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Biodesix Initiates Biomarker Study to Affirm Nodify XL2® Test’s Importance in Clinical Decision Making

On December 23, 2020 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, reported the launch and active recruitment of a firstin-class biomarker study aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer (Press release, Biodesix, DEC 23, 2020, View Source [SID1234573221]). The Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules (ALTITUDE), titled "A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules," is a randomized blinded controlled study with the objective of assessing how clinical decision making is impacted by the introduction of Nodify Lung test results into risk assessment. The study will focus on new, incidentally identified patients with lung nodules that are estimated to have low to moderate risk of lung cancer using the current standard of care.

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The study is designed to generate key data to provide further support for a testing strategy that improves on the current standard of care and that significantly enhances guidelines. Biodesix has selected Dr. Gerard Silvestri, Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina, to lead this trial. Dr. Silvestri is an internationally recognized researcher in all aspects of lung cancer care but with focused expertise in the early detection, evaluation and management of pulmonary nodules.

"I am excited to serve as principal investigator for the ALTITUDE trial, a study that I consider to be the first of its kind," said Dr. Silvestri. "We expect the trial to demonstrate that having the results of the Nodify XL2 Lung tests will lead to patients with benign disease avoiding unnecessary and invasive procedures. I believe that it will establish a new standard for future biomarker studies for the early detection of lung cancer."

With a total enrollment goal of 2,000 patients, Biodesix anticipates publishing interim results in 2022 and expects to complete the study in late 2023. "As a data-driven company, Biodesix is committed to continuing to study our tests and their impact on patients and the healthcare system. Through the ALTITUDE study, we want to better understand the impact on real-world decisions made in the clinic every day with the Nodify Lung test," said Scott Hutton, CEO of Biodesix. "We are proud that this important study will include leading experts in early detection of lung cancer from some of the most prestigious academic centers in the U.S."

BioInvent receives $3 million payment related to selection of antibodies under collaboration with Pfizer Inc.

On December 23, 2020 BioInvent International AB (OMXS: BINV ), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that Pfizer Inc. ("Pfizer") (NYSE: PFE) has selected antibodies directed at a previously-selected target under the companies’ cancer immunotherapy research collaboration and license agreement (Press release, BioInvent, DEC 23, 2020, View Source [SID1234573216]).

The agreement, into which the companies entered in December 2016, covers developing antibodies from BioInvent’s proprietary F.I.R.S.TTM drug discovery platform targeting tumor-associated myeloid cells.

The selection of these antibodies triggers a payment from Pfizer to BioInvent of $3,000,000. BioInvent is eligible for further milestone payments from development of these antibodies and potential selection and development of further antibodies directed at the same target.

BioInvent’s CEO Martin Welschof said: "Pfizer’s selection of antibodies under our agreement is a great demonstration of the actionable leads generated by our drug discovery technology platform. We are very pleased with how our partnership is progressing and look forward to further strengthening our collaboration. Our F.I.R.S.TTM platform is a patient-centric approach, drawing on our high-quality n-CoDeR antibody library to produce promising drug candidates, and we believe this partnership is an important validation of this technology."

Polymed Biopharma making progress in new drug discovery on PROTAC platform

On December 22, 2020 Polymed Biopharma reported that it recently submitted two patent applications for the discovery of novel PROTAC molecules for treatment of cancer and autoimmune diseases (Press release, Polymed Biopharmaceuticals, DEC 22, 2020, View Source [SID1234630612]). These molecules have demonstrated activities in the degradation of target proteins and proliferation inhibition of disease model cell line. Polymed plans to further study the safety and effectiveness of these molecules in related animal disease models.

Neomorph, Inc. Announces $109 Million Series A Financing to Advance Proprietary Protein Degradation Platform and Programs

On December 22, 2020 Neomorph reported a $109 million Series A financing to advance a proprietary targeted protein degradation platform and specific programs (Press release, Neomorph, DEC 22, 2020, View Source [SID1234627533]). Deerfield Management Company established Neomorph earlier this year with scientific founders Phil Chamberlain, DPhil; Eric Fischer, PhD; Benjamin Ebert, MD, PhD; and Scott Armstrong, MD, PhD.

