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Gossamer Bio Announces Addition of Two CNS-Penetrant BTK Inhibitors to its Product Candidate Pipeline: GB5121 & GB7208

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.

Redx Virtual R&D Day with Leading Experts and New Clinical Data for ROCK2 Inhibitor

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]).

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

Allergan Aesthetics Launches Series of Initiatives to Support Breast Cancer Awareness

On October 11, 2021 Allergan Aesthetics, an AbbVie company (NYSE: ABBV), reported that it is continuing its commitment to breast health, awareness, restoration, and research in support of breast cancer awareness month (Press release, AbbVie, OCT 11, 2021, View Source [SID1234591058]). For the month of October and into 2022, Allergan Aesthetics , The Power of You campaign will kick off a new series of initiatives and partnerships to support organizations creating a measurable impact in the fight against breast cancer.

The Power of You supports women as they navigate breast cancer. The campaign showcases real women and their authentic stories of courage, strength, and community as they embark on their journeys ahead. "Allergan Aesthetics is about empowering confidence in people every day. Through our Breast Cancer Awareness work, we are dedicated to educating women on their choices, and supporting women for what’s ahead," says Carrie Strom, Senior Vice President, AbbVie, and President, Global Allergan Aesthetics.

Starting October, Breast Cancer Awareness Month, and into 2022, Allergan Aesthetics will launch the following initiatives:

GOLDSHEEP: Limited Edition Breast Cancer Awareness Capsule Collection (October) – In partnership with Allergan Aesthetics and Keep A Breast, the athleisure brand, will launch their coveted #ISweatPink capsule collection including co-branded designs. 100% of the net proceeds from the limited-edition collection will be donated to Keep A Breast, an organization dedicated to educating women on Breast Cancer prevention and early detection. To contribute to the cause, Allergan Aesthetics will make an additional sponsorship of $10,000. Link to purchase HERE.
VIRTUAL FUNDRAISER: Bust A Move (October 16th) – Allergan Aesthetics will be partnering with Bust A Move for a series of live classes on the Peloton app that consumers can join throughout the day. The organization’s mission is to increase awareness of the differences in breast cancer in African American, Latina and younger populations. 100% of the money raised will go to four (4) different breast cancer organizations with an additional $50,000 by Allergan Aesthetics. Share, tag and challenge friends on social using #BUSTAMOVE. Link to sign up HERE.
PROJECT RESTORED: Book Launch (November 15th & 16) – Restored, a book by Erez Sabag and David Warren in collaboration with Jonathan Bank, MD and Ron Israeli, MD, illustrates the power of breast reconstruction by following twelve women’s journeys. Sponsored by Allergan Aesthetics, 100% of the profits from the sale of the book will go to the AiRs Foundation. The project will host a two-day exhibit in New York City featuring photographs, video, and the women’s life cast sculptures to launch the book. To learn more please visit, restoredexhibit.com
LADY: The Film (Fall 2022) – Supported by Allergan Aesthetics, the film is based on actress Devin Sidell’s personal story about testing positive for the BRCA1 mutation and her preventative surgeries and breast reconstruction. A dramedy-fantasy, it addresses complicated medical decisions, family relationships, and ultimately, the choice to put yourself first. Link for more information HERE.
Allergan Aesthetics’ year-round mission to support Breast Cancer Awareness also includes the Sisters Network BCAP Program & Stop the Silence Walk, Pink Lemonade Project MBC Educational Webinar (April 2021), LBBC Reach and Raise (May 2021), BCRC Art Bra Austin Virtual Runway Show (June 2021) and continued partnership in the Komen More Than Pink Walks in Orange County, Austin, San Francisco, New Jersey and Chicago.

Kintara Therapeutics to Present at the LD Micro Main Event Conference

On October 11, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer, Saiid Zarrabian, will present a corporate overview at the 14th Annual LD Micro Main Event Conference which is being held at the Luxe Sunset Bel-Air in Los Angeles from October 12 – 14, 2021 (Press release, Kintara Therapeutics, OCT 11, 2021, https://ir.kintara.com/news/detail/976/kintara-therapeutics-to-present-at-the-ld-micro-main-event-conference [SID1234591057]).

Mr. Zarrabian will deliver his corporate presentation on October 12, 2021 at 2:00 p.m. PT / 5:00 p.m. ET.

Mr. Zarrabian will be available for one-on-one meetings throughout the conference.

Ipsen appoints Mari Scheiffele as EVP and President, Specialty Care International

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 [SID1234591056]). Based in Boulogne, France, she will be reporting directly to David Loew, CEO, Ipsen, and serve on the Executive Leadership Team.

"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.

Associated Documents
Ipsen-Appointment-of-Mari-Scheiffele-11-October-2021.pdf