BiomX to Host First Quarter 2021 Financial Results Conference Call and Webcast on May 24, 2021

On May 18, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and a live audio webcast on Monday, May 24, 2021, at 8:00 a.m. EDT, to report first quarter 2021 financial results and provide business updates (Press release, BiomX, MAY 18, 2021, View Source [SID1234580218]). To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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Merck KGaA, Darmstadt, Germany, Announces Changes in Operating Model for Healthcare Business Sector

On May 18, 2021 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported changes in its operating model for the Healthcare business sector (Press release, Merck KGaA, MAY 18, 2021, View Source [SID1234580217]). Chris Round will become President of EMD Serono leading the North America Healthcare business; Andrew Paterson will assume the position of Chief Marketing Officer; and recruitment is ongoing for the position of Head of China & International.

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"Our redesigned Healthcare organization creates dedicated leadership for our strategic priorities with a focus on growth," said Peter Guenter, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. "Our clear intent is to bring meaningful value to more patients with our current and future portfolio."

Given the priority of North America as a driver of future growth for the Healthcare business sector of Merck KGaA, Darmstadt, Germany, dedicated leadership in this key market is essential. To this end, Chris Round will assume the role of President of EMD Serono, leading the US and Canada Healthcare business. Round has been with the organization since 2017, previously serving as Head of International and Core Franchises, and Head of EMEA. Round brings 25 years of global pharmaceutical experience to this position, including 20 years at Merck & Co., Inc. He will be based in Rockland, Massachusetts, USA.

The ongoing launches of BAVENCIO (avelumab), MAVENCLAD (cladribine) tablets and TEPMETKO (tepotinib) are critical elements of the business sector’s growth strategy. Global launch excellence for existing and future therapies will be led by Andrew Paterson, who will assume the role of Chief Marketing Officer for Healthcare. Paterson will lead the Speciality Franchises of Merck KGaA, Darmstadt, Germany, including Oncology, Neurology & Immunology and Fertility. In addition, Paterson will lead Global Market Access & Pricing and Global Strategic Insights. Paterson brings nearly 30 years of leadership experience in the biopharmaceutical industry to this appointment. He previously led both North America and the Global Innovative Medicine Franchises. Paterson will also be based in Rockland.

The executive role, Head of China & International, will lead China and Japan as well as the regions Europe, Latin America, Asia-Pacific, Middle East, Africa and Russia, and the franchise of Cardiovascular Metabolism & Endocrinology (CM&E). Recruitment for this position is ongoing.

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Iktos Announces Collaboration with Kadmon to Use AI for New Drug Design

On May 18, 2021 Iktos, a company specializing in Artificial Intelligence for new drug design, reported that it has entered into a Research Collaboration Agreement with Kadmon, a clinical-stage biopharmaceutical company based in New York, USA, pursuant to which, Iktos’s generative modelling artificial intelligence (AI) technology will be used to enable the rapid and cost-effective design of novel drug candidates for an undisclosed Kadmon drug discovery program (Press release, Kadmon, MAY 18, 2021, View Source [SID1234580216]). Under the agreement, Iktos will use its de novo structure-based generative modelling technology to identify novel compounds that match a pre-defined target product profile, with the aim of expediting Kadmon’s early phase discovery efforts.

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Kadmon discovers, develops and delivers small molecules and biologics to treat human diseases. Kadmon is expanding and integrating novel drug discovery platforms, with the aim of identifying and developing new product candidates for significant unmet medical needs. "Our collaboration with Iktos provides an exciting opportunity for Kadmon to combine Iktos’ innovative artificial intelligence (AI)-driven technology with Kadmon’s expertise in medicinal chemistry and structure-based drug design (SBDD) to accelerate novel target validation and to facilitate drug discovery", said Jean (Ji-In) Kim, Senior Vice President, Head of Chemistry at Kadmon.

Iktos’ AI technology, based on deep generative models, helps bring speed and efficiency to the drug discovery process. Iktos’ technology automatically designs virtual novel molecules that have all of the characteristics of a successful drug molecule. This approach, now validated through Iktos’ other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules which simultaneously satisfy multiple critical drug criteria, such as potency, selectivity, safety, and project-specific properties. In early-stage discovery projects, Iktos’ technology allows the design of novel hits with optimal protein-ligand interactions, as predicted by molecular modelling technology. This approach enables the exploration of chemical space in a unique way and produces innovative molecule designs with greater Freedom to Operate. Furthermore, it drastically shortens the hit finding and hit-to-lead optimization phases by enabling multi-parametric in silico optimization from the start of a project.

