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.

On February 10, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported that management will present a company overview at the SVB Leerink 9th Annual Global Healthcare Conference on Thursday, February 27, 2020 at 10:00 AM ET in New York, New York (Press release, Aclaris Therapeutics, FEB 10, 2020, View Source [SID1234554075]).

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A live audio webcast of the presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events’ section. An archived version of the presentation will be available for 30 days.

On February 10, 2020 Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the Office of Orphan Product Development division of the FDA has granted orphan drug designation to its leading therapeutic candidate, STP705, for the treatment of Hepatocellular Carcinoma (HCC) (Press release, Sirnaomics, FEB 10, 2020, View Source [SID1234554110]). This is the third such designation for this drug candidate, following the designation for Primary Sclerosing Cholangitis and Cholangiocarcinoma.

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Sirnaomics lead product candidate, STP705 is a siRNA (small interfering RNA) therapeutic that takes advantage of the Company’s proprietary dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. Sirnaomics has opened Investigational New Drug (IND) applications under the jurisdiction of the US FDA and Chinese FDA for clinical studies for Non-melanoma skin cancers (NMSC), Cholangiocarcinoma (CCA), and Hypertrophic Scar (HTS) Reduction.

"We are very pleased to reach another significant milestone and very excited to develop our lead product candidate for treatment of HCC with tremendous unmet needs" stated Patrick Lu, PhD, President and CEO. "This third grant of orphan drug designation for STP705 to treat HCC further consolidates our long-term strategy positioning us to take advantage of the regulatory arbitrage by achieving approval in US and then moving to the large market in China."

"Receipt of the orphan drug designation for Hepatocellular Carcinoma is a very important step for Sirnaomics. It provides the pathway allowing us to develop STP705 in a devastating oncology disease for which there is currently no effective therapy," stated Dr. Michael Molyneaux, MD, MBA, Chief Medical Officer. "This orphan drug designation aligns with our mission to alleviate human suffering and target diseases with high unmet clinical need and we anticipate the start of our clinical study for HCC in the second half of 2020."

About STP705 (Cotsiranib)
Sirnaomics leading product candidate, STP705, is an siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of Cholangiocarcinoma, Non-Melanoma skin cancer and Hypertrophic Scar. STP705 has also received Orphan Drug Designation for treatment of Cholangiocarcinoma and Primary Sclerosing Cholangitis. Preclinical animal models using STP705, have demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.

About Hepatocellular carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults, and is the most common cause of death in people with liver cirrhosis. It occurs in the setting of chronic liver inflammation, and is most closely linked to chronic viral hepatitis infection (hepatitis B or C) or exposure to toxins such as alcohol or aflatoxin. Certain diseases, such as hemochromatosis and alpha 1-antitrypsin deficiency, markedly increase the risk of developing HCC. Metabolic syndrome and NASH are also increasingly recognized as risk factors for HCC. Worldwide, approximately 840,000 people are diagnosed with primary liver cancer each year and about 500,000 of the patients are in China, even though HCC is designated as an orphan drug indication by US FDA. Abundant literature has directly linked high level expression of TGF-β1 to liver epithelial to mesenchymal transition (EMT) and tumorigenesis. Inhibition of COX-2 is able to reverse the drug resistance to the chemo drug treatment of HCC and also increased CD4+ T cells within the tumor.

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."

On February 10, 2020 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the availability of updated results from the Phase II CALYPSO study of the savolitinib / Imfinzi (durvalumab) combination in a cohort of patients with metastatic papillary renal cell carcinoma ("PRCC"), an investigator initiated study led by Professor Thomas Powles, Lead for Solid Tumour Research at Barts Cancer Centre, and sponsored by Queen Mary University of London (Press release, Hutchison China MediTech, FEB 10, 2020, View Source [SID1234554076]).

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Full data from the PRCC cohort of the CALYPSO study will be presented on Saturday, February 15, 2020, in oral and poster presentations at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU") in San Francisco, CA.

Further details from the presentation are as follows:

Presentation Title:

Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer

Presenting Author:

Cristina Suarez Rodriguez, Vall d’Hebron University Hospital and Institute of Oncology, Barcelona, Spain

Other Authors:

Thomas Powles, James M. G. Larkin, Poulam Patel, Begoña Pérez-Valderrama, Alejo Rodriguez-Vida, Hilary Glen, Fiona Thistlethwaite, Christy Ralph, Srinivasan Gopalakrishnan, Maria Jose Mendez-Vidal, Kelly Mousa, Aaron Prendergast, Laura Vosper, Wing-Kin Liu

Abstract #:

619 / Board D5

Oral Presentation:

Rapid Abstract Session C: Renal Cell Cancer

Date & Time:

Saturday, February 15: 11:35 AM-12:30 PM PST

Poster Presentation:

Session C: Renal Cell Cancer

Date & Time:

Saturday, February 15: 7:00 AM-7:55 AM PST

Preliminary results of this study (cut-off date of September 25, 2018) were first presented on February 16, 2019 at ASCO (Free ASCO Whitepaper)-GU.1

1 Powles,et al. A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO). 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium Abstract #545. Presented on February 16, 2019.

About PRCC in the CALYPSO study

PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for this specific indication. The CALYPSO study is an independently sponsored open-label Phase II study of Imfinzi in combination with several drug candidates in the treatment of renal cell carcinoma in the U.K. and Spain. Several arms of CALYPSO are evaluating the treatment of PRCC and clear cell renal carcinoma (ccRCC) with savolitinib, a highly selective inhibitor of the MET receptor tyrosine kinase, both as a monotherapy and in combination with Imfinzi (durvalumab), AstraZeneca’s anti-programmed death-ligand 1 (PD-L1) antibody. CALYPSO enrolls an all-comer PRCC population with planned retrospective molecular profiling. For further details, please refer to clinicaltrials.gov number NCT02819596.

About Savolitinib

Savolitinib is a potential first-in-class inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in global partnership with AstraZeneca, both as a monotherapy and in combination with immunotherapy, targeted therapy and chemotherapy drugs.