On July 16, 2015 PIQUR Therapeutics AG, a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative anti-cancer drugs based on PI3K and mTOR inhibition, reported the closing of an oversubscribed CHF 18 million (USD 19M) round of Series A2 financing (Press release, PIQUR Therapeutics, JUL 16, 2015, View Source [SID1234527274]). This round was backed by several existing investors, including Versant Ventures, as well as new, private investors.

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The new funding brings the total capital raised by PIQUR to date to over CHF 55 million (USD 60M). The company plans to use the funding to further strengthen its operational basis and to extend the financing horizon for additional Phase 2 studies for its lead compound PQR309, which has shown preclinical activity in different aggressive cancer cell lines inhibiting the PI3K/mTOR pathway, as well as clinical activity in phase 1. In addition, the new funding will support the preclinical safety and first clinical studies for one of its follow-up compounds.

"We greatly appreciate the continued support provided by our existing shareholders and welcome our new investors who bring valuable perspective, experience, and capital resources to the company," said Vladimir Cmiljanovic, CEO of PIQUR. Gaudenz von Capeller, PIQUR’s CFO, commented: "This financing strengthens our balance sheet as we work to achieve important milestones for our lead candidate as well as the follow-up compound."

Helping patients to survive cancer
PIQUR aims to help patients to survive cancer. Two out of three people are now living at least five years after their cancer has been diagnosed. Despite of significant medical innovations in the treatment of cancer, there remains a high unmet medical need for therapies that prolong patients’ survival and improve their quality of life. PIQUR targets both PI3K (phosphoinositide 3-kinase) and mTOR (mammalian target of rapamycin), two key signaling molecules that are vital to several essential biological processes involved in malignant disease, such as cell growth, proliferation, survival and metastasis, making them attractive targets in cancer therapy.

About PQR309
PIQUR’s lead compound, PQR309, is a novel, oral, balanced pan- PI3K/mTOR inhibitor with excellent prospects to become a powerful anti-cancer drug. PQR309 compares favorably to current and clinically most advanced pan-PI3K/mTOR inhibitors with respect to the drug-like properties. Unlike most of its competitors, PQR309 crosses the blood-brain barrier, expanding its use to oncologic as well as hematologic malignant diseases involving the brain. PQR309 showed preclinical activity in different aggressive cancer cell lines inhibiting the PI3K/mTOR pathway, as well as clinical activity in phase 1.

On July 15, 2015 Provectus Biopharmaceuticals reported that it continues to work with Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm A-Think Pharmaceutical Co., Ltd to reach an agreement on PV-10 use in China (Press release, Provectus Pharmaceuticals, JUL 15, 2015, http://www.pvct.com/pressrelease.html?article=20150715.1 [SID:1234506347]).

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Discussions continue with the frame of reference established in the original Memorandum of Understanding, or MOU, signed last year and extended since the passing of the original deadline. The original MOU was signed in August 2014, and, since then, the parties have sought to enter into a definitive licensing agreement, subject to additional negotiation, due diligence, and any required regulatory and corporate approvals.

Since the signing of the MOU, management of Provectus and senior personnel at Sinopharm-CSIPI and Sinopharm A-THINK have held numerous conference calls, have met face-to-face in both China and the US, and Chinese scientists on staff at Sinopharm have discussed in person PV-10 and its clinical results with the lead investigators at St. Luke’s University Hospital and Health Network and Moffitt Cancer Center.

Dr. Zhidan Jia , Chief Executive Officer of Sinopharm A-THINK, stated, "We continue to work closely with Provectus to arrive at an agreement which defines the terms of our collaboration in bringing PV-10 to the Chinese Market. We hope to come to terms in the near future."

On July 15, 2015 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that it has entered into an exclusive license agreement with privately-held immuno-oncology company, Apogenix (www.apogenix.com) to develop, manufacture and commercialize Apogenix’s lead product, APG101 in glioblastoma multiforme in China, Macao, and Hong Kong, with options for other indications (Press release, CANbridge Life Sciences, JUL 15, 2015, View Source [SID:1234510070]). APG101 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) superfamily. By blocking the CD95 ligand, APG101 restores the immune response against tumors and inhibits invasive tumor cell growth. APG101 showed an improved overall survival benefit in patients with relapsed glioblastoma in a Phase II trial conducted in Europe. Additionally, the trial showed that glioblastoma patients with a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. Apogenix is developing a companion diagnostic test to identify those patients most likely to benefit from APG101 treatment. APG101 is also in a Phase I trial for myelodysplastic syndromes (MDS) in Europe. Under the terms of the agreement, Apogenix will receive upfront and milestone payments, as well as royalty payments, at tiered, double-digit royalty rates following commercial launch of APG101 in China.

