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Elstar Therapeutics Closes $39M Series A Financing to Support Development of its Universal Targeted Immunotherapy Platform

On January 3, 2018 Elstar Therapeutics, a company fulfilling the promise of precision cancer immunotherapy through a powerful new approach to generating multi-functional therapies, reported the closing of a $39M Series A financing round by founding investor Apple Tree Partners (Press release, Elstar Therapeutics, JAN 3, 2018, View Source [SID1234522877]). The funds will be used to expand its growing pipeline and progress several early stage molecules towards the clinic.

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Elstar’s proprietary Universal Targeted Immunotherapy (UniTITM) platform allows rapid generation of multi-functional antibody-based molecules that enable patients to harness their own immune system to fight cancer. UniTITM molecules are unique in their composition of up to four distinct functional domains designed to regulate a broad-range of immunological activities, bringing unmatched targeting of tumor cells to reduce systemic toxicity while delivering excellent manufacturing and drug-like properties.

"Our multi-modal technology enables an enormous step forward from current generation cancer immunotherapy programs," said Steve Arkinstall, D.Phil., President and Chief Executive Officer of Elstar Therapeutics. "This financing will enable our experienced team to expand and advance our robust pipeline of cancer immunotherapy programs. Elstar’s goal is to rapidly move drug candidates into clinical trials for several serious hematological and solid malignancies."

"Elstar’s technology platform is designed to overcome barriers that have historically limited the success of promising immunotherapeutic approaches," said Elstar’s founder and Chief Scientific Officer Andreas Loew, Ph.D. "We are developing a new generation of drugs that can precisely target diseased cells. At the same time, these drugs can engage and regulate cells of both the adaptive and the innate immune system. While these molecules bring many biological advantages, at the core of the technology is the delivery of high yield molecules with drug-like properties that are manufactured using conventional antibody production and purification processes."

Elstar has assembled an accomplished leadership team to power its mission of being a part of the cure for cancer. The Company was founded by veteran protein engineer Andreas Loew, Ph.D., together with Apple Tree Partners, a life sciences-focused venture capital firm based in New York City. Before founding Elstar, Dr. Loew served as Executive Director of New Technologies / NIBR Biologics at the Novartis Institute for Biomedical Research, where he was responsible for the design and discovery of biotherapeutics including multi-specific antibodies and chimeric antigen receptor T cell therapies (CAR-T). Previously, Dr. Loew served in positions of increasing responsibility at Abbott Bioresearch Center.

Steve Arkinstall, D.Phil., Elstar’s President and Chief Executive Officer, has more than 25 years of experience in biopharmaceutical drug discovery research. Previously, he served in various roles at EMD Serono including President of the Serono Research Institute and SVP of Global Technologies before serving as Chief Scientific Officer of Kymab.

John Herrmann, Ph.D., serves as Chief Strategy Officer and EVP, Oncology. Dr. Herrmann is a portfolio strategist who previously was CSO of Oncology External Innovation at Eli Lilly & Co., before serving as SVP of Oncology at Catenion GmbH.

Peter Williams brings over twenty years of business development, deal negotiation and technology in-and out-licensing experience to Elstar as its Chief Business Officer. He has considerable expertise in technology and product partnering, particularly in the oncology landscape, having previously served as Senior Director, Business Development at Millennium Pharmaceuticals, Inc., Senior Director, Business Development at Alnylam Pharmaceuticals, Inc., and most recently as Vice President of Business Development at ImmunoGen, Inc.

"Elstar’s powerful UniTITM platform redefines how we think about multi-functional therapeutics and, together with a proven leadership team, positions the company to make a major impact on patients’ lives. Elstar’s initial focus on oncology has already generated candidates with great promise for various indications, but there are many other diseases where this technology could really transform the standard of care." said Aaron Kantoff, Principal at Apple Tree Partners and member of the Elstar Board of Directors.

