On December 12, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported the publication of a peer-reviewed paper in Cell Reports authored by Aduro scientists and Novartis collaborators as part of their ongoing research to study intratumoral stimulator of interferon genes (STING) pathway activation as a potential therapeutic approach for the treatment of cancer (Press release, Aduro Biotech, DEC 12, 2018, View Source;p=RssLanding&cat=news&id=2380389 [SID1234532015]). In this study, researchers determined an intratumoral dosing regimen of STING pathway activator, ADU-S100, optimized for adaptive immunity in mouse models. While high doses of ADU-S100 were effective at clearing injected tumors, researchers found that higher tumor ablative dosing regimens could compromise durable anti-tumor immunity. Lower immunogenic doses of ADU-S100 were shown to optimally elicit CD8+ T cell responses required for systemic and durable anti-tumor immunity, and were also found to be efficacious in combination with checkpoint inhibitor therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We previously established that intratumoral STING pathway activation by ADU-S100 results in tumor regression in preclinical models. Our publication in Cell Reports now highlights the importance of optimizing the therapeutic dose regimen for STING agonists with the aim to balance innate and adaptive immune responses triggered by STING activation in the tumor microenvironment," stated Andrea van Elsas, Ph.D. chief scientific officer of Aduro. "Our findings support the use of immunogenic doses of ADU-S100 with checkpoint inhibitors to drive efficacious anti-tumor CD8+ T cell responses. We are encouraged by the potential of ADU-S100 as a novel treatment for cancer as we continue clinical evaluation of our lead compound in combination with checkpoint inhibitors."

The paper titled "Magnitude of Therapeutic STING Activation Determines CD8+ T-Cell Mediated Anti-Tumor Immunity," can be accessed online ahead of the print version in the peer-reviewed Journal Cell Reports.

ADU-S100 is the first STING pathway activator compound to enter the clinic and is currently being evaluated in a Phase 1 clinical trial as a single agent and in combination with ipilimumab (see www.clinicaltrials.gov, identifier NCT02675439) and in a Phase 1b combination trial with spartalizumab (PDR001), Novartis’ investigational anti-PD-1 monoclonal antibody (see www.clinicaltrials.gov, identifier NCT03172936).

About STING Pathway Activator Technology
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Natural activation of STING is not always sufficient to prevent the growth and spread of cancer cells. In preclinical models, ADU-S100 directly activates STING to further amplify the natural anti-tumor response. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

Aduro’s lead molecule, ADU-S100, is the first therapeutic in development specifically targeting STING. In collaboration with Novartis, it is being tested in a Phase 1 clinical trial as a single agent and in combination with ipilimumab, and in a Phase 1b combination trial with spartalizumab (PDR001), an investigational anti-PD-1 monoclonal antibody. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. The trials are evaluating the ability of ADU-S100 to activate the immune system and recruit specialized immune cells to attack the injected tumor, leading to a broad immune response that seeks out and kills distant metastases.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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