Mission Therapeutics to Participate in the Solebury Trout Fall Private Company Showcase 2021

On October 11, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that its CEO, Anker Lundemose, will attend and present at the 8th Annual Solebury Trout Private Company Showcase, co-hosted with BMO, on 14 October 2021.

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Dr Lundemose will be available for one-to-one meetings and will discuss the Company’s business strategy, technology, discovery platform and development programmes in a 20-minute video presentation at 4.00pm EDT / 9.00pm BST.

As well as these 20-minute video presentations from attending companies, the event’s agenda includes two topical panels and virtual meetings with company executives.

For individuals interested in attending the meeting, please contact the organisers for further information.

CatalYm Presents Updated Tolerability and Preliminary Pharmacodynamics Data from GDF-15 Targeting First-in-Human Clinical Trial in Plenary Session at AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics

On October 11, 2021 CatalYm, reported an update from the dose escalation part of the ongoing first-in-human trial "GDFather" (GDF-15 Antibody-mediated Effector cell Relocation) investigating its lead product candidate, CTL-002, both in monotherapy and in combination with an immune checkpoint inhibitor, nivolumab. CTL-002 is a neutralizing antibody that specifically targets growth and differentiation factor 15 (GDF-15), which is recognized as a negative regulator of antitumoral T cell activity preventing T cell recruitment to the tumor microenvironment as well as potently suppressing an adaptive immune response by additional mechanisms recently identified (Press release, Catalym, OCT 11, 2021, View Source [SID1234591078]). Patients treated with CTL-002 and nivolumab at the first four of five dose levels to be evaluated showed an excellent tolerability profile and no dose limiting toxicities (DLT). Preliminary sequential tumor biopsy analyses for dose level 1-3 showed signs for a tumor-selective influx of T cell under CTL-002 treatment. GDFather is the most advanced clinical trial of a GDF-15-targeting therapeutic in immuno-oncology. The data was presented in an oral presentation at the plenary session ‘New Drugs on the Horizon II’ at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), on October 9, 2021.

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Prof. Dr. Eugen Leo, Chief Medical Officer at CatalYm commented, "GDF-15 has been recently identified by us and others as a tumor-derived key negative regulator of the immune response against cancer. We are delighted to see the excellent tolerability of CTL-002 in combination with nivolumab and initial evidence for targeted activity from dose level 1 onwards, which is reflected by induction of a tumor-selective influx of T cells. Additional biomarker analyses and relevant data for all cohorts will be available before year-end and we are very keen to take this drug forward into the next stage of clinical development to serve the anti-PD1/PD-L1 refractory patient population, which represents a significant number of patients in many solid tumors."

Dr. Phil L’Huillier, Chief Executive Officer at CatalYm added, "The opportunity to provide this data update at the "New Drugs on the Horizon" plenary session of the ACR-NCI-EORTC conference reflects the scientific innovation and clinical relevance presented by our approach. Although the data is still preliminary at this stage, it corroborates our preclinical data and confirms the proposed mode of action of CTL-002. Our ultimate goal is to provide meaningful clinical benefit to a patient population with very poor prognosis, refractory to checkpoint inhibitors and all other standard of care treatments. We look forward to further evaluating CTL-002 in this heavily pretreated patient population."

The ongoing first-in-human GDFather trial (GDF-15 antibody-mediated effector cell relocation) consists of two parts. In the dose escalation phase (Part A), up to 24 patients will receive escalating doses of CTL-002 in a "3+3" manner with the lead candidate given as a monotherapy and followed by combination with an anti-PD-1 checkpoint inhibitor. In the second dose expansion phase (Part B, phase 2a), several cohorts with tumors identified to be GDF-15-dependent will be treated to further evaluate safety and preliminary efficacy of CTL-002 treatment. Additional biomarker data, safety information and first efficacy readouts from all dose levels tested in dose escalation of CTL-002 both for monotherapy and in combination with nivolumab may be available by year-end.

About CTL-002

CTL-002 is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. CTL-002 counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.

ChemoCentryx Appoints Rita I. Jain, M.D. as Executive Vice President, Chief Medical Officer

On October 11, 2021 ChemoCentryx, Inc., (Nasdaq: CCXI), reported the appointment of Rita I. Jain, M.D., as Executive Vice President, Chief Medical Officer (Press release, ChemoCentryx, OCT 11, 2021, View Source [SID1234591077]). In this role, she will oversee development activities including clinical development, development operations, regulatory affairs, and drug safety and pharmacovigilance. Dr. Jain will continue to serve on the ChemoCentryx board of directors (where she has served since March of 2019) as an executive employee director. Dr. Jain, a board-certified rheumatologist, brings more than 20 years of drug development experience leading multiple global programs across early and late stages of development.

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"Today we bolster our strength as an organization – and across a range of extremely important therapeutic areas – by bringing Rita Jain to the ChemoCentryx leadership team," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We welcome her; we cite her impressive track record in drug development with years of experience in leading highly innovative programs. All of these qualities, combined with her dedication to making a fundamental difference in patients’ lives, are a perfect complement to our ChemoCentryx mission."

"Through my role on ChemoCentryx’s Board of Directors I’ve seen firsthand the value of the science and promise of the company’s pipeline. I’m excited to now join the leadership team and play a larger role in driving these assets forward, particularly at such a transformational time," said Dr. Jain. "I am impressed with the company’s successful execution to date and look forward to supporting its future achievements."

Dr Jain previously served as Chief Medical officer of Immunovant, Inc. and prior to that Senior Vice President and Chief Medical Officer of Akebia Therapeutics, Inc. Before joining Akebia, Dr. Jain was Vice President of Men’s and Women’s Health and Metabolic Development at AbbVie, Inc., and prior to that served in various leadership roles including Divisional Vice President at Abbott Laboratories. Dr. Jain led the design and execution of multiple late-stage programs, including for Orilissa and Oriahnn. She has also led programs across a diverse set of therapeutic areas including inflammation, pain, immunology and nephrology, among others.

Before Abbott, she held management positions in the Arthritis, Inflammation and Pain Group at G.D. Searle (acquired by Pharmacia and subsequently Pfizer). Earlier in her career, Dr. Jain was a faculty member at North Shore University Hospital in New York, with an academic appointment as Assistant Professor of Medicine, New York University School of Medicine.

Dr. Jain received her B.S. in biology from LIU/C.W. Post and her M.D. from the State University of New York at Stony Brook School of Medicine. Dr. Jain completed her medical training in internal medicine at Staten Island University Hospital followed by a Fellowship in Rheumatology at North Shore University Hospital and a Clinical Research Fellowship at the University of Texas Southwestern Medical Center, Dallas.

Horizon Therapeutics plc to Release Third-Quarter 2021 Financial Results and Host Webcast on Nov. 3, 2021

On October 11, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported that its third-quarter 2021 financial results will be released on Wednesday, Nov. 3, 2021 (Press release, Horizon Therapeutics, OCT 11, 2021, View Source [SID1234591075]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

aTyr Pharma to Participate in Piper Sandler Investor Lung Day

On October 11, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will participate in a fireside chat as part of the Piper Sandler Virtual Investor Day: Developing Therapeutics for Lung Indications on Friday, October 15, 2021, at 9:00am ET / 6:00am PT (Press release, aTyr Pharma, OCT 11, 2021, View Source [SID1234591074]).

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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 discussion will be moderated by Ted Tenthoff, Senior Research Analyst at Piper Sandler.

Following the event, a replay of the fireside chat will be available on the Investor’s section of the company’s website at www.atyrpharma.com and will be available for at least 90 days.