On September 29, 2020 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported that it has signed a license agreement with the National Cancer Institute (NCI) for the commercialization of mesothelin-targeting agents (Press release, Navrogen, SEP 29, 2020, View Source [SID1234567727]).

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Mesothelin is a cell surface protein that is over-expressed on a number of cancer types. Previous studies have found that certain therapeutic antibodies, which use humoral immune function for target cell killing, as well as antibody-drug conjugates (ADC) targeting mesothelin are negatively affected by factors produced in the tumor microenvironment. Navrogen has employed its proprietary Humoral Immuno Oncology (HIO) technology to screen for anti-mesothelin antibodies that are refractory to tumor-produced, immuno-suppressive factors from multiple sources and identified an anti-mesothelin antibody from the NCI collection. Navrogen has reformatted the antibody using next gen technologies and is advancing it into preclinical studies against a wide range of mesothelin-expressing cancers.

"We are pleased to obtain this commercial license from the NCI" said Dr. Nicholas Nicolaides, PhD, President and Chief Executive Officer of Navrogen. "Our team’s experience with this target will enable us to make key development decisions to maximize the opportunity for clinical success and offer patients with mesothelin-expressing cancers new therapeutic options."

Dr. Luigi Grasso, Chief Scientific Officer of Navrogen added, "We were delighted to identify an anti-mesothelin antibody that can naturally avoid the humoral immuno-suppressive effects caused by certain tumor-produced proteins. Our work with this antibody has shown positive activity across some of the more aggressive preclinical models tested. We look forward to expanding upon these preliminary findings and sharing our results with the oncology community in the near future."

On September 29, 2020 Immunomic Therapeutics, Inc. reported that it will participate in a panel at the MD Life Sciences Bio Innovation virtual conference in Maryland (Press release, Immunomic Therapeutics, SEP 29, 2020, View Source [SID1234567725]). On Monday, October 5, Chief Executive Officer at Immunomic, Dr. Bill Hearl, will participate in a panel titled, "Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency" alongside Novavax’s President and CEO, Stanley Erck, and Emmes’ President, Anne Lindblad.

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The Bio Innovation Conference is presented by Maryland Life Sciences, a division of the Maryland Tech Council that is driving the future of life sciences in Maryland. This conference provides a forum for professionals from industry, academia and government to discuss trends and insight into Maryland’s burgeoning life sciences industry and topics related to funding, structuring, commercialization and government relations.

Panel details are as follows:

Title: Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency

Panel Category: Life Science Track

Moderators:
Linda Segal, Principal, The McCormick Group
Gayatri Varma, Director, Transactions, Business Development & Licensing, AstraZeneca

Speakers:
Stanley Erck, President and CEO, Novavax
Bill Hearl, Ph.D., CEO, Immunomic Therapeutics
Anne Lindblad, Ph.D., President, Emmes

Panel Date and Time: Monday, October 5, 2020 10:25 AM

Location: MD Life Science Bio Innovation Virtual Event

On September 29, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate virtually in the following investor conferences in October (Press release, CRISPR Therapeutics, SEP 29, 2020, View Source [SID1234567724]):

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Jefferies Virtual Gene Therapy/Editing Summit
Date: Thursday, October 1, 2020
Time: 1:00 p.m. ET

Chardan Virtual 4th Annual Genetic Medicines Conference
Date: Tuesday, October 6, 2020
Time: 10:30 a.m. ET

A live webcast of these events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On September 29, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting (Press release, Infinity Pharmaceuticals, SEP 29, 2020, View Source [SID1234567723]). Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in TNBC. Earlier this year Infinity also received Fast Track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the company’s global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.

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"Fast Track designation is an exciting regulatory milestone that bolsters our momentum in TNBC," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "TNBC remains the deadliest form of breast cancer, and there is tremendous need to expedite the development of new treatments that have the potential to improve outcomes in these patients. We believe that adding eganelisib on top of standard of care in a novel triple combination front-line regimen with Tecentriq and Abraxane has the potential to provide meaningful benefits to patients and are particularly encouraged by the early signals of clinical activity we have seen in MARIO-3 to date. We look forward to presenting these important data later this year."

Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions while fulfilling an unmet medical need, enabling drugs to reach patients more rapidly. A drug or treatment regimen that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA on matters pertaining to the drug’s clinical development plan as well as eligibility for accelerated approval and priority review.

MARIO-3 is a Phase 2 study in collaboration with Roche/Genentech to evaluate the addition of eganelisib to standard of care treatment with Tecentriq and Abraxane in a novel triple combination front-line regimen in patients with locally advanced and/or metastatic TNBC. The study is designed to enroll approximately 60 patients across two cohorts, approximately 30 patients with programmed death-ligand 1 (PDL1) positive disease based on immunohistochemistry (IHC) and 30 patients with PDL1 negative disease based on IHC. The primary objective of the study is Complete Response (CR) rate as measured by RECIST v1.1 with assessments conducted through month 12. Secondary measures include objective response rate (ORR), time to complete remission (TTCR), time to response (TTR), duration of Complete Response (DOCR), duration of response (DOR), and progression-free survival (PFS).

On September 29, 2020 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the Company has entered into a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, through a subsidiary (Press release, Celyad, SEP 29, 2020, View Source [SID1234567722]).

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Celyad Oncology will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy, with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease.

"We are extremely pleased to enter into this clinical collaboration with MSD, as we believe the mechanism of actions of CYAD-101 and KEYTRUDA are highly complementary and could help to drive meaningful clinical benefit in patients with advanced metastatic colorectal cancer, in particular with microsatellite stable disease where a high unmet medical need exists" said Filippo Petti, Chief Executive Officer of Celyad Oncology. "In addition, the collaboration with MSD adds an important dimension to our clinical program for CYAD-101 for the treatment of mCRC and provides us with the opportunity to build upon the encouraging clinical activity we’ve reported to date from the ongoing alloSHRINK trial."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CYAD-101

CYAD-101 is an investigational, non-gene edited, allogeneic (healthy donor derived) CAR T candidate engineered to co-express a chimeric antigen receptor based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands and the novel inhibitory peptide TIM (TCR Inhibitory Molecule). The expression of TIM reduces signaling of the TCR complex, which is responsible for graft-versus host disease.