On October 11, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Mari Scheiffele as EVP and President, Specialty Care International, effective November 1st 2021 (Press release, Ipsen, OCT 11, 2021, View Source [SID1234591038]). Based in Boulogne, France, she will be reporting directly to David Loew, CEO, Ipsen, and serve on the Executive Leadership Team.

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"Along with the ELT, we are very pleased to welcome Mari to Ipsen. Her diverse experience will be critical in developing our three key therapeutic areas, Oncology, Rare Disease and Neuroscience, by continuing to strengthen Ipsen’s international commercial presence in over 115 countries, excluding North America. Mari also brings valuable capabilities in transformation which she built over the course of her previous roles at Novartis and McKinsey. We are looking forward to working closely with her," said David Loew, CEO, Ipsen.

Mari brings 20 years of healthcare leadership experience, from across the industry, having worked in the US, Europe and in Japan. She joins Ipsen from Novartis where she has been in both global strategic and country operational roles, first in Japan and then in the UK. Most recently, Mari has been General Manager, Novartis Oncology UK & Ireland where with a focus on patient-centricity, evidence-based medicine, and partnership, she has driven a successful business transformation.

In addition to her depth in Oncology, Mari has worked in other specialty care environments such as ophthalmology, neuroscience and immunology. Prior to Novartis, Mari was a partner at McKinsey & Company in New York and in Switzerland in Pharmaceuticals and Medical Products.

"I’m delighted to be joining Ipsen at such an exciting time," said Mari Scheiffele. "Ipsen has an inspiring strategy, strong growth and a fantastic culture of collaboration, and excellence. I look forward to working with my new colleagues on Ipsen’s International team, across its broad reach of markets, to bring Ipsen’s transformative innovations to patients around the World."

Mari speaks English, Finnish and Japanese and holds a doctorate in neuroscience from Harvard Medical School.

On October 11, 2021 Redx Pharma (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported it is hosting a Virtual R&D Day later today between 1:00pm-2:30pm BST (8:00am-9:30am EDT) (Press release, Redx Pharma, OCT 11, 2021, View Source [SID1234591060]).

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The R&D Day will feature updates from the Company’s leadership team and presentations from leading experts in the fields of colorectal cancer and fibrosis. Focus will be on Redx’s wholly owned lead product RXC004, a selective Porcupine inhibitor. Redx plans to commence a global Phase 2 monotherapy programme with RXC004 in three cancer types with Wnt-ligand dependent tumours: microsatellite stable metastatic colorectal cancer, pancreatic cancer and biliary tract cancer. RXC004 is also currently being investigated in a Phase 1 study in combination with the anti-PD-1antibody nivolumab.

There will also be an update on the wholly owned selective ROCK2 inhibitor RXC007, being developed for idiopathic pulmonary fibrosis. Encouraging new clinical data from the ongoing RXC007 Phase 1 study* in healthy volunteers shows:
• An excellent safety and pharmacokinetic profile
• No adverse events following single dose of 2-40 milligram
• Pharmacokinetics as predicted from preclinical data
• Essentially linear exposure for 2-40 milligram
• Biologically relevant exposures achieved at higher doses
• At 40 milligram the half-life was approximately 11 hours, suitable for once-daily dosing

The R&D event includes presentations from leading experts:
• Professor Scott Kopetz, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
• Professor Gisli Jenkins, Faculty of Medicine, National Heart & Lung Institute, Imperial College London
• Professor Toby Maher, Professor of Medicine and Director of Interstitial Lung Disease, Keck School of Medicine, University of Southern California, Los Angeles

To register and receive a link to view the webcast, please email [email protected]. A recording of the webcast will be available on Redx’s website www.redxpharma.com following the event. *Clinicaltrials.gov identifier NCT04931147; data cut-off date 14 September 2021

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.

On October 11, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the clinical trial of ALK-1 antibody (GT90001C) and Nivolumab (Opdivo) combination therapy for the treatment of systemic therapy naïve patients with advanced hepatocellular carcinoma ("HCC") was approved by the National Medical Products Administration (the "NMPA") of China on October 9, 2021 (Press release, Suzhou Kintor Pharmaceuticals, OCT 11, 2021, View Source [SID1234591040]).

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ALK-1 antibody is a fully human IgG2 neutralizing monoclonal antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis. Kintor Pharma obtained an exclusive global license for all oncological applications for ALK-1 antibody from Pfizer, Inc., in February 2018.