The founding management team comprises pharmaceutical veterans with deep industry knowledge in targeted protein degradation drug discovery. Led by Dr. Chamberlain as President and Chief Scientific Officer, Neomorph has recruited top industry talent who have made major contributions to the field, including: Rohan Beckwith, PhD; Gang Lu, PhD; Mary Matyskiela, PhD; Ben Wen, PhD; and Samer Chmait.

Targeted protein degradation offers opportunities to develop novel therapeutics across a broad range of disease areas, including oncology. Strategies for protein degradation have been shown to solve critical problems in drug discovery by enabling researchers to target previously "undruggable" proteins that lack suitable binding pockets required for conventional drug activity.

Of particular note, Neomorph’s founders are responsible for several fundamental scientific developments in the "molecular glue" field. Molecular glues are types of molecules that encourage proteins to come together that normally would not interact. Neomorph plans to build on the collective pivotal research findings of the team to advance the technology of targeted protein degradation and solve critical problems in human health.

"Having the ability to achieve this milestone during these unprecedented times is a testament to Neomorph’s capabilities in the protein degradation and molecular glue space," said Dr. Fischer, who is also an Associate Professor in the Department of Biological Chemistry and Molecular Pharmacology at Harvard Medical School and an Independent Investigator at the Dana-Farber Cancer Institute. "I am humbled to be a part of a team poised to make real strides in advancing the science. We believe we are in an excellent position to take our technology to the next level with the ultimate goal of delivering transformative treatments to patients in need."

"The Neomorph team has deep expertise in pharmacological approaches to targeted protein degradation and we are excited to be developing new therapeutics for patients with diseases that are currently difficult to treat," said Dr. Armstrong, who is also David G. Nathan, MD, Professor of Pediatrics at Harvard Medical School and the Dana-Farber Cancer Institute.

Utilizing Deerfield seed funding and operational support since the first quarter of 2020, Neomorph has established a research site in San Diego at the Genesis Science Center in Sorrento Mesa, California. This Series A financing will position Neomorph to further develop its platform, advance lead programs, and expand the research team.

"As a drug strategy, protein degradation has enormous potential as it leverages the cell’s natural system for clearing unwanted or damaged proteins," said Deerfield Partner Cameron Wheeler, PhD. "We believe there continues to be a significant opportunity in protein degradation, in particular as it relates to the glue space. Neomorph is in an exceptional position and couldn’t have a more seasoned and knowledgeable team in place to interrogate and advance drug targets. The Company’s success could potentially lead to life-altering therapies."

Neomorph will benefit from a close collaboration with the Center for Protein Degradation at Dana Farber Cancer Institute. With its investment, this expands Deerfield’s commitment in the space given the firm’s longstanding partnership and collaboration with Dana Farber Cancer Institute.

Skyhawk and Vertex Establish a Strategic Collaboration to Discover and Develop Novel Small Molecules that Modulate RNA Splicing for Serious Diseases

On December 22, 2020 Skyhawk Therapeutics, Inc. and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported a strategic research collaboration and licensing agreement aimed at the discovery and development of novel small molecules that modulate RNA splicing for the treatment of serious diseases (Press release, Skyhawk Therapeutics, DEC 22, 2020, View Source [SID1234626571]).

"We believe that splice site modulation holds significant promise for the treatment of diseases which today have limited or no therapeutic options," said Mark Bunnage, D.Phil., Senior Vice President and Site Head, Boston Research at Vertex. "This collaboration brings Skyhawk’s innovative technology together with Vertex’s research and development experience; and fits perfectly with our strategy of investing in new technologies that will help us transform multiple serious diseases."

"We are excited to enter this collaboration with Vertex, a global leader in creating transformative medicines through serial innovation," said Bill Haney, Chief Executive Officer of Skyhawk. "In collaboration with the Vertex team, we look forward to using our SkySTAR platform to discover and develop novel small molecule therapeutics that modulate RNA splicing which have the potential to transform the lives of patients with serious diseases."

Under the collaboration agreement, Vertex will pay Skyhawk $40 million upfront. Skyhawk will grant Vertex options to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Vertex’s exercise of its options, Vertex will be responsible for further development and commercialization. Skyhawk is also eligible to receive up to $2.2 billion in potential milestone payments, as well as potential royalties on future sales.