1stOncology™: Cancer Intelligence Service – Page 16109 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Provectus Biopharmaceuticals’ Data on PV-10 for Chemoablation of Liver Cancers Presented at ESMO 17th World Congress on Gastrointestinal Cancer

On July 2, 2015 Provectus Biopharmaceuticals reported that data from its phase 1 study of PV-10 for chemoablation of hepatocellular carcinoma (HCC) and cancer metastatic to the liver was presented at the ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer (ESMO-GI) (Press release, Provectus Pharmaceuticals, JUL 2, 2015, http://www.pvct.com/pressrelease.html?article=20150702.1 [SID:1234506021]). The main conclusion was that preliminary evidence of efficacy in treatment of liver cancers with PV-10 was observed. The poster presentation was made by Eric Wachter, Ph.D., Chief Technology Officer of Provectus.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Provectus has previously reported data on clinical and nonclinical testing of intralesional PV-10, a 10% solution of rose bengal, as an investigational treatment for metastatic melanoma, where it has demonstrated high rates of complete response and durable local control in melanoma lesions. The current phase 1 study reported at ESMO (Free ESMO Whitepaper)-GI was designed to assess safety, pharmacokinetics, and preliminary efficacy of PV-10 in subjects with non-resectable HCC or other types of cancer metastatic to the liver.

In the phase 1 liver study, subjects having a target lesion in the liver at least 1 cm in diameter were administered a single percutaneous injection of PV-10 into their target lesion. Plasma concentrations of PV-10 from 1 hour to 28 days after injection were measured. Radiologic assessments of the injected target lesion were performed to determine response over an initial 28-day and longer term 9-15 month follow-up period. Serum levels of potential liver injury markers were measured, and adverse events recorded.

In the initial study cohort, six subjects received PV-10 injections in two successive escalating dose cohorts of 0.25 and 0.50 mL per cm3 lesion volume. Significant adverse events were limited to injection site and photosensitivity reactions that resolved without sequelae. All injected tumors were stable in size at 28 days, and among four of the initial six tumors that had longer-term assessment, two had partial response.

Based on these data, the researchers concluded that preliminary efficacy in treatment of liver tumors with PV-10 was observed with acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to further assess safety and response in HCC and other cancers metastatic to the liver.

The poster is now available online at: http://www.pvct.com/publications/ESMO-2015-PV-10-LC-01.pdf.

About ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer

The ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer is the premier global event in the field, encompassing malignancies affecting every component of the gastrointestinal tract and aspects related to the care of patients with gastrointestinal cancer, including screening, diagnosis and the latest management options for common and uncommon tumors. For additional information about the ESMO (Free ESMO Whitepaper) 17th World Congress, please visit View Source

Provectus Biopharmaceuticals Signs Letter of Intent with Boehringer Ingelheim (China) to Collaborate in Bringing PV-10 to Market in China

On July 2, 2015 Provectus Biopharmaceuticals reported that it has signed a Letter of Intent (the "LOI") with Boehringer Ingelheim (China) Investment Co. Ltd. ("Boehringer") (Press release, Provectus Pharmaceuticals, JUL 2, 2015, http://www.pvct.com/pressrelease.html?article=20150702.2 [SID:1234506020]). The purpose of the LOI is to lay a foundation for the two parties to collaborate in bringing PV-10, Provectus’ novel investigational drug for cancer ("PV-10"), to market in mainland China, Hong Kong and Taiwan. Maxim Group LLC acted as strategic advisor to Provectus in structuring and negotiating the LOI.

Under the terms of the LOI, Boehringer will provide certain commercially reasonable support in the aspects of product registration with the China Food and Drug Administration ("CFDA"), communication preparation, market intelligence and other assistance to Provectus in China to the extent that is within Boehringer’s approved business scope and permissible by Chinese laws.

In return, Provectus will grant Boehringer the first priority to be the exclusive collaborator of Provectus in China for PV-10 in the event that PV-10 is successfully registered and approved by the CFDA. The exclusive collaboration may take the form of exclusive distribution and promotion, exclusive licensing or other agreement, subject to both parties’ mutual agreement. At the appropriate time, Provectus and Boehringer will enter into a definitive agreement, including a non-compete provision, for PV-10 to be exclusively developed, distributed and promoted through the collaboration within China, although there can be no assurance that the parties will enter into a definitive agreement.

