On January 9, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, reported the filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody radioimmunotherapy (RIT) (Press release, MabVax, JAN 9, 2017, View Source [SID1234517341]). Subject to receiving FDA authorization to proceed, MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies early in 2017. This is the third IND filed by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines. Schedule your 30 min Free 1stOncology Demo! The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.
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In this initial phase I trial the Company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria. The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.
In November 2016, MabVax reported positive interim results from two phase I trials. The first trial is evaluating the Company’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating 16 patients at three clinical sites. Patients continue to be recruited to establish the recommended phase II dose (RP2D). The second trial is evaluating the Company’s Immuno-PET diagnostic agent MVT-2163. The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution in the initial two cohorts of patients: the first cohort was administered MVT-2163 alone; and the second cohort was given MVT-2163 following administration of MVT-5873. Target specificity was demonstrated by correlation with lesions identified by conventional computerized tomography (CT) scans and patients are actively being recruited to this trial.
David Hansen, MabVax’s President and Chief Executive Officer, said, "Following the positive interim data readout from our two ongoing phase I trials, we are excited to take this next step forward in our development strategy. Subject to receiving FDA authorization to proceed, we plan on expanding the HuMab-5B1 program to include delivery of a potent new radiotherapy agent. We are hopeful that this approach will provide a new treatment option for these difficult-to-treat cancers."
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Atossa Genetics Provides Update on its Phase 2 Study of Fulvestrant Administered with its Microcatheter
On January 9, 2017 Atossa Genetics Inc. (NASDAQ: ATOS) reported that it is transferring the site of its Phase 2 study of fulvestrant administered with its patented microcatheters in patients with ductal carcinoma in situ or breast cancer who are scheduled for lumpectomy or mastectomy (Press release, Atossa Genetics, JAN 9, 2017, View Source [SID1234517340]). The study was initiated at Columbia University Medical Center Breast Cancer Programs (New York) and is now being transferred to Montefiore Medical Center in New York. This move comes about as the principal investigator, Dr. Sheldon M. Feldman, M.D., has relocated to Montefiore and is now Chief, Division of Breast Surgery & Breast Surgical Oncology, Director, Breast Cancer Services, and Professor, Department of Surgery, at the Montefiore Medical Center, The University Hospital for the Albert Einstein College of Medicine, Montefiore Einstein Center for Cancer Care. Schedule your 30 min Free 1stOncology Demo! Montefiore Health System consists of eleven hospitals; a primary and specialty care network of more than 180 locations across Westchester County, the lower Hudson Valley and the Bronx; an extended care facility; the Montefiore School of Nursing, and the Albert Einstein College of Medicine.
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Dr. Steve Quay, President and CEO, commented, "We look forward to continuing our Phase 2 study at Montefiore, which is a nationally-ranked, top hospital. Although enrollment in the study has been slower than we expected, particularly as the study site is being moved, we expect that Montefiore’s large hospital system and leading breast cancer care center will facilitate faster enrollment, which we now anticipate completing by August 2017."
Adaptimmune confirms GSK Nomination of Second Adaptimmune Target under Strategic Multi-Target Collaboration
On January 9, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that GlaxoSmithKline plc (NYSE:GSK) (LSE:GSK) has nominated a second target, PRAME (preferentially expressed antigen in melanoma), under the strategic collaboration and licensing agreement between the companies (Press release, Adaptimmune, JAN 9, 2017, View Source [SID1234517335]). Adaptimmune will be responsible for PRAME preclinical TCR development and delivery of the IND package to GSK. The nomination of a second target meets a milestone set forth in the agreement. Schedule your 30 min Free 1stOncology Demo! Adaptimmune and GSK initially announced their strategic collaboration and licensing agreement in June 2014 for up to five programs, the first being the NY-ESO SPEAR T-cell therapy program, and the agreement was subsequently expanded in February 2016 to accelerate development of Adaptimmune’s NY-ESO SPEAR T-cell therapy toward registration trials in synovial sarcoma. Following the nomination of PRAME as a second target, Adaptimmune will take the program through preclinical testing to IND. GSK retains the right to nominate up to three additional targets, if GSK exercises its option on NY-ESO; however, this excludes targets on which work is already under way, including Adaptimmune’s proprietary MAGE-A10, MAGE-A4 and AFP programs.
