggressive forms of blood cancer.

Tiffany Thorn, Chief Executive of BiVictriX Therapeutics plc, commented: "The delivery of these novel binders with species cross-reactivity is an important step for the team and our pipeline and a testament to our successful and ongoing collaboration with IONTAS. The team will begin validating these through in-house testing soon with the aim of determining the efficacy and specificity of the target affinity of each arm as we continue to develop our therapeutics."

António Parada, Chief Executive of IONTAS, added: "We’re delighted to have been able to support the development of BVX001 through our proprietary antibody discovery services. BiVictriX’s Bi-Cygni therapeutics, which target antigen co-expression fingerprints, or "twin antigens", on tumour cells look highly innovative and we wish the company every success as BVX001 progresses in preclinical development."

This announcement follows the recent appointment of Dr Oliver Schon as Vice President of Product Development and Chemistry Manufacturing and Controls and the Company’s successful listing on the London Stock Exchange’s AIM Market in August.

On September 22, 2021 The Coriell Institute for Medical Research and Van Andel Institute (VAI) reported that they have been awarded a prestigious Specialized Programs of Research Excellence (or SPORE) grant from the National Cancer Institute (award P50CA254897) (Press release, Van Andel Institute, SEP 22, 2021, View Source;utm_medium=rss&utm_campaign=spore-award-epigenetics-cancer-research [SID1234590242]). The five-year grant valued at an estimated $12.4 million will support nearly 20 scientists as they work to improve epigenetic therapies for cancer. The project is co-led by Coriell’s President and CEO Jean-Pierre Issa, M.D., Van Andel Institute’s Chief Scientific Officer Peter A. Jones, Ph.D., D.Sc. (hon), and Johns Hopkins University and VAI’s Stephen Baylin, M.D.

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NCI utilizes SPORE grants to empower interdisciplinary and collaborative research into specific aspects of cancer. This prestigious grant is the first of its kind at both Coriell and VAI, establishing them as premier institutions for cancer research. The award currently is the only SPORE grant awarded to an organization in New Jersey. This grant, which is also the first to support a thematic SPORE focused on epigenetics in NCI history, can be renewed indefinitely.

"SPORE grants hold a special place in translational cancer research. Through them, the NCI enables groundbreaking work and the trust it puts in the awarded scientists allows for unparalleled freedom and collaboration," said Dr. Issa. "It’s a true honor to receive this grant and it’s a sign of more exciting things to come for the Coriell Institute."

Jones, Baylin and Issa also collaborate on the Van Andel Institute (VAI)–Stand Up To Cancer (SU2C) Epigenetics Dream Team, which has launched more than a dozen epigenetic therapy clinical trials in recent years and will support trials from this SPORE. Jones and Baylin co-led both the first iteration of the SU2C Epigenetics Dream Team, which was established in 2009, and co-lead the current team, which was launched in 2014. Much of the SPORE project’s design was informed by SU2C’s collaborative model, which brings together experts and organizations to unite against cancer.

"Epigenetic therapies hold immense potential to shift the paradigm in cancer treatment," Dr. Jones said. "We’re thrilled to be recipients of a SPORE award, which is an exceptional mechanism for catalyzing collaboration and powering discovery."

Epigenetic therapy aims to treat cancer by correcting abnormal gene expression. In doing so, these therapies can also make other cancer therapies more effective. This SPORE seeks to improve on current epigenetic therapies by exploring new targets, investigating novel combinations of epigenetic therapies with other cancer treatments, and by designing, and running clinical trials to evaluate these promising strategies.

