Humanigen to Present at the 2021 LD Micro Invitational XI

On June 3, 2021 Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported it will present at the 2021 LD Micro Invitational XI, held virtually from June 8- 10, 2021 (Press release, Humanigen, JUN 3, 2021, View Source [SID1234583473]).

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LD Micro is host to some of the most influential conferences in the small-cap world. Humanigen has been selected to participate in the first day of the conference, during the "Hall of Fame" session, which highlights some of the top performers since the LD Micro conference began in 2008.

Management will discuss its lead product, lenzilumab, which has been submitted for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration, in addition to providing an update on the Company’s launch preparation efforts for lenzilumab, and an overview of the Company’s other development programs.

Details for the upcoming event are below:

2021 LD Micro Invitational XI

Date: Tuesday, June 8, 2021
Time: 12:00 PM ET
Link: View Source

Nucleix Establishes Collaborative Research and License Agreement with MD Anderson to Develop Methylation Assays to Assess Lung Cancer Patients

On June 3, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that it has entered into a collaborative research and license agreement with The University of Texas MD Anderson Cancer Center to evaluate and develop methylation assays focused on lung cancer, using Nucleix’s highly sensitive EpiCheck platform (Press release, Nucleix, JUN 3, 2021, View Source [SID1234583472]).

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The collaboration will focus initially on evaluating methylation markers believed to be important for the characterization of lung cancer subtypes. Selected markers will be evaluated using EpiCheck – Nucleix’s proprietary platform, which can be run using both PCR and next-generation sequencing technologies, and has shown best-in-class analytical sensitivity.

For those markers that demonstrate efficacy in helping with this characterization, Nucleix will lead the development of new assays. MD Anderson will work to validate assays using in vitro and in vivo cell lines, preclinical models and clinical samples.

"As described in a recent publication in the European Respiratory Journal, our Lung EpiCheck test is highly sensitive and has the potential to assist in the early detection of lung cancer for high-risk individuals, but we know there is also a significant need for patients who have already been diagnosed and are undergoing treatment," said Chris Hibberd, chief executive officer of Nucleix. "By collaborating with MD Anderson, we aim to expand the methylation tools available for the assessment and care of this patient population."

Nucleix’s Lung EpiCheck test analyzes changes in methylation patterns for early detection of lung cancer. The company is focused on advancing the test for the roughly 15 million high-risk smokers who are eligible for annual screening. In a recently published study, the test detected 85% of early stage lung cancers among individuals at high risk for developing the disease based on their history of smoking.

"Blood-based methylation assays are minimally invasive and have the potential to provide key information about a patient’s lung cancer that cannot be provided by standard genomic profiling of DNA mutations, helping physicians to better identify disease subtypes and emerging biomarkers in the clinic," said John V. Heymach, M.D., Ph.D., chair of Thoracic/Head and Neck Medical Oncology at MD Anderson. "We look forward to collaborating with Nucleix to advance methylation measurement tools with the goal of enabling physicians to provide more personalized, biomarker-driven treatment approaches for our patients."

About EpiCheck

EpiCheck is an ultra-sensitive technology for the detection of methylation changes and is compatible with both next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms. Nucleix is applying the NGS application of EpiCheck for deep discovery, to reveal new biomarkers that may be used in the early detection and monitoring of cancer. In turn, these discoveries can be advanced as highly sensitive tests using the PCR application of EpiCheck, with the potential to run cost-effectively in both centralized and local laboratories.

Stablix Therapeutics Launches with $63 Million Series A Financing

On June 3, 2021 Stablix Therapeutics, a biotechnology company pioneering the field of Targeted Protein Stabilization (TPS), reported a $63 million Series A financing led by founding investor Versant Ventures together with NEA, Cormorant, Euclidean Capital and Alexandria Real Estate Equities (Press release, Stablix Therapeutics, JUN 3, 2021, View Source [SID1234583471]).

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Many inherited and acquired diseases are caused by insufficient levels of specific proteins. With inherited diseases such as cystic fibrosis, mutations in the CFTR gene produce a protein that remains functional but is subject to excessive ubiquitination, leading to its rapid degradation via the proteasome. Excess ubiquitination is also a feature of cancer, where E3 ubiquitin ligases – enzymes that add ubiquitin to proteins – are frequently upregulated or amplified, driving the degradation of tumor suppressor proteins.

