Bold Therapeutics to Initiate Phase 1b Trial of BOLD-100 in the Treatment of GI Cancers

On February 10, 2020 Bold Therapeutics Inc., a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, reported that it has received clearance from Health Canada to initiate a Phase 1b trial of its first-in-class anti-resistance therapeutic, BOLD-100, in combination with FOLFOX for the treatment of gastric, pancreatic, colorectal and bile duct cancers (Press release, Bold Therapeutics, FEB 10, 2020, View Source [SID1234554127]).

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"Based on compelling preclinical efficacy in combination with a wide range of anti-cancer agents, we are excited about the prospects of BOLD-100 in combination with FOLFOX," said Jim Pankovich, EVP of Clinical Development. "The combination of exciting preclinical data in a range of challenging solid tumor models, including gastric, pancreatic, triple-negative breast, and lung cancers, as well an encouraging safety profile seen in early clinical trials, supports the continued clinical development of BOLD-100. I am hopeful that these results translate into improved outcomes for patients, significantly advancing treatment of these devastating diseases."

Bold Therapeutics Inc., a Canadian federal corporation, was founded in 2018 by a team of biopharma industry veterans to develop and commercialize BOLD-100, a first-in-class anti-resistance therapeutic that appears to significantly enhance the activity of a wide range of other anti-cancer therapies by disabling a critical and previously untargeted resistance, survival and proliferation pathway common across cancers. Based on compelling preclinical and early clinical results, Bold Therapeutics is focusing its development efforts on some of the most challenging cancer indications where existing therapies are largely ineffective, resulting in a significant unmet medical need.

"As Bold Therapeutics’ lead investor in its Series A round, we are pleased to see BOLD-100 advance further into the clinic," said Glenn Walthall, Chairman of Bold Therapeutics’ Board and Chief Investment Officer of Gaston Capital Partners. "Bold’s team continues to execute, and we look forward to the achievement of other key development and commercialization milestones in 2020 and beyond."

"In 2019, the Bold Therapeutics team built a strong foundation for rapid growth and development: raising capital, engaging with potential development partners, completing cGMP manufacturing of BOLD-100, establishing collaborations with leading academic institutions to further elucidate the mechanism of action of BOLD-100, and finalizing a protocol that should efficiently determine safety and preliminary efficacy in the treatment of GI cancers," said E. Russell McAllister, CEO. "I look forward to an exciting, data-driven 2020, with preliminary results from our pioneering Phase 1b trial expected by year-end."

Leidos Announces Formation of Scientific Advisory Board to Advance its Pre-Clinical Drug Development

On February 10, 2020 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported the formation of a Scientific Advisory Board (SAB) for its Explorations in Global Health (ExGloH) division within the Leidos Health Group (Press release, Leidos, FEB 10, 2020, View Source [SID1234554125]). The ExGloH SAB is an esteemed group of experts in oncology and drug development chosen to advance ExGloH in its development of their pre-clinical pipeline of peptide-based immune modulators.

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ExGloH is dedicated to developing new immunotherapies for cancer and infectious diseases. ExGloH SAB members will work closely with ExGloH leadership to evolve the pre-clinical development of its lead drug candidate LD10, a novel peptide-based, immuno-modulator for the treatment of cancer and infectious diseases.

"We are excited and privileged to have the opportunity to work with this group of oncology and infectious disease thought leaders on drug development initiatives from discovery through drug commercialization," said James Pannucci, Ph.D., vice president and director of ExGloH. "Their insights will help advance our pipeline of peptide-based checkpoint inhibitors, beginning with LD10 clinical development."

