On June 27, 2017 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focusing on addressing oncology drug resistance, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TPX-0005 for "treatment of non-small cell lung adenocarcinomas harboring ALK, ROS1, or NTRK oncogenic rearrangements (Press release, TP Therapeutics, JUN 27, 2017, View Source [SID1234519701])." Schedule your 30 min Free 1stOncology Demo! The FDA grants orphan drug designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including seven years of market exclusivity upon regulatory product approval, exemptions from certain FDA application fees, and tax credits for qualified clinical trials costs.
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About TPX-0005
TPX-0005 is a potent and orally bioavailable small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with crizotinib, ceritinib, alectinib, and brigatinib, already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. However, the successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. TPX-0005 will provide new opportunities in the clinic to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome multiple resistance mechanisms from the refractory patients. TPX-0005 is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about TPX-0005 trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].
Month: June 2017
First in Human Administration of UCART123 in Cellectis’ AML Phase I Clinical Trial at Weill Cornell Medicine, NewYork-Presbyterian Hospital
On June 27, 2017 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), reported the first administration in the Phase I clinical study in Acute Myeloid Leukemia (AML) for its investigational product UCART123, one of the Company’s wholly-controlled TALEN gene-edited product candidates (Press release, Cellectis, JUN 27, 2017, View Source [SID1234519699]). This marks the first allogeneic, "off-the-shelf" gene-edited CAR T-cell product candidate targeting CD123 to be investigated in clinical trials. Schedule your 30 min Free 1stOncology Demo! This clinical research in AML is led by Principal Investigator Dr. Gail J. Roboz, Professor of Medicine at Weill Cornell Medicine and Director of the Clinical and Translational Leukemia Programs at Weill Cornell Medicine and NewYork-Presbyterian Hospital.
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The clinical trial will investigate the safety and efficacy of UCART123 in patients with AML. AML is a devastating clonal hematopoietic stem cell neoplasm which is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure. In the U.S., there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year. While complete response rates can be as high as 80 percent in younger patients who undergo initial induction cytotoxic chemotherapy, the majority of AML patients relapse and die from the disease. AML patients with high-risk genetic features have an especially urgent unmet medical need, as their outcomes are dismal with all existing treatment modalities, including allogeneic stem cell transplantation.
"After being granted rapid approval from Regulatory Authorities and Institutional Review Boards to initiate UCART123 studies, the enrollment and treatment of the first patient represents a major milestone for Cellectis, and we are eager to hit the ground running with the recruitment of our first patient for our second UCART123 Phase I study in BPDCN soon," said Dr. Loan Hoang-Sayag, Cellectis Chief Medical Officer. "This first program targeting CD123 will be a paradigm shift for our Company, as it will provide a wealth of valuable additional knowledge and data to drive our gene-edited allogeneic CAR T-cell platform."
"We are excited to be enrolling our first patient with UCART123 and are hopeful that this novel immunotherapy modality will prove to be a significant and effective weapon against AML," said Dr. Roboz.
The clinical trial is part of a strategic translational research alliance that was formed between Cellectis and Weill Cornell Medicine in 2015. Dr. Monica Guzman, an associate professor of pharmacology in medicine at Weill Cornell Medicine, is co-principal investigator whose work focuses on preclinical and early-stage testing to optimize the development of stem cell-targeted cancer drugs.
MabVax Therapeutics Commences Patient Dosing in MVT-1075 Radioimmunotherapy Phase 1 Clinical Trial for the Treatment of Pancreatic, Colon and Lung Cancers
On June 27, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, reported that the first patient has been dosed in the Phase 1 clinical trial evaluating MVT-1075, the Company’s fully human antibody radioimmunotherapy (RIT), for the treatment of CA19-9 positive malignancies including pancreatic, colon and lung cancers. Schedule your 30 min Free 1stOncology Demo!
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This Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 in up to 22 patients with CA19-9 positive malignancies in the U.S. The primary objective is to determine the maximum tolerated dose and safety profile in patients with recurring disease who have failed prior therapies. Secondary endpoints are to evaluate tumor response rate and duration of response by RECIST 1.1, and to determine dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The investigative sites will include Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City.
"MabVax is pleased to announce that we have advanced into the clinic with the dosing of the first patient in our MVT-1075 RIT lead development program. This significant milestone is a tribute to the integrated collaboration of our research and development staff with our clinical collaborators to bring this potentially life-changing therapy to patients with pancreatic, colon and small cell lung cancers," said David Hansen, MabVax’s President and Chief Executive Officer. "This is the third HuMab-5B1 based clinical trial that the Company has initiated in the last sixteen months. We believe that the development of this product candidate expands our pipeline to include a more potent therapy combining the clinically demonstrated tumor targeting characteristics of our fully human HuMab-5B1 antibody and commercially validated 177Lutetium, to deliver a dose of radiation to the targeted cancer cells. We look forward to continuing enrollment, and expect to report interim trial results by the end of 2017."
