On May 17, 2022 Sanofi reported that New research at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 underscores it’s commitment to improving care across its core focus areas, including multiple myeloma, lung and breast cancers (Press release, Sanofi, MAY 17, 2022, View Source [SID1234614715]).

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!

Dietmar Berger
Chief Medical Officer, Global Head of Development at Sanofi
"Oncology is a core area for Sanofi, as evidenced by the doubling of our pipeline between 2019 and 2022. As we continue to pursue transformative research to develop advanced medicines for people living with cancer, our portfolio has grown to more than ten therapies in clinical trials. In parallel, we continue to leverage external innovation through strategic collaborations and investments in cutting edge technologies. Over ten value-creating acquisitions and business development deals in the past two years have reshaped our footprint in oncology, expanding our capacities with leading talent, as well as state-of-the-art molecules and technologies in immuno-oncology, molecular oncology, and genomic medicine."

Safety and efficacy data for tusamitamab ravtansine add to growing body of evidence for our potential first-in-class therapy for the treatment of nonsquamous non-small cell lung cancer (NSQ NSCLC) with CEACAM5 expression*

Abstract 9039: Safety and efficacy of tusamitamab ravtansine (SAR408701) in long-term treated patients with NSQ NSCLC expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)

Early clinical data for Sarclisa (isatuximab) in combination with pomalidomide-dexamethasone highlight potential for subcutaneous administration by an on-body delivery system for the treatment of relapsed refractory multiple myeloma (RRMM)

Abstract 8025: Subcutaneous (SC) isatuximab administration by an on-body delivery system (OBDS) in combination with pomalidomide-dexamethasone (Pd) in patients with RRMM: Interim phase 1b study results

Updates on trials for amcenestrant, an oral selective estrogen receptor degrader (SERD), for the potential treatment of breast cancer*

Abstract TPS607: Adjuvant study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer (EBC), who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (AMEERA-6)
Abstract 528: AMEERA-4: A preoperative window-of-opportunity (WOO) study to assess the pharmacodynamic (PD) activity of amcenestrant or letrozole in postmenopausal patients with ER+/HER2- primary breast cancer
Biomarker research for SAR444881, a potential first-in-class anti-ILT2 monoclonal antibody*

Abstract 2571: Evaluation of pharmacodynamic and patient enrichment biomarkers for SAR444881, a first-in-class anti-ILT2 monoclonal antibody for cancer immunotherapy

Trial in progress for investigational use of Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC)

Abstract TPS9592: C-POST protocol update: A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post surgery and radiation therapy (RT) in patients with high-risk CSCC

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Safety and efficacy data for SAR439459, a transforming growth factor beta (TGF-β) inhibitor*

Abstract 2524: Safety and efficacy results from the expansion phase of the first-in-human study evaluating TGFβ inhibitor SAR439459 alone and combined with cemiplimab in adults with advanced solid tumors

Immunogenomic analysis for IL-2-based immunotherapies*

Publication Only: Detailed immunogenomic analysis of high dose IL-2 pharmacodynamic effects: A benchmark for next-generation IL-2-based immunotherapies

Health economics and outcomes research in NSCLC

Publication Only: Insights into the advanced non-small cell lung cancer patient journey: Treatment decision-making, preferences, and quality of life considerations

Click here to view these abstracts located in the ASCO (Free ASCO Whitepaper) Meeting Library.

*These assets are currently under investigation and their safety and efficacy has not been fully evaluated by any health authority.

On May 17, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that William Collier, Arbutus’ President and Chief Executive Officer, will present at the H.C. Wainwright Global Investment Conference on Tuesday, May 24, 2022, at 11:30 am ET in Miami, FL (Press release, Arbutus Biopharma, MAY 17, 2022, https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-present-hc-wainwright-global-investment-conference [SID1234614732]).

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!

A live webcast of the presentation can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com. An archived replay of the webcast will be available on the Arbutus website after the event.

On May 17, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference (Press release, Decibel Therapeutics, MAY 17, 2022, View Source [SID1234614748]). The fireside chat will be available for on-demand viewing starting Tuesday, May 24, 2022 at 7:00 a.m. E.T.

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!

A webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.

On May 17, 2022 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported to highlight the strategic purchase of arimoclomol by KemPharm, Inc. ("KemPharm") (Press release, CytRx, MAY 17, 2022, View Source [SID1234614766]).

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!

KemPharm is a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system ("CNS") diseases. KemPharm has announced a definitive agreement with Orphazyme A/S ("Orphazyme") to acquire arimoclomol, a first-in-class heat shock protein potentiator being developed as a treatment for Niemann-Pick disease type C ("NPC"). NPC is a rare neurodegenerative disease characterized by abnormal accumulation of cholesterol and lipids in neuronal tissues. Under the terms of the agreement, KemPharm will purchase substantially all of the assets and operations of Orphazyme, including arimoclomol, for a cash payment of USD $12.8 million. The transaction is expected to close on or before June 1, 2022.

CytRx licensed arimoclomol to Orphazyme for milestones and royalties on sales, and CytRx expects the terms of its license with Orphazyme to remain intact as the arimoclomol asset transfers to KemPharm.

In the press release issued by KemPharm, Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm stated, "The acquisition of arimoclomol aligns perfectly with our strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including our lead clinical candidate, KP1077 in idiopathic hypersomnia. We have carefully evaluated the CRL issued by the FDA and the minutes from the subsequent Type A meeting, as well as the data that has been generated from the development work performed to date. We believe the efficacy signal for arimoclomol in NPC is convincing and that there is a viable regulatory path that could enable a successful NDA resubmission. KemPharm has significant experience with challenging regulatory situations, having successfully led or participated in three FDA product approvals, two of which followed an initial CRL. We welcome the opportunity to work with the FDA on the resubmission of the NDA for arimoclomol in NPC, which we expect to file as early as the first quarter of 2023."

Stephen Snowdy, PhD, Chief Executive Officer of CytRx commented, "CytRx is very pleased to see that arimoclomol will enjoy the support and resources of KemPharm, and that KemPharm sees value in the human trials data collected on arimoclomol through the course of 10 Phase 1, four Phase 2 and three pivotal Phase 2/3 trials. We are especially pleased to see that KemPharm, with its experience in challenging regulatory submissions, plans to re-submit arimoclomol to the FDA as early as Q1 2023. With a mean age of death of 13 years, patients desperately need a solution to Niemann-Pick disease type C."

On May 17, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference, which is being held virtually and in-person from May 23-26, 2022 (Press release, Gritstone Oncology, MAY 17, 2022, https://ir.gritstonebio.com/news-releases/news-release-details/gritstone-participate-hc-wainwright-global-investment-conference [SID1234614781]).

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 fireside chat will be available on-demand beginning Tuesday, May 24 at 7 a.m. ET via the Investors & Media section of Gritstone’s website at View Source An archived replay will be accessible for 30 days following the event.