The phase II clinical trial of the combination therapy of ALK-1 antibody and Nivolumab on patients with advanced HCC has started on May 7, 2019 in Taiwan, China ("Taiwan phase II clinical trial"), evaluated the efficacy and safety of ALK-1 antibody in combination with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first-line therapy with Sorafenib or Lenvatinib. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO (Free ASCO Whitepaper) GI 2021 (held between January 15 – 17, 2021), and showed positive efficacy and safety results. The overall response rate ("ORR") was 40%.

On 11 February 2021, the investigational new drug application of multiregional phase II clinical trial of combination therapy of ALK-1 antibody and Nivolumab for the second-line treatment of advanced HCC was greenlighted by the United States Food and Drug Administration.

Dr. Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, commented, "Liver cancer has been ranked no. 4 in terms of incident rate and no. 2 in terms of mortality rate in China, and HCC accounts for 75-85% of liver cancer. ALK-1 antibody was in-licensed from Pfizer, which has made Kintor the leader in the clinical development of this anti-cancer angiogenesis inhibitor with the first-in-class potential globally. ALK-1 antibody, in combination with Nivolumab, has demonstrated very positive results in the clinical trial of treating HCC patients who failed sorafenib or Lenvatinib. Currently we are in co-development with Alphamab to test ALK-1’s combo therapy with KN046 bispecific for treating a bunch of solid tumors including HCC. NMPA’s formal approval of ALK-1 antibody in combination with Nivolumab as the first-line treatment of HCC, which provides a great opportunity for this combo therapy as a potential standard of care for HCC. If successful, the market prospect and commercial value are very promising."

On October 11, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported the addition of two CNS-penetrant Bruton’s tyrosine kinase (BTK) inhibitors to its product candidate pipeline (Press release, Gossamer Bio, OCT 11, 2021, View Source [SID1234591061]).

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Gossamer plans to initiate first-in-human studies of the first of these candidates, GB5121, in the fourth quarter of 2021. Gossamer intends to develop GB5121 in CNS-oncology indications, including relapsed / refractory primary CNS lymphoma (PCNSL), for which a potentially registrational Phase 1b / 2 study is expected to initiate in the first half of 2022.

The second product candidate, GB7208, is currently in IND-enabling studies and is expected to enter the clinic in the second half of 2022. In a BTK-dependent pre-clinical disease model, GB7208 demonstrated superior outcomes vs. tolebrutinib, a BTK inhibitor being studied in a broad Phase 3 program for multiple sclerosis (MS).

"We are thrilled to be able to share our latest product candidates, the CNS-penetrant BTK inhibitors GB5121 and GB7208," said Faheem Hasnain, Chairman, co-founder and CEO of Gossamer Bio. "These two promising product candidates are the result of intensive internal research, and we are excited to advance them into the clinic where there remains a high unmet need in treating malignant brain tumors and neurologic diseases."

"BTK inhibitors have emerged as an important class of treatment, particularly in oncology, but existing molecules have not been optimized for the treatment of central nervous system disorders," said Laura Carter, Ph.D., Chief Scientific Officer of Gossamer Bio. "GB5121 and GB7208 were designed specifically with these disorders in mind, and in pre-clinical models, they have been shown to be potent, highly selective BTK inhibitors, with potentially best-in-class brain penetrance and target occupancy."

GB5121: Oral, CNS-Penetrant, Irreversible BTK Inhibitor for Treatment of PCNSL

Superior CNS penetration in preclinical models compared to other BTK inhibitors in development for oncology
Highly selective for BTK, with no non-TEC kinases inhibited at greater than 50% in a broad kinome scan
First-in-human Phase 1 clinical trial expected to initiate in the fourth quarter of 2021
First-in-patient Phase 1b/2 clinical trial in patients with relapsed / refractory CNS lymphoma expected to initiate in the first half of 2022
Relapsed and refractory PCNSL provides potential accelerated path to registration
GB7208: Oral, CNS-Penetrant, Irreversible BTK Inhibitor for Treatment of MS

Potentially best-in-class brain penetrance among BTK inhibitors being developed for neuroinflammatory and neurodegenerative diseases based on pre-clinical models
In a BTK-dependent pre-clinical disease model, demonstrated superiority vs. tolebrutinib, a CNS-penetrant BTK inhibitor in Phase 3 development for MS
Potent inhibition of microglia inflammation in vitro and in vivo
First-in-human Phase 1 clinical trial expected to initiate in the second half of 2022
Gossamer will host a conference call and webcast today, Monday, October 11, 2021, for investors and analysts at 2:30pm ET to discuss its new product candidates. As part of the event, Gossamer Bio management will be available for questions.

Details below:

Conference Call and Webcast

Gossamer will host a conference call and live audio webcast today, Monday, October 11, 2021, at 2:30 pm ET to discuss its new product candidates. The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company’s website, www.gossamerbio.com.