GeneCentric Therapeutics Announces Research Collaboration on Drug Response Biomarkers for Lung Cancer

On January 3, 2018 GeneCentric Therapeutics, Inc. reported a research collaboration to evaluate the potential of GeneCentric’s Cancer Subtype Platform (CSP) to identify responders to G1 Therapeutics’ oral CDK4/6 inhibitor G1T38 for the treatment of non-small cell lung cancer (NSCLC) (Press release, GeneCentric Therapeutics, JAN 3, 2018, View Source [SID1234522885]). As part of the research collaboration, GeneCentric will apply its lung cancer subtyping profilers (LSP) in preclinical, patient-derived xenograft models to determine NSCLC subtype associations with G1T38 response, as well as examine potential drug response associations with specific genes. Financial terms were not disclosed.

GeneCentric’s proprietary core technology, CSP, identifies biologic subtypes of cancer through an integrated analysis of tumor genomics. The subtypes, which combine gene expression data with disease-related molecular pathways and immune cell expression have potential to function as universal biomarkers of drug response and enable more precision drug development. GeneCentric’s Lung Cancer Profilers (LSP 210 and LSP 220) define molecular subtypes of the two most common forms of NSCLC, adenocarcinoma and squamous cell carcinoma. Published studies have demonstrated that the subtypes, while indistinguishable by standard morphology, have different genetic, molecular and clinical attributes, and immune profiles that may drive drug response.

"G1T38 is a novel and promising targeted therapeutic with potential in many cancers," said Myla Lai-Goldman, M.D., CEO of GeneCentric. "This collaboration could identify subtypes of lung cancer where the compound is most likely to be efficacious."

Asana BioSciences Announces Acceptance of IND Application for Its Oral ERK1/2 Inhibitor

On January 3, 2018 Asana BioSciences, an oncology-focused, clinical stage biopharmaceutical company, reported that the U.S. FDA has accepted the IND application for ASN007, a potent and selective ERK1/2 inhibitor (Press release, Asana BioSciences, JAN 3, 2018, View Source [SID1234522875]).

"We are extremely pleased with the acceptance of this IND for evaluation of our potential Best-in-Class, oral ERK1/2 inhibitor that shows potent anti-proliferative activity in cancer models driven by MAP Kinase pathway mutations, as well as those resistant to BRAF and MEK inhibitors," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. "We continue to execute on our strategy of developing novel drugs that work on clinically validated targets, are clearly differentiated from the competition, and expected to offer significant benefit over the existing standards of care. This represents the 5th successful IND of our proprietary portfolio in the past 3 years, and is a testament to the capabilities, dedication and high efficiency of Asana’s R&D team," said Dr. Gupta.

The RAS/RAF/MEK/ERK (MAP Kinase) signaling pathway is frequently hyperactivated in a wide range of cancers through mutations in upstream targets such as BRAF, RAS and receptor tyrosine kinases. Inhibition of ERK1/2 offers a promising therapeutic strategy for these cancers, particularly those driven by RAS mutations. Enrollment in this Phase 1, open-label, dose-finding study of ASN007 in patients with advanced solid tumors is expected to start soon. The study will evaluate the safety, tolerability and preliminary efficacy of ASN007 in patients with BRAFV600, KRAS, HRAS or NRAS mutations.

Rasna Therapeutics, Inc. Announces Follow Up Phase II Clinical Data Confirming Efficacy of Actinomycin D in Patients with NPM1-mutated Acute Myeloid Leukemia

On January 3, 2018 Rasna Therapeutics, Inc. (OTCQX: RASP), a clinical stage biotechnology company focused on the development of disease-modifying drugs for hematological malignancies, reported follow up Phase II clinical data showing that 4 out of 9 (44%) evaluable AML patients carrying the NPM1 gene mutation treated with actinomycin D ("Act D"), achieved complete remission (CR) (Press release, Rasna Therapeutics, JAN 3, 2018, View Source [SID1234522873]). Treatment with Act D was well tolerated, except that patients experienced oral mucositis as the major toxicity. Rasna Therapeutics has developed a proprietary nanoparticle based formulation of Act D (RASP-101), which is anticipated to maximize efficacy while minimizing oral mucositis. RASP-101 could potentially be a first-in-class modality for treatment of NPM1-mutated acute myeloid leukemia (AML).

