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.

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.