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.