On July 14, 2020 Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, reported it has appointed Christopher Slapak, MD, as Chief Medical Officer (Press release, Vor BioPharma, JUL 14, 2020, View Source [SID1234561856]). Dr. Slapak has more than 20 years of leadership experience in oncology drug development and previously led global clinical development for all early-stage oncology compounds for Eli Lilly and Company.

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"As Vor rapidly advances to become a clinical-stage company, it is wonderful for Christopher to commit to this full-time role leading the development of our oncology therapeutics," said Robert Ang, MBBS, MBA, Vor’s President and Chief Executive Officer.

Dr. Slapak has served as Vor’s Interim Chief Medical Officer since July 2019 as part of his work as an independent consultant advising on scientific and medical aspects of oncology drug development. For more than 20 years, he held leadership roles at Eli Lilly and Company, including positions as Distinguished Lilly Scholar and Vice President, Early Phase Research. He oversaw the global clinical development of all early-stage oncology compounds for Lilly and ImClone (which was acquired by Lilly in 2008), including the successful early-stage development of abemaciclib (Verzenio).

Dr. Slapak received his medical degree from the University of Chicago Pritzker School of Medicine, where he also completed his residency in internal medicine. After fellowship training in hematology and oncology at Tufts/New England Medical Center, Dr. Slapak was appointed Instructor and then Assistant Professor of Medicine at the Dana-Farber Cancer Institute/Harvard Medical School. He is board certified in internal medicine, medical oncology and hematology and currently has a joint appointment as Clinical Associate Professor of Medicine and Pharmacology at the Indiana University School of Medicine.

"Vor’s approach to engineering hematopoietic stem cells that are invulnerable to targeted therapies is a major innovation in stem cell transplantation," Dr. Slapak said. "Acute myeloid leukemia, a cancer of the bone marrow and our lead indication, constitutes a major unmet medical need – more than 20,000 people in the U.S. are diagnosed annually and less than 30% survive five years after diagnosis. By rendering healthy blood and bone marrow cells invisible to CD33-targeted therapies, we hope to provide long-term remissions for these patients, ultimately improving and prolonging life."

On July 14, 2020 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported the closing of its initial public offering of 16,100,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 2,100,000 additional shares of common stock, at a public offering price of $18.00 per share (Press release, Nkarta, JUL 14, 2020, View Source [SID1234561855]). The aggregate gross proceeds from the offering were $289.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nkarta. All shares in the offering were offered by Nkarta. Nkarta’s common stock began trading on The Nasdaq Global Select Market on July 10, 2020 under the ticker symbol "NKTX."

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Cowen, Evercore ISI, Stifel and Mizuho Securities acted as joint book-running managers for the offering.

A registration statement relating to these securities was filed with the Securities and Exchange Commission and became effective on July 9, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from Cowen and Company, LLC, Attn: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone at (415) 364-2720 or by email at [email protected]; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, or by email at [email protected], or by telephone at (212) 205-7600.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 14, 2020 ImmunSYS, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative cancer immunotherapy products, reported that it hosted a virtual Analyst Day event on Tuesday, July 7th, 2020 (Press release, ImmunSYS, JUL 14, 2020, View Source;utm_medium=rss&utm_campaign=immunsys-announces-it-hosted-a-virtual-analyst-day-event-on-july-7-2020 [SID1234561854]).

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Eamonn Hobbs, Chairman and CEO of ImmunSYS and Charles J. Link, Jr., M.D., Chief Medical Officer and President of ImmunSYS provided a business overview and highlighted upcoming milestones. Two world-renowned, key opinion leaders, E. David Crawford, M.D. Professor of Urology at the University of San Diego, and Steven J. O’Day, M.D., Executive Director of the John Wayne Cancer Institute and Cancer Clinic provided updates on the current prostate cancer landscape and reviewed new data on the company’s platform technology, YourVaccx. Dr. O’Day provided an in-depth review of the company’s Proof of Concept (PoC) study data that was recently presented at the 2020 AACR (Free AACR Whitepaper) Virtual Annual Meeting II.

A replay of the event can be accessed on the ImmunSYS website in the ‘Publications’ section at www.immunsys.com/publications

On July 14, 2020 Sanofi and The University of Texas MD Anderson Cancer Center reported a five-year strategic collaboration to accelerate the development of investigational treatments, including targeted and immune-therapies, for patients with cancer (Press release, Sanofi, JUL 14, 2020, View Source [SID1234561852]). The alliance will combine MD Anderson’s clinical trials infrastructure and Sanofi’s pipeline of investigational treatments to lead biomarker-driven clinical studies to better understand how novel cancer drugs work.

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"Our goal is to improve the outcome for patients with a range of difficult-to-treat cancers, which is best achieved through a deep understanding of how investigational new drugs work," said Peter Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. "This alliance leverages MD Anderson’s agile approach to early phase clinical trials, their laboratory capabilities and broad scientific expertise. This will get us to go/no-go decisions much faster and help us identify potential new combinations and indications more accurately. That will save precious time and help us expand the spectrum of patients who could potentially benefit from our therapies."

MD Anderson manages one of the country’s largest oncology clinical trial programs, with well-established platforms for tissue collection, molecular and immune profiling, and data analysis. This infrastructure enables the comprehensive study of tumor samples taken before, during and after treatment to uncover valuable insights that help streamline patient selection and hasten the identification of new therapy combinations and indications.

"Not only do clinical trials help us to advance life-saving new treatments for our patients in need, they provide us with valuable information to understand which therapies may be more effective for which patients," said Funda Meric-Bernstam, M.D., chair of Investigational Cancer Therapeutics. "We are pleased to collaborate with Sanofi in this effort to accelerate the development of a pipeline of innovative cancer therapies."

The new alliance also will support investigations into additional indications and combinations for studies already in the clinic. Sanofi and MD Anderson scientists will collaborate on experimental design, applying a core set of biomarkers and assays. Joint projects also will apply novel investigational agents developed at Sanofi to existing tumor samples to obtain further data on their effects at different disease stages.

"MD Anderson’s expertise in deep immune phenotyping and molecular profiling will provide invaluable insights into our emerging immunotherapy assets, helping us refine our selection of indications and explore new avenues," said Dmitri Wiederschain, Ph.D., Global Head of Immuno-Oncology Research at Sanofi. "The knowledge we gain in this collaboration will also deepen our shared understanding of cancers’ potential vulnerabilities."

New findings, as well as large-scale molecular and phenotype datasets, will be applied to the design of new translational studies on selected Sanofi molecules, and guide the selection of indications. The collaboration is expected to launch its first projects in summer 2020.

On July 14, 2020 GlaxoSmithKline reported the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, GlaxoSmithKline, JUL 14, 2020, View Source [SID1234561851]). Two committee members could not participate in the final vote.

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Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "We are pleased the committee recognised the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options. We look forward to working with the FDA as they complete their review of our Biologics License Application."

The recommendation was based on data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme, including the pivotal DREAMM-2 study which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.[i] The six-month primary results from the study were published in The Lancet Oncology in December 2019 and serve as the basis for the Biologics License Application (BLA).

The FDA will consider the recommendation of the committee but is not obligated to follow it. The FDA granted breakthrough therapy designation to belantamab mafodotin in 2017 and priority review designation for the BLA earlier this year. A Marketing Authorisation Application for belantamab mafodotin also is under accelerated assessment by the European Medicines Agency.

Belantamab mafodotin is not currently approved for use anywhere in the world.

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[ii] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[iii]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.iii

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.