"Research in the last decade has reinforced the promise of epigenetic therapies both as a standalone treatment strategy and as a way to enhance existing approaches such as immunotherapy," Baylin said. "The SPORE award will allow us to investigate the underpinnings of epigenetics in cancer, with the goal of translating our findings to the clinic."
The three research projects in this SPORE include:

Project 1: A collaboration between the Coriell Institute and Hackensack Meridian School of Medicine led by Dr. Issa and Hackensack Meridian’s Yi Zhang, Ph.D., a member of the Hackensack Meridian Center for Discovery and Innovation and part of the Georgetown Lombardi Comprehensive Cancer Center. This group will investigate the potential of a certain group of kinases, enzymes that regulate proteins, as therapeutics targets.
Project 2: A collaboration between Baylin and VAI’s Scott Rothbart, Ph.D. This team will investigate a potentially novel therapeutic strategy for treating solid tumors by inhibiting DNMT and EZH1/2 enzymes.
Project 3: A collaboration between Indiana University’s Ken Nephew, Ph.D., and Kathy Miller, M.D., and University of Maryland School of Medicine’s Feyruz Rassool, Ph.D. This team will investigate the impact of epigenetic therapy on cancers driven by BRCAness, a major cancer-related vulnerability.
To aid these research projects, the SPORE grant also will support two shared scientific resource cores: A Genomics Core at Coriell Institute and a Pathology and Biorepository Core at VAI. Scientists working on these related research projects can utilize these resources in conducting their work.

Additionally, the SPORE will include the creation of a Career Enhancement Program and a Developmental Research Program, which provide research awards to faculty (inside and outside of the SPORE group) to support recruitment and retention of scientists with a focus of bolstering diversity in the field.

Dr. Issa is also currently an investigator on The Joe Moakley Leukemia SPORE, a program supported by a SPORE grant administered out of The University of Texas MD Anderson Cancer Center. That grant is in its 18th year.

On September 22, 2021 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported its collaboration with the Mount Sinai Health System to increase accessibility of SARS-CoV-2 testing in New York City (Press release, PerkinElmer, SEP 22, 2021, View Source [SID1234590204]). The laboratory system located at the Mount Sinai Beth Israel hospital campus now has the capacity to process 25,000 (and ultimately up to 100,000) tests per day with PerkinElmer’s instrument and reagents.

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RT-PCR testing is the most accurate method for detecting SARS-CoV-2, the virus that causes COVID-19. The relationship forged between Mount Sinai Health System and PerkinElmer makes gold standard RT-PCR based SARS-CoV-2 screening available to schools and businesses throughout New York City.

HOW: According to the U.S. Food & Drug Administration (FDA) companion resource, a highly sensitive RT-PCR test should be used for screening asymptomatic individuals. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is the most sensitive commercially available COVID-19 molecular diagnostic test authorized for emergency use, as reported by FDA’s reference panel study, and is ideally suited to support screening programs.

WHY:
"Mount Sinai has shown extraordinary commitment and leadership in scientific and clinical efforts to beat this pandemic. We developed one of the first highly sensitive antibody tests, pioneered innovative therapies to treat COVID-19, and are researching the lingering effects suffered by ‘long-haulers.’ The Mount Sinai Covid Lab and testing program is designed to help our community in slowing transmission and getting us back to normal," said David L. Reich, MD, President and Chief Operating Officer, The Mount Sinai Hospital. "We are proud to partner with PerkinElmer in expanding our testing capacity and footprint to serve our communities."

"PerkinElmer is proud to lend its expertise in SARS-CoV-2 testing by supplying and supporting the Mount Sinai Health System with reagents, automation equipment and consumables that are critical to meet laboratory operational needs," said Arvind Kothandaraman, managing director, specialty diagnostics at PerkinElmer. "We are humbled and inspired by the work of our long-standing collaborators at Mount Sinai, who go above and beyond to help underserved communities in New York City that have been profoundly affected by the pandemic."

MORE: As the Delta variant is threatening to upend another school year, RT-PCR testing remains the preferred method for COVID-19 diagnostics. PerkinElmer’s comprehensive SARS-CoV-2 portfolio includes high throughput RNA extraction, RT-PCR, antigen testing, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.

