On December 12, 2018 Gibson Oncology, LLC ("Gibson"), a privately held clinical stage company developing a novel class of oncology drugs for treating adult and pediatric cancers resistant to traditional cancer drugs, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to LMP-400, Gibson’s novel small molecule topoisomerase 1inhibitor for the treatment of Ewing sarcoma, a rare pediatric cancer (Press release, Gibson Oncology, DEC 12, 2018, View Source [SID1234532034]). LMP-400 has successfully completed multiple phase I human clinical trials as a single agent in advanced stage cancer patients with demonstrated anti-cancer activity and improved safety attributes over first generation topoisomerase inhibitors.

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Mr. Randall Riggs, President & CEO of Gibson Oncology, stated that "Gibson Oncology is excited that the U.S. FDA has granted LMP-400 RPDD, which has the potential to greatly benefit kids diagnosed with Ewing Sarcoma. We intend to conduct phase 2 trials with LMP-400 that will employ a recently discovered biomarker called Schlafen11 to select pediatric patients most likely to respond."

In a previous study performed at the National Cancer Institute (NCI) by Dr. Pommier et. al., cancer cells expressing high levels of Schlafen11 were hypersensitive to LMP-400. Ewing Sarcoma patients commonly have very high expression levels of Schlafen11 and are therefore excellent candidates for treatment with LMP-400.

The FDA grants RPDD for diseases that primarily affect children from birth to age 18, and affect fewer than 200,000 persons in the U.S. This program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

About Ewing Sarcoma

Ewing sarcoma is the second most common bone malignancy among children and adolescents. According to a study published in the Journal of Hematology/Oncology, the incidence is about 3 cases per 1 million per year in children younger than age 20. Despite the favorable prognosis, an American Cancer Society study showed that approximately 30-40% of patients develop metastases or local recurrence, and the long-term survival rate for refractory or recurrent disease is only 22-24%. The relapsed and refractory statistics underscore the need for new treatment options.

On December 12, 2018 Apexian Pharmaceuticals reported is shedding light on the question of how pre-leukemic cells transform into full-blown leukemia (Press release, Apexian Pharmaceuticals, DEC 12, 2018, View Source [SID1234532134]).

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Genetic mutations by themselves are rarely enough to flip the switch. Inflammation also plays a role. But, until now, the question of "how" remained unanswered.

Apexian Chief Science Officer Mark Kelley, PhD, and his colleagues presented their findings at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s December 1, 2018 meeting in San Diego, California. When a putative tumor-suppressor gene called TET2 does not function well, acute inflammation or infection can enhance the production of myeloid stem and progenitor cells in the bone marrow that are precursors to circulating mature myeloid cells. The TET2 loss of function amplifies; inflammatory proteins increase, and myeloid cells rapidly mature, increasing in sheer numbers as well as developing resistance to programmed cell death.

Myeloid cells, which contribute to immunity, are normally very short-lived. However, when those cells live too long or become too numerous, dangerous levels of inflammation can result. Using a mouse model, Kelley and his colleagues demonstrated that Apexian’s flagship compound APX3330 can prevent precancerous cells from proliferating and block cells from making inflammatory proteins.

Such anti-inflammatory therapy could be of clinical value in people carrying TET2 mutations.

"Apexian continues to develop a robust portfolio of APE1/Ref-1 compounds that have broad utility in oncology, hematology and other diseases", says Steve Carchedi, President and CEO. "We are excited by the recent scientific findings and continue to expand our research and development beyond solid tumors"

APX3330 also has clinical utility with solid tumors. A Phase 1 trial for patients with advanced solid tumors is concluding.

On December 12, 2018 Checkmate Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused upon activation of innate immunity to treat advanced cancer, reported that it has appointed Barry Labinger as President and CEO. Arthur M. Krieg, MD, Checkmate’s founder and current President and CEO, will assume the newly-created role of Chief Scientific Officer (Press release, Checkmate Pharmaceuticals, DEC 12, 2018, View Source [SID1234532035]). Both Mr. Labinger and Dr. Krieg will serve on Checkmate’s Board of Directors.

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Checkmate also announced the completion of a $22 million financing led by a new investor, Decheng Capital. The financing also included participation from existing investors, Sofinnova, venBio, and F-Prime.

"Checkmate’s encouraging early clinical data provide a strong foundation for its further growth as a leading cancer immunotherapy company with broad potential. Barry’s deep experience in oncology drug development and commercialization, along with this additional funding, will support Checkmate’s further progress," commented Mike Powell, Chairman of the Board of Checkmate, and General Partner, Sofinnova Ventures. "Art has successfully led the company to this critical stage in its growth, including this planned leadership transition. We are delighted to have Barry as CEO and Art as CSO. We are confident that they will successfully guide Checkmate to its next stage of evolution," continued Dr. Powell.

Mr. Barry Labinger brings to Checkmate nearly three decades of pharmaceutical and biotech industry experience, most recently serving as President, CEO, and Director of Biothera Pharmaceuticals, a clinical stage cancer immunotherapy company focused on innate immune activation. Prior to Biothera, he was Executive Vice President and President, Biosciences Division, at Emergent BioSolutions Inc., where he led the development and commercialization of oncology, immunology, and hematology products and product candidates. He previously held leadership roles at Human Genome Sciences, 3M Pharmaceuticals, and Immunex.

