(Filing, 10-K, Advaxis, JAN 8, 2016, View Source [SID:1234508711])

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!

On January 8, 2016 Zymeworks Inc. and Kairos Therapeutics Inc., both privately-held biotech companies headquartered in Vancouver, reported they have entered into a strategic partnership whereby Zymeworks, a leader in the development of bi-specific and multi-specific antibodies, has made an undisclosed equity investment in Kairos which specializes in the discovery and development of antibody drug conjugates (ADCs) and is a spin-out of The Centre for Drug Research and Development (CDRD) (Press release, Zymeworks, JAN 8, 2016, View Source [SID:1234513928]). Under the terms of this agreement, Zymeworks and Kairos also have the option to merge to further integrate their respective platforms, resources and pipelines to accelerate the development of novel anti-cancer biotherapeutics.

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!

Kairos Therapeutics is developing a pipeline of antibody-drug conjugate therapeutics based on a proprietary toxin, linker and site-specific conjugation platform. The platform, which is currently partnered through numerous collaborations, is a key contributor to personalized medicine as it allows scientists to develop therapeutics that target cancer with increased potency and efficacy while reducing toxic side-effects.

"We are excited to work with the team at Kairos in bringing together complementary technologies for the creation of novel and highly efficacious therapies for cancer patients," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "This is an excellent opportunity to leverage the therapeutic potential of ADCs in combination with our Azymetric, AlbuCORE, and EFECT platforms to help us create first-in-class biotherapeutics. This strategic investment and opportunity to integrate Kairos’ ADC platform and expertise furthers our strategy of acquiring innovative technologies that can augment internal capabilities and accelerate development programs."

"We believe we have developed a superior antibody-drug conjugate platform which has demonstrated significant advantages over existing ADC platforms, and our proprietary approach shows promise in the development of treatments for a range of different cancers," said John Babcook, President and Chief Scientific Officer of Kairos. "I’m excited to bring together the complementary technologies of Kairos and Zymeworks to create cancer therapeutics that have the potential to be transformative to the lives of patients."

CDRD President and CEO, Karimah Es Sabar added, "We are proud of the Kairos ADC platform and the work that has led to this agreement with Zymeworks. As Canada’s national drug development and commercialization centre, CDRD is in a unique position to provide world-class drug development infrastructure to incubate many exciting technologies, and this enabled and accelerated the development of Kairos’ novel platform. The combined forces of these two BC-based Canadian companies is a testament to the strength of this cluster and the innovation and translation capabilities in British Columbia – and across Canada."

On January 8, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported the presentation of new data describing the novel mechanism by which galeterone degrades the androgen receptor (Press release, Tokai Pharmaceuticals, JAN 8, 2016, View Source;p=RssLanding&cat=news&id=2127712 [SID:1234508732]). Galeterone, Tokai’s lead product candidate, is being developed for the treatment of men with metastatic castration-resistance prostate cancer (mCRPC).

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!

The presentation, "Galeterone-induced Degradation of the Androgen Receptor Involves Inhibition of a Deubiquitinating Enzyme," was one of three made by Tokai researchers at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium this week in San Francisco. Additional presentations highlighted favorable results from a drug-drug interaction study involving galeterone and oral midazolam, and described Tokai’s progress in implementing a novel clinical trial assay for selecting AR-V7+ patients for enrollment in the ongoing pivotal Phase 3 ARMOR3-SV study.

Presentation Overview
Galeterone is a highly selective oral small molecule drug candidate that disrupts androgen receptor (AR) signaling by degrading the androgen receptor. Galeterone has been demonstrated to induce AR degradation in forms of the disease that exhibit full-length AR, as well as in those with a truncated AR where the ligand-binding domain is not present, such as in AR-V7+ and AR567es+ disease. These and earlier observations demonstrate that an intact ligand binding domain is not required for galeterone-induced AR degradation.

To elucidate the galeterone mechanism further, researchers conducted a series of biochemical and cell-based in vitro studies which pinpointed two deubiquitinating enzymes that galeterone inhibits – USP12 and USP46. By doing so, galeterone induces AR degradation through a unique mechanism that does not exist with other currently available AR-targeting agents. These new data provide a strong preclinical rationale for galeterone’s enhanced ability to induce AR degradation, even in the absence of the ligand binding domain.

"These data provide a view into the novel activity of galeterone and highlight its potential to treat segments of the mCRPC population currently underserved by available therapies," said Jodie Morrison, President and Chief Executive Officer of Tokai. "These data further support the rationale for the ARMOR3-SV pivotal study and inform our ongoing clinical development strategy as we seek to advance galeterone for all patient populations who may benefit."

On January 8, 2016 Pfizer Inc. (NYSE:PFE) reported an expansion of its Research & Development (R&D) investment strategy to include early-stage companies on the leading edge of scientific innovation, providing them with both equity and access to resources for research in promising areas aligned with Pfizer’s core interests (Press release, Pfizer, JAN 8, 2016, View Source [SID:1234508725]). The first four investments of the newly focused initiative include $46 million in financing to companies at early stages of the discovery process that are actively exploring Conditionally Active Biologics (CABs), immuno-oncology, neurodegenerative technologies and gene therapy. Additional opportunities will continue to be identified by Pfizer’s scientific leadership through their active involvement, and Pfizer will help recipient companies fully explore their platforms in the hopes of advancing new therapeutic pathways.

