Anticancer Bioscience Announces its First Granted US Patent for Synthetic Lethal Approach to Identifying Novel Cancer Treatments

On September 9, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported its first granted US patent (11104633), entitled "cancer treatment using compounds that selectively target polyploid cancer cells for disruption", which was issued by the US Patent and Trademark Office (USPTO) on August 31 (Press release, Anticancer Bioscience, SEP 9, 2021, View Source [SID1234587452]).

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The method covered in this patent has been used to identify compounds that selectively kill polyploid cells, key to the discovery of inhibitors of MYC, overexpression of which occurs in over half of tumors, and is correlated with poorly differentiated and aggressive cancer.

Dun Yang PhD, Founder, President, and CEO of ACB, said: "The grant of our first patent in the USA is a key milestone and underlines our innovative approach to identifying first-in-class and best-in-class approaches for the treatment of cancer, using synthetic lethal approaches. It forms part of our growing patent estate with nine additional patents pending, covering both methods and composition of matter."

ACB is applying synthetic lethal approaches to develop targeted cancer therapies. These have the potential to be much safer and more effective than current therapies. ACB has access to world-leading cancer biology expertise and drug discovery platforms that enable the company to identify novel compounds that can target both genetic and epigenetic vulnerabilities of cancer cells. ACB has bespoke chemical compound libraries and has invested in developing one of the world’s largest natural product libraries, providing a rich screening resource for potential cancer therapeutics.

With five drug discovery programs, ACB is progressing rapidly through optimization to candidate selection toward IND enabling studies, with the aim of initiating two clinical trials in the USA in 2022.

Anavex Life Sciences to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 9, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held from September 13-15, 2021 (Press release, Anavex Life Sciences, SEP 9, 2021, https://www.anavex.com/anavex-life-sciences-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference/ [SID1234587451]).

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A webcast of the on-demand presentation will be available beginning Monday, September 13, 2021, at View Source or on the Company’s website at www.anavex.com. The on-demand presentation will open on September 13 at 7:00 A.M. (ET). A webcast replay will be accessible for 30 days following the event.

Erasca Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Evaluate ERAS-007 and Encorafenib Combination

On September 8, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) for the BRAF inhibitor encorafenib (BRAFTOVI) (Press release, Erasca, SEP 8, 2021, View Source [SID1234639384]).

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This agreement will support a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with encorafenib and the EGFR inhibitor cetuximab for the treatment of patients with BRAF V600E-mutant mCRC. This combination will be investigated as part of the Phase 1b/2 HERKULES-3 trial expected to initiate in the second half of 2021. Erasca will sponsor the study, and Pfizer will supply encorafenib. The two companies will form a Joint Development Committee to review the clinical trial results.

"We are excited to work with Pfizer to explore this promising combination in colorectal cancer," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "MAPK signaling is constitutively activated in patients with BRAF V600E mutations, who often have a poor prognosis. Combining upstream EGFR inhibition, midstream BRAF inhibition, and downstream ERK inhibition fits squarely within Erasca’s strategies to erase cancer and has potential to limit pathway reactivation, offering the therapeutic potential to comprehensively shut down the RAS/MAPK pathway in this tumor type."

Worldwide, approximately 1.8 million cases of CRC are diagnosed annually, with BRAF V600E mutations occurring in approximately 10% of these patients. The combination of encorafenib and cetuximab was approved in April 2020 for previously treated patients with BRAF V600E-mutant mCRC. The combination demonstrated improved overall survival compared to the chemotherapy control arm; however, only 20% of patients experienced an objective response, and the progression-free survival was approximately four months. Therefore, emergence of resistance is a major therapeutic barrier to long-term clinical benefit. Erasca is exploring whether ERK inhibition with ERAS-007 in combination with encorafenib plus cetuximab can reduce the emergence of resistance and further improve treatment benefit for patients with BRAF V600E-mutant mCRC.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of four HERKULES clinical trials that span multiple tumor types and includes both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.

A-Alpha Bio Secures $20M Series A Financing to Accelerate Drug Discovery by Measuring Protein-Protein Interactions at Scale

On September 8, 2021 A-Alpha Bio, a biotechnology company that works with pharmaceutical industry partners to accelerate drug discovery with massively multiplexed measurements of protein interactions, reported that it has closed a $20M Series A Financing Round to dramatically expand capabilities and throughput (Press release, A-Alpha Bio, SEP 8, 2021, View Source [SID1234636941]). The round was led by Madrona Venture Group with participation from Perceptive Advisors’ Perceptive Xontogeny Venture Fund (PXV Fund) and Lux Capital. Madrona Venture Group’s Matt McIlwain and Xontogeny’s Ben Askew, Ph.D. have joined A-Alpha Bio’s Board of Directors as part of the financing.

