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Stemline Therapeutics Provides Update on Clinical Programs

On February 21, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, reported an update on its clinical programs (Press release, Stemline Therapeutics, FEB 21, 2017, View Source [SID1234517780]).

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SL-401

Patient enrollment has continued to advance, without interruption, in all SL-401 clinical trials across multiple indications, including the Phase 2 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Given the enrollment trends, the projected timeline for completing enrollment in the final cohort (Stage 3) of the BPDCN pivotal trial remains on track for this quarter.
SL-801

Patients with advanced solid tumors are currently enrolling into a Phase 1 dose escalation study involving six centers. Four dosing cohorts have been completed, and enrollment in the fifth cohort is ongoing. Further trial updates are expected later this year.
SL-701

In a Phase 2 trial, adult patients with second-line glioblastoma received SL-701 alone or in combination with bevacizumab. The trial has been completed, and patients are being followed to assess survival. Further updates are expected later this year.

Loxo Oncology Announces Completion of Clinical Trial Enrollment for Larotrectinib NDA Primary Efficacy Analysis

On February 21, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the company has completed clinical trial enrollment for the larotrectinib New Drug Application (NDA) primary efficacy analysis (Press release, Loxo Oncology, FEB 21, 2017, View Source [SID1234517779]). This determination is based on written feedback from the U.S. Food and Drug Administration (FDA), which affirmed the target enrollment goal for the primary efficacy analysis data set to support an NDA filing.

All larotrectinib clinical trials will remain open to provide a mechanism for drug access to newly identified patients during forthcoming regulatory interactions and review.

The primary efficacy analysis for larotrectinib will be based on RECIST v1.1 overall response rate (ORR), as determined by independent radiology review, for NTRK fusion patients enrolled across the three ongoing larotrectinib clinical studies. Durability of response and safety are also critical elements of the regulatory risk-benefit determination. The company expects to report top-line data for the NDA dataset in the second half of 2017, and expects to submit a New Drug Application in late 2017 or early 2018, and a European Marketing Authorisation Application (MAA) in 2018.

Loxo Oncology intends to submit for approval for the same indication statement upon which the FDA granted Breakthrough Therapy Designation for larotrectinib, "for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments."

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

About Loxo Oncology

VBL Therapeutics Reports Full Data for VB-111 Monotherapy in Phase 2 Trial for Recurrent Thyroid Cancer

On February 21, 2017 VBL Therapeutics (NASDAQ:VBLT), reported full results from its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer (Press release, VBL Therapeutics, FEB 21, 2017, View Source [SID1234517778]). The data will be presented today by Dror Harats, M.D., CEO of VBL Therapeutics, at the Federation of the Israel Societies for Experimental Biology (FISEB) conference in Eilat, Israel.

The primary endpoint of the trial, defined as 6-month progression-free-survival (PFS-6) of 25%, was met with a dose response. Forty-seven percent (47%; 8/17) of patients in the therapeutic-dose cohort reached PFS-6, versus 25% (4/12) in the sub-therapeutic cohort, both groups meeting the primary endpoint. Reduction in tumor measurement after the first dose was seen in 44% (7/16) of patients in the therapeutic-dose cohort, compared to 9% (1/11) in the sub-therapeutic-dose cohort. An overall survival benefit was seen with a tail of more than 40% at 3.7 years for the therapeutic-dose cohort (mOS 684 days). This is similar to historical data for pazopanib* (Votrient), a tyrosine kinase inhibitor; however, most patients in the VB-111 study had tumors that previously had progressed on pazopanib or other kinase inhibitors.

"We are encouraged to see dose-dependent responses and an overall survival benefit with VB-111 monotherapy, in thyroid cancer patients with end-stage disease whose tumors had not responded to multiple lines of therapies, including kinase inhibitors," said Dr. Dror Harats, CEO. "This trial, together with our Phase 2 trials showing promise for VB-111 in recurrent glioblastoma and platinum-resistant ovarian cancer, point to the potential therapeutic application of VB-111 across multiple solid tumors. We look forward to advancing VB-111 towards commercialization, through our ongoing Phase 3 pivotal GLOBE trial in rGBM and our planned Phase 3 trial in ovarian cancer," added Dr. Harats.

The open-label dose-escalating study enrolled patients with advanced, recently-progressive, differentiated thyroid cancer that was unresponsive to radioactive iodine, in two cohorts. Most patients had tumors that had not responded to multiple therapies prior to enrollment, including radiation and kinase inhibitors. In the first cohort, thirteen patients received a single intravenous infusion of VB-111 at a sub-therapeutic dose of 3X1012 viral particles (VPs). The second cohort included seventeen patients, who received VB-111 at a therapeutic dose of 1013 VPs every two months until disease progression. One patient proceeded from a single low dose to receive later multiple high doses at progression and was included in both groups (for PFS only). VB-111 was well-tolerated in this study, with no signs of clinically significant safety issues.

