Aileron Therapeutics Announces the Appointment of Dr. Manuel Aivado as Chief Executive Officer

On September 6, 2018 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported that Manuel Aivado, MD, PhD, has been named President and Chief Executive Officer and elected to its Board of Directors (Press release, Aileron Therapeutics, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366358 [SID1234529310]). Since 2012, Dr. Aivado has served as Aileron’s Senior Vice President and Chief Medical and Scientific Officer. He succeeds John P. Longenecker, PhD, who was appointed interim CEO on May 15, 2018.

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"We are very pleased to announce this well-deserved promotion for Dr. Aivado," said Aileron Chairman Jeff Bailey. "Manuel clearly best exemplifies the skill set and talent needed to lead the company through its next stage of development."

"I am very excited to take on this new responsibility at Aileron as we further expand the clinical development of our lead product candidate, ALRN-6924, into combination therapies. ALRN-6924 represents the proof-of-concept for Aileron’s stapled peptide technology, which I believe to be capable of producing additional novel drug candidates that address previously undruggable targets," said Dr. Aivado. "In the future, we plan to broaden the applicability of our technology and expand our external collaborations. I am pleased with the external recognition that ALRN-6924 and our stapled peptide technology have earned in the scientific community, and I look forward to additional collaborations translating this recognition into therapeutic and commercial success."

Dr. Aivado brings more than 20 years of scientific, medical, and executive leadership to this position. Most recently, Dr. Aivado led Aileron’s clinical testing of stapled peptides against intracellular targets and designed and implemented the ALRN-6924 first-in-human trial. ALRN-6924 was selected for the "Best of ASCO (Free ASCO Whitepaper) Meetings," which highlights the most cutting-edge science and education from the world’s premier oncology event. Prior to joining Aileron, Dr. Aivado served as Vice President of Clinical Development and Pharmacovigilance at Taiho Oncology, Inc. He previously served as a Senior Medical Director in clinical development at GlaxoSmithKline. In addition, Dr. Aivado was an Instructor in Medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for nearly ten years, during which he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician in internal medicine, hematology and medical oncology. He received his MD and PhD degrees from the Medical School of the University of Dusseldorf, Germany.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild-type p53 tumor suppression by disrupting the interactions between p53 and its two primary suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, the Company believes there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

ZETAGEN THERAPEUTICS, INC. AWARDED $300,000 USD GRANT FROM THE NATIONAL CANCER INSTITUTE (NCI) FOR PHASE I STUDY OF NOVEL, ADJUVANT IMPLANT FOR POST-METASTATIC SKELETAL LESIONS

On September 5, 2018 Zetagen Therapeutics, Inc., a private, US-based biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported its award of a $300,000 (USD) grant from the National Cancer Institute of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, SEP 5, 2018, View Source [SID1234643681]). The grant will be used for a Phase I validation study of the Company’s proprietary, drug-eluding implant called ZetaMet (Zeta-BC-003). ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic being developed to suspend tumor growth and regrow bone.

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"We are pleased that the National Cancer Institute, through this award, has recognized the potential ZetaMet (Zeta-BC-003) may hold for treating metastatic bone lesions," said Nikhil Thakur, MD, CMO of Zetagen Therapeutics, Inc. "Osteolytic metastases are among the most challenging of cancers to treat as they both destroy bone and cause debilitating pain in patients."

The grant is part of the Small Business Innovation Research Program (SBIR), a three-phase award system created by the Federal Government for small businesses to engage in research and development that has the potential for commercialization and public benefit. Zetagen exclusively licensed its platform technology from the State University of New York in 2016. The Company’s Phase I validation study will begin in Q4 2018.

Chi-Med Announces the Approval of Fruquintinib Capsules for Previously Treated Colorectal Cancer in China

On September 5, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of metastatic colorectal cancer ("CRC") patients, who have failed at least two prior systemic antineoplastic therapies including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-vascular endothelial growth factor ("VEGF") or anti-epidermal growth factor receptor ("EGFR") therapies (Press release, Hutchison China MediTech, SEP 5, 2018, View Source [SID1234529315]). Fruquintinib is a highly selective and potent small molecule oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3 designed to be a global best-in-class VEGFR inhibitor for many types of solid tumors. Fruquintinib capsules are to be marketed in China under the brand name Elunate. The approval is based on results from the Phase III FRESCO trial, which were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Meeting and published in the JAMA (Journal of the American Medical Association) in 2018 .

