Boundless Bio Announces Presentations at Additional Conferences in February

On February 18, 2020 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported presentations at the following upcoming conferences this month (Press release, Boundless Bio, FEB 18, 2020, View Source [SID1234554456]):

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16th UC San Diego Moores Cancer Center Industry/Academia "Next Generation Precision Oncology" Symposium: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will speak during a session devoted to solid tumors. The presentation will take place at 9:15 a.m. PST on Thursday, February 20, 2020 in La Jolla, California.
9th Annual SVB Leerink Global Healthcare Conference: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will provide a company overview at 2:00 p.m. EST on Tuesday, February 25, 2020 in New York, New York.
Biocom’s Annual Global Life Sciences Partnering Conference: Scott Moorefield, Ph.D., Chief Business Officer of Boundless Bio, will present a company overview at 11:45 a.m. PST on Wednesday, February 26, 2020 in La Jolla, California.
About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

Mylan to Release 2019 Fourth Quarter, Full Year Results and 2020 Guidance on Feb. 27, 2020

On February 18, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that it will release its fourth quarter and full year 2019 financial results, as well as its 2020 financial guidance, on Thursday, Feb. 27, after the close of the U.S. financial markets (Press release, Mylan, FEB 18, 2020, View Source [SID1234554472]). The company also will host a webcast at 4:30 p.m. ET on Feb. 27 to discuss the results and 2020 guidance.

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The briefing can be accessed live by calling 855.493.3607 or 346.354.0950 for international callers (ID#: 9599904) or at the following address on the company’s website: investor.mylan.com. A replay of the webcast also will be available on the website.

Cytokinetics to Announce Fourth Quarter Results on March 3, 2020

On February 18, 2020 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report fourth quarter results on March 3, 2020 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future (Press release, Cytokinetics, FEB 18, 2020, View Source [SID1234554510]).

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 8698309.

An archived replay of the webcast will be available via Cytokinetics’ website until March 10, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 8698309 from March 3, 2020 at 7:30 PM Eastern Time until March 10, 2020.

CANBRIDGE PHARMACEUTICALS COMPLETES US$98 MILLION SERIES D FINANCING

On February 18, 2020 CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, reported the completion of a US$98 million Series D financing (Press release, CANbridge Life Sciences, FEB 18, 2020, View Source [SID1234554425]). The round was led by General Atlantic, a leading global growth equity firm, and WuXi AppTec. Each firm also has the option to invest up to an additional $10 million, upon the satisfaction of certain conditions by CANbridge. Additional participating investors in this round include RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed. The proceeds, the majority of which come from global investors, will be used to accelerate and expand the CANbridge rare disease pipeline through internal development and external partnerships, further build CANbridge’s commercial infrastructure and capabilities in China and supplement working capital.

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CANbridge has a deep rare disease pipeline, including Hunterase, for which it filed a New Drug Application (NDA) in China and has plans to commercialize the drug this year. In addition, CANbridge recently entered into the commercial stage with two approved oncology products, Caphosol, in mainland China, and NERLYNX (neratinib), in Hong Kong.

"That most of this capital raise comes from global life science investors, indicates the level of enthusiasm CANbridge is generating on the world stage as an industry leader in rare disease in China," said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. "We look to the future, as CANbridge continues to advance as a commercial-stage company with the powerful backing and endorsement of such investors."

"CANbridge is an early mover and a leader in China’s rare disease market," said Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic. "The company has built a rich pipeline of candidates, and we believe that CANbridge is well-positioned to capture the substantial market opportunity in the Chinese biotechnology space. We are excited to partner with the CANbridge team to support the company’s vision to bring innovative therapeutics to patients across China."

"CANbridge is developing a compelling and deep pipeline of assets, focused around directly addressing the unmet needs of patients with rare genetic diseases in China and around the world," said Derek DiRocco, PhD, Principal, RA Capital Management. "The leadership team at CANbridge is equipped with an impressive background, anchored in the development of rare disease therapeutics, and is poised to build the regulatory and commercial infrastructure necessary to significantly advance the rare disease segment of China’s biotech industry. RA Capital is excited to partner with CANbridge, and shares in leadership’s vision of building an innovative biotech company that aims to deliver effective therapeutics to patients in need."

Mustang Bio Announces First Subject Treated in Phase 1/2 Trial with the Optimized CD20-targeted CAR T Cell Therapy MB-106

On February 18, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the first subject treated with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration between Mustang and Fred Hutchinson Cancer Research Center ("Fred Hutch"), has achieved a complete response (CR) at the lowest starting dose in an ongoing Phase 1/2 clinical trial (Press release, Mustang Bio, FEB 18, 2020, View Source [SID1234554441]). The trial is evaluating the safety and efficacy of MB-106 in subjects with relapsed or refractory B-cell non-Hodgkin lymphomas.

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are thrilled to announce that we have achieved a complete response in the first subject dosed with MB-106 following Mustang and Fred Hutch’s enhancement to the cell process. MB-106 targets CD20, a commercially validated target on the surface of cancer cells that has lacked a strong CAR T-based clinical focus in the U.S. The complete response was seen on Day 28 in a subject with relapsed follicular lymphoma, and no cytokine release syndrome or neurologic toxicity were observed. The response was especially encouraging, since the subject received a dose of only 3.3 x 105 CAR T cells/kg. While this initial success of the optimized MB-106 is important, additional clinical testing is necessary. We are looking forward to follow-up data, as well as continuing to establish the safety of the therapy, which appears to be well tolerated to date. We are excited to work further with Fred Hutch to develop MB-106 and anticipate providing additional clinical results by year end."

The Phase 1/2, open-label, dose-escalation trial is evaluating the maximum tolerated dose of MB-106. Secondary endpoints include safety and toxicity, preliminary antitumor activity as measured by overall response rate and complete remission rate, progression-free survival, and overall survival. Fred Hutch intends to enroll approximately 30 subjects on the trial, which is being led by principal investigator Mazyar Shadman, M.D., M.P.H., Assistant Member of Fred Hutch’s Clinical Research Division.

About B-cell Non-Hodgkin Lymphoma (NHL)
There are several forms of NHL, including follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma and small lymphocytic lymphoma, which account collectively for about 45% of all cases of NHL. Most types of NHL are incurable with available therapies, except for allogenic hematopoietic stem cell transplant (allo-SCT). More than 70,000 new cases of B-cell NHL are diagnosed each year in the United States, and more than 19,000 patients die annually due to this group of diseases.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research partner, Fred Hutchinson Cancer Research Center, in the laboratory of Oliver Press, M.D., Ph.D., and Brian Till, M.D., in the Clinical Research Division and exclusively licensed to Mustang Bio in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in B-cell non-Hodgkin lymphoma patients. Additional information on the trial can be found at www.clinicaltrials.gov using the identifier NCT03277729.