DarwinHealth announces scientific collaboration with Prelude Therapeutics to develop new biomarkers for multiple candidates in oncology

On October 14, 2021 DarwinHealth, Inc. reported a scientific research collaboration using its biomarker enrichment strategies for trials ( BEST platform ) to find new biomarkers to guide trajectories translational of several oncological molecules developed by Prelude Therapeutics (Press release, Prelude Therapeutics, OCT 14, 2021, View Source [SID1234591260]).

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As part of this collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated principal regulator (MR) protein and tumor checkpoint approaches to identify novel protein-based biomarkers that will add significant precision to the selection of the patient cohort for clinical trials to be conducted at Prelude’s discretion in hematologic and solid tumors.

"The goal of this biomarker-focused collaboration," explained Professor Andrea Califano , Clyde Chair and Helen Wu , Chair of the Department of Systems Biology at Columbia University.and co-founder of DarwinHealth, "is to assess and characterize the global and tumor-specific mechanisms of action of molecules in the Prelude pipeline in order to identify new biomarkers likely to associate these agents with reactive patient cohorts. In addition, the collaboration will mechanically characterize the potential therapeutic opportunities for molecules in the Prelude pipeline targeting various oncogenic pathways in several hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics. The study will be based on the VIPER algorithm to characterize the activity of these various compounds against key protein modules (tumor checkpoints) of the primary regulator (MR) necessary for the viability of subtype-specific tumors. "

"The BEST initiative will provide precise and actionable compound and tumor information to assess the potential of molecules in the Prelude pipeline to reverse the activity of subtype-specific tumor checkpoints," explains Dr. Mariano Alvarez , Scientific Director of DarwinHealth. "The aim of these studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based and mechanism-based roadmaps for biomarker development and patient selection to potentially speed up clinical studies. "

As part of the BEST initiative, DarwinHealth will provide a comprehensive read on the potential clinical value of certain molecules in the Prelude pipeline in a range of tumor types. Through quantitative modeling and biomarker-centric translational pathways, DarwinHealth will also help design in vivo validation studies to take advantage of key opportunities that may not be apparent with conventional technologies.

"The collaboration with BEST addresses one of the critical unmet needs of the biotechnology and biopharmaceutical spaces focused on cancer drug discovery, namely the development of biomarkers that are highly predictive of clinical response to compounds, whose efficacy final may be the result of an incompletely decipherable range of drug effects both on and off target directed at multiple targets of the regulatory programs that underlie cancer addictions "noted Dr Gideon Bosker, CEO and Co-Founder of DarwinHealth. "These uncertainties lend themselves to the extension of the concept of biomarker beyond the primary (ie high affinity) target of a drug, to multiprotein classifiers identified by our computational and integrative experimental methodologies. "

In particular, new multiprotein classifiers identified by the BEST platform have already been reported by DarwinHealth for multiple myeloma (N Engl J Med 2019; 381: 727-38. View Source NEJMoa1903455 ) and diffuse large B cell lymphoma (DBLC) (British Journal of Haematology; August 02, 2021, View Source ).

These technologies are ideally suited for identifying mechanistic alignments between drug candidates and cancer patients, based on the ability of the drugs to inactivate patient-specific MR proteins that are necessary to maintain tumor status. Importantly, these findings can be quickly transformed into precision human, biomarker-based clinical trials and commercial development.

Quantum to Release Fiscal Second Quarter 2022 Financial Results and Host Investor Conference Call on Wednesday, November 3rd

On October 14, 2021 Quantum Corporation (NASDAQ: QMCO) reported it will release financial results for its second fiscal quarter ended September 30, 2021, on Wednesday, November 3, 2021, after the close of the market. Jamie Lerner, Quantum’s Chairman and CEO, and Mike Dodson, Chief Financial Officer, will host a conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss the financial results.

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Analysts and investors are invited to dial into the conference call using the following information:

Date: Wednesday, November 3, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)
Conference Call Number: 1-866-424-3436
International Call Number: +1-201-689-8058
Passcode: 13724393
Webcast link (listen only) and presentation slides: View Source

A telephone replay of the conference call will be available approximately two hours after the conference call and will be available through November 10, 2021. To access the replay dial 1-877-660-6853 and enter the pass code 13724393 at the prompt. International callers should dial +1-201-612-7415 and enter the same passcode. Following the conclusion of the live call, a replay of the webcast will be available on the Company’s website for at least 90 days.

Gilead Sciences to Release Third Quarter 2021 Financial Results on Thursday, October 28, 2021

On October 14, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2021 financial results will be released on Thursday, October 28, after the market closes (Press release, Gilead Sciences, OCT 14, 2021, View Source [SID1234591255]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s third quarter 2021 financial results and will provide a business update .

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A live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.

Tizona Initiates Phase 1b Expansion Study of TTX-080 in Advanced Refractory or Resistant Malignancies

On October 14, 2021 Tizona Therapeutics, Inc., a privately held, clinical-stage company developing first-in-class cancer immunotherapies, reported that its lead investigational therapy, TTX-080, a novel antibody targeting HLA-G, has advanced to Phase 1b (Press release, Tizona Therapeutics, OCT 14, 2021, View Source [SID1234591254]). This phase includes expansion tumor arms to evaluate the safety and efficacy of TTX-080 as monotherapy and combination regimens in patients with advanced malignancies.