Until now, it has not been possible to inhibit the ubiquitin-proteasome system in a target-selective manner. Stablix’s RESTORED platform generates heterobifunctional small molecules (RESTORACS) that recruit deubiquitinase enzymes to remove ubiquitin from targeted proteins and consequently stabilize or increase target protein levels and activity. The company initially is leveraging the platform to develop programs to treat rare diseases, cancer and immunological disorders.

"Stablix possesses a first-in-category platform that can restore protein stability and function in a target-selective manner," said Carlo Rizzuto, Ph.D., partner at Versant and acting CEO of Stablix. "We are very pleased to launch this company to address this important therapeutic white space for numerous devastating diseases."

Targeted Protein Stabilization (TPS)

Protein stabilization can be thought of as the inverse of protein degradation. The underlying concept of augmenting protein stabilization has been validated in nature. Many viruses encode their own E3 ligases and deubiquitinases to coopt the ubiquitin-proteasome system as part of their life cycles. This demonstrates that the system can be manipulated via exogenous intervention.

The therapeutic value of augmenting protein stabilization has also been demonstrated with proteasome inhibitors. These inhibitors are potent cancer therapeutics but have also been profiled for activity in Mendelian diseases in multiple animal and patient studies. In these studies, proteasome inhibitors were able to increase levels of deficient proteins across a range of targets and organ systems. However, because proteasome inhibitors globally inhibit protein degradation in a non-specific manner, their use outside of oncology is limited by poor tolerability, highlighting the need for targeted approaches.

The Stablix platform originated in the laboratory of Henry Colecraft, Ph.D., John C. Dalton Professor of Physiology and Cellular Biophysics at Columbia University. Co-founders Dr. Colecraft and Scott Kanner, Ph.D., developed an approach to selectively recruit deubiquitinases (DUBs) to proteins of interest. Their pioneering work demonstrated the functional rescue of CFTR and of a second target, KCNQ1, a gene that when mutated causes Long QT syndrome.

"It is gratifying to see the work on precise stabilization of proteins now being translated into new therapies," said Dr. Colecraft. "I look forward to working closely with the Stablix team to bring these treatments to patients."

The company’s RESTORED platform has two primary components. The first is a library of binding moieties capable of recruiting selected DUBs. These recruiting moieties are conjugated with linkers to targeting ligands to create bispecific molecules that co-localize a DUB and a target. Second, a suite of biochemical and functional assays is used to monitor the ubiquitination and functional status of target proteins in cells. Stablix will initially focus pipeline development on rare diseases, oncology and immunology.

Operating plans and scientific leadership

Stablix plans to use the proceeds from the Series A financing to build out its platform and advance a portfolio of protein stabilizers towards the clinic. In addition, the company has established a lab facility in New York City, where it is building a research team led by co-founders Brian Bowman, Ph.D., head of in vitro pharmacology, and Kevin Sprott, Ph.D., head of drug discovery, with Dr. Kanner, head of platform development, leading technology transfer.

For its Scientific Advisory Board, Stablix has recruited a leading group of researchers with extensive experience in DUB biology and chemistry. In addition to Dr. Colecraft, SAB members include Benedikt Kessler, professor of biochemistry and mass spectrometry at the Target Discovery Institute, University of Oxford; Andrew Turnbull, senior principal scientist at Cancer Research UK; Chris Dinsmore, CSO at Kronos Bio; and Chris Roberts, CSO at Black Diamond Therapeutics.

"Stablix’s unique approach presents the company with a massive opportunity to create an impact for patients with rare diseases, cancer or immunological disorders," said Ali Behbahani, M.D., general partner at NEA and a Stablix board member. "We are pleased to join this high-quality syndicate and look forward to the continued development of Stablix’s platform and programs."

venBio Raises $550 Million Venture Capital Fund Focused on Life Sciences

On June 3, 2021 venBio reported the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise (Press release, Venbio Partners, JUN 3, 2021, View Source [SID1234583470]). The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

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Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team takes an active role with each of their portfolio companies, providing strategic guidance on a range of business activities including intellectual property, chemistry, manufacturing and controls (CMC), as well as assisting with clinical trials: from trial design to endpoints to regulatory deliberations.

