On September 9, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that it will host a data update webcast for investors and analysts during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting 2021, September 17, 2021 at 1:30 p.m. ET (Press release, Gritstone Oncology, SEP 9, 2021, View Source [SID1234592012]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The event will highlight the GRANITE (individualized neoantigen immunotherapy) Phase 1/2 data in advanced solid tumors which is being presented during a mini- oral presentation at ESMO (Free ESMO Whitepaper) 2021, in addition to data from the SLATE v1 shared neoantigen immunotherapy program in KRAS mutant advanced solid tumors.

Presenters:

Andrew Allen, M.D., Ph.D., Gritstone’s chief executive officer, will provide a brief overview of the company, its neoantigen directed approach to immunotherapy, and next steps for the GRANITE and SLATE oncology programs
Daniel Catenacci, M.D., assistant professor of medicine, University of Chicago, will review the most recent GRANITE data
Thierry Andre, M.D., professor of medical oncology, St. Antoine Hospital, Assistance Publique Hôpitaux de Paris, will discuss the current treatment landscape and unmet medical need in treating patients with microsatellite stable colorectal cancer (MSS-CRC)
The presentation will be followed by a Q&A session.

To register for the webinar, please click here. The call and accompanying slides will be webcast live on the "Events" page under the "Investors & Media" section of the company’s website at www.gritstone.com. A replay of the webcast will be accessible at the same link approximately one day after its completion.

Daniel Catenacci, M.D., is an associate professor of medicine and director of the gastrointestinal oncology program at the University of Chicago. He serves as the assistant director of Translational Research in the Comprehensive Cancer Center. In addition to his clinical practice as an adult gastrointestinal medical oncologist, Dr. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach) cancers. His bench-to-bedside translational research has an overarching goal to validate and improve personalized treatment, immunotherapy, and precision medicine for gastroesophageal cancer and other GI cancers. Additionally, Dr. Catenacci designs and executes novel clinical trials to implement treatment strategies based on these laboratory and clinical discoveries. Dr. Catenacci serves as an associate editor for the Journal of American Medical Association Network Open (JAMA Netw Open) and is on the editorial board of the Journal of Clinical Oncology Precision Oncology (J Clin Oncol PO).

Thierry André, M.D., is a professor of medical oncology at the University Pierre et Marie Curie (UMPC), Paris VI, and head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hôpitaux de Paris. He is the founding member and general secretary of the GERCOR (Multidisciplinary Oncology Research Group) and leads the colorectal task force of GERCOR and also serves as a member of the Adjuvant Colon Cancer Endpoints (ACCENT) group. Dr. André’s main research interest is in gastrointestinal malignancies. Dr. André is a member of several scientific organizations including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), and was chairman of the GI Cancer Board for Research of the French National Institute (INCA).

On September 9, 2021 Greenwich LifeSciences, Inc., a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, provided updates on recent and upcoming developments (Press release, Greenwich LifeSciences, SEP 9, 2021, View Source [SID1234587472]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of the close of markets on September 8, 2021, Greenwich LifeSciences has the highest listed share price return of all 307 biotech IPOs tracked since February 2019 based on the Company’s share price increase of approximately 763% from its IPO offering price (Source: BioPharmCatalyst with data from IPOScoop).

CEO Snehal Patel commented, "We look forward to celebrating the upcoming first year anniversary of our IPO. In addition, we are pleased that H. C. Wainwright initiated analyst coverage of the Company on September 1, 2021 with a price target of $78 per share, consistent with the $75 price target from our first covering analyst. Another important milestone is our addition to the Russell 2000, which placed more of our public float in the hands of long-term investors."

"The analyst coverage, participation in investor conferences, and addition to the Russell 2000 will continue to support our outreach to institutional investors and our transition to investment banking partners that focus on M&A, licensing, and long-term biotech institutional investors. We want to thank Aegis Capital and their investors for their support during our first year as a public company and for their continued support as we expand our investment banking team and investor base."

Mr. Patel added, "We are grateful to our loyal shareholders and breast cancer patients who continue to reach out to us offering encouragement and support. In the near future, the Company plans to announce updates on the manufacturing of GP2 and initiation of the upcoming Phase III clinical trial, as well as the publication of additional data from the Phase IIb clinical trial."

About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On September 9, 2021 Precision BioSciences, Inc., a clinical-stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, and iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, reported a license and collaboration agreement under which iECURE plans to advance Precision’s PBGENE-PCSK9 candidate into Phase I studies and gain access to Precision’s PCSK9-directed ARCUS nuclease to develop additional gene editing therapies for genetic diseases, initially targeting liver diseases (Press release, Precision Biosciences, SEP 9, 2021, View Source [SID1234587486]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, iECURE plans to file a clinical trial application as early as 2022 to advance the PBGENE-PCSK9 clinical candidate through Phase 1 clinical studies for the treatment of familial hypercholesterolemia (FH). Precision will retain rights to PBGENE-PCSK9, including all products developed for genetic indications with increased risk of severe cardiovascular events such as FH. In return, Precision has granted iECURE a license to use its PCSK9-directed ARCUS nuclease to insert genes into the well-characterized PCSK9 locus to develop treatments for four other pre-specified rare genetic diseases. Precision will receive an equity stake in iECURE and is eligible to receive milestone and royalty payments on sales of iECURE products developed with ARCUS.

