On May 27, 2020 Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, reported the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for MSB11455, the company’s pegfilgrastim biosimilar candidate for Neulasta (Press release, Fresenius Kabi Oncology, MAY 27, 2020, View Source [SID1234558575]).

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This is Fresenius Kabi’s first U.S. biosimilar regulatory submission. Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy. The drug works by stimulating the body’s own production of white blood cells to fight infection.

"Pegfilgrastim plays a vital role in oncology care, and this acceptance by FDA is an important step toward giving oncologists and their patients greater access by providing another option to help support the immune system following chemotherapy," said Seema Kumbhat, M.D., chief medical officer for Fresenius Kabi USA.

Fresenius Kabi has global expertise in the development, manufacturing and distribution of generic pharmaceuticals with a focus on quality, reliability of supply and responsive customer and patient support.

"The acceptance of Fresenius Kabi’s submission of pegfilgrastim marks a key milestone as we seek approval for our first biosimilar in the United States," said John Ducker, president and CEO of Fresenius Kabi USA. "Fresenius Kabi is well positioned to become a U.S. market leader in biosimilars. In the U.S., we offer oncologists the industry’s broadest portfolio of injectable medicines, and we look forward to bringing this experience to producing high-quality biosimilars."

Fresenius Kabi’s BLA submission for its pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data. The application includes the results of two pivotal clinical trials that showed equivalent pharmacokinetic and pharmacodynamic profiles to the originator Neulasta, as well as similar immunogenicity in healthy volunteers. The safety of MSB11455 was also comparable to Neulasta.

Fresenius Kabi is participating as an Enhanced Exhibitor at ASCO (Free ASCO Whitepaper)20 Virtual, a meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is taking place virtually May 29-31, 2020. #ASCO20 #biosimilars

On May 27, 2020 Kinnate Biopharma Inc., a precision oncology company focused on the discovery and development of novel kinase inhibitors, reported the appointment of Nima Farzan as Chief Executive Officer, and a member of the Board of Directors (Press release, Kinnate Biopharma, MAY 27, 2020, View Source [SID1234558574]). Farzan brings nearly two decades of executive leadership and commercial and development experience in the biopharmaceutical industry to the Kinnate team, most recently as president and CEO of PaxVax. Company co-founder and former CEO Stephen Kaldor, PhD, has been appointed Chairman.

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Kinnate is developing best- and first-in-class small molecule therapies targeting kinases for genetically defined and hard-to-treat cancers. The company’s current portfolio includes a RAF dimer inhibitor targeting Class II and III mutations and an FGFR2/3 inhibitor. The company is also advancing a number of other programs, including a CDK12 inhibitor, which is a potentially first-in-class candidate.

"Kinnate has built unparalleled strength in structure-based drug design coupled with a deep understanding of the genetic mutations driving cancer progression through its internal expertise and scientific collaborations," said Keith T. Flaherty, MD, Director of Clinical Research at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School and Kinnate Board member and Scientific Advisor. "Nima’s demonstrated leadership in building innovative science-focused commercial organizations will add invaluable experience to the Kinnate team as they continue to accelerate their portfolio of precision medicines towards clinical testing."

At PaxVax, Farzan successfully led a team of 250 people through a number of commercial product launches and negotiated the acquisition of the company by Emergent BioSolutions in 2018. Prior to PaxVax, he held a series of roles with increasing responsibility at Novartis AG, most recently as Vice President of US Marketing in the company’s Vaccines & Diagnostics division. Prior to Novartis, Farzan worked at DoubleTwist, a pioneering genomics company, and was a consultant with Boston Consulting Group. He is currently a member of the Keros Therapeutics (NASDAQ: KROS) Board of Directors. Farzan holds a BA in Human Biology from Stanford University and an MBA from the Harvard Business School.

"With less than 10 percent of cancer patients benefiting from precision therapies, there remains a huge unmet medical need for genetically targeted medicines," said Farzan. "It is a privilege to join a company of this caliber and work with such a seasoned group of drug discovery leaders and our world-class partners who, like us, are driven by the urgency of cancer patients who need more effective therapies."

Kinnate has also announced today the appointment of Mark Meltz as Chief Operating Officer and General Counsel. Meltz joins Kinnate from Audentes Therapeutics where he was Senior Vice President and General Counsel and helped lead the sale of the company to Astellas Pharma in January 2020. Prior, he was Executive Vice President and Chief Business Development and Legal Officer at PaxVax where he helped lead the sale of the company to Emergent BioSolutions, served as Associate General Counsel at Biogen and was Head of Legal for North America at Novartis in its Vaccines & Diagnostics division. He holds a BA with Departmental Honors in Psychology from Yale University and a JD, Magna Cum Laude, from Boston College Law School.

In December 2019, Kinnate announced a $74.5M Series B financing and the expansion of its Board of Directors which in addition to Farzan and Dr. Kaldor, includes Dr. Flaherty (Massachusetts General Hospital, Harvard Medical School), Carl Gordon, PhD (OrbiMed), Michael Rome, PhD (Foresite Capital), and Brett Zbar, MD (Foresite Capital).

On May 27, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that management will present a corporate overview for 2020 at BIO Digital from June 8-12. For 2020, the BIO International Convention has transitioned to a new, virtual event format (Press release, TYME, MAY 27, 2020, View Source [SID1234558572]). The Company will present its corporate overview for 2020 with a special focus on multiple growth opportunities driven by advances in the science of cancer metabolism, pivotal trial in pancreatic cancer, clinical trial in ultra-rare metastatic sarcoma and expanding clinical plans for its lead candidate SM-88 (racemetyrosine) in pancreatic, prostate, breast and/or hematological cancers.

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Event: BIO Digital
Place: View Source
Presentation Date: June 8-12, 2020

The presentation will be accessible on the events page under the Investor Relations section of Tyme Technologies’ website at www.tymeinc.com. There is no webcast for this event.

On May 27, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported its participation in the following upcoming virtual investor conferences (Press release, Moderna Therapeutics, MAY 27, 2020, View Source [SID1234558571]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 10:30 a.m. ET.
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 2:10 p.m. ET.
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for 30 days following the presentation.

On May 27, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in fireside chats at the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2020, View Source [SID1234558570]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 3:00 p.m. ET
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 1:20 p.m. ET
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.