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)

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.

On Apr 7, 2015 Panther Biotechnology, Inc. ( OTC PINK : PBYA ), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic and autoimmune disorders reported that it has entered into a definitive agreement with privately held Faulk Pharmaceuticals, Inc. to acquire Faulk’s pharmaceutical technology assets (Press release, Panther Biotechnology, APR 7, 2015, View Source [SID1234517414]). The transaction will provide Panther Biotechnology with a proprietary, multinationally patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications.

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The lead development program is a ligand-drug conjugate, TRF-DOX, a combination of transferrin glycoproteins with Doxorubicin for targeted delivery to tumors with the reduction of serious side effects. Clinical results demonstrate significant improvement over Doxorubicin. In a randomized, double blind, controlled study of patients with advanced FIGO stage IV ovarian cancer, the addition of either TRF-DOX or Doxorubicin to conventional chemotherapy was compared. Treatment with TRF-DOX resulted in a statistically significant increase in survival over Doxorubicin in patients with drug resistant ovarian cancer. In a non-blinded study in patients with acute leukemia, TRF-DOX was dosed at 10% of the usual dose and demonstrated an 87% decline in cancer cells circulating in the blood and no extension of the disease to bone marrow in 100% of the patients. TRF-DOX also exhibited a complete response of both the primary tumor and metastatic lesions in a patient with angiosarcoma after having failed three months of standard chemotherapy. Panther plans to submit applications for a phase 2 study in ovarian cancer and a phase 1a / 1b study in lung cancer.

TRF-DOX leverages the targeting ability of the plasma protein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself. Cytotoxicity studies demonstrate that a dose reduction of ten to one hundred-fold kills all cancer cells in multiple indications. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.

Under the terms of the agreement, in exchange for substantially all the assets of Faulk Pharmaceuticals, Panther will issue shares of the common stock of Panther Biotechnology, Inc. in addition to a tiered royalty payment agreement based on the achievement of specified revenue milestones for any commercialized products based on the acquired technology. As part of the agreement, Panther will also gain access to a strong research and development network and a portfolio of domestic and international patents. The transaction is expected to close by the end of May.
"We are very excited to be acquiring Faulk Pharmaceutical’s technology, which we see as complementary to our efforts to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer," stated Evan Levine, Chief Executive Officer of Panther Biotechnology. "This acquisition is a continuation of our strategy to build out a robust pipeline with novel pharmaceutical technologies that improve the efficacy and tolerability of validated therapies."

"Panther’s expanded pipeline now includes both early and later stage drugs that address multi-billion dollar market opportunities for cancer and autoimmune diseases. The oncology assets under exploration include molecules targeting certain cancer stem cells," said Dr. Jayesh Mehta who is a Director of Panther and Professor of Medicine at the Northwestern University Feinberg School of Medicine, and heads the Hematopoietic Stem Cell Transplant Program of Northwestern Memorial Hospital.

"Our decision to join Panther has been driven both by our conviction in their ability to leverage our technology platform and also by the high value we see in the TRF-DOX program," stated Dr. W. Page Faulk, founder of Faulk Pharmaceuticals. "We look forward to taking an active role in advancing TRF-DOX into new clinical trials, in addition to furthering the development of the pipeline of drug candidates we created. We are very pleased to become part of a company that shares our commitment to improving the lives of patients suffering from cancer and other diseases with high unmet medical needs."

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."