Elicio Therapeutics Presents Preclinical Data on AMP TCR-T Combination Therapy in Solid Tumors at the CAR-TCR Annual Summit 2021

On September 10, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it presented preclinical data on its Amphiphile (AMP) platform in combination with TCR-T therapy in solid tumors at the 6th Annual CAR-TCR summit, that was held virtually from August 30 – September 2, 2021 (Press release, Elicio Therapeutics, SEP 10, 2021, https://elicio.com/2021/09/elicio-therapeutics-presents-preclinical-data-on-amp-tcr-t-combination-therapy-in-solid-tumors-at-the-car-tcr-annual-summit-2021/ [SID1234587518]). The data was presented in a session co-chaired by industry leaders Adrian Bot, MD, PhD, Vice President of Translational Medicine at Kite, and member of Elicio’s Scientific Advisory Board, and Christopher Heery, MD, Chief Medical Officer of Arcellx Inc., as part of the "Understanding and Managing Toxicity to Enhance Patient Outcomes" workshop.

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"The preclinical data showed that AMP-boosting transformed an ineffective TCR-T cell monotherapy regimen into a combination which induced long-term non-progression in a fraction animals. It also showed that the AMP combination therapy not only enhanced the expansion and functionality of transferred TCR-T cells but also induced a T-cell response to additional tumor antigens from the original therapy, called antigen spreading, to more broadly attack the tumor." said Peter DeMuth, Ph.D., Elicio Vice President of Research. "We are encouraged by these results because they demonstrate the AMP platform’s ability to enhance multiple axes of immune activation, both systemically as well as in the tumor microenvironment, which may help overcome known challenges to T cell therapy for solid tumors in the clinic."

Adrian Bot, MD, PhD, co-chair of that session, added, "Elicio’s AMP technology is showing promising results in terms of enhancing T cell therapy, through effectively restimulating in vivo the T cells, via deployment of professional antigen presenting cells and co-delivery of biological response modifiers."

This effort expands on the previous work reported in Science from studies conducted at MIT and exclusively licensed to Elicio combining AMP and CAR-T. As observed in the TCR-T combination setting, AMP-boosting of CAR-T cells can promote CAR-T expansion and solid tumor infiltration, contributing to durable responses and resistance to relapse due to loss of CAR-target loss in recurring tumors. Elicio is currently applying this strategy in collaboration with Moffitt Cancer Center to improve CAR-T cell therapies for patients with hematological cancers. This effort is focused on evaluating the combination of CD19 CAR-T AMPlifier, referred to as ELI-011, together with CD19-targeted CAR-T therapy, in mouse models of B cell lymphoma. Positive results in these preclinical assessments may support the advancement of the program into clinical trials.

Presentation will be available on the Elicio Therapeutics website following the Summit via link.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

Amphiphile platform is thought to deliver immunotherapeutics to target the lymph node directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

Deciphera Pharmaceuticals to Host Virtual Investor Event Featuring Key Opinion Leaders to Discuss Rebastinib and Vimseltinib Data Presented at ESMO Congress 2021

On September 10, 2021 Deciphera Pharmaceuticals, Inc. reported that the Company will host a virtual investor event to review the rebastinib and vimseltinib clinical data to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on Friday, September 17, 2021, from 10:00 AM to 12:30 PM ET (Press release, Deciphera Pharmaceuticals, SEP 10, 2021, View Source [SID1234587517]).

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Deciphera’s senior executive team will be joined by the following key opinion leaders at the event:

Dr. Robert L. Coleman, M.D., FACOG, FACS, Gynecologic Oncologist and Chief Scientific Officer at US Oncology Research
William D. Tap, M.D., Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center

Coherus Management to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 10, 2021 Coherus BioSciences, Inc., reported that senior management will present at the 23rd Annual H.C. Wainwright Global Investment Conference (Press release, Coherus Biosciences, SEP 10, 2021, View Source [SID1234587516]). The presentation will be made available at 7 a.m. ET on Tuesday, September 14, 2021, during the virtual conference.