Supporting the MVT-1075 RIT clinical investigation are the Company’s successful Phase 1a safety and target specificity data reported at the annual meetings of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) earlier this month, including the clinical results for the Company’s HuMab-5B1 products, MVT-5873, a single agent therapeutic antibody and MVT-2163, an immuno-PET imaging agent. The combined results from 50 patients in the Phase 1 MVT-5873 and MVT-2163 studies, established safety and provided significant insight into drug biodistribution and an optimal dosing strategy, which the Company has incorporated into the MVT-1075 program. In April, the Company reported preclinical results for MVT-1075 at the American Association of Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrating marked suppression, and in some instances, regression of tumor growth in xenograft animal models of pancreatic cancer, potentially making this product an important new therapeutic agent in the treatment of pancreatic, colon and lung cancers.
For additional information about the Phase 1 MVT-1075 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT03118349.
About MVT-1075
MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. It has the potential to deliver a more potent HuMab-5B1 based product. MVT-1075 uses small doses of the Company’s MVT-5873 antibody, coupled to a radioisotope to target pancreatic cancer cells and kill them.
OXIS AGREES TO ACQUIRE GEORGETOWN TRANSLATIONAL PHARMACEUTICALS, APPOINTS NEW CHIEF EXECUTIVE OFFICER AND CHIEF MEDICAL OFFICER
On June 26, 2017 Oxis International Inc. (OTCQB: OXIS) and (Euronext Paris: OXI.PA) reported that it has executed a binding LOI agreement to acquire Georgetown Translational Pharmaceuticals, Inc. (GTP), a deal that will add new management and a class of close-to-market Central Nervous Systems (CNS) products that will add significant value to the Oxis business model (Press release, OXIS International, JUN 26, 2017, View Source [SID1234539561]).
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Oxis has agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close on or before 90 days as per the agreement.
GTP, founded by Kathleen Clarence-Smith, MD, PhD, and Mark J. Silverman, JD, was incorporated in Delaware in 2015.
Dr. Clarence-Smith will become Chief Executive Officer of Oxis as part of the acquisition and will be appointed to the Oxis Board of Directors. Also joining the company’s executive management team as part of the merger will be a Chief Medical Officer (name to be disclosed upon closing), who was formerly Vice President and Chief Medical Officer and Medical Director, Oncology Clinical R&D of Pfizer, Inc. (PFE).
Anthony J. Cataldo, who has served as Chief Executive Officer of Oxis since July 2014, will become Executive Chairman of the company. Steven Weldon will continue as Chief Financial Officer.
Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016.
Under the deal, Allergan agreed to pay $125 million upfront along with potential Regulatory and commercial milestones of up to $875 million to the shareholders of Chase.
Dr. Clarence-Smith also held executive management positions with Sanofi, Roche, Otsuka Pharmaceutical and Prestwick Scientific Capital. She is co-founder and a managing member of KM Pharmaceutical Consulting in Washington, D. C.
"The merger of Oxis and GTP will greatly accelerate the clinical development of exciting new treatments to meet the medical needs of those suffering from cancer and neurologic disease," said Dr. Clarence-Smith. "Harnessing the immune system to fight cancer has the potential to soon bring the cure for certain cancers within our reach, and our CNS pipeline includes drugs that have the potential to improve the quality of life of many patients."
Oxis’ incoming CMO said: "The drugs in the Oxis pipeline are at the forefront of targeted immunotherapeutics and represent the wave of the future. The non-clinical and clinical data is impressive and validates this approach to cancer therapy. Once approved, these agents will herald a major breakthrough in the field of immunotherapy and offer patients hope against some of the most difficult diseases to treat."
Mr. Cataldo said: "The addition of Dr. Clarence-Smith as CEO and our new incoming CMO will be instrumental in completing Oxis’ FDA phase 2 clinical trial of OXS-1550 and our plans to advance the highly-valued TriKE platform oncology assets, which are set to go into FDA clinical trials soon. Further, we are very excited with the incoming GTP product pipeline, which will add significant value as they continue to move towards a commercial license."
Oxis’ lead drug candidate, OXS-1550 (DT2219ARL), is a novel drug that binds to targets and destroys cancer cells, due to the action of the drug’s cytotoxic payload. OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. It is currently in a FDA-approved Phase 2 trial at the University of Minnesota.
