Asana BioSciences to Present Updates on its Oncology Development Pipeline at theAACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 24, 2017 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that it will present updates regarding three of its lead molecules at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) to be held in Philadelphia, PA, October 26-30, 2017 (Press release, Asana BioSciences, OCT 24, 2017, View Source [SID1234521148]).

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“The presentations will highlight the well differentiated profile of our clinical and preclinical programs, including first disclosure on our next clinical candidate ASN007, a potent ERK1/2 inhibitor.”
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“We are very pleased with the progress made in advancing our oncology portfolio,” said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. “The presentations will highlight the well differentiated profile of our clinical and preclinical programs, including first disclosure on our next clinical candidate ASN007, a potent ERK1/2 inhibitor.”

The presentation details are as follows:

1. A Phase 1 PK/PD study of ASN003, a novel, highly selective BRAF and PI3K dual inhibitor, in patients with advanced solid tumors.

Authors: Drew Rasco1, Nehal Lakhani2, Ryan Sullivan3, Monica Mita4, Jaimini Shah5, Helena Usansky5, Sanjeeva Reddy5, Niranjan Rao5, Louis J. Denis5, Anthony Tolcher1, Keith Flaherty3. 1START San Antonio, San Antonio, TX; 2START Midwest, Grand Rapids, MI; 3Mass Gen Hosp CC, Boston, MA; 4Cedars-Sinai Medical Center, Los Angeles, CA; 5Asana BioSciences.
Session: PO.B21 – Therapeutic Agents: Small-Molecule Kinase Inhibitors
Poster # B 147; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

2. ASN007, a novel oral ERK1/2 inhibitor, shows robust antitumor activity in RAS mutant cancer models.

Authors: Sanjeeva Reddy, Dhanalakshmi Sivanandhan, Purushottam Dewang, Niranjan Rao, Roger A. Smith and Scott Thompson.
Session: PO.B21 – Therapeutic Agents: Small-Molecule Kinase Inhibitors
Poster # B 150; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

3. ASN004, a novel 5T4-targeted Dolaflexin ADC, causes complete and durable tumor regressions in a variety of tumor xenograft models.

Authors: Roger A. Smith, David J. Zammit, Sanjeeva P. Reddy.
Session: PO.B19 – Therapeutic Agents: Biological
Poster # B 109; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

ASN003 is a potent and highly selective inhibitor of both B-RAF and PI3 kinases. RAS-RAF-MEK and PI3K-AKT-mTOR are two major pathways involved in tumor cell signaling and growth. Components of these pathways are frequently mutated in a broad range of tumors. Selective BRAF inhibitors induce dimerization of RAF proteins, leading to paradoxical activation of the RAF-MEK-ERK cascade. This activation is a major limitation for the clinical use of selective RAF inhibitors, as it leads to resistance and results in side effects in the skin limiting their use in patients with BRAF mutant tumors. In addition, elevated signaling through the PI3K/AKT pathway, with or without concomitant MAPK reactivation, represents an alternative path to resistance to BRAF inhibitors. Preclinical data with ASN003, demonstrates broad anti-proliferative activity in tumor cell lines and strong tumor growth inhibition in tumor xenograft models, including BRAF inhibitor resistant models. ASN003 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer and non-small cell lung cancer. ASN003 is well tolerated and shows the potential to be developed as a monotherapy or in combination with checkpoint inhibitors or standard of care.

ASN007 is a potent inhibitor of the extracellular-signal-regulated kinases, ERK1 and ERK2 (ERK1/2), key players in the RAS/RAF/MEK (MAPK) signaling pathway. This pathway is frequently hyper-activated 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. ASN007 shows potent anti-proliferative activity in cancer lines that are selectively driven by the MAPK-pathway, including RAS mutant cell lines. Furthermore, ASN007 demonstrates strong inhibition of tumor growth in multiple BRAF and KRAS mutant patient-derived and cell line-derived xenograft models, including those that are resistant to BRAF and MEK inhibitors. The IND-submission is planned to evaluate safety and efficacy in patients with advanced solid tumors, including BRAF and KRAS mutant cancers.

