On September 2, 2020 Orca Bio and Lyell Immunopharma reported a research partnership to jointly identify next generation T cell therapies that will combine precision purification T cell technologies from Orca Bio with the scientific expertise in T cell biology from Lyell to generate potentially synergistic therapeutic solutions for solid tumors (Press release, ORCA Biosystems, SEP 2, 2020, View Source [SID1234564311]).

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Lyell Immunopharma has brought together an unrivaled scientific team focused on advancing the science of therapeutic T cells, including the role of T cell differentiation. Orca Bio has developed T cell therapies for patients with blood diseases while also streamlining the commercial manufacture of high-precision cell therapies using OrcaSort, an ultra-fast, clinically compatible cell sorter.

The ability to produce optimal starting cell populations is one of many continuing challenges in the development of curative T cell therapies. Evidence from current generation cell therapies suggest that the proportion of cell types and their stages of differentiation may impact the safety and efficacy of T cell therapies. Together, the companies aim to mitigate this challenge by utilizing their proprietary technologies to effectively treat solid tumor cancers.

"Lyell Immunopharma is focused on developing curative T cell therapies for solid tumor cancers by defining starting cell preparations and modulating T cells, so they are functional in the immunosuppressive tumor microenvironment," said Nick Restifo, M.D., Executive Vice President of Research for Lyell Immunopharma. "This collaboration with Orca Bio provides the potential to more efficiently define starting cell preparations, which I believe could lead to more effective T cell therapies."

"Orca Bio has developed extremely pure doses of stem and immune cells that can be precisely formulated to treat cancers," said Ivan Dimov, PhD, co-founder and CEO of Orca Bio. "By combining our scientific expertise with that of Lyell Immunopharma, and by applying our specialized manufacturing platform, we aim to create the scalable production of adoptive T cell therapies that can reach patients with unprecedented speed."

Lyell Immunopharma and Orca Bio will each continue to pursue programs independently and through their other partnerships.

On September 2, 2020 Incyte (Nasdaq: INCY) reported that data from the Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that treatment with Tabrecta (capmatinib) resulted in positive overall response rates (ORR) with durable responses among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to skipping of MET exon 14 (METex14) have been published in The New England Journal of Medicine (Press release, Incyte, SEP 2, 2020, View Source [SID1234564310]).1

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MET, a receptor tyrosine kinase coded by the MET gene, normally plays an important role in cell signaling, proliferation and survival.2 Many cancers are associated with abnormal signaling through the MET receptor pathway, caused by multiple mechanisms including point mutations, insertions/deletions that lead to skipping of exon 14.2 Results from the GEOMETRY mono-1 study describe METex14 as an important biomarker for physicians to consider when selecting metastatic NSCLC treatment options; and emphasize the importance of broad molecular testing for NSCLC patients.

"The GEOMETRY mono-1 study results published in The New England Journal of Medicine further highlight the clinical benefit that Tabrecta can provide to patients with metastatic METex14 NSCLC," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Having a therapy that targets a recognized oncogenic driver offers a much-needed treatment option for patients living with this aggressive form of lung cancer and we are proud that the world-class discovery program at Incyte contributed to the fulfillment of this unmet medical need."

Published data from the GEOMETRY mono-1 study demonstrate that in the METex14 population (n=97), the ORR as confirmed by the Blinded Independent Radiology Committee (BIRC) was 68% (95% CI, 48-84) among treatment-naïve patients (n=28) and 41% (95% CI, 29-53) among previously treated patients (n=69).1 In patients with METex14 who responded to treatment with Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.6-not estimable) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.6-13.0) in previously treated patients (28 responders).1

Thirteen of 14 patients with METex14 had brain metastases at baseline (3 treatment-naïve and 10 previously treated patients) and were considered evaluable by the BIRC.1 In a post-hoc analysis, 7 intracranial responses were observed, including 4 complete responses.1

The most common treatment-related adverse events (incidence ≥20%) were peripheral edema (43%), nausea (34%), increased blood creatinine (18%) and vomiting (19%). The majority of AEs were grades 1 or 2.1

NSCLC accounts for approximately 85% of lung cancer diagnoses.3 METex14 occurs in 3-4% of newly-diagnosed metastatic NSCLC cases4 and is a recognized oncogenic driver.2,5 Tabrecta is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation the leads to METex14.

Novartis has exclusive worldwide development and commercialization rights to Tabrecta. Incyte is eligible for a total of over $500 million in milestones as well as royalties of between 12-14% on global net sales by Novartis.

Full prescribing information for Tabrecta can be found at: View Source

About Tabrecta

Tabrecta (capmatinib) is a kinase inhibitor that targets MET discovered by Incyte and licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. Incyte is eligible for a total of over $500 million in milestones as well as royalties of between 12-14% on global net sales by Novartis.

On September 2, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that Jacob Chacko, M.D., chief executive officer, will participate in the following investor conferences in September (Press release, ORIC Pharmaceuticals, SEP 2, 2020, View Source [SID1234564308]):

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Citi’s 15th Annual BioPharma Virtual Conference – Participating in "Precision Targeted Drugs in Oncology" panel discussion on September 9, 2020, at 11:40 a.m. ET
H.C. Wainwright 22nd Annual Global Investment Conference – Presenting company overview on September 15, 2020, at 10:00 a.m. ET
2020 Cantor Virtual Global Healthcare Conference – Hosting virtual investor meetings on September 17, 2020
Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit – Participating in a virtual fireside chat on September 22, 2020, at 11:40 a.m. ET
Webcasts of the Citi, H.C. Wainwright and Oppenheimer presentations will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the events.

On September 2, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will present an overview and update, as well as host investor meetings, at the Wells Fargo 2020 Virtual Healthcare Conference on Wednesday, September 9, 2020 at 9:20 a.m. ET (Press release, Supernus, SEP 2, 2020, View Source [SID1234564306]).

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Investors interested in arranging a virtual meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company’s website after the conference.

On September 2, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported it will participate in three investor conferences in September 2020, including presenting at the H.C. Wainwright 22nd Annual Global Investment Conference being held virtually on September 14-16, 2020 (Press release, Aeglea BioTherapeutics, SEP 2, 2020, View Source [SID1234564303]).

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Conference Presentation Details

Conference: H.C. Wainwright Global Investment Conference
Date: September 14, 2020
Time: 11:00 a.m. EDT
Presenter: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer
Location: View Source

To access the live and archived webcast, visit the Presentations & Events section of the Company’s website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary. Replays of the webcast will be available for 30 days thereafter.

Conference Participation Details

Conference: Wells Fargo 15th Annual Healthcare Conference
Date: September 9-10, 2020
Participants: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer and Charles N. York II, M.B.A., Aeglea’s chief financial officer

Conference: Cantor Global Healthcare Conference
Date: September 15-17, 2020
Participants: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer and Charles N. York II, M.B.A., Aeglea’s chief financial officer