About the Federation of the Israel Societies for Experimental Biology (FISEB)
ILANIT/FISEB is a federation of 31 Israeli societies of experimental biology. ILANIT’s conference is held every three years in Eilat, with attendance by researchers and students. This year’s conference, taking place February 20-23, is the culmination of the most exciting research performed in Israel in many disciplines. For more information, refer to View Source

About Thyroid Cancer
Thyroid cancer occurs in the thyroid gland, a hormone-producing organ at the base of the neck that regulates heart rate, blood pressure, body temperature and weight. According to the National Cancer Institute, there are an estimated 535,000 people currently living with thyroid cancer in the United States, with an estimated 60,000 new cases each year. The type of treatment depends on the cancer cell type, tumor size and severity of the disease. First-line treatment is surgical removal of the thyroid gland, and is recommended for most patients. Treatment with radioactive iodine after surgery to destroy any remaining thyroid tissue may be recommended for more advanced disease. If radioactive iodine is ineffective, other treatments are prescribed, such tyrosine kinase inhibitors and systemic chemotherapy. However, if such treatments are unsuccessful, the therapeutic options for patients are currently very limited. There are an estimated 1,850 annual deaths in the U.S. as a result of the disease. This subset of patients has an unmet need for novel therapeutic options.

Analysis From Two Institutions Shows Strong Tumor Response, Overall Survival Potential of Delcath Investigational PHP Therapy

On February 21, 2017 Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reporteded that a retrospective, multicenter study demonstrated that 45.7 percent of patients with ocular melanoma that metastasized to the liver who underwent percutaneous hepatic perfusion (PHP) using investigational Melphalan/HDS experienced a complete or partial response (Press release, Delcath Systems, FEB 21, 2017, View Source [SID1234517777]). The study further showed that among those who responded to treatment, overall survival was projected to be more than three years.

The findings were reported at the Regional Cancer Therapies 12th International Symposium in an oral presentation titled, "Percutaneous Hepatic Perfusion for Unresectable Metastatic Ocular Melanoma to the Liver: A Multi-Institutional Report of Outcomes." The analysis was conducted by teams from Moffitt Cancer Center in Tampa, Fla., and the University Hospital Southampton in the United Kingdom. The presentation was led by Dr. Alexandra Gangi of the Moffitt Cancer Center.

The analysis reviewed outcomes of 49 patients treated between 2008 and 2016 with Melphalan/HDS at either the Moffitt Cancer Center or the University Hospital Southampton. Patients underwent a total of 115 PHP treatments. The median number of treatments per patient was two, with patients receiving one-to-six treatments. PHP is a minimally invasive procedure that isolates the liver from the body’s circulatory system, so that a high dose of chemotherapy (melphalan hydrochloride) may be infused directly into the liver. Blood from the liver is then filtered to remove the chemotherapeutic agent thereby minimizing systemic exposure.

Hepatic response to PHP was evaluable in 46 patients, among whom 45.7 percent showed complete or partial response, and 37.0 percent had stable disease. Median overall survival was not reached, but was projected to be 657 days (1.8 years). Among patients with a complete or partial response, overall survival was projected to be 1,207 days (3.4 years). Most common side effects following treatment were anemia, thrombocytopenia and neutropenia.

"Patients diagnosed with metastatic ocular melanoma to the liver have an average of 6-8 months of survival. This retrospective analysis reported a much longer survival after Melphalan/HDS , and provided an interesting long-term look at patient outcomes after treatment with Delcath Melphalan/HDS," said Dr. Jennifer K. Simpson, President & CEO of Delcath. "The projected 657-day median OS and 1,207 day median OS in those with a partial or complete response is very impressive, and we believe speaks to the potential of the system to provide meaningful durable response."

PHP with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.

TG Therapeutics, Inc. Announces Publication of Clinical Data from the Phase 1/2 Trial of TG-1101 (ublituximab) Monotherapy in the British Journal of Haematology

On February 21, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab (Press release, TG Therapeutics, FEB 21, 2017, View Source [SID1234517775]). The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs. TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy. These data are described further in the manuscript titled, "A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab," which was published online today in the British Journal of Haematology. The online version of the article can be accessed at View Source

"We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data. Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies. This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered. The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. Mr. Weiss continued, "These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year."

"The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL. Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients," stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center.