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AVEO Announces EUSA Pharma Granted Positive NICE Recommendation for FOTIVDA® (tivozanib) as First Line Treatment for Advanced Renal Cell Carcinoma

On February 12, 2018 AVEO Oncology (NASDAQ:AVEO) reported that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending FOTIVDA (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC) (Press release, AVEO, FEB 12, 2018, View Source;p=RssLanding&cat=news&id=2331779 [SID1234523907]). In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with aRCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for aRCC.1 Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

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EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia. The positive recommendation triggers a $2M milestone payment to AVEO from EUSA Pharma.

"The recommendation from NICE marks the first European Union reimbursement approval for FOTIVDA, helping ensure broadening patient access to FOTIVDA in key European markets following its launch in Germany in the fall of 2017," said Michael Bailey, president and chief executive officer of AVEO. "This recommendation underscores the strength and commercial-stage value of our partnership with EUSA Pharma, and triggers a $2 million milestone payment to AVEO. We continue to execute on our strategic plans, and we have had a very productive 2018 thus far, with the recent presentation of positive preliminary data from our tivozanib and nivolumab combination TiNivo study in RCC and an investigator sponsored study of tivozanib in liver cancer. We look forward to several potential additional key milestones in 2018, including further EU reimbursement decisions as well as topline data in the second quarter from our Phase 3 TIVO-3 study."

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $386 million in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy. As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

Advaxis Announces Publication of Phase 2 Results Evaluating Axalimogene Filolisbac for the Treatment of Recurrent Metastatic Cervical Cancer in the International Journal of Gynecological Cancer

On February 12, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that data from an earlier Phase 2 clinical study of axalimogene filolisbac (ADXS11-001) as a treatment for persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) was accepted for publication in the May edition of peer-reviewed International Journal of Gynecological Cancer (Press release, Advaxis, FEB 12, 2018, View Source [SID1234523905]). The article is titled, "A Randomized Phase 2 Study of ADXS11-001 Listeria monocytogenes-Listeriolysin O Immunotherapy With or Without Cisplatin in Treatment of Advanced Cervical Cancer."

This multicenter, randomized Phase 2 study conducted in India compared axalimogene filolisbac as a monotherapy with axalimogene filolisbac in combination with chemotherapy (cisplatin) in 110 patients with PRmCC. The primary endpoint was overall survival (OS), and patients were followed every three months for up to 18 months for tumor response and survival status.

The 12-month OS rate was approximately 35% (n = 38/109). Median OS was 8.28 months in the axalimogene filolisbac monotherapy arm and 8.78 months in the combination arm (p=non-significant). Overall, approximately 25% of patients (n = 27/109) reached the 18-month survival milestone. There were 3 confirmed complete responses (RECIST 1.1) and 1 confirmed partial response.

The most commonly reported treatment related adverse events were mild-to-moderate and related to cytokine release symptoms (chills, fever, vomiting and nausea), consistent with the observed safety profile in later clinical studies.

"These compelling results led to the conduct of the Phase 2 GOG-0265 study, where the 12-month OS rate with axalimogene filolisbac was subsequently replicated in a more heavily-pretreated PRmCC population in the U.S. In addition, these data are supportive of our upcoming planned submission of a conditional Marketing Authorization Application with the European Medicines Agency for axalimogene filolisbac for the treatment for metastatic cervical cancer, and give us added confidence in our immunotherapy as a treatment for these patients with limited treatment options," stated Anthony Lombardo, interim Chief Executive Officer of Advaxis.

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 antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a Phase 2 trial evaluating axalimogene filolisbac for the treatment of PRmCC, the product candidate showed a 12-month overall survival rate of 38% observed in 50 patients in the trial. This is a 55% improvement over an expected, model-predicted, 12-month survival rate of 24.5%.

Axalimogene filolisbac has achieved multiple regulatory milestones, including classification as an EMA advanced therapy-medicinal product for the treatment of cervical cancer, receipt of the U.S. Food and Drug Administration (FDA) Fast Track Designation as an adjuvant therapy for treating high-risk, locally advanced cervical cancer (HRLACC), receipt of a Special Protocol Assessment agreement with the FDA for the Phase 3 AIM2CERV trial, and orphan drug designations in three HPV-associated indications (PRmCC, head and neck, and anal cancer).

Actinium Announces Submission of IND For Actimab-A in Combination with CLAG-M for Patients with Relapsed or Refractory AML

On February 12, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that an Investigational New Drug (IND) application has been submitted with the U.S. Food and Drug Administration (FDA) for Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia (AML) patients (Press release, Actinium Pharmaceuticals, FEB 12, 2018, View Source [SID1234523904]). The planned Phase 1 trial studying Actimab-A in combination with CLAG-M will be an investigator initiated trial conducted at the Medical College of Wisconsin in a Phase 1, dose escalation study led by principal investigator Dr. Ehab Atallah in collaboration with Dr. Sameem Abedin. CLAG-M, a salvage chemotherapy regimen consisting of cladribine, cytarabine, and filgrastim, with mitoxantrone, is designed to induce remission in AML patients who are refractory to or have relapsed after standard induction therapy.