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"Today’s approval is a major achievement for Chi-Med," said Simon To, Chairman of Chi-Med. "Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomized clinical trial in China," he added, "This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China’s emerging biotech ecosystem."

"We are particularly grateful to the patients, their families, investigators, nurses, caregivers and study team members who participated in the clinical development of Elunate and now look forward to making this world-class new therapy available as quickly as possible to patients with CRC in China."

In the FRESCO trial led by Dr. Jin Li and Dr. Shukui Qin, Elunate was shown to provide a statistically significant and clinically meaningful improvement in overall survival ("OS") versus placebo, with median OS of 9.3 (95% CI 8.2, 10.5) vs. 6.6 (95% CI 5.9, 8.1) months, respectively (HR=0.65, 95% CI 0.51-0.83; p<0.001), and a manageable safety profile. In addition to the significant efficacy, fruquintinib’s good kinase selectivity has been shown to limit off-target toxicity and deliver what Chi-Med assesses to be best-in-class tolerability. This allows it to be evaluated in combination with other agents such as chemotherapies, targeted therapies and immunotherapies, thereby maximizing the number of potential patients who may benefit from this novel cancer treatment.

CRC is the second most common cancer type in China,1 with about 380,000 new cases per year.2 There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.

The market launch of Elunate in China will be through collaboration with our partner Eli Lilly & Company ("Lilly"). Dr. Wang Li, Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, said, "The approval is a testament to the overall clinical profile of Elunate and is an important step forward for our collaboration with Chi-Med." This approval also triggers an approximately US$13.6 million milestone payment to Chi-Med from Lilly.

About Elunate

Elunate is the brand name of fruquintinib capsules. Fruquintinib (HMPL-013) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. The global market for anti-angiogenesis therapies was estimated at approximately US$18 billion in 2017, with both monoclonal antibodies and small molecules approved in around 30 tumor types. During the discovery research process, which began at Chi-Med in 2007, fruquintinib was successfully designed to be differentiated by improving kinase selectivity in comparison to other approved small molecule tyrosine kinase inhibitors (TKIs), to minimize off-target toxicities, improve tolerability and provide more consistent target coverage, resulting in better clinical efficacy. The superior tolerability, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for innovative combinations with other anti-cancer therapies.

In October 2013, Chi-Med entered into a licensing, co-development and commercialization agreement in China with Lilly for fruquintinib. Under the terms of the agreement, the costs of development of fruquintinib, carried out by Chi-Med, are shared; Chi-Med has received upfront payments and development and regulatory approval milestone payments; and upon commercialization in China, Chi-Med would receive royalties. Chi-Med and Lilly agreed to develop fruquintinib in three initial solid tumor indications, CRC, non-small cell lung cancer ("NSCLC") and gastric cancer.

The most common adverse reactions included hypertension, hand-foot syndrome and proteinuria. Clinically effective management of these adverse effects is feasible. For important safety information about Elunate, please see www.chi-med.com.

About Fruquintinib Development in CRC in China

Clinical development of fruquintinib began in 2011 with an initial Phase I trial in 40 solid tumor patients, followed by a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients. Chi-Med began enrollment in December 2014 of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients in China, and subsequently reported positive top-line results in March 2017.

In October 2016, fruquintinib was the first novel drug to be granted Market Authorization Holder ("MAH") designation under the Shanghai FDA, a new system designed to improve speed and efficiency of novel drug development in China. The New Drug Application ("NDA") for fruquintinib in CRC, that was submitted in June 2017 and awarded priority review status in September 2017, was supported by data from the successful FRESCO study. FRESCO was highlighted in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting held on June 5, 2017, and then the full results were published in the JAMA on June 26, 2018. Additional details about the FRESCO study can be found at clinicaltrials.gov, using identifier NCT02314819.

Fruquintinib is only approved for use in mainland China with the approved dose in CRC being 5mg orally once per day, on a three-weeks-on / one-week-off cycle and it will be made available in the market in both 1mg and 5mg capsule packages.

About Other Fruquintinib Development Programs

Lung cancer in China: FALUCA is an ongoing randomized, double-blind, placebo-controlled, multi-center, Phase III registration study of fruquintinib treating patients with advanced non-squamous NSCLC, who have progressed after two lines of systemic chemotherapy. The trial completed enrollment of 527 patients in February 2018 (clinicaltrials.gov identifier NCT02691299) and top-line results are expected in late 2018. FALUCA was initiated following a similar Phase II clinical trial in 91 third-line NSCLC patients. Results were highlighted in an oral presentation at the 17th World Conference on Lung Cancer on December 6, 2016 (clinicaltrials.gov identifier NCT02590965).

