On November 1, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that it will announce financial results for the third quarter of 2021 and recent corporate updates on Monday, November 8 (Press release, Mirati, NOV 1, 2021, View Source [SID1234594133]). During a conference call at 4:30 p.m. ET / 1:30 p.m. PT on November 8, company executives will provide company updates and review financial results.

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Investors and the general public are invited listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free 313-209-7315 or international +1 877-614-0009, confirmation code: 3962567. Materials related to the call will be available at the same website at the time of the conference call. A replay of the call will be available approximately 2 hours after the event has ended at the same website or by dialing in the U.S. toll free 719-457-0820 or international +1 888-203-1112, confirmation code: 3962567.

On November 1, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on November 22, 2021, at 4:30 p.m. ET to discuss its financial results for the fiscal year ended September 30, 2021 (Press release, Arrowhead Pharmaceuticals, NOV 1, 2021, View Source [SID1234594131]).

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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

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 8074256.

A replay of the webcast will be available on the Company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 8074256.

On November 1, 2021 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200301 (Press release, HiFiBiO Therapeutics, NOV 1, 2021, View Source [SID1234594087]). HFB200301 is a first-in-class monoclonal agonist antibody designed to promote an antitumor response by stimulating both innate and adaptive immune systems through TNFR2 in solid tumors identified through HiFiBiO’s Drug Intelligent Science (DISTM) platform.

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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

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"The FDA’s clearance of our IND for HFB200301 is an important milestone for HiFiBiO as it further demonstrates the power of our single cell-powered DIS platform to identify and develop novel therapeutics. This milestone also signifies our transition to a clinical stage company," said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. "The FDA’s clearance brings us one step closer toward achieving our mission of delivering novel therapeutics that improve treatment options for cancer patients"

"We were excited to discover that our TNFR2 clinical candidate not only stimulated effector CD4 and CD8 T cells, but also activated NK cells to drive anti-tumor activity" shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. "HFB200301 has shown strong in vivo efficacy alone and combined with anti-PD-1 at doses well tolerated in mice and NHPs."

"The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts in selected solid tumors identified through HiFiBiO DISTM platform. The company is also exploring a potential combination with checkpoint inhibitor therapy", said Luigi Manenti, M.D., CMO of HiFiBiO Therapeutics. "We remain committed to further developing novel immune therapies for patients with cancer and autoimmune diseases."

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select patients who may benefit the most from HFB200301 treatment.

On November 1, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that the company will provide an update on its ACTengine IMA203 trial in a late-breaking oral presentation as well as an update on Immatics’ next-generation CD8ab TCR-T approach at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) (Press release, Immatics, NOV 1, 2021, View Source [SID1234594068]). The conference will take place, both in person and virtually, from November 10 – 14, 2021.

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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

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Today, SITC (Free SITC Whitepaper) announced presentation titles and timings as follows:

IMA203 Phase 1a Clinical Data Update:

Presentation Title: Safety and anti-tumor activity of TCR-engineered autologous, PRAME-directed T cells across multiple advanced solid cancers at low doses – clinical update on the ACTengine IMA203 trial
Speaker: Martin Wermke, MD, Coordinating Investigator of Immatics ACTengine trials in Germany and Head of the Early Clinical Trial Unit of the National Center for Tumor Diseases Dresden (NCT/UCC) at the University Hospital Carl Gustav Carus in Dresden, Germany
Abstract Number: 959
Category: Late-breaking oral abstract presentation
Date & Time: Saturday, November 13, 2021; 12:00 – 12:15 pm EDT

Next-generation CD8ab TCR-T approach – Preclinical Data Update:

Presentation Title: Improved anti-tumor activity of next-generation TCR-engineered T cells through CD8 co-expression
Speaker: Mamta Kalra, PhD, Director CMC (Process Development) at Immatics
Abstract Number: 163
Category: Poster abstract presentation
Date & Time: Friday, November 12, 2021; Poster Hall Hours: 7 am–8:30 pm EDT

All posters presented at the poster hall will be made available as virtual ePosters throughout the SITC (Free SITC Whitepaper) 36th Annual Meeting.

About ACTengine IMA200 programs
Each of the product candidates of the IMA200 programs is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. IMA204 is currently in pre-clinical development. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine IMA200 Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

On November 1, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation (Press release, BioNTech, NOV 1, 2021, View Source [SID1234594067]). The presentation is scheduled for the late-breaking abstract poster session at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held both in person and virtually from November 10 – 14, 2021.

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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

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"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial (NCT04503278) to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Poster Details:

Program: BNT211
Poster Title: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Abstract Number: 958
Presenter: Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany
Date & Time: Friday, November 12, 2021; 12.25 – 12.40 pm ET