ASN004 is an Antibody Drug Conjugate (ADC) that targets the 5T4 oncofetal antigen that is expressed in a wide range of malignant tumors, while very limited expression is found in normal tissues. ASN004 demonstrates robust antitumor activity leading to complete tumor regressions in multiple human tumor xenograft models with no development of resistance to ASN004 treatment. The IND-enabling program for ASN004 is near completion and a First-in-Human Phase 1 trial is being planned in 2018.

Anaeropharma has presented new research outcomes at AACR Conference on Tumor Immunology and Immunotherapy

At AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy took place October 1-4, 2017 in Boston, MA, Anaeropharma has presented its new research outcomes regarding cancer immunotherapy titled “Anti-PD-1 antibody scFv producing recombinant Bifidobacterium exerts antitumor effect in a larger fraction of the treated mice comparing to full length anti-PD-1 antibody” (Press release, Anaeropharma Science, OCT 24, 2017, View Source [SID1234521147])

Minneamrita Announces FDA Clearance of Investigational New Drug (IND) Application and Initiation of a Phase I Clinical Trial of an Oral Formulation of Minnelide in Patients with Advanced Cancer

On October 24, 2017 Minneamrita reported that an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 trial of an oral formulation of the company’s Minnelide for patients with advanced cancers is now active (Press release, Minneamrita Therapeutics, OCT 24, 2017, View Source [SID1234521145]). The first patient to participate in this exciting clinical trial received treatment this past week at HonorHealth Research Institute.

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Dr. Erkut Borazanci, the Principal Investigator at HonorHealth Research Institute, states, “Minnelide has shown promising activity in several different types of preclinical models of cancer. The promise of the drug as an oral formulation, along with combining it with additional chemotherapy like Abraxane, gives us another great option for those with cancer.”

HonorHealth participated in the trial for the intravenous form of Minnelide and is the first clinical site to be open for enrollment for this clinical trial of the new and improved oral formulation. Additional sites are planned to be opened and enrolling patients in the coming months, including the Mayo Clinic.

“With the responses seen in the Phase I trial with the IV formulation, we are hopeful that the improved and more convenient oral administration will demonstrate the same or improved clinical benefit,” said Daniel D. Von Hoff, MD, FACP, and the Virginia G. Piper Distinguished Chair for Innovative Cancer Research.

“We have developed an oral formulation to have an ease of administration, compliance and efficacy. Patients with advanced gastrointestinal cancers and breast cancer can participate in this trial,” said Mohana R. Velagapudi, MD, Chief Executive Officer and Co-Founder of Minneamrita Therapeutics LLC, the trial’s sponsor.

“While we have made significant progress in the treatment of various cancers, patients with cancers arising from the gastrointestinal tract, especially pancreatic cancer, continue to have very poor prognosis. Minnelide has had very promising results in preclinical studies and the Phase I trial. Thus, we are hopeful that it will change the face of these deadly cancers,” said Ashok Saluja, Ph.D., Chief Scientific Officer and Co-Founder of Minneamrita Therapeutics.

Minneamrita chose Translational Drug Development (TD2) as its regulatory and clinical partner in 2012 and has continued its efforts in the development of the oral formulation of Minnelide. “We are honored that Minneamrita selected TD2 as its regulatory and clinical team,” said Dr. Stephen Gately, President and Chief Executive Officer of TD2. “We are proud of the successful IND application filings we have completed for them over the years, and the TD2 team is excited to manage the clinical trial for this important new medicine for patients with cancer.”

Minnelide is a drug derived from the thunder God vine (Tripterygium wilfordii)—also known as lei gong teng—and is native to China, Japan and Korea. Traditional Chinese medicine has used this vine for more than 2,000 years as a treatment for everything from fever to inflammation and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis.