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!

"There is exciting scientific discovery happening both within Pfizer and beyond our walls, and we look forward to continuing to explore opportunities to bring our resources to emerging companies investigating in areas where we feel we could make a difference for patients," said Mikael Dolsten, M.D., Ph.D., President of Pfizer Worldwide Research and Development. "The key for Pfizer is to be flexible in how we partner with different companies; we use a range of investment vehicles and collaboration models in R&D to help ensure we tap into the vast, rapidly-evolving ecosystem of healthcare innovation, looking to complement each other’s capabilities so that together we can make a bigger impact."

Today, Pfizer is announcing its investments in the following companies:

BioAtla employs expertise in protein engineering to develop monoclonal antibodies with CAB profiles, a new class of biologic therapeutics that are activated in selected microenvironments within the body, such as those associated with cancerous tumors. As part of the agreement, BioAtla and Pfizer will each have a license to the other’s respective technology to pursue the development and commercialization of several drug-conjugated conditionally-active antibodies. Pfizer also gains an exclusive option to develop and commercialize BioAtla CAB antibodies that target CTLA4, an immuno-oncology target in humans.

NextCure Inc., a new biopharmaceutical company Pfizer helped to form, is focused on the discovery and development of novel immuno-oncology therapeutic products. NextCure was founded by Michael Richman, former CEO of Amplimmune, Inc., who will serve as president and CEO, and Lieping Chen, M.D., Ph.D., United Technologies Endowed Professor of Cancer Research, Professor of Immunobiology, Dermatology, and Medicine at the Yale School of Medicine. The company will develop product candidates licensed from Dr. Chen’s laboratory utilizing a proprietary platform to discover and develop potential novel immuno-oncology targets.

Cortexyme, Inc. is developing novel treatments that aim to alter the course of neurodegenerative diseases. The company is seeking to develop therapeutics based on data supporting a new theory about the underlying cause of Alzheimer’s disease and other degenerative disorders, targeting a specific, undisclosed pathogen linked to neurodegeneration. The target has been validated in a number of animal models and Cortexyme is currently testing several potential lead therapeutics in preclinical studies.
4D Molecular Therapeutics, Inc., an emerging biopharmaceutical company, is working to design, develop and commercialize potentially transformative gene therapy products for serious unmet medical conditions. The company’s Therapeutic Vector Evolution discovery platform allows for the generation of gene vectors that are optimized for efficient gene delivery and uptake, tissue specificity, and evasion of pre-existing antibodies present in most patients. With this investment, Pfizer has been granted an option to exclusively license one or more adeno-associated virus (AAV) vectors for selected cardiac disease-related targets.

Through flexible equity investment and partnership models, Pfizer provides access to world-class scientists, expertise and drug-discovery capabilities, including enabling proprietary technologies, and actively participates in the development of early-stage innovations. The ultimate goal of these investments is to accelerate the pace at which good scientific ideas can become promising therapies. This expanded R&D investment strategy is focused on high-priority therapeutic areas of research where Pfizer is best positioned to bring unique, high-impact therapies to patients not well-served by current treatments. Particular areas meeting these criteria include chronic inflammatory and autoimmune diseases, vaccines, oncology, neuroscience and pain, cardiovascular and metabolic disease, and rare diseases.

On January 8, 2016 Diffusion Pharmaceuticals LLC, a clinical-stage biotechnology company focused on the development of novel small molecule therapeutics for cancer reported the successful completion of its merger with RestorGenex Corporation (OTCQX:RESX) (Press release, Diffusion Pharmaceuticals, JAN 8, 2016, View Source [SID:1234508714]). The combined company is changing its name to Diffusion Pharmaceuticals Inc.

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!

"Becoming a public company is a key element of our strategy, and the completion of this merger is a significant accomplishment for the Diffusion team," said David Kalergis, chairman and chief executive officer of Diffusion Pharmaceuticals. "We believe that our novel oncology therapeutics for treatment-resistant solid cancers have tremendous potential, and that becoming a publicly traded company affords us the greatest opportunity to capitalize on this large and growing market opportunity." Mr. Kalergis added, "We would like to thank the board and management team of RestorGenex for their confidence in merging our two companies for the benefit of our respective stockholders."

Diffusion Pharmaceuticals Inc. will continue to develop its lead drug candidate, trans sodium crocetinate (TSC), which has demonstrated positive results in a Phase 2 clinical trial in patients newly diagnosed with glioblastoma multiforme (GBM). TSC has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of GBM and expects to enter a Phase III study in newly diagnosed GBM patients in 2016. Future development of TSC includes other orphan indications. The company is planning to commence a Phase II/III trial in pancreatic cancer in 2016 with a Phase II/III study in brain metastases to follow. TSC’s novel mechanism of action enhances the diffusion of oxygen to cancerous tumors, improving the effects of cancer treatments like radiation therapy and chemotherapy. Diffusion will review and prioritize products formerly in the RestorGenex pipeline.

MTS Securities, LLC. acted as exclusive financial advisor to Diffusion and Dechert LLP acted as legal counsel to Diffusion. Raymond James & Associates, Inc. acted as exclusive financial advisor to RestorGenex and Fox Rothschild LLP acted as legal counsel for RestorGenex.