On January 7, 2015 Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, reported that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the US Food and Drug Administration (FDA) (Press release, Soligenix, JUL 1, 2015, View Source [SID:1234512918]).

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Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX301 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

"We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received. We believe that the FDA’s action in granting fast track designation validates the unmet medical need that currently exists for first-line treatment in CTCL and for the potential key role SGX301 can serve as a first-line therapy in this rare, life-threatening disease," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the pivotal Phase 3 protocol now cleared through the FDA and completion of the recent targeted financing, we look forward to working closely with our esteemed Medical Advisory Board to initiate the clinical study in the first half of 2015."

About CTCL
Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug designation from the FDA.

On June 30, 2015 AVEO reported that additional biomarker analyses from the BATON- (Biomarker Assessment of Tivozanib in ONcology) CRC study will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer, taking place July 1-4 in Barcelona, Spain (Press release, AVEO, JUN 30, 2015, View Source;p=RssLanding&cat=news&id=2063535 [SID:1234506008]). Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor (VEGF) with a long half-life and activity against all three VEGF receptors.

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The BATON-CRC study is a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer (CRC). The presentation, titled "Neuropilin 1 (NRP1) may be Prognostic and Identify a Subgroup of Patients with Metastatic Colorectal Cancer (mCRC) who Benefit from Tivozanib + mFOLFOX6 compared to Bevacizumab + mFOLFOX6," will be presented in an oral session titled "Session X: Presentation of Selected Abstracts: Colorectal Cancer," which begins at 8:00 a.m. CEST on Friday, July 3, 2015, and in a poster session that begins at 10:25 a.m. CEST that day.

As previously announced, the additional analyses, which produced similar results to those presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Angiogenesis and Vascular Normalization Conference in March 2015 used a different NRP1 assay and were conducted as part of the Company’s ongoing effort to develop an NRP1 assay suitable for further clinical study and eventual commercialization. Al B. Benson III, MD, FACP, Professor of Medicine at the Feinberg School of Medicine, Associate Director for Clinical Investigations at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and principal investigator of the BATON-CRC study, will present the updated findings.

A copy of the poster presentation will be available, beginning at the time of presentation, on AVEO’s website at www.aveooncology.com.

On June 30, 2015 Medigene AG (MDG1, Frankfurt, Prime Standard) completed the capital increase reported on 12 June 2015 for the funding of its cancer immunotherapy programmes, achieving gross proceeds of approximately EUR 46.4 million by placing the maximum number of 5,594,178 new offered shares to existing shareholders and selected new institutional investors for the subscription and placement price of EUR 8.30 (Press release, MediGene, JUN 30, 2015, View Source [SID:1234506543]). Gross proceeds from the placement exceeded the Company’s targeted EUR 40 million raise by over 15%. The rump placement was oversubscribed. A US-based specialist institutional investor participated as the cornerstone investor in the transaction and as a new investor in Medigene AG.

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Dr Frank Mathias, Chief Executive Officer of Medigene AG: "With this capital measure which was successfully completed despite a difficult European market environment we are now well-positioned to further advance our cancer immunotherapy programmes into decisive new stages of development. We plan to deliver final clinical data from the current phase I/II trial with our DC vaccines, initiate up to three clinical trials with our TCR programme and develop up to 10 TCR lead candidates thereby extending and accelerating the clinical development of our T cell based therapies. We feel encouraged by having gained new and leading international biotech investors for our goals and are highly motivated to make our promising cancer therapies usable for patients."

By issuing 5,594,178 new shares from authorised capital, the share capital of Medigene AG increases by EUR 5,594,178.00 from EUR 14,051,815.00 to EUR 19,645,993.00. The gross proceeds generated from the issuing of new shares amounts to EUR 46,431,677. The new shares are scheduled to be admitted to trading from 6 July up to 13 August with ISIN DE000A161NA3, securities identification number WKN A161NA and stock exchange symbol MDGJ. From 14 August 2015 on, the new shares will have the same ISIN, securities identification number (WKN) and stock exchange symbol as the existing Medigene shares (ISIN: DE000A1X3W00, WKN: A1X 3W0, MDG1).

Baader Bank AG acted as sole global coordinator and sole bookrunner. Trout Capital LLC acted as the US selling agent.

About Medigene’s Immunotherapies: Medigene is working on three complementary immunotherapy strategies for the treatment of different forms and stages of cancer with focus on T-cells which play a central role in the immune system. The Company is developing new generation antigen-tailored dendritic cell vaccines (DCs), T-cell receptor-based adoptive T-cell therapies and T-cell-specific monoclonal antibodies (TABs).

The DC vaccines are currently being evaluated in a company-sponsored clinical trial in acute myeloid leukaemia (AML). Further studies utilizing Medigene’s DC vaccine technologies include two ongoing clinical investigator-initiated trials (IITs), a clinical phase II trial (prostate cancer) at Oslo University Hospital and a clinical phase I/II trial (AML) at the Ludwig-Maximilians University Hospital Großhadern, Munich, as well as a compassionate use programme[1] including patients with diverse malignancies.

For the TCR platform, the activities are focused on the preparation of the first clinical trial with TCR product candidates and on the further development of a GMP compliant production process. In addition, novel TCRs with specificities for promising tumour-associated antigens will be isolated and further characterised. Medigene plans to participate in an academic Phase I trial for the treatment of haematological malignancies which is projected to commence in the first half of 2016, subject to grant funding.

On June 30, 2015 Ignyta reported the release for clinical use of its first clinical trial assay to support patient identification and enrollment into its STARTRK ("Studies of Tumor Alterations Responsive to Targeting Receptor Kinases") clinical development program for entrectinib (Press release, Ignyta, JUN 30, 2015, View Source [SID:1234506011]). Entrectinib is the company’s proprietary oral tyrosine kinase inhibitor, targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK.

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"A key tenet of Ignyta’s vision to be a leading precision oncology company is our ability to seamlessly integrate Rx with Dx to detect appropriate cancer patients to treat with highly targeted agents," said Jonathan Lim, M.D., Ignyta’s Chairman and Chief Executive Officer. "Today we have taken a major step toward achieving that vision by releasing for clinical use Ignyta’s first clinical trial assay, which was co-developed with ArcherDx and validated within Ignyta’s own diagnostic labs. Ignyta’s CLIA-registered, QSR-compliant diagnostic lab in San Diego will utilize this assay in acting as the central testing lab for patient screening for the STARTRK-2 study."

STARTRK-2 is a global Phase 2 study that will further evaluate the safety and efficacy of entrectinib, and the design was recently summarized at Ignyta’s Management Presentation during the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference.

The NGS-based clinical trial assay will initially be performed only to identify potential patients for clinical trial enrollment and will not be offered for commercial use.

On June 30, 2015 Aeterna Zentaris reported that it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer (Press release, AEterna Zentaris, JUN 30, 2015, View Source;q=675 [SID:1234506531]). The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival.

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Following its first pre specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016.

David A. Dodd, Chairman and CEO of Aeterna Zentaris, commented, "We are very excited to have completed patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer earlier than expected, and I would like to thank everyone involved in this project for their steadfast commitment. We believe zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that we do not intend to pursue ourselves. Furthermore, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to provide therapies to patients and their physicians that can potentially improve and extend the quality of lives."

About the ZoptEC Phase 3 trial

The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.

For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).

About Zoptarelin Doxorubicin

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique, significantly lower cost in the manufacturing process.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 55,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.