"I firmly believe in the importance of innate immune activation to enhance the benefits of other cancer immunotherapeutics," said Mr. Labinger. "CMP-001 has demonstrated best-in-class potential, and I’m excited to join Art, the Checkmate team, and our Board to maximize the potential of CMP-001 to improve outcomes for cancer patients."

"My initial goal in founding Checkmate was to determine if intratumoral TLR9 activation could induce tumor regression in anti-PD-1 refractory advanced cancer patients," Dr. Krieg commented. "Now that we have achieved that goal, I am delighted to turn over Checkmate’s leadership to Barry, so that I can focus my own efforts on the further scientific development of our platform. I believe that our complementary experience and our shared vision will enable us to accelerate and maximize Checkmate’s further development."

Proceeds from the financing will support ongoing clinical development of Checkmate’s lead product CMP-001 in advanced melanoma and non-small cell lung cancer (NSCLC) refractory to prior anti-PD-1 therapy, along with expansion into additional solid tumor types.

On December 1, 2018 BiomX Ltd., a microbiome company developing customized phage therapies, reported that it has appointed Dr. Sailaja Puttagunta, M.D., as its Chief Medical Officer (CMO) (Press release, BiomX, DEC 11, 2018, View Source [SID1234532001]). With her extensive experience in conducting Phase I to IV clinical trials, contributing to NDA submissions in anti-microbial disease areas and product launch preparations, Dr. Puttagunta will oversee BiomX’s clinical development and strategy as the company prepares to enter the clinic with its Acne and Irritable Bowel Disease (IBD) programs. The company’s Acne program is expected to enter the clinic in mid 2019, and the IBD program is expected to commence clinical trials in 2020. Dr. Puttagunta will be based in United States’ East Coast and will work closely with BiomX’s Israeli management.

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"Sailaja’s broad experience and knowledge of the U.S. and global drug development field will accelerate our phage therapeutics advancement toward the clinic," stated Jonathan Solomon, CEO of BiomX. "BiomX is also establishing a presence in the U.S. with Sailaja’s appointment. Her clinical expertise and extensive contacts in the medical community will help build a strong foundation for our global footprint."

"BiomX’s novel approach to targeting harmful bacteria in our microbiome, harnessing bacteria’s natural enemies, bacteriophages, bodes great promise not only due to the phages’ lethality, but also due to their high specificity, which enables not harming the beneficial bacteria," added Dr. Puttagunta. "I am looking forward to bringing this technology to the clinic where it has the potential to help patients with chronic and sometimes life-threatening diseases."

Dr. Sailaja Puttagunta, M.D., was most recently Vice President, Development at Iterum Therapeutics, a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens. Prior to Iterum, Dr. Puttagunta served as VP, Medical Affairs for Anti-infectives at Allergan from early 2015 and was the VP of Development and Medical Affairs at Durata Therapeutics, Inc. prior to its acquisition by Actavis plc. From 2006 to 2012, Dr. Puttagunta led teams within clinical development and medical affairs on various antibiotic compounds at Pfizer Inc. Dr. Puttagunta has 20 years of clinical, academic and research experience in medicine and in the sub-specialty of infectious diseases. She graduated from Gandhi Medical College in Hyderabad, India and completed her residency in Internal Medicine and a fellowship in Infectious Diseases at Yale University School of Medicine. She also holds an M.S. in Biochemistry from the New York University School of Medicine.

On December 11, 2018 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported the appointment by its Board of Directors of Bertrand de Castelnau as its Chief Executive Officer (Directeur Général) (Press release, Theradiag, DEC 11, 2018, View Source;utm_medium=rss&utm_campaign=appointment-of-bertrand-de-castelnau-as-chief-executive-officer-of-theradiag [SID1234532002]).

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Bertrand de Castelnau will replace Michel Finance, whose term expires on December 31, 2018, and will take up his post from January 21, 2019. To this end, the Board of Directors appointed Fabienne François, currently Chief Financial and Administrative Officer at Theradiag, as interim Chief Executive Officer for the period from January 1 to January 20, 2019.

Aged 58, Bertrand de Castelnau has more than 25 years’ experience in the field of diagnostics. He began his career as a Commercial Attaché in Islamabad, Pakistan. He then joined Roche in Switzerland, as a Corporate Auditor before moving to the Diagnostics division and then taking charge of the Asia-Pacific region for Roche Diagnostics, based in Singapore. Bertrand went on to become Operations Manager at Guerbet for four years, before spending 10 years running the Horiba ABX Group and its Horiba Medical division. Finally he joined DiaSys as head of Marketing, Sales and Finance.

A fluent speaker of several languages, he holds an MBA from the Ecole des Hautes Etudes Commerciales (HEC) and a law degree from Paris.

Pierre Morgon, Chairman of the Board of Directors of Theradiag commented: "We are delighted to welcome Bertrand as Chief Executive Officer of Theradiag. His 25 years’ experience in the field of diagnostics and his track record of creating partnerships and developing international businesses will be key advantages for the expansion of Theradiag."

Bertrand de Castelnau, incoming Chief Executive Officer of Theradiag, added, "I am joining the Theradiag team with great enthusiasm and look forward to contributing my skills and experience to the growth and the expansion of the international reach of Theradiag and of biotherapy monitoring."

Changes to the Board of Directors

Following the resignation of Dominique Costantini from her position as Director, the Board of Directors is now as follows:

Pierre Morgon, Chairman of the Board of Directors
Sylvie Bratel, Independent Director
Vincent Fert, Independent Director
John Li, Director
Dominique Takizawa, Independent Director