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "CLAG-M has become a widely used regimen for patients that is the standard of care at many institutions across the U.S. based on its ability to produce remissions in patients in relapse. By utilizing Actimab-A with CLAG-M, we expect to leverage Actimab-A’s potency and minimal extramedullary toxicities to derive synergies when used in combination with other active AML drugs. This important Phase 1 study will assess safety of the combination and determine an appropriate dose level for future studies. In future studies, we believe that this exciting combination could increase remission rates in relapsed patients. We also expect to use the Actimab-A CLAG-M combination regimen to increase the rate of successful stem cell transplant in relapsed patients, via improved myeloablation with the combination regimen. We look forward to work with Dr. Atallah and his colleagues at the Medical College of Wisconsin."

Actinium will host a conference call on Tuesday, February 13, 2018 at 4:30 PM ET that will be led by Dr. Mark Berger, Actinium’s Chief Medical Officer, and Dr. Atallah.

Webcast Registration:
View Source
U.S. Participant Dial-in: (646) 402-9440
U.S./Canada Toll Free Dial-in: (855) 698-6739
Conference ID: 2540

Sandesh Seth, Actinium’s Chairman and CEO said, "The advantageous properties of our CD33 targeting ARC or Antibody Radio-Conjugate have enabled us to expand our CD33 Program from a single indication to the only multi-disease program in the industry. In addition to the Actimab-A trial in newly diagnosed older AML, we have the only CD33 targeting agent in multiple myeloma via the Actimab-M trial. We are also exploring its use in targeted myeloablation in high-risk MDS with Dr. Roboz and the MDS Clinical Research Consortium via the planned Actimab-MDS trial. We are excited to now be studying the combination with CLAG-M for a large relapsed, refractory AML patient population with high unmet needs. Our intent is to further improve our positioning as the best in class CD33 program with applications as a therapeutic, myeloablative agent, and also the synergistic value of adding internalized radiation as a therapeutic modality to chemotherapy and other treatment approaches. In doing so, we intend to maximize the value of the program to a great number of potential partners and collaborators."

About Actimab-A

Actimab-A is Actinium’s lead drug candidate from its CD33 program and is an Antibody Radio-Conjugate (ARC) that is comprised of the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope. Actimab-A is currently being studied in Phase 2 clinical trial in patients that are newly diagnosed with AML who are over the age of 60 that are ineligible for intense chemotherapy, also known as unfit patients. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration and the European Medicines Agency. The Company expects to complete patient enrollment of the Phase 2 trial in the first half of 2018 and report top line data results in the second half of 2018. The Company is also developing Actimab-M and Actimab-MDS, which are also CD33 actinium-225 ARCs. Actimab-M is being studied in a Phase 1 investigator-initiated trial for patients with refractory multiple myeloma. The Phase 1 Actimab-M trial is expected to complete enrollment and report top line data in the second half of 2018. Actimab-MDS is expected to begin a Phase 2 clinical trial in the second half of 2018 following a pre-IND meeting with the FDA in the first half of 2018. Actimab-MDS is intended to bridge patients with high-risk myelodysplastic syndrome (MDS) that have a p53 genetic mutation to a bone marrow transplant via targeted myeloablation. Actimab-A is a second-generation therapy from the Company’s CD33 Program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in over 100 patients in four clinical trials.

Corporate Presentation

On February 12, 2018 Lipocine reported to have presented its Corporate presentation (Press release, Lipocine, DEC 12, 2018, View Source [SID1234523947]).

VistaGen Therapeutics Reports Third Quarter Fiscal 2018 Financial Results

On February 12, 2018 VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, reported financial results for its third fiscal quarter ended December 31, 2017 (Press release, VistaGen Therapeutics, FEB 12, 2018, View Source [SID1234523927]).

"Building on our significant progress last quarter, our team is prepared and eager to launch, during the current quarter, our AV-101 Phase 2 clinical development program, initially focused on adjunctive treatment of Major Depressive Disorder patients with an inadequate response to standard, FDA-approved antidepressants. This year has the potential to be transformative for VistaGen and the millions of depression patients seeking new generation treatment options that are fundamentally different from all currently available therapies," commented Shawn Singh, Chief Executive Officer of VistaGen.

Financial Results for the Fiscal Quarter Ended December 31, 2017:
Net loss attributable to common stockholders for the fiscal quarter ended December 31, 2017 was approximately $3.5 million, compared to $2.9 million for the fiscal quarter ended December 31, 2016.

Research and development expense totaled approximately $1.6 million for the fiscal quarter ended December 31, 2017, compared with approximately $1.6 million for the fiscal quarter ended December 31, 2016. Research and development expense was primarily attributable to the Company’s development of AV-101, its oral, new generation CNS drug candidate initially focused on displacing adjunctive atypical antipsychotics in the current Major Depressive Disorder (MDD) treatment paradigm, including final preparations to launch its AV-101 MDD Phase 2 adjunctive treatment study in patients with an inadequate response to standard FDA-approved antidepressants.

General and administrative expense was approximately $1.3 million in the fiscal quarter ended December 31, 2017, compared to approximately $2.3 million in the fiscal quarter ended December 31, 2016. The decrease was primarily attributable to decreased professional services expenses, a decrease in noncash expense attributable to grants of common stock for services, and a decrease in noncash warrant modification expense, partially offset by increased salary and benefits and noncash stock compensation expenses.

At December 31, 2017, the Company had cash and cash equivalents of approximately $13.0 million, compared to approximately $2.9 million at March 31, 2017.