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Apexian Pharmaceuticals Presents Findings at ASH Meeting Demonstrating APX3330 Impact on Inflammation and Leukemia in Preclinical Models

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 [SID1234532036]).

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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

Checkmate Pharmaceuticals Announces CEO Transition and $22 Million Financing

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.

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.

Gibson’s Novel Anti-cancer Drug, LMP-400, Receives FDA Rare Pediatric Disease Designation for the Treatment of Ewing Sarcoma

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.

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.

AVEO Oncology Announces Immuno-Oncology Clinical Collaboration with AstraZeneca

On December 12, 2018 AVEO Oncology (NASDAQ: AVEO) reported that it has entered into a clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with FOTIVDA (tivozanib), AVEO’s oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) in first-line hepatocellular carcinoma (HCC), or liver cancer, in a Phase 1/2 study (Press release, AVEO, DEC 12, 2018, View Source [SID1234532033]).

AVEO will serve as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company. The Phase 1 portion of the study is expected to commence in 2019.

"We are thrilled to collaborate with AstraZeneca to explore another tivozanib-immunotherapy combination and look forward to understanding the potential of combining tivozanib with durvalumab in liver cancer," said Michael Bailey, president and chief executive officer of AVEO. "TKI-immunotherapy combinations have demonstrated important clinical potential across multiple tumor types, though toxicities associated with these combinations have limited their potential use. Our goal is to establish tivozanib as the TKI of choice for use with immunotherapies by demonstrating efficacy with reduced toxicity."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3, and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

About Durvalumab (IMFINZI)

Durvalumab (IMFINZI) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with immuno-oncology (IO) agents, small molecules, and chemotherapies across a range of tumors and stages of disease.

Avacta Appoints Dr Jose Saro as Chief Medical Officer

On December 12, 2018 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that Dr Jose Saro has been appointed as Chief Medical Officer to lead the Group’s therapeutic development strategy and drive the in-house programmes into the clinic (Press release, Avacta, DEC 12, 2018, View Source [SID1234532032]).

Dr Saro brings over 20 years’ experience in the pre-clinical, translational and early clinical development of oncology assets, spanning small molecules, biologics and drug conjugates. Dr Saro joins Avacta from Roche where he held the role of Senior Translational Medicine Leader at the Roche Innovation Center Zurich in which he focused on immuno-oncology and the development of combination products.

Prior to his position at Roche, Dr Saro was Executive Director Oncology Global Development and Medical Affairs at Bristol Myers Squibb, based in Paris, where he led and contributed to many oncology clinical development programmes, including Sprycel, Ipilimumab (Yervoy anti-CTLA4), Nivolumab (anti-PD1), anti-PDL1, anti KIR, anti LAG3, Brivanib, MEK inhibitor and Elotuzumab.

Previously, Dr Saro was Executive Director of Translational Medicine and Early Clinical Development (Oncology) at Novartis. Prior to that, he held senior positions at Eisai, and Wyeth.

Dr Saro has also experience of the small biotech environment, having spent several years as Vice President Oncology Clinical Development at PharmaMar, an oncology focused biotech. There, he was Head of Clinical Research & Development teams, comprising approximately 45 people, located in both Madrid and Boston, MA.

Alastair Smith, Chief Executive of Avacta Group commented: "I am delighted that Dr Jose Saro is joining Avacta to lead the therapeutic development strategy and to drive the in-house Affimer programmes into the clinic. His extensive experience in developing pre-clinical assets and translating those into clinical development will be an invaluable asset to Avacta.

Jose joins Avacta at a hugely exciting time as we progress towards the first Affimer clinical studies, which is a significant value inflection point for both the technology and Group. We very much look forward to working with Jose on our established programmes and on leveraging his knowledge to expand the pipeline of innovative and valuable immuno-oncology assets for the future."

Dr Jose Saro commented: "Due to their simple structure, Affimer proteins can be formatted to deliver the right characteristics required for the next generation of immuno-oncology therapeutics.

There are many opportunities for such a platform technology, and the recent collaboration with Tufts University Medical School is one example of a potentially game changing approach that is possible with Affimers.

I am very excited to be part of Avacta as it continues to develop such transformative approaches using the Affimer platform, that I believe will be a huge benefit to many oncology patients who currently have limited therapeutic options."