On September 22, 2021 The Charcot–Marie–Tooth Association (CMTA), the largest philanthropic funder of CMT research worldwide, and Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported a collaboration to investigate a potential therapy for CMT type 1A (CMT1A), the most common subtype of the disease, which affects approximately 1.5 million people (Press release, Addex Therapeutics, SEP 22, 2021, View Source [SID1234590196]).

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The primary goal of the collaboration is to evaluate the benefit of Addex’s proprietary positive allosteric modulator’s (PAM’s) targeting the gamma-aminobutyric acid subtype B (GABAB) receptor in rodent models of CMT1A. The GABAB receptor has previously been shown to be instrumental in controlling the overexpression of Peripheral Myelin Protein-22 (PMP22) in a rat model of CMT1A. Elevated PMP22 is closely associated with the disabling peripheral neuropathy that accompanies CMT1A.

The CMTA’s Strategy to Accelerate Research (STAR) connects leading CMT clinicians and researchers with pharmaceutical partners committed to developing treatments and a cure for CMT. Strategic alliances with pharmaceutical partners like Addex Therapeutics support drug development efforts to deliver therapies to CMT patients.

"We are excited to establish this partnership with Addex Therapeutics as they work to advance their PAM’s to treat CMT1A," said CMTA’s CEO Amy Gray. "Strategic research partnerships with companies like Addex is a central part of our strategy to accelerate the development of treatments for the CMT community. Since launching STAR 12 years ago, the CMTA has been able to establish research partnerships with almost 40 pharmaceutical and biotech companies, and leading research labs around the world. We share Addex’s enthusiasm and passion for developing life-changing treatments for patients."

The research alliance with Addex will include joint study planning aimed at the chronic dosing of select GABAB PAM’s in rodent models of CMT1A, followed by detailed assessments aimed at measuring the improvement of key outcomes. These outcome measures include biomarkers, motor function, electrophysiology and peripheral nerve histology. This is made possible through the CMTA’s preclinical testing alliance: www.cmtausa.org/our-research/for-researchers/cmta-preclinical-testing-network/

"By combining the expertise of both the Charcot-Marie Tooth Association with our proven track record in the discovery and development of allosteric modulators, we aim to further understand how targeting GABAB with a positive allosteric modulator could benefit patients with CMT1A," said Tim Dyer, CEO of Addex Therapeutics. "As we move towards IND enabling studies, we look forward to working with the CMTA to build scientific evidence supporting our approach to tackle this tremendous unmet need."

On September 22, 2021 IV BioHoldings (IVBH) reported the public launch of its bio innovation studio, debuting with a portfolio of three home-grown liquid biopsy companies, including LiquidLung, Inc., HepGene, Inc. and Mammogen, Inc. Collectively, the IVBH companies comprise eight clinical-ready diagnostics, spanning the care continuum for lung cancer, non-alcoholic fatty liver disease (NAFLD) and breast cancer, respectively (Press release, IV BioHoldings, SEP 22, 2021, View Source [SID1234590170]).

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IVBH has also announced today its partnership with P4 Diagnostix (P4), a leader in diagnostic pathology, to fast-track commercial efforts of molecular diagnostic tests and meet clinical demand for earlier, easier and more precise detection, diagnosis and treatment of pulmonary, metabolic, and women’s health disease. Offering best-in-class testing services and proprietary healthcare informatics, P4 will serve as the exclusive laboratory partner for all clinical assay development and clinical validation across the lung cancer, NAFLD and breast cancer programs for each of the IVBH companies.

"What we’re seeing out of the IVBH ecosystem is platform test development capabilities that are years ahead of traditional test development in the liquid biopsy space, representing an opportunity for P4 to get on the ground floor of this dynamic area of molecular medicine," said Marcus Cognetti, Co-Founder of P4. "By partnering across the IVBH portfolio, we’re providing an industry-first opportunity to scale the speed and rate at which non-invasive diagnostics are made available to the millions of people for whom this testing is not available or are underserved by the existing standards of care. The novelty of the science, strength of the data, and competitive intellectual property built around these existing indications is quite astonishing, and is a testament to the efficiency of the IVBH business model and its progressive approach to R&D."