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Aurinia Pharmaceuticals to Participate in H.C. Wainwright 23rd Annual Global Investment Conference

On September 10, 2021 Aurinia Pharmaceuticals Inc. reported that members of the senior management team will participate in the H.C. Wainwright & Co. 23rd Annual Global Investment Conference, September 13-15, 2021 (Press release, Aurinia Pharmaceuticals, SEP 10, 2021, https://ir.auriniapharma.com/news/detail/235/aurinia-pharmaceuticals-to-participate-in-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587514]). The Aurinia presentation will be available on-demand beginning September 13, 2021 at 3 pm ET.

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The audio webcast is available here. Interested parties can also register and access the presentation under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

Aileron Therapeutics to Present New Clinical Data at ESMO Virtual Congress 2021 Supporting Novel, Selective Chemoprotective Agent ALRN-6924

On September 10, 2021 Aileron Therapeutics, a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported two upcoming poster presentations at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, which is being held September 16-21, 2021 (Press release, Aileron Therapeutics, SEP 10, 2021, View Source [SID1234587513]). In these posters, Aileron will present preliminary data from its ongoing Phase 1 study of ALRN-6924 in healthy volunteers and final data from its completed Phase 1b study of ALRN-6924 in patients with small cell lung cancer (SCLC) receiving second-line topotecan treatment. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s attack on cancer cells, an emerging concept known as chemoprotection. ALRN-6924, a first-in-class MDM2/MDMX dual inhibitor, is designed to activate p53, which in turn upregulates p21, a known inhibitor of the cell replication cycle.

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"We are excited to share preliminary findings from our ongoing study of ALRN-6924 in healthy volunteers as well as final results from our completed Phase 1b study of ALRN-6924 in patients with small cell lung cancer at the upcoming ESMO (Free ESMO Whitepaper) Congress," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron. "These findings support the design of our ongoing randomized, double-blind, placebo-controlled study of ALRN-6924 in patients with non-small cell lung cancer and are helping us plan for future clinical studies of ALRN-6924 in multiple p53-mutated cancers and types of chemotherapy."

Aileron ESMO (Free ESMO Whitepaper) Poster Presentations

Title: A Phase 1b Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression
Abstract/Poster #: 1654P

Title: A Phase 1 Study of the Dual MDMX/MDM2 Inhibitor, ALRN 6924, in Healthy Volunteers
Abstract/Poster #: 1791P

Archived versions of Aileron’s ESMO (Free ESMO Whitepaper) poster presentations will be available under the Scientific Publications section of Aileron’s website at View Source

About the Phase 1 Study in Health Volunteers

Aileron is conducting a multi-part Phase 1 pharmacology study in healthy volunteers to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALRN-6924. Aileron will present the findings from Parts 1 and 2 of the study at ESMO (Free ESMO Whitepaper). The objectives of these first two parts are to determine a dose of ALRN-6924 that initiates p53-mediated transcriptional regulation and yields transient cell cycle arrest via p21 induction in human bone marrow with minimal signal for apoptosis (Part 1), and to determine the time to onset, magnitude, and duration of bone marrow PD effects (Part 2). The study is ongoing, and Aileron anticipates presenting additional findings at a later date.

About the Phase 1b Study in Patients with p53-Mutated SCLC

In October 2020, Aileron presented positive clinical data from the Phase 1b trial in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe neutropenia, anemia and thrombocytopenia in patients with p53-mutated SCLC treated with second-line topotecan. The final data set from this trial, which Aileron will present at ESMO (Free ESMO Whitepaper), includes results from 13 additional patients, including two new cohorts of seven patients receiving 0.3 mg/kg ALRN-6924 given six hours before topotecan; four patients receiving 0.2 mg/kg ALRN-6924 given 24 hours before topotecan; and two new patients receiving 0.3 mg/kg ALRN-6924 given 24 hours before topotecan. These data are in line with the proof-of-concept data previously presented and with Aileron’s expectation that administering ALRN-6924 at 0.3 mg/kg and 24 hours before topotecan is the optimal dose and schedule in this patient population.