Along with FALUCA, fruquintinib is concurrently being studied in a Phase II study in combination with Iressa (gefitinib) in patients with untreated advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116). Preliminary results were highlighted in an oral presentation at the 18th World Conference on Lung Cancer on October 16, 2017.

Gastric cancer in China: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol (paclitaxel), known as the FRUTIGA study, in approximately 500 patients with advanced gastric or gastroesophageal junction ("GEJ") adenocarcinoma who have progressed after first-line standard chemotherapy (clinicaltrials.gov identifier NCT03223376). An interim analysis on FRUTIGA, to establish proof-of-concept ("POC"), is anticipated during the first half of 2019 and if successful could trigger a POC milestone from Lilly. The FRUTIGA study followed a Phase I/II clinical trial in 34 patients with gastric cancer that demonstrated that combination therapy of fruquintinib and Taxol was generally well-tolerated with promising tumor response (clinicaltrials.gov identifier NCT02415023).

United States: In December 2017, Chi-Med initiated a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier NCT03251378).

Moffitt Cancer Center and ITUS Corporation Announce Scheduling of Pre-IND Meeting with the FDA for their CAR-T Therapy

On September 5, 2018 ITUS Corporation (NASDAQ: ITUS) and its research partner, Moffitt Cancer Center, reported that a pre-IND meeting with the US FDA has been scheduled on Tuesday, October 16, 2018 (Press release, Anixa Biosciences, SEP 5, 2018, View Source [SID1234530493]). The meeting is to discuss numerous aspects of the planned clinical trial of their CAR-T therapy for ovarian cancer.

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Dr. Amit Kumar, CEO of ITUS stated, "We are pleased to be meeting with the FDA this fall, as anticipated. We have submitted pre-clinical data, as well as a series of questions, to the FDA. Coming out of this meeting, our goal is to have a good understanding of the design for the clinical trial in our Investigational New Drug (IND) application. Assuming the FDA does not require additional animal studies, we hope to file the IND application in early 2019, with human testing potentially beginning shortly thereafter."

Dr. Jose Conejo-Garcia, Co-head of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy, added, "We are heading towards the first in human trial of our hormone receptor based Chimeric Antigen Receptor T-cell technology, which internally we refer to as Chimeric Endocrine Receptor T-cell technology (CER-T). Our unique approach, could create a whole new platform for CAR-T that takes advantage of hormone-receptor combinations. To date CAR-T therapy has only shown efficacy in certain liquid tumors. We hope our approach will enable chimeric receptors expressed on T cells to work on the vastly larger numbers of solid tumors relative to hematological malignancies".

Orion Biotechnology acquires patent portfolio for potent CCR5 chemokine antagonist

On September 25, 2018 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported that its subsidiary, Orion Biotechnology Switzerland Sàrl, has successfully closed a transaction with the Mintaka Medical Research Foundation for the acquisition of the 5P12-RANTES molecule (Press release, Orion Biotechnology, SEP 5, 2018, View Source [SID1234530101]) . 5P12-RANTES is a potent CCR5 chemokine antagonist which Orion will develop in a number of areas, including; immuno-oncology, multiple sclerosis and HIV prevention.

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The acquisition includes its worldwide patent portfolio, and has resulted in a partnership with the Geneva, Switzerland based Mintaka Medical Research Foundation, and the Wellcome Trust of London, England. No financial details of the transaction were released.

"We are thrilled to add the enormous potential of the 5P12-RANTES portfolio to our pipeline" said Mark Groper, President and CEO of Orion Biotechnology. "It adds depth to our pipeline, strengthens our intellectual property portfolio, and provides the basis for the development of several additional novel immunotherapies".

"I’m excited that we were able to successfully form this partnership with Orion Biotechnology" said Robin Offord, Executive Director of the Mintaka Medical Research Foundation. "Mintaka looks forward to continuing its work on humanitarian (anti-HIV) uses of 5P12-RANTES with the help of the highly innovative and capable team at Orion and the substantial resources that they bring to the table. Also, 5P12-RANTES has surprised us all by its potential in a wide range of other medical indications and Orion is well placed to exploit these applications to the full".

Daniel Gill, from Wellcome’s Innovations team said: "HIV remains a significant global health issue and we are pleased to continue our collaboration on the development of 5P12-RANTES with Orion Biotechnology. 5P12-RANTES has significant potential in other areas of unmet need and we are excited that Orion will expand development of the molecule in other therapeutic areas such as immune-oncology and multiple sclerosis."