In the LOI signed today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2015 in Barcelona, the two parties have agreed to meet regularly and maintain effective communication in order to move forward with the registration and commercialization of the product and assess the potential cooperation between them in China, which may be adopted in a form of exclusive commercial supply, distribution and promotion, partnership or any other forms suitable to both parties’ interests.

Stephen Doyle, Vice President and Head of Specialty Care, China, at Boehringer, said, "We are impressed with the work the management of Provectus and its researchers have done so far in developing PV-10 as a potential treatment option for melanoma and cancers of the liver. At Boehringer Ingelheim we are committed to research and development in areas of high unmet need such as liver cancer. If successful, we believe that many Chinese patients could benefit from being treated with PV-10. Because of this, and the data generated so far, we are prepared to provide the commercially reasonable support Provectus may need to get PV-10 through the drug development and registration approval process in China."

Peter Culpepper, CFO and COO of Provectus, said, "We are excited about the potential of PV-10 in China and in commencing a working relationship with Boehringer Ingelheim to bring PV-10 to market there. We are confident that Boehringer Ingelheim’s expertise in navigating the regulatory requirements in China will prove beneficial to us, and we are also confident that a commercial collaboration will benefit both companies. In addition, we believe that a successful partnership with Boehringer Ingelheim in China will provide us with experience in dealing with regulatory systems outside the US and help us take PV-10 to a global marketplace."

Adaptimmune Announces FDA Acceptance of Investigational New Drug (IND) Application for MAGE-A10 T in Patients with Non-small Cell Lung Cancer

On July 2, 2015 Adaptimmune reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for autologous genetically modified T-cells expressing enhanced T cell receptors
(TCRs) specific for MAGE A10 (MAGE-A10 T) in patients with locally advanced or metastatic non-small cell
lung cancer (NSCLC), and that the IND is now active (Press release, Adaptimmune, JUL 2, 2015, View Source [SID:1234506018]).

The acceptance of this IND allows Adaptimmune to initiate an open label Phase I/II study designed to
evaluate its wholly-owned MAGE-A10 T therapeutic candidate in NSCLC. Site initiation activities are now
underway, and the Company anticipates that enrollment will begin in 2015.

Know more, wherever you are:
Latest on CAR/TCR Therapies in Oncology, book your free 1stOncology demo here.

MAGE-A10 (melanoma antigen family A10) is a member of the MAGE-A family of cancer/testis tumorassociated
antigens. It is believed to be expressed in approximately 30 percent of lung (squamous cell
carcinoma), bladder and skin melanomas, and at a lower incidence in many other cancers. Adaptimmune’s
proprietary technology enables the Company to routinely generate TCRs which address intracellular
targets, such as MAGE-A10, that are not accessible to certain other experimental modalities.

"The FDA’s acceptance of this IND represents an important step in our strategy to identify and develop new
T-cell-based immunotherapeutics to combat non-small cell lung cancer and other cancers, and we are
excited to be working toward initiating clinical development of another of our promising TCR therapeutic
candidates," said James Noble, Adaptimmune’s Chief Executive Officer. "In addition, this validates the
progress we are making in applying our platform to develop a broad pipeline of novel proprietary TCR
therapeutics."

This will be an open label phase I/II dose escalating study of three doses of genetically engineered MAGEA10
T-cells in HLAA*0201 and HLA-A*02:06 patients with advanced (stage IIIB or stage IV) NSCLC whose
tumors express this antigen. The study will assess the safety and tolerability of MAGE-A10 T in these
patients. Secondary objectives will include the assessment of efficacy of MAGE-A10 T, measurements of
durability of persistence of MAGE-A10 T-cells in the blood, and evaluations of the phenotype and
functionality of MAGE-A10 T-cells.