In addition, Oxis holds the rights to commercialize OXS-3550, also known as TriKE, a targeted immunotherapy platform drug that directs Natural Killer (NK) cells to kill cancer cells without drug-related toxicity. "The first molecule called 161533 TriKE will target the CD33 antigen on acute myeloid leukemia cells. The 161533 TriKE will enable NK cells to become antigen specific and also drive the immune response through its IL-15 linker. Our existing Oncology products have now reached the point where Dr. Clarence-Smith’s experience in taking drugs through FDA approvals and into the market, will bring significant value to our shareholders," Mr. Cataldo said.
The agreement to acquire GTP marks another major value-added inflection point for the shareholders of Oxis. The company continues to progress with recently announced partnership and milestone accomplishments.
Advaxis’ Axalimogene Filolisbac Data Selected for Poster Presentation at ESGO 2017
On June 26, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company developing cancer immunotherapies, reported that the European Society of Gynaecologic Oncology (ESGO) has accepted an abstract for a poster presentation at its 2017 congress on the identification of potential baseline biomarkers indicative of survival benefit from treatment with the company’s lead immunotherapy candidate, axalimogene filolisbac (Press release, Advaxis, JUN 26, 2017, View Source [SID1234519687]). ESGO is Europe’s landmark gynecologic oncology meeting. Held biennially, ESGO congress brings together professionals to learn and discuss the latest medical and scientific developments in gynecologic cancers research, treatment and care.
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Advaxis researchers identified certain pre-treatment baseline levels of serum proteins that were strongly associated with overall survival (OS) benefit in patients with persistent or recurrent metastatic carcinoma of the cervix (PRmCC) that were treated with axalimogene filolisbac in the Phase 2 GOG/NRG-0265 study. The 12-month survival rate in this study was 38 percent (19/50), and these results were presented at a medical meeting earlier this year.
This analysis of pre-treatment baseline serum proteins of 45 patients from the study showed that levels of a group of four closely-aligned proteins were strongly correlated with OS. One cluster of patients (n=25), had relatively lower levels of all four proteins and exhibited an OS of 56 percent, while the second cluster (n=20), with relatively higher levels, exhibited an OS of 15 percent. These data are statistically significant (HR=0.23; 95% CI: 0.10-0.48; P<.001) and suggest that the baseline levels of these analytes have prognostic value for OS, and high levels of these individual proteins were negatively associated with clinical outcomes in the trial.
Importantly, it was found that much of this effect was due to levels of one particular protein, which was found to be most highly correlated with OS in the study. This particular protein was previously not known to be associated with survival in cervical cancer. Advaxis will continue to evaluate this particular protein as a potential biomarker to help identify patients most likely to benefit from treatment with axalimogene filolisbac.
"In the field of cancer immunotherapy, biomarkers have been playing an increasing role in guiding patient selection and identifying early indicators of treatment response," said Robert Petit, Chief Scientific Officer of Advaxis. "The discovery of this potential biomarker, which previously has not been known to be associated with survival in cervical cancer, is significant and could be a biomarker to predict efficacy, similar to how PD-L1 expression is used as a biomarker for checkpoint inhibitors. PD-L1 testing has become an important and routine strategy to guide treatment, and this biomarker has the promise to do the same for axalimogene filolisbac."
Sandy Hayes, PhD, Associate Director of Research and Biomarker Lead at Advaxis, is the first author and presenter of "Baseline Serum Protein Levels Associated with Survival in Axalimogene Filolisbac (Axal)-Treated Metastatic Cervical Cancer Patients: The GOG/NRG-0265 Trial." The poster will be presented at ESGO 2017, held Nov. 4 to 7 in Vienna, Austria, and will also be published in a supplement to the International Journal of Gynecological Cancer.
About Cervical Cancer
Cervical cancer is the fourth most common cancer affecting women worldwide. An estimated 13,000 cases were diagnosed in the United States in 2016, and 4,100 women will have this disease as their cause of death each year, according to the National Cancer Institute. Decades of research have shown that persistent HPV infection, particularly with high-risk virus types such as HPV-16 and HPV-18, is the most important factor in the development of cervical cancer. The prognosis for women with advanced and recurrent cervical cancer remains poor, with median survival of only six to seven months following initiation of palliative treatment with chemotherapy. According to the American Cancer Society, the five-year survival rate for stage IV disease is at 15 to 16 percent. There is no approved therapy following failure of first-line treatment, and there has been limited advancement in developing new therapeutics for advanced cervical cancer over the last 30 years.
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack.
Axalimogene filolisbac has received Fast Track designation as an adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac is the only active product candidate to have received the U.S. FDA orphan drug designation in cervical cancer.
Advaxis, in collaboration with Bristol-Myers Squibb, is evaluating ADXS-DUAL, the next generation immunotherapy candidate targeting HPV-associated cancers, with the PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer. Expected to start by the end of 2017, the study will evaluate this combination regimen in women with PRmCC who have failed at least one prior line of systemic chemotherapy.