The CEO of BioInvent Michael Oredsson will resign at the end of the year

On October 24, 2017 BioInvent International AB (OMXS: BINV) reported that Michael Oredsson will resign as CEO of BioInvent 31 December 2017 (Press release, BioInvent, OCT 24, 2017, http://www.bioinvent.com/en/media/press-releases/releases?id=BAC528D34E9A30A6 [SID1234521144]). Michael took office as CEO of BioInvent in 2013 to restructure the company and refocus on oncology. Now, both the board and Michael believe that it is a good time for a change in leadership, as the company is transitioning to a specific focus on clinical development and R&D.

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“On behalf of the board, I would like to thank Michael for a highly valuable contribution to the company. He has been instrumental in taking the company through a critical phase and I wish him all the best in the future”, says Björn O. Nilsson, Chairman of the Board.

“The challenges of a biotech company are many, but with highly skilled and devoted employees, my work has been both rewarding and stimulating. It has been a privilege to lead the BioInvent organization, but the company now needs more scientific skills in the CEO role. I will of course continue to follow the company closely”, says Michael Oredsson.

The board has initiated a process to recruit a new CEO. If a new CEO is not in place by 1 January, 2018, the present CSO, Björn Frendéus, will serve as acting CEO until the new CEO has been appointed and taken office.

A Virus, a Gene and a Pill Used to Harness the Immune System to Fight Brain Tumor in Children

ZIOPHARM Oncology is pleased to share a story from the Ann & Robert H. Lurie Children’s Hospital in Chicago on the Ad-RTS-hIL-12 plus veledimex clinical trial for pediatric patients with brain cancer (Press release, Ziopharm, OCT 24, 2017, View Source [SID1234521136]). As we announced last week, Stewart Goldman, M.D., Division Head Hematology-Oncology, Neuro-Oncology & Stem Cell Transplantation at Lurie Children’s dosed the first patient in this pediatric trial.

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First patient on a new Phase 1 pediatric brain tumor study injected with a common cold virus bioengineered to deliver a gene that mobilizes the immune system; a pill is used to control the targeted immune response

The first patient in a new Phase 1 gene therapy trial for pediatric brain tumors underwent a leading-edge procedure at Ann & Robert H. Lurie Children’s Hospital of Chicago. During surgery to remove the brain tumor, the patient was injected with an adenovirus, a common cold virus, at the tumor site. The virus was bioengineered not to cause illness but rather deliver a gene that produces human interleukin 12 (hIL-12), a powerful protein to jumpstart the immune system to kill remaining tumor cells. For the next 14 days, the patient is given a pill – veledimex – to activate the gene and control the immune response, so that the inflammation fights the tumor without overwhelming the rest of the body.

“Using the immune system to fight cancer is one of the most exciting new directions in cancer research,” said Stewart Goldman, MD, Principal Investigator at Lurie Children’s, Division Head of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplantation,​ and Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “What is most challenging is regulating the immune response we unleash, and that is what we are doing in this study. The pill dose acts like a thermostat with which we can adjust the intensity of the patient’s immune response.”

This is the first gene therapy clinical trial of this type for pediatric brain tumors. It will initially include patients with recurrent or progressive glioblastoma multiforme (rGBM) in the cortex of the brain. At a later date, children with diffuse intrinsic pontine glioma (DIPG), an incurable tumor located in the brain stem, will be added.

“Studies of this approach in adults with rGBM are showing promising results,” said Goldman. “We are hopeful that this will offer a viable treatment to children with gliomas who currently do not have any curative options.”

In addition to Lurie Children’s, the Phase 1 study will be conducted at Dana-Farber Cancer Institute in Boston and the University of California, San Francisco. It is sponsored by ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a Boston-based biopharmaceutical company focused on developing new gene and cell-based immunotherapies for cancer. Lurie Children’s cancer program is part of Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Research at Ann & Robert H. Lurie Children’s Hospital of Chicago is conducted through the Stanley Manne Children’s Research Institute. The Manne Research Institute is focused on improving child health, transforming pediatric medicine and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children’s is ranked as one of the nation’s top children’s hospitals in the U.S.News & World Report. It is the pediatric training ground for Northwestern University Feinberg School of Medicine. Last year, the hospital served more than 208,000 children from 50 states and 58 countries.