Cancer Research Technology and Medivir collaborate to develop new class of cancer drugs

On April 13, 2015 Cancer Research Technology (CRT), Cancer Research UK’s commercialisation and development arm, and Medivir AB (Nasdaq Stockholm: MVIR) reported a partnership to develop a new class of drugs that has shown promise for treating a range of different cancers, especially breast and pancreatic cancer (Press release, Cancer Research Technology, APR 13, 2015, View Source [SID1234523206]).

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As part of the collaboration, CRT and Medivir will conduct a two-year research programme to optimize and develop small molecules targeting the cell surface protein ADAM8, which has been linked to tumour survival, cell invasion and metastasis.

Under the terms of the agreement Medivir receives an exclusive, global license to research, develop, manufacture and commercialize ADAM8 inhibitor drugs resulting from development. CRT receives an upfront payment and future success milestones as well as royalties on sales which are shared with the academic collaborators.

Blocking ADAM8 in mice with pancreatic cancer prevented the spread of the disease, shrunk tumours and significantly extended lifespan. This is thought to be due to its involvement in cell adhesion, cell migration, inflammation and the growth of blood vessels – key processes that many cancers rely on for growth and development. High levels of the protein have been linked with more aggressive tumours including those in pancreatic, brain, prostate, lung, head and neck, and kidney cancers.

This research will be led by Professor Jörg Bartsch as head of the TransMIT-Project Division for Research in Neuro-Oncology at TransMIT GmbH, located at Marburg University in Germany, in collaboration with Medivir. Prof. Bartsch previously worked at King’s College London where the initial patent application was filed by King’s College IP and Licensing team. Further proof of concept studies were funded by Cancer Research UK at King’s College.

Professor Bartsch said: "We are very glad and excited to see this collaboration come to life. The synergy of expertise between Medivir and our Laboratory forms an excellent platform for successful exploration of this first-in-class approach to targeted therapy against ADAM8. This really is ‘bench-to bedside’ research at its best."

Niklas Prager, Medivir’s CEO, said: "This collaboration is a demonstration of our commitment to advance oncology drug discovery at Medivir and we are pleased to partner with such a renowned institution such as Cancer Research UK, and with Professor Bartsch, a leading researcher in the field."

Dr Keith Blundy, Cancer Research Technology’s chief executive officer, said: "Medivir’s significant expertise in protease inhibitor design coupled with CRT’s proven track record in drug development will hopefully pave the way for an exciting new class of drugs for treating cancer. Exploratory studies indicate that ADAM8 is an attractive target across many types of cancer, and potentially other diseases driven by inflammation, and we look forward to further exploring that promise through this innovative collaboration."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

SignPath Pharma has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, SignPath Pharma, APR 9, 2015, View Source [SID1234502976]).

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Boston Strategic Corporation Announces Name To Strategia Therapeutics, Inc.

On April 8, 2015 Boston Strategic Corporation, an innovative pharmaceutical R&D company that specializes in streamlining the drug development processes, reported its new name: Strategia Therapeutics, Inc., effective immediately (Press release, Boston Strategics, APR 8, 2015, View Source [SID:1234514749]).

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The change, which comes on the Boston-based company’s third anniversary, more accurately reflects its emphasis on serving patients in need, says President and CEO Keizo Koya, Ph.D. "Strategia’s vision is to change the existing drug research and development paradigm," Koya says. By creating a nimble approach to drug development, he notes, the company can reduce overall costs and time to market, thereby making new, affordable drugs available to patients whose medical needs would otherwise be unmet.

Strategia’s approach is a dramatic break from existing R&D models, which rely mainly on a single company’s in-house research, testing, and production. Instead of using one team to create many different drugs, Strategia pulls together customized global project teams for each new therapeutic agent under development. These teams, which Strategia manages, are made up of partners with specific expertise relevant to a certain drug or medical condition.

"We place drug development strategy first," says Koya. "This approach streamlines existing research and development extensively, and it lets Strategia create new, effective therapeutics faster and more efficiently than ever before," he adds. "Our primary goal is positively impacting patient health—so our success is measured by how quickly and effectively we make new drugs accessible to those patients," he says.

Strategia was founded in April 2012. Since then, the company has collaborated with global partners who have the same vision and passion for improved patient care, and has advanced many new pharmaceutical R&D projects from research to clinical development. Its core team of strategists collectively have more than 200 years of experience in drug development.

The company’s new logo design and tagline ("A New Vision. A Better Future for Patients,") symbolize its new mission.

Former name:Boston Strategics Corp.
New name:Strategia Therapeutics, Inc.