"We are excited to continue working with Jim Wilson under this new in vivo gene editing license and collaboration agreement with iECURE, as iECURE looks to rapidly advance our PBGENE-PCSK9 candidate, file for a clinical trial application in 2022, and use our PCSK9-directed ARCUS nuclease, and its knock-in capabilities, to pursue new treatments for rare genetic diseases," said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. "Through this collaboration we expect to gain important clinical validation for in vivo gene editing with ARCUS, while retaining rights to this PCSK9-directed nuclease, which we believe offers a safe harbor locus for DNA gene editing knock-in without deleterious effects when the PCSK9 gene is disrupted."

"We founded iECURE with the aim of focusing on genetic diseases with significant unmet need that we could target in a mutation-agnostic manner. After evaluating different gene editing technologies and platforms, we believe gene editing with ARCUS, including use of the uniquely designed ARCUS nuclease as a gene insertion tool targeting the PCSK9 gene will help us rapidly advance several candidates to the clinic with the potential to deliver on the promise of highly efficient, specific, and safe gene insertion," said Joe Truitt, Chief Executive Officer of iECURE. "We are excited to partner with Precision on this key pillar of our gene editing strategy, to advance this work for rare genetic diseases."

James M. Wilson, M.D., Ph.D., Chief Scientific Advisor of iECURE and Professor in the Departments of Medicine and Pediatrics, Perelman School of Medicine, University of Pennsylvania, Director, Gene Therapy Program, will present new non-human primate data demonstrating ARCUS-mediated gene addition today, September 9, 2021 during the Precision BioSciences gene editing R&D event. Dr. Wilson and his team have demonstrated in non-human primates that it is possible to use ARCUS to insert new genes stably into the PCSK9 locus, which could be used as a potential approach for treating multiple genetic diseases with a single therapeutic strategy.

About ARCUS

ARCUS is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock in), remove (knockout), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision’s platform and products are protected by a comprehensive portfolio including more than 80 patents to date.

On September 9, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the following investor conferences in September (Press release, Tempest Therapeutics, SEP 9, 2021, View Source [SID1234587544]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright 23rd Annual Global Investment Conference available on-demand Monday, September 13, 2021 at 7:00 a.m. ET
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday September 22, 2021 at 9:55 a.m. ET
To access the live or archived recording of the company presentations, please visit the investor section of the Tempest website at View Source

On September 9, 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 dosing of the first patient in the HERKULES-2 Phase 1b/2 trial evaluating ERAS-007 in combination with various agents in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Erasca, SEP 9, 2021, View Source [SID1234639383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As the foundation of Erasca’s lung cancer platform, HERKULES-2 is a master protocol designed to inhibit multiple oncogenic drivers of the RAS/MAPK pathway to address high unmet needs in lung cancer. Initially focused on patients with mutant EGFR or KRAS NSCLC, HERKULES-2 will further progress to evaluate other combinations targeting additional subtypes of NSCLC," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Erasca’s series of HERKULES trials also includes tissue-specific master protocols in gastrointestinal cancers and hematological malignancies as well as a tissue-agnostic trial, tailored to evaluate promising combinations to inhibit oncogenic signaling and prevent the emergence of resistance."

HERKULES-2 will initially examine the safety, tolerability, and preliminary efficacy of ERAS-007 in combination with osimertinib (TAGRISSO) in patients with advanced NSCLC harboring an epidermal growth factor receptor mutation (EGFRm). After a recommended dose is determined, the Phase 2 expansion portion will further evaluate the safety and efficacy of the combination in patients whose disease has developed resistance to osimertinib, a setting in which there are currently no approved targeted therapies. Future sub-studies of HERKULES-2 will explore ERAS-007 or the SHP2 inhibitor ERAS-601 in combination with other agents in patients with different mutational subtypes, including a KRAS G12C mutation.

ERAS-007, a potential best-in-class inhibitor of the extracellular signal-regulated kinases (ERK), targets the terminal node of the RAS/MAPK pathway. The broad applicability of ERAS-007 across a wide range of indications and tumor types was recently highlighted in a preclinical study published in Cell Reports Medicine, supporting durable ERK blockade and potent antiproliferative efficacy in both solid tumor and hematological malignancy cell lines. ERAS-007 demonstrated preferential anti-tumor activity for tumor types harboring mutant BRAF, KRAS, NRAS, or HRAS, as well as robust inhibitory activity across a range of mutant KRAS subtypes.

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. The broad therapeutic potential of ERAS-007 is being investigated initially across four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1, 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, and HERKULES-2, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with NSCLC, are currently enrolling patients. HERKULES-3, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers, is expected to begin by year-end. HERKULES-4, a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies, is anticipated to begin in the first quarter of 2022.