Intellia Therapeutics Names David Lebwohl, M.D., Chief Medical Officer

On April 30, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA) reported that has named David Lebwohl, M.D., as its new executive vice president and chief medical officer (Press release, Intellia Therapeutics, APR 30, 2020, View Source [SID1234556893]). Dr. Lebwohl brings decades of biopharmaceutial leadership and drug development experience, and joins Intellia to lead its clinical development and regulatory organizations.

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"Dr. Lebwohl joins Intellia during an exciting time for the company, as we continue to rapidly progess our first systemic CRISPR/Cas9-based therapy to the clinic. David’s vast experience in rare diseases, engineered cell therapy and clinical development complement our R&D capabilities and leadership team strength," said Intellia President and Chief Executive Officer John Leonard, M.D. "He has been at the helm of premier development organizations that launched breakthrough oncology therapies to patients, most notably the recent CAR-T therapy, Kymriah, and the multi-indication blockbuster, Afinitor. Under his leadership, we look forward to the impact he can make in delivering Intellia’s CRISPR/Cas9-based treatments to patients."

Dr. Lebwohl’s Professional and Academic Credentials

Dr. Lebwohl’s career spans three decades in the biopharmaceutical industry, successfully bringing novel medicines through all phases of clinical trials and global regulatory approvals. During his career, he has overseen multiple full-scale development programs with more than 200 clinical studies across myriad indications. He joins Intellia from Semma Therapeutics, Inc., where he was chief medical officer and led the company’s regenerative medicine efforts using stem-cell-derived pancreatic islets to cure type I diabetes starting in November 2018. Semma was acquired by Vertex Pharmaceuticals Inc., in October 2019. Prior to his role at Semma, Dr. Lebwohl held numerous senior-level drug development leadership positions at the global healthcare company, Novartis Pharmaceuticals Inc. (Novartis), where most recently he was senior vice president and franchise global program head, CAR-T, Promacta and SEG101 Global Program Teams, responsible for the development of the breakthrough therapy Kymriah (tisagenlecleucel), approved for the treatment of B-cell acute lymphoblastic leukemia. Dr. Lebwohl also was responsible for numerous other Novartis oncology drug development programs, and led the company’s Cell and Gene Therapies Unit. Under his leadership, the blockbuster drug, Afinitor (everolimus), was approved for five indications including metastatic breast, kidney, brain and lung cancers. Prior to working at Novartis, Dr. Lebwohl spent five years at Bristol Myers Squibb, Inc., where he worked in the Oncology Clinical Development group at the company’s Pharmaceutical Research Institute. He is a well-recognized medical oncologist, with certifications in hematology and internal medicine.

Dr. Lebwohl received an undergraduate degree in Biochemical Sciences from Harvard College, and an M.D. from the Yale University School of Medicine. He completed his fellowship training at Memorial Sloan Kettering Cancer Center, and his residency in Internal Medicine at Brigham and Women’s Hospital in Boston. He has authored more than 50 peer-reviewed publications.

"I am thrilled to join Intellia’s leadership team as we propel the first systemic CRISPR/Cas9 genome editing treatment to the clinic this year," said Dr. Lebwohl. "I am passionate about working on the next generation of treatments, like genome editing therapies, that are both game-changing for medical practice and can address the unmet needs of patients. I look forward to leading the Development organization and building on the company’s clinical capabilities."

Immutep Announces First INSIGHT-004 Data and New TACTI-002 Data to be
Included in Poster Presentations During the ASCO 2020 Annual Meeting

On April 30, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") reported new data are scheduled to be presented in two poster presentations during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting, a leading global scientific meeting for oncology professionals, taking place from 29 May – 31 May 2020 (Press release, Immutep, APR 30, 2020, View Source [SID1234556892]). This year ASCO (Free ASCO Whitepaper) is being held in a virtual format due to restrictions resulting from the COVID-19 pandemic. Abstracts and poster presentations will be published on the ASCO (Free ASCO Whitepaper) website (click here) at 8 a.m. ET on Friday, May 29, 2020. In addition, Immutep will make the data available on its website following its publication at ASCO (Free ASCO Whitepaper), at www.immutep.com.