The ExGloH SAB will be comprised of the following members:

Chairman, Philip Hinds, Ph.D, professor and chair of the Department of Developmental, Molecular, and Chemical Biology (DMCB) at Tufts University School of Medicine (TUSM), specializes in oncology, cell and developmental biology, and molecular biology. His seminal studies were the first to demonstrate that P53 possesses tumor suppressor activity and is subject to inactivating point mutations in human cancers.
Jose Conejo-Garcia, MD, Ph.D., is the chair of the Department of Immunology at H. Lee Moffitt Cancer Research Institute, and co-leader of the Immunology Program at H. Lee Moffitt Cancer Center. An expert in the field of Tumor Immunology, he has been cited in numerous publications for his contributions to elucidate many of the mechanisms driving protective immunity against gynecologic cancers.
Patrick K. Lucy, a founder and current chief business officer (CBO) of Pfenex Inc, is an experienced leader with more than 26 years of experience in the bio-pharmaceutical industry. As CBO he is responsible for the overall portfolio strategy and business development for the company. Lucy also has experience in the areas of alliance management, product and technology licensing, intellectual property, and bio-pharmaceutical processing, operations, facility design, construction and validation.
About ExGloH

ExGloH is a division within the Leidos Health Group dedicated to developing new immunotherapies for cancer and infectious diseases. ExGloH’s strives to develop a new class of anti-cancer and infectious disease peptides which can be used in primary and home care settings. The advancement of the Microtide platform allows for further discovery of checkpoint receptors. For more information, visit www.leidos.com/markets/science/biotechnology/exgloh.

Compugen to Release Fourth Quarter and Full Year 2019 Results on Thursday, February 20, 2020

On February 10, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the Company will release its fourth quarter and full year 2019 financial results on Thursday, February 20, 2020 before the U.S. financial markets open (Press release, Compugen, FEB 10, 2020, View Source [SID1234554124]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S.,
or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

Insmed to Host Fourth Quarter and Full Year 2019 Financial Results Conference Call on Tuesday, February 25, 2020

On February 10, 2020 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its fourth quarter and year-end financial results on Tuesday, February 25, 2020 (Press release, Insmed, FEB 10, 2020, View Source [SID1234554123]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Tuesday, February 25, 2020 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (888) 317-6003 (domestic) or (412) 317-6061 (international) and referencing conference ID number 3317351. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately one hour after its completion through March 3, 2020 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing replay access code 10139238. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

Citius Pharmaceuticals to Present at Noble Capital Markets’ 16th Annual Investor Conference

On February 10, 2020 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported that the Company will present at Noble Capital Markets’ 16th Annual Investor Conference on Monday, February 17, 2020 at 4:00 PM ET (Press release, Citius Pharmaceuticals, FEB 10, 2020, View Source [SID1234554122]). The conference is being held at the Seminole Hard Rock Hotel & Casino in Hollywood, Florida on February 16-18, 2020.

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Event: Noble Capital Markets’ 16th Annual Investor Conference

Presentation Date: Monday, February 17, 2020

Presentation Time: 4:00 PM ET – Terrace Ballroom A

Location: Seminole Hard Rock Hotel & Casino – Hollywood, FL

Mr. Leonard Mazur, Chairman of Citius, will deliver an update on the Company, including a discussion of the recent positive outcome of its interim futility analysis for the Phase 3 Mino-Lok pivotal trial, and provide an overview of its other pipeline products, Mino-Wrap and Halo-Lido. Additionally, Mr. Mazur will also be available at the conference for one-on-one meetings with investors. To arrange a meeting with the Company, please contact Mr. Andrew Scott: [email protected].

Mr. Mazur’s presentation will be available for playback at the link below approximately 24 hours following his live address and be archived for 90 days following the conference: View Source

This is the 16th year Noble Capital Markets has hosted "NobleCon" and invited emerging growth companies to present to and meet with attending investors. NobleCon will feature approximately 125 small growth companies presenting across four tracks occurring simultaneously, company executives meeting with investors in 1×1/face-to-face formats, and special panel sessions featuring key opinion leaders on topics such as cannabis, biotechnology, and mining, just to name a few. Noble Capital Markets will be broadening access to investors worldwide by hosting the conference site on Channelchek.com, its web-based market platform that emphasizes emerging growth companies.