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A-Alpha Bio is building a high-resolution model of biology by measuring millions of protein-protein interactions, leveraging the intersection of synthetic biology, protein engineering, and machine learning. Compared to traditional technologies for screening protein interactions, including biophysical and display platforms, A-Alpha Bio’s proprietary AlphaSeq platform is able to measure protein interactions at a scale and to a degree of precision that is otherwise inaccessible. The quantity and quality of AlphaSeq data is ideal for drug discovery and also critical for training highly predictive ML-models for protein-protein binding.

"Understanding and characterizing protein-protein interactions is fundamental to the future of drug discovery and development and we are excited to back this impressive team that is at the intersection of innovation – bringing together life and computer sciences to uncover previously inaccessible discoveries," said Matt McIlwain, Managing Director, Madrona Ventures Group. "We have been impressed by the traction David and the team have made since we invested in the seed round and believe they are well on their way to helping to develop treatments for diseases and create a data advantage that could change the future of antibody and small molecule discovery."

A-Alpha Bio will deploy the new capital announced today to build a new production laboratory, generate the largest ever database of protein interaction measurements, and fill key roles in their rapidly growing team. These investments will enhance the company’s partnerships with leading pharmaceutical companies to discover new drugs – with a focus on antibodies and molecular glues. With a massive and ever-growing protein interaction data asset, A-Alpha Bio also plans to expand their machine-learning capabilities to uncover the complex rules of protein binding and enable in silico modeling of complex protein interaction networks.

"Our mission is to improve human health by accelerating drug discovery with synthetic biology and machine learning. I’m incredibly proud of the phenomenal team we’ve built and the impactful work we’ve already accomplished with leading pharma and biotech partners," said Dr. David Younger, Co-Founder and CEO of A-Alpha Bio. "Our Series A investors share our vision and optimism for the future of medicine. I’m especially delighted to welcome Matt McIlwain and Ben Askew as Board Members who bring decades of experience building high-impact companies across the technology and pharmaceutical industries."

Protein interactions are central to antibody and small-molecule drugs, and AlphaSeq represents the first high-throughput and quantitative approach for measuring protein-protein binding. By leveraging AlphaSeq, partners have been able to accelerate antibody discovery by measuring millions of interactions between antibodies and antigens for high-throughput determination of properties like affinity, specificity, cross-reactivity, and epitope. Instead of narrowly funnelling an antibody library and characterizing the few strongest binders, AlphaSeq allows partners to maintain a wide funnel with thousands of antibodies to avoid missing therapeutic candidates with unique and desirable properties. AlphaSeq is also leveraged for molecular glue target discovery by measuring weak and likely druggable interactions between a library of E3 ubiquitin ligases and a library of neo-substrates.

"When it comes to measuring protein-protein interactions and assisting pharma in the discovery of antibodies and molecular-glue targets, AlphaSeq is unmatched," said Ben Askew Ph.D., Partner, PXV Fund. "AlphaSeq is enabling pharma companies to find the high-value needles in the haystack, a process so prohibitively expensive, rare, or slow that these opportunities might have never been found. We’re thrilled to support A-Alpha Bio’s next phase of growth as they continue to set new standards for protein and molecular glue research."

To date, A-Alpha Bio has worked with a number of partners across the pharmaceutical and biotech industry to advance drug discovery, ranging from mid-sized biotechs to top-ten pharma. Additionally, A-Alpha Bio has ongoing awards from the Bill & Melinda Gates Foundation to support the discovery of therapeutics for infectious diseases and the National Science Foundation to support molecular-glue target discovery and ML-guided antibody discovery.

Bolt Biotherapeutics Announces Clinical Collaboration with Bristol Myers Squibb to Study BDC-1001 in Combination with Opdivo® for Treatment of HER2-Expressing Solid Tumors

On September 8, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY) to investigate Bolt Biotherapeutics’ BDC-1001 in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab) (Press release, Bolt Biotherapeutics, SEP 8, 2021, View Source [SID1234618695]). BDC-1001 is a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors .

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"We look forward to working with BMS in our continued development of BDC-1001, which has shown promising results in preclinical and early clinical studies," said Randall Schatzman, CEO of Bolt Biotherapeutics. "Our unique ISAC approach initiates an innate and an adaptive immune response that may be synergistic with BMS’ innovative PD-1 inhibitor Opdivo. The combination of BDC-1001 and Opdivo holds potential as a treatment for cancer patients, and we welcome the opportunity to investigate this in a clinical setting." He added, "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Bolt’s clinical studies."

BDC-1001 is a human epidermal growth factor receptor 2 (HER2) ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists with an intervening non-cleavable linker, for the treatment of patients with HER2-expressing solid tumors. It is currently being investigated in a Phase 1/2 clinical trial (NCT04278144) in patients with solid tumors, including breast, gastroesophageal and colorectal, that are HER2+ or HER2-low, for which Bolt recently presented preliminary data detailing safety, tolerability, and signs of activity at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The trial is being conducted in four parts, with dose-escalation and dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Bolt Biotherapeutics is the study sponsor and will be responsible for costs associated with the trial execution. The combination dose escalation is expected to start later in 2021.

Opdivo is a trademark of Bristol-Myers Squibb Company.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.