M2GEN & ORIEN at ASH 2022 Highlighting Discoveries Using Avatar Data

On December 5, 2022 M2GEN, an oncology-focused health informatics solutions company, reported that its participation as a presenter, exhibitor, and research partner at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition December 10th through 13th, 2022 in New Orleans, Louisiana (Press release, M2Gen, DEC 5, 2022, View Source [SID1234624789]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Five poster presentations will be presented at ASH (Free ASH Whitepaper) utilizing the rich longitudinal clinicogenomic data from M2GEN’s Oncology Research Information Exchange Network (ORIEN) Avatar program, and showcase the collaboration of scientists across ORIEN, M2GEN, and other leading cancer centers across the nation. These projects highlight research discoveries in multiple myeloma and mantle cell lymphoma. Partnering with our 18 ORIEN members, M2GEN enables breakthrough scientific research to advance patient care.

We look forward to meeting with colleagues, researchers, partners, and future clients individually and at our booth #3628 during the conference. To inquire about partnering with M2GEN and the Oncology Research Information Exchange Network (ORIEN), or to learn more about how our rich longitudinal clinicogenomic ORIEN Avatar dataset could support your research efforts, contact [email protected].
Learn more about how ORIEN investigators are collaborating with fellow Network members and M2GEN to leverage the expansive clinical and molecular Avatar database, for the research being featured at ASH (Free ASH Whitepaper) 2022. The schedule of M2GEN supported poster presentations at ASH (Free ASH Whitepaper) 2022 includes:

Saturday, December 10

Lymphoid Oncogenesis poster session
Rafael Renatino-Canevarolo, PhD, of H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "Multiple Myeloma Evolution Is Characterized By Dynamic Epigenetic Landscapes" (Abstract: 1306, Full Text).

Multiple Myeloma and Plasma Cell Dyscrasias poster session
Praneeth Reddy Sudalagunta, PhD, of H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "A Multiomic Approach to Reversing Therapy Resistance in Multiple Myeloma Using Paired Ex Vivo Drug Sensitivity Measures and RNA Sequencing Data" (Abstract: 1848, Full Text).

Sunday, December 11

Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms poster session
Ryan T Bishop, PhD, of the H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "Acid Ceramidase (ASAH1) Is a Key Mediator of Drug Resistance in Refractory Multiple Myeloma" (Abstract: 2661, Full Text).

Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological poster session
David A. Bond, MD, BS, of Ohio State University will present a poster entitled "Favorable Overall Survival Following First and Second Relapse of MCL with Availability of Novel Therapies: Results from the Lion Prospective Observational Registry" (Abstract: 2897, Full Text).

The abstract presented by Dr. Bond will feature research completed by seven ORIEN institutions working together to study relapse/refractory Non-Hodgkin’s lymphoma. This group is also a recipient of a Novel Oncologic Visionary Award (NOVA) from the ORIEN Foundation.

Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Prognostic Markers in Multiple Myeloma oral program
Francesco Maura, MD, of Sylvester Comprehensive Cancer Center at University of Miami will present an oral presentation entitled "Individualized Treatment-Adjusted Risk Stratification in Newly Diagnosed Multiple Myeloma" (Abstract: 646, Full Text).

Completion of Acquisition or Disposition of Assets

On December 5, 2022 Jazz Pharmaceuticals Ireland Limited ("Jazz"), a subsidiary of Jazz Pharmaceuticals plc (the "Company"), and Zymeworks BC Inc. ("Zymeworks"), a subsidiary of Zymeworks Inc., reported it has entered into a License and Collaboration Agreement (the "License and Collaboration Agreement") granting Jazz the exclusive rights to develop and commercialize zanidatamab, a HER2-targeted bispecific antibody with novel mechanisms of action, in the United States, Europe, Japan and other territories except for those Asia/Pacific territories that Zymeworks previously licensed to BeiGene, Ltd. (the territories subject to the License and Collaboration Agreement are referred to as the "Territory") (Filing, 8-K, Jazz Pharmaceuticals, DEC 5, 2022, View Source [SID1234624787]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The effectiveness of the License and Collaboration Agreement was subject to customary closing conditions, including all relevant antitrust clearances and the expiration or termination of all applicable waiting periods under any antitrust laws. On November 29, 2022 (the "Effective Date"), the Agreement became effective following expiration of the waiting period under the United States Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended.

Under the terms of the License and Collaboration Agreement, Jazz was granted an exclusive, royalty-bearing license, with the right to grant sublicenses, under certain of Zymeworks’s intellectual property, to research, develop, manufacture, and commercialize in the Territory pharmaceutical products containing or incorporating zanidatamab or certain related antibodies (such antibodies, collectively, "Licensed Antibodies" such pharmaceutical products, "Licensed Products"). Licensed Antibodies and Licensed Products expressly exclude all antibody-drug conjugates, including Zymeworks’s proprietary antibody-drug conjugate, zanidatamab zovodotin (also known as ZW49). Zymeworks also granted to Jazz a non-exclusive license, with the right to grant sublicenses, under certain of Zymeworks’s intellectual property, to research, preclinically develop and manufacture Licensed Products outside the Territory for the sole purpose of furthering the development and commercialization of Licensed Products in the Territory.

