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Transgenomic Provides Update On Its Planned Merger And Reports Change in Listing Status

On February 21, 2017 Transgenomic, Inc. (TBIO) (OTQB: TBIO) reported that trading in its shares will begin on the OTCQB exchange under the ticker "TBIO" effective at the open of business on February 22, 2017 (Press release, Transgenomic, FEB 21, 2017, View Source [SID1234517783]). On February 17, 2017, the Company received written notification from the staff of the Nasdaq Stock Market LLC ("Nasdaq") that it had determined to delist the Company’s shares from Nasdaq and accordingly, trading in the Company’s shares will be suspended effective at the open of business on February 22, 2017, as a result of the Company no longer meeting certain Nasdaq continued listing requirements. As previously disclosed, Nasdaq had informed Transgenomic that its shares would no longer continue to trade on Nasdaq, unless the Company met the minimum share price and shareholder equity requirements on or before February 19, 2017. Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the Securities and Exchange Commission (the "SEC") after the applicable appeal periods have elapsed.

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On February 3, 2017, Transgenomic filed a preliminary proxy statement with the SEC with respect to the previously announced merger of its wholly owned subsidiary, New Haven Labs Inc., with Precipio Diagnostics, LLC in a transaction which has been structured, in part, to result in a combined entity that will meet all initial listing standards for the Nasdaq Capital Market. Additionally, the new company that will be created by the merger, and which will be known as Precipio, has applied in advance to Nasdaq to list its shares, and trading on the Nasdaq Capital Market is expected to resume when the merger closes, under the proposed ticker "PRPO". Transgenomic currently expects that the merger, which is subject to approval of the Transgenomic stockholders and certain other conditions, will close during the second quarter of 2017.

Paul Kinnon, President and Chief Executive Officer of Transgenomic, commented, "We are working diligently toward completion of the merger and we are excited about the opportunities the combination will create and believe that the combined company will be well positioned to build on its unique assets in the rapidly growing fields of advanced diagnostics and personalized medicine."

Ilan Danieli, Precipio’s founder and Chief Executive Officer noted, "We look forward to the closing of our merger with Transgenomic so that we can begin the process of integrating our teams, technologies, services and growing this platform. We believe the distinctive strengths of our two companies are complementary and, together, we expect to be a dynamic, growing, value-added player in the rapidly changing healthcare sector."

Lead cancer immunotherapy candidate receives FDA fast track designation

On February 21, 2017 Cell Medica, a leader in developing cellular immunotherapy for the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology product CMD-003 for patients with relapsed/refractory lymphoma and post-transplant lymphoproliferative disease associated with the oncogenic Epstein Barr virus (EBV) (Press release, Cell Medica Inc, FEB 21, 2017, View Source [SID1234517781]).

CMD-003, also known as baltaleucel-T, is an investigational therapy in which the patient’s T cells are activated to kill malignant cells expressing EBV antigens. The product has the potential to address a range of EBV-associated lymphomas, nasopharyngeal carcinoma and gastric cancer. The FDA Fast Track designation follows Orphan Drug Designations from both the FDA (EBV-associated non-Hodgkin lymphoma) and European Commission (extranodal NK/T lymphoma, nasal type and post-transplant lymphoproliferative disease).

The FDA’s Fast Track is a process designed to facilitate the development and to expedite the review of drugs to treat serious conditions and fill an unmet medical need. The FDA will take appropriate actions to advance the development and review of the application for approval of such a product. FDA Fast Track status also allows for more frequent interactions with the FDA review team and a rolling Biologics License Application (BLA) for earlier product review.

CMD-003 is currently being investigated in the international, open label Phase 2 CITADEL clinical trial for patients with extranodal natural killer T cell lymphoma (ENKTCL), a type of non-Hodgkin lymphoma. Cell Medica has also opened the Phase 2 CIVIC clinical trial to explore the potential benefits of CMD-003 for patients with EBV-associated diffuse large B cell lymphoma (DLBCL), Hodgkin lymphoma, and post-transplant lymphoproliferative disease (PTLD).

Dr Kurt Gunter, Chief Medical Officer of Cell Medica, said:

"The Fast Track designation supports the potential for CMD-003 to address an important area of high unmet clinical need. The potential eligibility for accelerated approval and priority BLA review will help facilitate the development of our lead cancer immunotherapy candidate. We are committed to bringing this novel treatment to patients as soon as possible."

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]).

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.