NPM1-mutated AML is a specific genetic leukemia entity that accounts for approximately one-third cases of AML in adults. As we reported previously, intravenous treatment of refractory or relapsed NPM1-mutated AML patients with Act D (12.5 µg or 15 µg/day) for 5 consecutive days produced hematological complete response in some of them (Falini et al., N Eng J Med. 373: 12, 2015).

In a follow-up phase II clinical study (ActD-AML-PG01, EudraCT 2014-000693-18) in refractory/relapse (R/R) AML patients carrying NPM1 gene mutation, treatment with Act D at 15 µg/kg/day for 5 days every 28 days induced CR in 4 out of the 9 evaluable patients (44.4%) with only 1 or 2 cycles of therapy. Three out of the 4 (75%) patients who obtained CR relapsed after 3, 5 and 7 months, respectively. One patient underwent haploidentical allogeneic PBSC transplantation at 3 months after CR achievement and is alive in molecular CR (MRD-negative) after 24 months.

"The precise mechanism of action of Act D in NPM1-mutated AML is still not clearly understood. Follow up data confirms our earlier findings and further support the use of Act D to induce complete hematological remissions with possible long-term molecular responses in NPM1-mutated AML patients. To note, our first previously reported NPM1-mutated AML patient (resistant to hypomethylating therapy) treated with Act D remains in molecular remission at over 3 years since CR achievement," said Dr. Brunangelo Falini, a member of the scientific advisory board of Rasna Therapeutics, Inc.

"We have developed a proprietary formulated Act D (RASP-101), which we anticipate will produce a superior clinical outcome with improved efficacy and safety profile. Emerging data from the multicenter clinical studies will allow us to develop a biomarker strategy to select responsive patients and improve clinical outcome for this unmet clinical need" commented Alessandro Padova, Chairman of Rasna.

About Actinomycin D (Dactinomycin)

Actinomycin D, also known as dactinomycin, a cytotoxic antibiotic produced by Streptomyces parvullus, was approved for medical use in the United States in 1964. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system. It is believed to work by blocking RNA synthesis. The drug has been used to treat a number of types of cancers, including Wilms tumor, rhabdomyosarcoma, Ewing’s sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer.

About Dr. Brunangelo Falini, M.D.

Brunangelo Falini is the head of the Institute of Hematology and Hemopoietic Stem Cell Transplantation at the University of Perugia, Perugia, Italy. His research activity has mainly focused on the genetic characterization of lymphomas and leukemias using monoclonal antibodies and, more recently, NGS technologies. He led the research group who discovered NPM1 mutations in AML in 2005 and the BRAF-V600E mutation in hairy cell leukemia in 2011. Both these seminal discoveries have already translated into a better diagnosis and therapy of patients affected by these hematological malignancies. Dr. Falini is the recipient of numerous prestigious prizes, including the "Josè Carreras Award" from EHA (Free EHA Whitepaper) (Barcelona, 2010), the "Leopold Griffuel Prize" from ARC (Paris, 2015) and the "Prize for Excellence in Medicine" from the American-Italian Cancer Foundation (New York, 2017).

IntelGenx To Present at Biotech Showcase™ 2018

On January 4, 2018 IntelGenx Corp. (TSX VENTURE:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported that its President and Chief Executive Officer, Dr. Horst Zerbe, is scheduled to present an overview of the Company’s business at the 10 th Annual Biotech Showcase conference on Tuesday, January 9 at 9:00 a.m. Pacific Time at the Hilton San Francisco Union Square Hotel (Press release, IntelGenx, JAN 3, 2018, View Source [SID1234522909]).

The presentation will be webcast live and archived for 90 days on the Company’s website, at www.intelgenx.com , under "Investors".

Andre Godin , Executive Vice President and Chief Financial Officer, and Dr. Dana Matzen , Vice President Business and Corporate Development, from IntelGenx will also be available for one-on-one meetings in San Francisco from January 8 through 10 . To arrange an investor meeting with IntelGenx , please contact Stephen Kilmer ( [email protected] ) and to arrange a business development meeting please contact Dr. Laëtitia Rodes ( [email protected] ) .