"We are thrilled that Kadmon is engaging with Iktos to try expedite the discovery of a drug candidate on a promising target," commented Yann Gaston-Mathé, President and CEO of Iktos. "We are proud to have earned the trust of our collaborators and are confident that Iktos’ software will improve Kadmon’s medicinal chemists’ ability to identify promising novel chemical matter and solve complex multi parametric optimization problems. The feedback from Kadmon’s research team will be highly valuable as we work to improve our product offering. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

Mustang Bio and City of Hope Announce First Patient Dosed in Phase 1 Clinical Trial of MB-101 (IL13Rα2-specific CAR T cells) to Treat Leptomeningeal Brain Tumors

On May 18, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, and City of Hope, a world-renowned independent cancer research and treatment center, reported that the first patient has been dosed in a clinical trial to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-CAR T cells) to patients with leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma) (Press release, Mustang Bio, MAY 18, 2021, View Source [SID1234580215]). The trial will enroll up to 30 patients and is taking place at City of Hope, where this chimeric antigen receptor T ("CAR T") cell therapy was initially developed. Even though it is a single center clinical trial, Mustang and City of Hope will facilitate patient transfers from other centers, as needed.

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All subjects enrolled in the Phase 1 single-center, two-arm clinical trial will undergo surgery for the placement of an intraventricular (ICV) Rickham catheter for CAR T cell delivery. The Phase 1 trial will determine the safety and feasibility of administering MB-101 through the ICV Rickham catheter over four weekly cycles in patients with glioblastoma (Arm 1) and ependymoma or medulloblastoma (Arm 2). The primary endpoints that will be evaluated are toxicity and survival at three months. Secondary endpoints include overall survival, CAR T and endogenous T cell levels, cytokine levels and phenotype detection in peripheral blood, tumor cyst fluid and cerebrospinal fluid.

Lisa Feldman, M.D., Ph.D., a neurosurgeon and assistant clinical professor in the Division of Neurosurgery at City of Hope and principal investigator of the clinical trial, commented, "Based on our research to date, including a previous clinical trial at City of Hope, further evaluation is warranted for this CAR T cell therapy. The prior clinical trial demonstrated encouraging potential of administering autologous IL13Rα2-CAR T cells intraventricularly to help treat patients with leptomeningeal brain tumors, a form of metastatic brain cancer that is difficult to treat. We continue to work closely with the Mustang team to potentially bring a safe, effective treatment option to patients suffering with this life-threatening disease."

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The successful dosing of the first patient in this clinical trial of MB-101 is an important milestone in Mustang’s development program. We are pleased to support City of Hope to further study MB-101 in leptomeningeal brain tumors to potentially bring hope to patients suffering from this devastating and fatal disease. MB-101 has already demonstrated therapeutic potential when infused into the ventricular system, including delivering a complete response in a patient with leptomeningeal glioblastoma that was published in the New England Journal of Medicine. We aim to generate additional data that supports the advancement of this program."

Additional information about the trial can be found on clinicaltrials.gov using the identifier NCT04661384.

About MB‐101 (IL13Rα2‐specific CAR T cells)
IL13Rα2 is an attractive target for CAR T therapy as it has limited expression in normal tissue but is overexpressed on the surface of the majority of malignant glioma cells, including glioblastoma multiforme, ependymoma and medulloblastoma. CAR T cells are designed to express a membrane‐tethered IL‐13 receptor ligand (IL‐13) incorporating a single‐point mutation that provides high affinity for IL13Rα2 and reduces binding to IL13Rα1 in order to reduce healthy tissue targeting. Mustang is developing MB‐101 as an optimized CAR T product incorporating enhancements in CAR design and T cell engineering to improve antitumor potency and T cell persistence. MB‐101 includes a second‐generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off‐target Fc interactions, the 4-1BB (CD137) co‐stimulatory signaling domain for improved persistence of CAR T cells and the extracellular domain of CD19 as a selection/safety marker. To further improve persistence, central memory T cells are enriched and genetically engineered using a manufacturing process that limits ex vivo expansion to reduce T cell exhaustion and maintain a memory T cell phenotype.

Veracyte to Present at Upcoming Investor Conferences

On May 18, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie H. Anderson, chairman, chief executive officer and incoming executive chairman, and Marc Stapley, incoming chief executive officer, are scheduled to participate in two upcoming virtual investor conferences (Press release, Veracyte, MAY 18, 2021, View Source [SID1234580213]):

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UBS Global Healthcare Virtual Conference
Fireside Chat on Tuesday, May 25, 2021, at 10:00 a.m. EDT
7th Annual Truist Securities 2021 Life Sciences Summit
Fireside Chat on Thursday, May 27, 2021, at 12:30 p.m. EDT
Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.