IVBH was founded in 2018 by Marty Keiser, with the vision of dramatically reducing the time, cost and risk associated with healthcare innovation through unique applications of data analysis using advanced technology. Its business model was purpose-built to accelerate value creation of novel intellectual property by allowing each of its disease-specific companies to leverage shared resources and tap into strategic partnerships formed by the studio.

In just over two years since launching LiquidLung, the first company to emerge from the studio, and one month after announcing the closing of a $2M seed round at its women’s health startup, Mammogen, the studio has now emerged from stealth with its portfolio of intellectual property positioned to address unmet clinical needs for 220 million Americans and over one billion people globally.1

IVBH partnered with Liquid Biosciences (LBS), whose Emerge bio-analytics platform has been radically reducing diagnostic and drug development time, cost and risk for a decade. IVBH and LBS collaborated on novel biomarker discovery and validation to develop the following liquid biopsy solutions:

LiquidLung, Inc. – Non-invasive early detection, confirmatory diagnosis, and histological typing and subtyping of lung cancer. In a study conducted in peripheral whole blood for lung cancer detection, the technology achieved 97% sensitivity, 85% specificity, including 100% detection of patients with stage I lung cancer, without the use of any demographics, clinical risk-factors, or radiological data.
HepGene, Inc. – Non-invasive early detection of NAFL, classification of NAFL versus non-alcoholic steatohepatitis (NASH), and definitive diagnosis of NASH. HepGene’s technology was validated across a diverse range of tissue types and biofluids (including blood), achieving 92% sensitivity, 97% specificity for early detection of NAFL and 94% sensitivity, 86% specificity for definitive diagnosis of NASH. The company IP also includes a proprietary portfolio of promising novel therapeutic targets for the treatment of NASH, which emerged from robust in vivo analysis of diseased patients and is supported by strong proof-of-principle that establish and validate biological plausibility.
Mammogen, Inc. – Non-invasive early detection and confirmatory diagnosis of breast cancer. Mammogen’s core technology, validated across peripheral blood mononuclear cells as well as saliva, is initially geared towards women under 40 and women over 55, two populations of women who are underserved by existing screening guidelines and current standards of care for breast cancer. Optimizing for women under 40, Mammogen’s technology achieved 93% sensitivity, 97% specificity. Optimizing for women over 55, the technology achieved 97% sensitivity, 87% specificity. Results were achieved without the use of any demographics or clinical risk-factors.
The introduction to P4 was made by Elizabeth Cormier-May, CEO of Mammogen and commercialization expert within the inner echelons of the IVBH studio, who has had a longstanding working relationship with the molecular lab throughout the course of her near twenty-year career in diagnostics.

"P4’s repeated success in diagnostic commercialization, seven CLIA certified laboratories strategically located across the US, and its proprietary IT solutions enabling electronic health record (EHR) integration, ensures that our clinical and commercial phases of development will be consistent with the efficiency of our model, making them the ideal partner for IVBH," stated Cormier-May.

"What normally takes the diagnostics industry at least six years to accomplish on a per product basis, we did for eight clinical-ready diagnostic products in just over two years," said IVBH founder and CEO Marty Keiser. "There’s no question that accelerated R&D timelines, and the corresponding reduction in risk associated with over 200 novel scientific discoveries across the lung, liver and breast programs, were a direct result of IVBH’s powerful partnership model and intentional application of exponential technologies such as that of our partners at LBS. With the addition of P4, we’re able to progress from R&D to commercialization with the level of speed, efficiency and quality that all human beings deserve."

IVBH is now scaling to support its flagship lung, liver and breast programs through clinical development and commercialization. Other plans on the horizon include a focus on pipeline expansion across pulmonary, metabolic and women’s health disease, and incubation of future company creations.

For more information on IV BioHoldings, visit www.ivbh.studio. To explore partnership opportunities, email [email protected].

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