"We remain committed to our unique approach and strategy and hope the results speak for themselves – our portfolio companies have delivered four drugs to market for six clinical indications, and another seven drug candidates are demonstrating promising late-stage efficacy," said Dr. Adelman.

"Our portfolio is directly impacting patient lives and we could not have accomplished that without the ongoing commitment from our limited partners, and we are grateful for their continued support for Fund IV," said Dr. Goodman. "With Fund IV we intend to continue our proven approach of helping to build 12-15 companies per fund while doubling down on winners by providing stronger support for our portfolio companies in crossover rounds and at IPO."

"We are delighted to announce with the closing of Fund IV, the promotion of Dr. Rich Gaster to Managing Partner," said Dr. Royston. "Our core investment team and investment strategy remain the same as we launch our new fund."

"Our strategy at venBio has always been to turn exceptional science into impactful medicine," said Dr. Gaster. "Every member of our team is involved in every investment that we make, and we believe this collaborative approach is what helps drive our success."

Sidley Austin LLP served as legal adviser to venBio.

Janux Therapeutics Appoints Dr. Wayne Godfrey as Chief Medical Officer

On June 3, 2021 Janux Therapeutics, a biopharmaceutical company developing novel T cell engager immunotherapies, reported the appointment of Wayne Godfrey, M.D., as Chief Medical Officer, effective June 1, 2021 (Press release, Janux Therapeutics, JUN 3, 2021, View Source [SID1234583469]). Dr. Godfrey will lead the clinical advancement of Janux’s pipeline of next-generation T cell engager immunotherapies designed to potentially treat multiple solid tumor indications, including metastatic castrate-resistant prostate cancer (mCRPC), colorectal cancer (CRC), triple-negative breast cancer (TNBC), urothelial cancer (UC), and non-small cell lung cancer (NSCLC). Dr. Godfrey brings more than 25 years of drug development, clinical strategy, and research experience in cancer immunology and immunotherapy at leading pharmaceutical and biotechnology companies.

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"We are pleased to welcome Wayne to the Janux team as we look to advance our proprietary pipeline of next generation immunotherapies into clinical development," said David Campbell, Ph.D., President and CEO of Janux Therapeutics. "Wayne has deep clinical development and leadership experience in the field of immuno-oncology, and I look forward to working closely with him on our goal to fulfill the potential of our TRACTr platform technology to transform the lives of cancer patients."

"I am impressed with the thoughtful modular design of the TRACTr platform technology and Janux’s current drug product candidates, which are designed to deliver highly tumor-specific activation of T cell activity while incorporating crossover pharmacokinetics to minimize healthy tissue toxicity. I’ve hit the ground running and am looking forward to bringing Janux’s initial TRACTr product candidates into the clinic."

Prior to joining Janux, Dr. Godfrey served as the Vice President of Clinical Development of IGM Biosciences, Inc., where he led the global clinical development of IGM’s emerging pipeline of proprietary bispecific T-cell engaging IgM antibodies. Prior to IGM, he served as Senior Director, Clinical Development at Kite Pharma, a biotechnology company and subsidiary of Gilead Sciences, where he led the CAR-T CD19-directed pivotal Phase 2 study, ZUMA-5. Dr. Godfrey also served as Chief Medical Officer at Etubics, and Senior Director, Clinical Research Oncology at Gilead where he advanced ZYDELIG (idelalisib) through late-stage development, leading the design of global Phase 3 trials, and helping to obtain accelerated approval for its use for follicular lymphoma. Prior to Gilead, he worked as Vice President of Clinical Development at Bavaian-Nordic on Prostate and Breast cancer vaccines, and helped develop PROVENGE (sipuleucel-T) at Dendreon. He earned a B.A. in biochemistry and molecular biology from UC Santa Barbara, an M.S. in biology from Stanford University, and an M.D. from Washington University School of Medicine in St. Louis. Dr. Godfrey completed his internal medicine residency and fellowships in clinical immunology, hematology, and bone marrow transplantation at Stanford University.