On October 24, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that the Company has filed a patent application for its series of HuMab-Tn fully-human monoclonal antibodies that target the tumor associated Thomsen-nouveau (Tn) antigen that will be developed as therapeutic and diagnostic products targeting ovarian, lung and breast cancers (Press release, MabVax, OCT 24, 2017, View Source [SID1234521277]). The Tn target is a carbohydrate antigen significantly expressed on the surface of cancer cells as a result of the transformation of normal cells into cancer cells. The Tn target is present on a broad array of tumor types but not found on normal tissues. This patent represents another valuable antibody asset brought forward by MabVax and the third patent filed on the antibody portfolio created through the Company’s unique discovery platform.

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The patent application covers the recovery of anti-Tn antibodies from patients who were vaccinated against their solid tumors with a vaccine that contained the Tn antigen. The discovery of fully human antibodies directly from vaccinated cancer patients is highly unique and has advantages including a potential for greater specificity and reducing the toxicities associated with non-human antibodies. The patent application also covers the additional work done by the Company’s antibody research and development team to optimize the recovered antibodies as well as detailing the resulting positive characteristics of the antibodies selected for patenting. The newly filed patent application, if issued by the U.S. Patent Office, will provide exclusivity for these antibodies until 2038.

“The filing of this patent is an important component of our broad strategy in expanding our robust patent estate. Importantly, this filing is timely as we look to select additional product candidates to fuel our pipeline that have the potential to address significant unmet therapeutic needs,” stated David Hansen, MabVax’s President and Chief Executive Officer.

The Company has demonstrated its ability to translate these discoveries through preclinical development and into clinical development with its HuMab-5B1 program, currently being evaluated in Phase 1 clinical trials as a therapeutic agent, an immunoPET diagnostic agent, and as a radioimmunotherapy (“RIT”). The Company envisions that the HuMab-Tn antibody portfolio has similar applicability, including as a bi-specific antibody, as an antibody conjugated with a payload to form an antibody drug conjugate (“ADC”), with a radionuclide as an immunoPET imaging agent or with a radionuclide as a RIT product.

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.

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])

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.

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.