About Adaptimmune’s TCR Technology
Adaptimmune’s proprietary TCR technology enables the Company to genetically optimize T-cell receptors
(TCR) in an effort to equip them to recognize and bind cancer antigens that are presented in small
quantities on the surface of a cancer cell, whether of intracellular or extracellular origin, thus initiating cell
death. The Company’s differentiated, proprietary technology allows it to reliably generate parental TCRs to
naturally presented targets, affinity optimize its TCRs to bind cancer proteins from solid and hematologic
cancers that are generally unavailable to naturally occurring TCRs, and to significantly reduce the risk of
side effects resulting from off-target binding of healthy tissues.

About NSCLC
Lung cancer is the third most common form of cancer in the US after prostate cancer in men and breast
cancer in women. However, it is by far the leading cause of cancer deaths in both men and women in the
United States. Non-small cell lung cancer or NSCLC is the most common type of lung cancer, representing
approximately 85 percent of lung cancers. The 1- and 5-year relative survival rates for lung cancer are 44
percent and 17 percent, respectively. More than half of lung cancer patients (57 percent) are diagnosed at
a late stage of cancer development, for which the 1- and 5-year survival is only 26 percent and 4 percent,
respectively.

FDA Grants Soligenix “Fast Track” Designation for SGX301 for the First-Line Treatment of Cutaneous T-Cell Lymphoma

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]).

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.

4SC strengthens patent protection for lead cancer compound resminostat

On July 1, 2015 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for cancer and autoimmune diseases, reported that the company has managed to further strengthen its patent portfolio for its lead clinical anti-cancer programme resminostat (Press release, 4SC, JUL 1, 2015, View Source [SID:1234506542]).

For the epigenetic agent resminostat, an HADC inhibitor targeting in particular HDAC 1, 2, 3 and 6, the US Patent Office has granted the patent for the medical use in cancer indications. The patent relates to the so-called method of treatment claims, and covers medical application of resminostat in mono- and/or combination therapy for cancer indications.

In addition, the Canadian patent authority has granted the composition of matter patent for resminostat. Thus resminostat has now composition of matter protection in all major markets including the US, Europe, Japan, China, South Korea, Russia, India, and now Canada.

The granting of the two patents constitutes an additional protection against potential competitors and thus further strengthens the protection of 4SC’s intellectual property assets, including the composition of matter, mesylate salt and manufacturing patents of resminostat, for which up to date patents have been granted in 58 countries, including the major markets.

Enno Spillner, Chief Executive Officer of 4SC, said: "We are pleased to announce the recent additions to our patent portfolio. The two patents will further strengthen not only the wide strategic position of our resminostat programme but also of 4SC as an important player in the field of epigenetic cancer therapies." Enno Spillner continued: "Especially, the resminostat medical application patent shows the broad possibilities of future use of our lead drug candidate. This is in particular evident in the light of the recently announced additional clinical use by our partner Yakult Honsha in pancreatic and biliary tract cancer as well as our own planned European Phase II trial in the indication of CTCL."

About Resminostat
Resminostat (4SC-201) is an oral histone-deacetylase (HDAC) inhibitor, targeting in particular HDAC 1, 2, 3 and 6, with an innovative epigenetic mechanism of action that potentially enables the compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications, both in monotherapy and, in particular, in combination with other cancer drugs. Like other epigenetic therapies, resminostat modifies transcription of genes in cancer cells and, thereby, reprograms the phenotypes of such cancer cells. Additionally, resminostat has immunotherapeutic effects by activating NK cells, restoring MHCI and MHCII proteins and suppression of unspecific immunosuppression. Resminostat is assumed to be able to halt tumour progression and induce tumour regression. Furthermore, due to its epigenetic mode of action resminostat is supposed to 2 develop additional synergetic effects when combined with classical cancer therapies and to counteract the development of tumour cell resistance.

Resminostat – by 4SC and its Japanese partner Yakult – has been investigated or is currently being investigated in a broad clinical campaign comprising liver cancer (HCC), Hodgkin’s Lymphoma (HL), colorectal cancer (CRC), non-small-cell lung cancer (NSCLC), pancreatic and biliary tract cancer. Resminostat is partnered with Yakult Honsha for Japan and with Menarini AP in the Asia Pacific (APAC) region excluding Japan. 4SC is currently in preparations of a randomised, controlled Phase II trial in the indication of advanced cutaneous T-cell lymphoma (CTCL) in Europe.