【Startegia Therapeutics, Inc. Profile】
Company Name: Strategia Therapeutics, Inc.
President and CEO: Keizo Koya, Ph.D.
Headquarter Address: 214 Union Wharf, Boston, MA 02109-1204, USA
About Strategia Therapeutics, Inc. (Strategia)

Alligator Bioscience Starts a Clinical Phase 1 Multicenter Trial

On April 7, 2015 Alligator Bioscience AB, a privately held Swedish biotech company developing immuno-oncology antibodies for directed immunotherapy of cancer, reported initiation of a phase 1 clinical trial of ADC-1013 for patients with advanced solid tumor disease (Press release, Alligator Bioscience, APR 7, 2015, View Source [SID1234538695]). ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immunostimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulation of CD40 on dendritic cells initiates a process leading to a dramatic increase in T effector cells attacking the tumor. In addition, a tumor-specific memory is established leading to long term immunity to the cancer.

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"This is a very important milestone for Alligator Bioscience" said Peter Benson, Chairman of the Board of Directors. "ADC-1013 has a very strong pre-clinical data package that gives high hopes for impressive clinical efficacy as well as an excellent safety profile that would allow combinations with other immune-oncology antibodies".

The phase 1 trial is a first-in-human, multicenter, open-label, multiple ascending dose study in patients with advanced solid tumors to determine the safety, pharmacokinetics and pharmacodynamics of intratumorally administered ADC-1013. The study includes a dose escalation part followed by an expansion at the optimal biological dose level. The primary endpoints are to identify the maximum tolerated dose and to study the safety and tolerability of ADC-1013. In addition, the trial will evaluate pharmacokinetics, immunogenicity, pharmacodynamics, antitumor activity, as well as mechanism of action of ADC-1013. The study will enroll up to 40 patients during the dose escalation and expansion phases at five centers in the United Kingdom, Denmark and Sweden. The study is managed by the international oncology contract research organization Theradex.

ADC-1013 has been developed in close collaboration with Professor Thomas Tötterman, Uppsala University, Sweden. Professor Tötterman is a pioneer in directed immunotherapy of cancer, a concept where the immune system is selectively activated locally in the tumor microenvironment in order to reduce systemic side effects while optimizing systemic anti-tumor effects. Professor Tötterman´s group has performed a number of successful in-vivo experiments demonstrating the powerful immune mediated anti-tumor effects of ADC-1013. The pre-clinical assessment of ADC-1013 indicates a favorable tolerability profile, which is likely to be further improved by the intratumoral route of administration in the first clinical trial. Manufacturing of ADC-1013 was performed by Cobra Biologics, using the maxXpress platform and the Ubiquitous Chromatin Opening Element (UCOE) technology, and by BioInvent International, who performed process development and manufacturing of the non-GMP and GMP batches.

AMPHIVENA THERAPEUTICS ACHIEVES DEVELOPMENT MILESTONES UNDER AGREEMENT WITH JANSSEN

On April 7, 2015 Amphivena Therapeutics, Inc., a developer of cancer immunotherapeutics reported the achievement of the first and second milestones under the terms of its agreement with Janssen Biotech, Inc. Amphivena and Janssen have selected a clinical candidate against an undisclosed tumor antigen for further development in hematologic malignancies (Press release, Amphivena Therapeutics, APR 7/, 2015, View Source [SID:SID1234515577]). The milestones triggered the release of payments to Amphivena. The financial details were not disclosed.
The agreement was facilitated by Johnson & Johnson Innovation.

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Amphivena’s clinical candidate is based on the RECRUIT-TandAb platform, licensed from Affimed GmbH. RECRUIT TandAbs are bispecific molecules, with two binding sites for each specificity, that mediate potent and efficient tumor cell lysis by selectively binding to a tumor antigen on a cancer cell and the CD3 receptor complex on a T cell. They offer pharmacokinetic advantages over smaller, monovalent bispecific constructs.

"We are delighted to have achieved our milestones earlier than anticipated and look forward to advancing our therapeutic candidate rapidly to the clinic to address the unmet needs of patients suffering from life-threatening cancers," said Jeanmarie Guenot, Ph.D., president and chief executive officer of Amphivena Therapeutics.

"We believe Amphivena’s clinical candidate holds significant promise as a new, potent anti-cancer therapy," stated Luke Evnin, Managing Director of MPM Capital, and Amphivena’s lead investor. "We also appreciate Janssen’s ongoing support of, and participation in this important program, which we believe offers further validation of this novel approach to cancer treatment."