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.

Exicure, Inc. Announces Participation in Upcoming Conferences

On June 3, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that CEO David Giljohann will participate in the following upcoming conferences (Press release, Exicure, JUN 3, 2021, View Source [SID1234583468]):

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BIO Digital 2021
Format: Corporate update presentation
Date: June 10, 2021
Time: 7:00 AM ET
Location: The presentation will be available to registered conference attendees for on-demand viewing beginning June 10, 2021 at 7:00 AM ET via the virtual conference link and will be archived for 90 days on Exicure’s website following the conference.

BMO Biopharma Day: Spotlight on Rare Disease and Ophthalmology
Format: Rare Disease Panel: Central Nervous System
Date: June 22, 2021
Time: 10:30 AM ET
Location: The panel discussion will be available for live streaming to conference attendees at the virtual conference link.

Clinical Oncology Findings From Seattle Cancer Care Alliance (SCCA) Clinicians to Be Featured at the 2021 ASCO Annual Meeting

On June 3, 2021 Seattle Cancer Care Alliance (SCCA) reported the presentations from the organization’s clinicians that will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Seattle Cancer Care Alliance, JUN 3, 2021, View Source [SID1234583467]).

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SCCA clinicians contributed to studies across multiple cancer types addressing the full continuum of cancer care – from prevention to diagnosis to treatment. Presentations will highlight results from trials in Phase 1, CAR T-cell therapy, breast cancer, bladder cancer, non-small cell lung cancer and hematologic cancers. Additionally, there are multiple studies on the impact of the COVID-19 pandemic on cancer diagnosis, clinical care and oncology clinical trials. SCCA clinical researchers also contributed to new findings related to genetic profiling, prostate needle biopsy pathology and precision therapy for salivary gland cancer.

"SCCA is a leader in groundbreaking clinical trials turning scientific discovery into exciting new treatments that often change the way cancer care is delivered," said Nancy Davidson, MD, president and executive director of Seattle Cancer Care Alliance and a former ASCO (Free ASCO Whitepaper) president. "The work being presented by our physician-researchers at ASCO (Free ASCO Whitepaper) 2021 further demonstrates these continued efforts to improve the way patients are treated and advance multidisciplinary cancer care."

More information about SCCA’s presentations and publications at ASCO (Free ASCO Whitepaper) is available at: View Source

Presentation Details:

Breast cancer screening for carriers of ATM, CHEK2, and PALB2 pathogenic variants: A comparative modeling analysis.
Abstract: 10500
SCCA author: Kathryn P. Lowry, MD

Impact of disruptions in breast cancer control due to the COVID-19 pandemic on breast cancer mortality in the United States: Estimates from collaborative simulation modeling.
Abstract: 6562
SCCA author: Kathryn P. Lowry, MD

Phase I study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express a chimeric antigen receptor, huMNC2-CAR44 specific for a cleaved form of MUC1 (MUC1*).
Abstract: TPS2663
SCCA author: Jennifer M. Specht, MD and David G. Maloney, MD, PhD

Efficacy of enobosarm, a selective androgen receptor (AR) targeting agent, correlates with the degree of AR positivity in advanced AR+/estrogen receptor (ER)+ breast cancer in an international phase 2 clinical study.
Abstract: 1020
SCCA author: Hannah M. Linden, MD

AMEERA-1: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with palbociclib (palbo) in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).
Abstract: 1058
SCCA author: Hannah M. Linden, MD

Case-Based Panel: Optimizing Precision Therapy in Salivary Gland Cancers With a Look at the Future
SCCA speaker: Cristina P. Rodriguez, MD

PrE0807: A phase Ib feasibility trial of neoadjuvant nivolumab (N) without or with lirilumab (L) in cisplatin-ineligible patients (pts) with muscle-invasive bladder cancer (MIBC).
Abstract: 4518
SCCA author: Petros Grivas, MD, PhD

Avelumab first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): Analysis of time to end of next-line therapy in JAVELIN Bladder 100.
Abstract: 4525
SCCA author: Petros Grivas, MD, PhD

The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial.
Abstract: TPS5099
SCCA author: Risa L. Wong, Jonathan L. Wright, MD, MS, Heather H. Cheng, MD, PhD and Evan Y. Yu, MD

Clinical accuracy of information extracted from prostate needle biopsy pathology reports using natural language processing.
Abstract: 1557
SCCA author: Risa L. Wong and John L. Gore, MD, MS, FACS

Clinically advanced pelvic squamous cell carcinomas (pSCC) in men and women: A comprehensive genomic profiling (CGP) study.
Abstract: 3130
SCCA author: Petros Grivas, MD, PhD

Concordance of DNA damage repair (DDR) gene mutations in paired primary and metastatic prostate cancer (PC) samples.
Abstract: 5020
SCCA author: Michael T. Schweizer, MD, Evan Y. Yu, MD and Colin C. Pritchard, MD, PhD

Case Based Panel: Optimizing Urothelial Cancer Management From Organ-Confined to Metastatic Disease: A Multidisciplinary Approach
SCCA Moderator/Chair: Evan Y. Yu, MD

Oral Session: Germline Genetic Testing for Prostate Cancer
SCCA Discussant: Colin C. Pritchard, MD, PhD

CD19 CAR T-cell product type independently impacts CRS and ICANS severity in patients with aggressive NHL.
Abstract: 7532
SCCA author: Jordan Gauthier, MD, MSc, Mazyar Shadman, MD, MPH, David G. Maloney, MD, PhD and Cameron J. Turtle, MBBS, PhD, FRACP, FRCPA

Efficacy of clinical breast examination in chest-irradiated female survivors of childhood Hodgkin lymphoma (HL).
Abstract: 10028
SCCA author: Janie M. Lee, MD, MSc

Demographics, outcomes, and risk factors for patients (Pts) with sarcoma and COVID-19: A multi-institutional cohort analysis.
Abstract: 11523
SCCA author: Michael J. Wagner, MD

Avelumab in patients with previously treated Merkel cell carcinoma (JAVELIN Merkel 200): Updated overall survival data after more than five years of follow up.
Abstract: 9517
SCCA author: Paul Nghiem, MD, PhD

Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Abstract: 9007
SCCA author: Christina S. Baik, MD, MPH

Oral Session: Emerging Trends in Radiation for Localized Lung Cancers
SCCA discussant: Ramesh Rengan, MD, PhD

Phase 1b dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GS-3583, a FLT3 agonist Fc fusion protein, in patients with advanced solid tumors.
Abstract: TPS3147
SCCA author: John A. Thompson, MD

First-in-human phase I/II study of CYT-0851, a first-in-class inhibitor of RAD51-mediated homologous recombination in patients with advanced solid and hematologic cancers.
Abstract: 3006
SCCA author: Ryan C. Lynch, MD

Education Session: COG Perspective on the Impact of COVID-19 on Pediatric Oncology Clinical Trials and Implications for the Future
SCCA speaker: Douglas S. Hawkins, MD

Poster Discussion Session: COVID-19 and Cancer: Learning As We Go Along
SCCA discussant: Petros Grivas, MD, PhD

Cancer diagnosis and adverse financial events: Evidence from credit reports.
Abstract: 6504
SCCA author: Veena Shankaran, MD, MS

Choosing Wisely: Selecting the Right Population at the Right Time for DNA-Damaging Therapy
SCCA discussant: Elizabeth M. Swisher, MD