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Poster Presentations at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program:

Title: Initial results from a phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab
Date: Available from 8 a.m. ET on Friday, MAY 29, 2020
Presenter: Dr. Enriqueta Felip, investigator
Abstract: 3100
Poster: 164
Title: Open-label, phase I study evaluating feasibility and safety of subcutaneous IMP321 (LAG-3Ig fusion protein, eftilagimod alpha) combined with avelumab in advanced stage solid tumor entities: results from stratum D of the INSIGHT platform trial
Date: Available from 8 a.m. ET on Friday, MAY 29, 2020
Presenter: PD. Dr. Thorsten O. Goetze, investigator
Abstract: 3099
Poster: 163
About TACTI-002

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

About INSIGHT-004

INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (IKF). It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of Immutep’s lead immunotherapy product candidate efti when given in combination with avelumab in 12 patients with advanced solid malignancies.

ERYTECH Granted U.S. FDA Fast Track Designation for eryaspase in Second-Line Pancreatic Cancer

On April 28, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track Designation for the development of a second-line treatment of patients with metastatic pancreatic cancer (Press release, ERYtech Pharma, APR 28, 2020, View Source [SID1234556890]).

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"This is yet another significant milestone and meaningful validation of our technology as we continue our TRYbeCA-1 Phase 3 trial evaluating eryaspase in second-line metastatic pancreatic cancer," said Gil Beyen, CEO of ERYTECH. "We believe that the FDA’s Fast Track designation for eryapase underscores its potential to address this high unmet medical need."

ERYTECH’s lead product candidate, eryaspase, is being evaluated in a Phase 3 trial (TRYbeCA-1) in second-line metastatic pancreatic cancer in 11 countries in Europe and the United States. More than 75% of the approximately 500 patients to be enrolled in the trial have been randomized. An interim superiority analysis, to be conducted by an independent data monitoring committee (IDMC) when two-thirds of the events have occurred, is currently expected to take place around year-end 2020 and the final analysis in the second half of 2021.

In a previous Phase 2b trial, eryaspase demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS) with a Hazard Ratio (HR) of 0.60 and 0.59 respectively. Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.

Fast Track is a program designed to facilitate the expedited development and review of a new drug, alone or in combination with other drugs, to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.

About Pancreatic Cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.

About TRYbeCA-1

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.

About FDA Fast Track Designation

Fast Track is a program designed to facilitate the expedited development and review of a new drug alone or in combination with other drugs to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. Fast Track addresses a broad range of serious conditions. A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings and interactions with the review team at the FDA to discuss the drug’s development and ensure collection of appropriate data needed to support drug approval as well as to discuss accelerated approval, the structure and content of an NDA, and other critical issues.

More frequent written communications from FDA about such things as the design of the proposed clinical trials and use of biomarkers.

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the marketing application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

Lilly to Participate in Bank of America Securities Health Care Conference

On April 23, 2020 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Bank of America Securities 2020 Health Care Conference on Wednesday, May 13, 2020. Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines, will participate in a virtual fireside chat at 10:20 a.m. EDT (Press release, Eli Lilly, APR 30, 2020, View Source [SID1234556889]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay will be available for approximately 90 days.

BIOLASE, Inc to Report First Quarter 2020 Results on May 7, 2020

On April 30, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported that it will release first quarter 2020 financial and operating results on Thursday, May 7, 2020 after the close of the U.S. financial markets and will host a conference call and webcast that day at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results and corporate developments (Press release, Biolase Technology, APR 30, 2020, View Source [SID1234556884]).

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-353-6461. For international participants outside the U.S./Canada, the dial-in number is 334-323-0501. For all callers, refer to the Conference ID 6799229. To access the live webcast, go to BIOLASE Investor Events Page.