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The Phase 1b is a dose expansion study designed to assess TTX-080 as monotherapy and in combination with either pembrolizumab or cetuximab in patients with advanced refractory or resistant solid tumor malignancies, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and triple negative breast cancer. In addition to evaluating the anti-tumor activity of TTX-080, the study will continue to evaluate the safety, pharmacokinetics, and immunogenicity of TTX-080. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

"The initiation of the Phase 1 dose expansion study is an important milestone for the TTX-080 clinical development program," said Christine O’Brien, Chief Executive Officer, Tizona. "As a novel checkpoint inhibitor, the TTX-080 program offers an opportunity to apply new understandings of immune regulation within the tumor microenvironment in solid tumor indications where patient outcomes remain a major unmet medical need."

The Phase 1b expansion study follows the Phase 1a study, an open label, multicenter, dose escalation clinical trial designed to assess the safety and tolerability of TTX-080 as monotherapy. The Phase 1a stage of the study, which has completed enrollment, determined a recommended Phase 2 dose of TTX-080 when administered as a single agent.

About TTX-080

TTX-080 is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types. By blocking the interaction of HLA-G with its receptors, TTX-080 prevents the suppression of both innate and adaptive immune activity and has the potential to enhance anti-tumor responses. Tizona is currently enrolling patients in a Phase 1b clinical trial (NCT04485013) evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.

Kriya Therapeutics Appoints Theresa Heah, M.D., MBA as Chief Medical Officer and President of Kriya Ophthalmology™, a Newly Launched Division of Kriya Therapeutics

On October 14, 2021 Kriya Therapeutics, Inc., a fully integrated company pioneering novel technologies and therapeutics in gene therapy, reported the appointment of Theresa Heah, M.D., MBA as Chief Medical Officer and President of Kriya’s newly launched ophthalmology division, Kriya Ophthalmology (Press release, Kriya Therapeutics, OCT 14, 2021, View Source [SID1234591253]). Dr Heah will be responsible for advancing Kriya’s current pipeline of ophthalmology gene therapies and continuing to expand Kriya’s ophthalmology portfolio through its in-house R&D and business development engines.

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Kriya Ophthalmology is focused on the discovery and development of transformative gene therapies for ocular diseases with high unmet need. By leveraging Kriya’s computationally enabled vector design, data analytic and manufacturing technologies, Kriya Ophthalmology is uniquely positioned to accelerate the development of best-in-class gene therapies for rare and prevalent ocular diseases. Kriya Ophthalmology is currently advancing therapeutic programs in uveitis, geographic atrophy and additional undisclosed disease areas.

"Gene therapy has the potential to deliver transformative clinical benefits to address severe ocular diseases for which there are currently few effective treatment options," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya Therapeutics. "The launch of Kriya Ophthalmology, and the appointment of Theresa to lead our specialized division focused exclusively on diseases of the eye, reflects our commitment to delivering better products to patients suffering from a range of rare and prevalent ocular diseases. We believe that Kriya’s advanced technology platforms, combined with Theresa’s leadership and track record in ophthalmology, uniquely position this division to become one of the industry leaders in the development of gene therapies for ocular diseases."

"We are thrilled to welcome Theresa to lead Kriya Ophthalmology," said Ilise Lombardo, M.D., Chief Medical Officer of Kriya Therapeutics. "Her success in developing and launching treatments for ocular diseases will help Kriya play a pivotal role in the advancement of novel gene therapies that address a range of severe ocular conditions."

Dr. Heah is an accomplished executive with more than 20 years of R&D, regulatory strategy and clinical development experience. She previously served as Chief Medical Officer and Executive Vice President of Operations for AsclepiX Therapeutics where she led the company’s Series A financing and advancement of its pipeline products into the clinic. Prior to joining AsclepiX Therapeutics, Dr. Heah served as Chief Medical Officer at Applied Genetic Technologies Corporation (AGTC), where she worked to develop gene therapies in ophthalmology and rare diseases. She has also held several leadership positions with increasing responsibility in early-stage private companies (Fovea Pharmaceuticals), publicly traded companies (Aerie Pharmaceuticals, Allergan) and big pharmaceutical companies (Bayer Healthcare, Sanofi).

Dr. Heah has led multiple successful global regulatory submissions and commercialization of products including Ozurdex, EYLEA, Rhopressa and Rocklatan. While at Bayer, she launched EYLEA successfully into its eventual status as a blockbuster drug. She earned her M.D. from Guy’s, King’s and St. Thomas’ School of Medicine, King’s College, University of London, and her Executive Master’s in Business Administration from the European School of Management & Technology (ESMT), Berlin.

"My career has been dedicated to patients and the development of transformative and meaningful therapies aimed at improving their quality of life," said Dr. Heah. "Many still suffer from serious eye diseases for which there are no viable treatments. There is immense untapped potential in gene therapy, and it will be our mission to uncover and advance novel medicines for the betterment of underserved patient communities."