On September 09, 2021 Ashvattha Therapeutics, a clinical stage biotech company focused on novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in neurology, neuro-oncology, and ophthalmology, reported that Jeffrey Cleland, Ph.D., Chairman, CEO and President will be presenting at the following upcoming virtual and in-person investor conferences (Press release, Ashvattha Therapeutics, SEP 9, 2021, View Source [SID1234587466]).

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HC Wainwright 23rd Annual Global Investment Conference, Virtual (Sept 13-15)
Cantor Fitzgerald Global Healthcare Conference, Virtual (Sept 27-30)
BioFuture, Cure by Deerfield, 345 Park Avenue South, New York, NY (Oct 5-6)
Jeffrey Cleland, Ph.D., Chairman, CEO and President will present a corporate overview focused on Ashvattha’s clinical pipeline and corporate strategy.

"We recently announced positive interim data from our ongoing Phase 2 PRANA clinical study of our lead candidate OP-101 in severe COVID-19 patients, and will give an update on our additional clinical programs," said Dr. Cleland. "OP-101 is the only clinical-stage therapeutic with the ability to shut down multiple pathways causing hyperinflammation. We look forward to speaking with investors and potential partners at these upcoming events, as we advance our novel pipeline of hydroxyl dendrimer therapeutics. Updates will include the plans for D-4517.2, a subcutaneous treatment for ocular neovascular disease, and OP-801, a novel radio-imaging agent, to be studied in combination with OP-101 in ALS patients."

On September 9, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in three virtual investor conferences in September 2021b (Press release, Mustang Bio, SEP 9, 2021, View Source [SID1234587540]).

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Details of the events are as follows:

H.C. Wainwright 23rd Annual Global Investment Conference: The company’s presentation will be available for on-demand viewing on Mustang’s website beginning on Monday, September 13, 2021, at 7:00 a.m. ET and will remain available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting. The company will participate in one-on-one meetings during the conference as well.
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: The company will participate in a fireside chat on Monday, September 20, 2021, at 12:25 p.m. ET and will participate in one-on-one meetings during the conference. A webcast of the company’s chat will be available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting.
Cantor Global Healthcare Conference: The company will participate in a fireside chat on Monday, September 27, 2021, at 10:40 a.m. ET and will participate in one-on-one meetings during the conference. A webcast of the company’s chat will be available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting.

On September 9, 2021 ITM AG, a leading radiopharmaceutical company, reported that it will host a virtual industry satellite symposium titled, "A Global Perspective on the Management of Neuroendocrine Tumors – the Evolving Role of Targeted Radionuclide Diagnostics and Therapy" at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, ITM Isotopen Technologien Munchen, SEP 9, 2021, View Source [SID1234587556]). The symposium will feature renowned key opinion leaders in the field and will be held on Friday, September 17th, 2021, from 10:30 am – 12:00 pm CEST on channel 3, open to ESMO (Free ESMO Whitepaper) registered participants.

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The speakers are key precision oncology experts and will lead critical discussions addressing the changes within the treatment and diagnosis of neuroendocrine tumors. They will cover a range of topics examining the impact of NET diagnostic paradigms, treatment guidelines, and recent advancements within the clinical studies of Targeted Radionuclide Therapy. In addition to the ongoing COMPETE trial, the new phase III trial COMPOSE, a prospective study in high Grade 2 and Grade 3 gastroenteropancreatic NETs, will be presented. Participants will be able to interact with the speakers in a Q&A session at the end of the event.

Scientific Program and Participating Experts:

Welcome & Introduction
Raj Srirajaskanthan, MD, FRCP King’s College Hospital, London, UK (5 mins)
Changes in the Incidence and Prevalence of NETs – Impact of New Diagnostic Paradigms
Simon Singh, MD, MPH Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada (20 mins)
The Evolution of Guidelines for the Treatment of NETs
Namrata Vijayvergia, MD, FACP Fox Chase Cancer Center, Philadelphia, U.S. (20 mins)
The Role of Targeted Radionuclide Therapy in Clinical Trials
Grace Kong, MBBS (Hons), FRACP, FAANMS Peter MacCallum Cancer Center, Melbourne, Australia (20 mins)
Q&A and Closing Remarks (25 mins)
For further information please visit ITM’s ESMO (Free ESMO Whitepaper) 2021 Symposium website or the official ESMO (Free ESMO Whitepaper) webpage.

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]).

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"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.

On September 09, 2021 BeyondSpring, a global pharmaceutical company focused on the development of cancer therapeutics, reported three poster presentations of new data supporting the combination of plinabulin and G-CSF for the prevention of chemotherapy-induced neutropenia (CIN) at the European Society for Medical Oncology 2021 Congress taking place virtually September 16-21, 2021 (Press release, BeyondSpring Pharmaceuticals, SEP 9, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-three-poster-presentations-about-its-chemotherapy-induced-neutropenia-prevention-program-at-the-european-society-for-medical-oncology-2021-congress [SID1234587468]). Plinabulin in combination with G-CSF is currently under U.S. and China regulatory review with an FDA PDUFA date of November 30, 2021. The posters will become available on September 16, 2021 at 8:30 AM CEST and will remain available throughout the entire duration of the Congress.

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Additional Details:

Title: Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN)
Presentation Number: 1708P
Speaker: Ramon Mohanlal, M.D., Ph.D., executive vice president, research and development, chief medical officer, BeyondSpring Pharmaceuticals

Title: Prediction of Febrile Neutropenia (FN), Hospitalization (Hosp) Rates, and Infection (Inf) Rates in Chemotherapy-Induced Neutropenia (CIN) Patients (pts) Treated with the Plinabulin and Pegfilgrastim Combination (Plin+Peg) using a Meta-Analysis (MA)-based Tool
Presentation Number: 1709P
Speaker: Stephan Ogenstad, Ph.D., founder and president of Statogen Consulting LLC, North Carolina

Title: Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia (CIN), on Patient Quality of Life (QoL)
Presentation Number: 1710P
Speaker: Douglas W. Blayney, M.D., professor of medicine (oncology), Stanford Medicine

"We’re pleased to have three poster presentations supporting our CIN program included at this year’s ESMO (Free ESMO Whitepaper) Congress, highlighting the clinically meaningful benefit of the plinabulin and G-CSF combination in preventing CIN," said Dr. Ramon Mohanlal, executive vice president, R&D, and chief medical officer, BeyondSpring Pharmaceuticals. "It’s critical that we continue to raise awareness about the unmet need in CIN since it can be a life-threatening side effect of chemotherapy, and preventing it can make a significant impact on the lives of patients. Plinabulin has received Breakthrough Designation, and in combination with G-CSF, is currently undergoing the U.S. and China’s regulatory review for CIN prevention. We look forward to bringing this new treatment option to patients in need."

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.