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Curadigm announces the selection of its Nanoprimer technology by the National Cancer Institute for a characterization & development collaboration

On March 9, 2020 Curadigm, an early-stage nanotechnology company committed to improving treatment outcomes by redefining the therapeutic balance between bioavailability, toxicity, and efficacy, reported the selection of its Nanoprimer technology by the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory (NCL) for characterization, based on its potential to significantly impact treatments in multiple disease indications, including cancer (Press release, Curadigm, MAR 9, 2020, View Source [SID1234555326]).

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The broad utility of the Nanoprimer technology is due to its unique nanomedicine approach to improve therapeutic action without modifying the therapeutic in any way. Rather, the Nanoprimer is administered intravenously just prior to a therapeutic, specifically and transiently occupying the liver pathways responsible for clearance. This temporarily increases the therapeutic’s bioavailability and subsequent accumulation in target tissue. This mechanism, targeting the universal upstream pathways involved in intravenous drug clearance, means the Nanoprimer can be used in combination with multiple classes of nanomedicines including nucleic acid and small molecule therapeutics or gene editing technologies.

Through this collaboration, the NCL, a leader in the characterization and development of Nanomedicines, will perform in-depth pre-clinical characterizations. These studies will support the Nanoprimer’s development, driving advancement toward filing an Investigational New Drug (IND) with the Food and Drug Administration (FDA) and future clinical development. This work will also support ongoing and future collaborations combining the Nanoprimer with therapeutics across diverse clinical indications.

Curadigm is a 2019 Nanobiotix spin-off, that aims to reshape and elevate the efficacy of intravenously administered therapeutics. The Nanoprimer technology is based on engineered, biocompatible nanoparticles that are administered just prior to the therapeutic and acts rapidly to temporarily occupy the Kupffer and liver sinusoidal endothelial (LSEC) cells. This precision-based approach leads to enhanced systemic bioavailability for increased therapeutic action.

The NCL was established to study the use of nanoparticles and nanomedicines to advance cancer research and to accelerate the development of promising and safe nanotechnology-based cancer therapeutics. The program provides pre-clinical testing and services on a competitive acceptance basis to companies, such as Curadigm, and is working in concert with other US agencies such as the FDA to accelerate the use of nanomedicines from early-stage development to clinical applications.

"The selection of our nanoprimer by the NCL is a major step for Curadigm," said Matthieu Germain, CEO of Curadigm. "The standardized cascade assay developed by the NCL is a great opportunity to accelerate the development of the Nanoprimer by providing additional data about its physico-chemical properties, safety and mechanism of action that will facilitate regulatory review. The results generated through this collaboration will also be instrumental in supporting our discussions with partners to develop their therapeutics with the Nanoprimer."

Invicro Collaborates with Yale’s Dr. David Rimm to Expand the Utility of Quanticell™ for Clinical Pathology Applications

On March 9, 2020 Invicro LLC, a Konica Minolta Company reported it has entered into a strategic research partnership with industry leading pathologist, Dr. David Rimm, MD, PhD, at The Yale University School of Medicine to advance the development of Quanticell, Konica Minolta’s proprietary tissue biomarker detection technology (Press release, invicro, MAR 9, 2020, View Source [SID1234555325]).

Invicro is a global provider of imaging biomarkers, core lab services, CAP-CLIA pathology services, advanced analytics and software solutions for drug discovery and development. Dr. Rimm is the Professor of Pathology and Medicine; Director of Pathology Tissue Services; and Director of Translational Pathology at Yale University.

Quanticell is an ultra-sensitive, quantitative, amplification-free technology that detects proteins at the cellular and subcellular level using photostable, highly bright phosphor-integrated dots (PIDs). This nanoparticle-based detection technology circumvents the limitations observed with traditional multiplex chromogenic and fluorescent-based assays, such as signal saturation, non-linearity and high background.

"With his unmatched knowledge and experience in anatomical pathology, product commercialization, and late-stage clinical trials, Dr. Rimm is a leading pioneer in the quantitative pathology space," said Dr. Ken Bloom, Chief Medical Officer for Advance Pathology Solutions for Invicro. "We could not be happier to have him as a scientific research partner. I am highly confident that his efforts will support the advancement of Quanticell for specific drug development initiatives."

Chromogenic-based Immunohistochemistry (IHC) is ubiquitously used in research and clinical practice, including companion diagnostics (CDx). Despite IHC’s wide use, underperforming assays often require additional molecular testing due to narrow detection range. With expertise in quantitative and digital pathology and having invented the AQUA technology for predicting response to therapies or recurrence in a myriad of disease indications, Dr. Rimm and his research team will evaluate a multitude of assay conditions to assess Quanticell’s technology performance for quantifying HER-2 expression across a much wider dynamic range.