Pursuant to the License and Collaboration Agreement, Jazz will pay Zymeworks an upfront, non-refundable cash payment of $50.0 million. In addition, should Jazz decide to retain its licenses and other rights under the License and Collaboration Agreement following the delivery to Jazz of top-line data from Zymeworks’ ongoing study of zanidatamab in subjects with advanced or metastatic HER2-amplified biliary tract cancers (HERIZON-BTC-01), then it will be required to make a second, one-time payment of $325.0 million to Zymeworks. Jazz also agreed to pay to Zymeworks potential regulatory milestone payments of up to an aggregate of $525.0 million, and potential commercial milestone payments of up to an aggregate of $862.5 million. Pending approval, Zymeworks is eligible to receive tiered royalties between 10% and 20% on annual net sales of Licensed Products in the Territory.

The foregoing description of the terms of the License and Collaboration Agreement is not complete and is qualified in its entirety by reference to the full text of the License and Collaboration Agreement, a copy of which is filed as Exhibit 2.1 hereto and is incorporated herein by reference.

iBio® to Showcase the RubrYc® Discovery Engine During Poster Presentations at Antibody Engineering & Therapeutics Conference 2022

On December 5, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that it will present two posters at the Antibody Engineering & Therapeutics Conference 2022 [AE&T] in San Diego, California, December 4-8 (Press release, iBioPharma, DEC 5, 2022, View Source [SID1234624786]). The AE&T Conference features the latest science and research in antibody engineering, design, and selection to drive commercial advances in fields such as immuno-oncology.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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iBio will highlight applications of iBio’s artificial intelligence-powered RubrYc Discovery Engine in the following posters:

"Epitope-Targeted Antibody Discovery with AI-Designed Structural Immunogens," including applications for two challenging targets, a PD-1 Agonist and the EGFRvIII tumor-specific epitope, presented by Alexander Taguchi, Ph.D., Director of Machine Learning.
"Fully Human & Developable Antibody Optimization Libraries Using Human Sequence-Trained AI and Mammalian Display," demonstrating the identification of a more potent PD-1 Agonist antibody, a CCR8 ADCC Cell Killing Assay, and use of the EGFRvIII tumor-specific epitope to target and kill tumor cells while preserving healthy cells, presented by Matthew Greving, Ph.D., Vice President of Platform Technology and Machine Learning.
The RubrYc Discovery Engine is designed to tackle complex and challenging drug targets with the goal of developing safer and more effective immunotherapies for difficult-to-treat cancers. By combining proprietary epitope steering with an advanced library, the RubrYc Discovery Engine consistently delivers hits on difficult targets in a fraction of the time of traditional lead optimization.

Hepion Pharmaceuticals, Inc. Granted 180-day Extension by Nasdaq to Meet the Minimum Bid Price Requirements

On December 5, 2022 Hepion Pharmaceuticals, Inc. (Nasdaq:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that is has received written notification from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") granting the Company’s request for a 180-day extension to regain compliance under the Nasdaq Listing Rule 5550(a)(2) (Press release, Hepion Pharmaceuticals, DEC 5, 2022, View Source [SID1234624785]). The Company now has until May 30, 2023, to meet the requirement.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Nasdaq’s extension notice has no immediate effect on the continued listing status of the Company’s common stock on The Nasdaq Capital Market LLC under the trading symbol, "HEPA." If at any time during the additional 180-day extension, the bid price of the Company’s common stock closes at, or above, $1.00 per share for a minimum of ten (10) consecutive business days, the Nasdaq Listing staff will provide the Company with written confirmation of compliance and the matter will be closed.

The Company was first notified by Nasdaq of its failure to maintain a minimum bid price of $1.00 per share under Rule 5550(a)(2) on June 3, 2022, and was given until November 30, 2022, to regain compliance. The Company will continue to monitor its bid price of its common stock.

If the Company does not meet the minimum bid requirement during the additional 180-day extension, Nasdaq will provide written notification to the Company that it’s common stock will be subjected to delisting. At such time, the Company may appeal the delisting determination to the Nasdaq Hearings Panel ("the Panel"). There can be no assurance that if the Company does appeal a subsequent delisting determination, that such appeal would be successful.

BIO Hong Kong 2022

On December 5, 2022 EVERSANA reported that it is a proud sponsor of BIO Hong Kong taking place 14-17 December 2022 at the Hong Kong Convention and Exhibition Centre (Press release, EVERSANA, DEC 5, 2022, View Source [SID1234624784]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A first of its kind in Asia – BIOHK2022 promotes pioneering biotechnologies. Join us in person to meet and gain inspirations from other startup founders, investors and biotech experts in Hong Kong!

Connect with EVERSANA at BIO Hong Kong 2022

With our regional headquarters in Singapore and offices across Asia Pacific and worldwide, EVERSANA provides integrated services and solutions to accelerate clinical and commercial success. We are constantly evolving and adapting to solve the complex challenges our Asia Pacific clients are facing in local and global markets.

Connect with EVERSANA’s experts in-person at BIO Hong Kong.