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"The nomination of this next target marks an important step forward for the collaboration," commented Helen Tayton-Martin, Adaptimmune’s Chief Operating Officer and responsible for the alliance. "The early clinical results we have seen in synovial sarcoma with our SPEAR T-cell therapy targeting NY-ESO-1, the first target nominated by GSK, have been promising thus far, and we are accelerating that program toward registration studies. The nomination of PRAME as GSK’s second target is further validation of our technology, and our goal is to deliver this IND package as expeditiously as possible."
Under the terms of the agreement, the potential development milestones Adaptimmune is eligible to receive solely in relation to the PRAME program could amount to approximately $300 million, if GSK exercises its option and successfully develops this target in more than one indication and more than one Human Leukocyte Antigen (HLA) type. Adaptimmune would also receive tiered sales milestones and mid-single to low double-digit royalties on worldwide net sales.
TG Therapeutics Announces Orphan Drug Designation for the Combination of TG-1101 and TGR-1202 for Treatment of Chronic Lymphocytic Leukemia
On January 9, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, JAN 9, 2017, View Source [SID1234517334]). The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL as well as the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Schedule your 30 min Free 1stOncology Demo! "Receiving orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 provides another layer of exclusivity protection on top of the composition of matter patents which were issued for TG-1101 and TGR-1202 last year and patents on the combination that have been filed and are pending approval," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. "Additionally, with enrollment into our UNITY-CLL Phase 3 trial currently exceeding our expectations, we expect to be able to commence a regulatory filing for the combination in 2018 and having orphan drug designation will provide certain cost saving advantages for us during the regulatory approval process."
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ABOUT ORPHAN DRUG DESIGNATION
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.
ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States.
Update on Dispute between Exelixis and Genentech, a Member of the Roche Group
On January 9, 2017 Exelixis, Inc. (Nasdaq:EXEL) reported that Genentech, Inc. has withdrawn its counterclaim against Exelixis in the ongoing JAMS arbitration concerning alleged breaches of the parties’ collaboration agreement (Press release, Exelixis, JAN 9, 2017, View Source [SID1234517332]). Genentech had asserted a counterclaim for breach of contract, which sought monetary damages and interest related to cost allocations under the collaboration agreement. When notifying the arbitral panel, and Exelixis, of this unilateral action, Genentech further stated that it is changing the manner in which it allocates promotional expenses of the COTELLIC (cobimetinib) plus Zelboraf (vemurafenib) combination therapy. Schedule your 30 min Free 1stOncology Demo! As a result of Genentech’s decision to change its cost allocation approach, Exelixis is relieved of $18.7 million of disputed costs previously charged by Genentech. Exelixis has invoiced Genentech an additional $7.1 million with interest for expenses that Exelixis paid previously.
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Genentech’s revised allocation applies retrospectively and prospectively and will substantially reduce Exelixis’ exposure to costs associated with promotion of the COTELLIC + Zelboraf combination in the United States. Exelixis and Genentech have shared promotional costs since commercial activities were initiated in early 2013. As detailed in previous regulatory filings, Exelixis charged its Profit and Loss Statement approximately $38 million for promotional costs through the third quarter of 2016. With the new approach that Genentech has adopted unilaterally, Exelixis’ liability for promotional costs will be reduced to approximately $15 million for the same period.
Other significant issues remain in dispute between the parties. Genentech’s action does not address the claims in Exelixis’ Demand for Arbitration related to Genentech’s clinical development, pricing and promotional costs for COTELLIC in the United States, nor does it fully resolve claims over revenue allocation. And, Genentech has not confirmed how it intends to allocate promotional costs incurred with respect to the collaboration’s promotion of other combination therapies that include cobimetinib for other indications that are in development and may be approved. Exelixis will continue to press its position before the arbitral panel to obtain a just resolution of these claims and the clarity it requires.
About the Dispute
On June 3, 2016, Exelixis filed a Demand for Arbitration before JAMS in San Francisco, California asserting claims against Genentech related to its clinical development, pricing and promotion of COTELLIC, and cost and revenue allocations in connection with COTELLIC’s promotion in the United States. The arbitration demand asserts that Genentech has breached the parties’ contract by, amongst other breaches, failing to meet its diligence and good faith obligations. The demand seeks various forms of declaratory, monetary, and equitable relief, including without limitation that the cost and revenue allocations for COTELLIC be shared equitably consistent with the collaboration agreement’s terms, along with attorneys’ fees and costs of the arbitration. Genentech had asserted a counterclaim for breach of contract, which sought monetary damages and interest related to the cost allocations under the collaboration agreement.