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"Development of this targeted therapeutic fits the CANbridge mission of bringing promising Western treatments to China and other Asian territories, where patients’ severe medical needs are going unmet," said James Xue, CANbridge Chairman and CEO. "The mortality rate of malignant glioma is one of the top ten among all cancers in China. With very limited treatment options, the outcomes for Chinese patients are even more grim than in the West. The potential to develop a targeted immuno-oncology product represents a tremendous advance for glioblastoma treatment in China."

"The licensing agreement with CANbridge represents an important milestone in our goal to develop and commercialize our immuno-oncology compound APG101 as a new therapy for difficult-to-treat tumor indications on an international level," said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. "We are delighted to have found a strong and committed partner with a seasoned management team and extensive drug development expertise in these important Asian markets. We look forward to working with CANbridge to obtain approval for APG101 in China, Macao, and Hong Kong, so we can provide patients suffering from glioblastoma with a novel, much-needed therapeutic option as soon as possible."

"The CANbridge and Apogenix missions and cultures are perfectly aligned, which bodes well for the success of this partnership," said Henri Termeer, CANbridge’s Advisor and former Chairman and CEO of Genzyme Corporation. "Each company is dedicated to bringing forth treatments in their respective markets for patients with few options. Together, CANbridge and Apogenix can move this exciting program forward more effectively than either could alone in China."

"Glioblastoma multiforme is a very serious disease with limited therapeutic options at present. Based upon the data already generated by Apogenix, I am very excited about the possibility of APG101 to greatly improve clinical outcomes in patients with glioblastoma multiforme," said Mark Goldberg, MD. Medical Advisor to CANbridge and practicing hematologist and oncologist at Brigham and Women’s Hospital and Dana Farber Cancer Institute.

On July 15, 2015 Apogenix, a next generation immuno-oncology company, reported that it has entered into an exclusive licensing agreement with CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, for the development and commercialization of lead immuno-oncology drug candidate APG101 in China, Macao, and Hong Kong (Press release, Apogenix, JUL 15, 2015, View Source [SID1234524582]). Under the terms of the agreement, Apogenix will receive upfront and milestone payments, as well as royalty payments at tiered, double-digit royalty rates following commercial launch of APG101 in China .

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APG101 is a CD95 ligand inhibitor which restores the immune response against tumors and inhibits invasive tumor cell growth. The drug candidate is being developed for the treatment of solid tumors and malignant hematological diseases. In a controlled phase II proof-of-concept trial in patients with recurrent glioblastoma, treatment with APG101 in combination with radiotherapy has demonstrated clinical superiority in all study endpoints compared to treatment with radiotherapy alone.

"The licensing agreement with CANbridge represents an important milestone in our goal to develop and commercialize our immuno-oncology compound APG101 as a new therapy for difficult-to-treat tumor indications on an international level," said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. "We are delighted to have found a strong and committed partner with a seasoned management team and extensive drug development expertise in these important Asian markets. We look forward to working with CANbridge to obtain approval for APG101 in China, Macao, and Hong Kong, so we can provide patients suffering from glioblastoma with a novel, much-needed therapeutic option as soon as possible."

In the phase II trial, glioblastoma patients expressing a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. The trial showed a statistically significant prolongation of overall survival in biomarker-positive patients treated with APG101, with a median overall survival of 16.1 months compared to 7.3 months in patients treated with radiotherapy alone. Apogenix is developing a companion diagnostic test based on this biomarker to identify those patients most likely to benefit from APG101.

"Development of this targeted therapeutic fits the CANbridge mission of bringing promising Western treatments to China and other Asian territories, where patients’ severe medical needs are going unmet," said James Xue, CANbridge Chairman and CEO. "The mortality rate of malignant glioma is one of the top ten among all cancers in China. With very limited treatment options, the outcomes for Chinese patients are even more grim than in the West. The potential to develop a targeted immuno-oncology product represents a tremendous advance for glioblastoma treatment in China."

"The CANbridge and Apogenix missions and cultures are perfectly aligned, which bodes well for the success of this partnership," said Henri Termeer, CANbridge’s Advisor and former Chairman and CEO of Genzyme Corporation. "Each company is dedicated to bringing forth treatments in their respective markets for patients with few options. Together, CANbridge and Apogenix can move this exciting program forward more effectively than either could alone in China."

(Filing, 10-Q, MultiCell Technologies, JUL 15, 2015, View Source [SID:1234506346])

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