"I am thrilled to be working on this cutting-edge technology that has the potential to revolutionize molecular drug target testing that will in turn maximize therapeutic efficacy and reduce undesired toxicity," said Dr. Rimm. "In previous studies performed in my laboratory, we have found that HER-2 protein expression spanned three logs of dynamic range and discovered DAB-based methods typically only show a linear range of one log, which we hypothesize can be addressed with Konica Minolta’s novel detection technology."

Refuge Biotechnologies Promotes Francesco M. Marincola, M.D., to President

On March 9, 2020 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, reported the promotion of Francesco M. Marincola, M.D., to president (Press release, Refuge Biotechnologies, MAR 9, 2020, View Source [SID1234555324]). He will retain his role as chief scientific officer.

"Since Franco joined Refuge as our chief scientific officer in 2018, he has transformed our immune cell therapy research program into one that can compete with the best in the world. His knowledge, insight and relationships in both academia and industry have paved a clear path for us as we continue to advance our pipeline of intelligent cell therapies to fight cancer," said Bing C. Wang, Ph.D., co-founder and chief executive officer of Refuge. "In parallel, he has demonstrated a strength in mentorship by training internal scientists to grow into their potential and has set the standard for our company’s culture and expectation of leadership in scientific pursuits. We are proud to recognize his leadership across the organization with the promotion to president."

"One key motivation behind pioneering the CRISPR interference and activation technology was to find new ways to innovate treatments of cancers in a precise way without making permanent cuts to the DNA. With this approach, the technology can deliver multiplex treatments to T cells all at once – making the process inexpensive and efficient," said Stanley Qi, Ph.D., scientific founder. "It’s been remarkable to witness the progress that Refuge has made with translating this technology into next-generation cell immunotherapies that could have meaningful impacts. Much of that success is in part to Franco’s profound scientific vision, leadership, and clinical mindset as Refuge matures into a clinical-stage program. This promotion is well-deserved."

Dr. Marincola joined Refuge as chief scientific officer in May 2018, focused on the development of the intelligent cell therapy platform and lead therapeutic programs. In his career, he served as a distinguished research fellow and strategist for immune oncology discovery at AbbVie, developed and led a genetic research institute at Sidra Medical and Research Center in Qatar, and served as president of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Dr. Marincola has spent his career studying tumor immunology and was a pioneer in the development of technologies for studying the dynamics of the tumor microenvironment adaptations during immune therapy in real-time.

Pacira BioSciences to Present at the 2020 Barclays Global Healthcare Conference

On March 9, 2020 Pacira BioSciences, Inc. (NASDAQ: PCRX) today reported that it will present at the 2020 Barclays Global Healthcare Conference at 9:00 AM ET on Thursday, March 12, 2020 (Press release, Pacira Pharmaceuticals, MAR 9, 2020, View Source [SID1234555323]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

Zydus and XOMA Announce IL-2-Based Immuno-Oncology Therapy Licensing Agreement

On March 9, 2020 Zydus Cadila, an innovation-driven global pharmaceutical company, and XOMA Corporation (Nasdaq: XOMA) reported they have entered into a licensing agreement to advance an IL-2-based immuno-oncology (IO) drug candidate that combines Zydus’ IL-2 with XOMA’s novel anti-IL-2 monoclonal antibody (Press release, Zydus Cadila, MAR 9, 2020, View Source [SID1234555322]).

As part of the agreement, Zydus will advance the new IO candidate through formal clinical trials. Zydus has been granted exclusive rights to develop and commercialize the therapy in India, Brazil, Mexico and other emerging markets, and XOMA has the potential to receive single-to double-digit royalties on commercial sales in those territories. XOMA retains rights in all other territories (i.e., XOMA territory). Through this collaboration, Zydus will develop the new IO drug candidate through human proof-of-concept and each company has the potential to receive pre-defined shares of future proceeds that may arise from licensing and commercialization activities.

Speaking about the development, Managing Director of the Zydus group, Dr. Sharvil Patel said, "IL-2 will be the backbone of IO-based therapies for cancer treatment in the future. In this win-win agreement, we see a great strategic fit between our IL-2 and XOMA’s anti-IL-2 monoclonal antibody as together they have the potential to provide a safe and efficacious medicine to address the unmet needs of patients living with cancer."

Jim Neal, Chief Executive Officer at XOMA commented, "IL-2 has long been recognized as an effective anti-tumor agent, but its utility has been limited by its toxicity. XOMA has developed unique, fully human antibodies that promote IL-2 action specifically to the cytotoxic effector immune cell populations relevant for anti-tumor activity while simultaneously limiting the unwanted stimulation of immunosuppressive T cells, thereby minimizing its undesired side effects. This IL-2 and monoclonal antibody combination has the potential to turn the immune system against the cancer cells, and Zydus is an ideal partner to advance this combination through clinical development."