EdiGene and Immunochina Announce Research and Development Collaboration to Develop Allogeneic CAR-T Therapy for Cancer

On May 27, 2020 EdiGene, Inc., which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, and Immunochina,a company dedicated to innovative gene and cellular technology,reported that they have formed a research and development collaboration to develop allogeneic CAR-T therapy for cancer (Press release, EdiGene, MAY 27, 2020, View Source [SID1234558569]).

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Under this partnership, both companies will combine EdiGene’s expertise in genome editing and allogeneic T-cell process with Immunochina’s expertise in innovative CAR-T technology to develop potentially best-in-class allogeneic CAR-T therapeutics. Terms are not disclosed.

"EdiGene is a leading gene-editing company with cutting edge technology platform. It is our great pleasure to work with this team," said Ting He, Ph.D.,founder and CEO of Immunochina, "Make the Incurable Curable, which is Immunochina’s vision. We have accumulated considerable experience in late-stage hematological malignancies, with two IND approvals. Although a number of break throughs have been made by autologous T cells lately, allogeneic T cells could also play an important role in the future. The cooperation is a big step for both teams, and I believe we will make exciting discoveries together."

"We are excited to collaborate with Immunochina, one of the leading clinical-stage CAR-T companies," said Dong Wei, Ph.D.,CEO of EdiGene, "We believe that allogeneic T-cell therapeutics has tremendous potential, by offering innovative T-cell therapies ‘off the shelf’ with more effective quality control and lower cost. By combining the expertise of EdiGene and Immunochina, we will be well positioned to develop such therapeutics and advance to clinics, one step closer to help the cancer patients in need."

AbCellera Closes $105 Million Series B Financing to Further Advance World-Leading Antibody Drug Discovery Platform

On May 27, 2020 AbCellera reported that it has closed a US$105 million Series B financing (Press release, AbCellera, MAY 27, 2020, View Source [SID1234558568]). The financing was led by OrbiMed and current investor DCVC Bio, with an investor syndicate that includes Viking Global Investors, Peter Thiel, Founders Fund, Eli Lilly and Company, University of Minnesota, and Presight Capital . With the proceeds of the financing, AbCellera will expand its capacity and invest in technologies that complement and extend its proprietary antibody discovery engine.

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"Drug development takes too long, fails too often, and costs too much. With the backing of visionary investors, we will double-down on our strategy of making long-term investments in technology and teams that are needed to put drug development on the fast track," said Carl Hansen, Ph.D., CEO of AbCellera. "We’re building a modern operating system for drug developers to ensure the best science is translated quickly into new therapies for patients."

AbCellera screens, selects, and analyzes millions of naturally produced antibodies to find next-generation drug candidates. By accelerating the arduous and unpredictable process of antibody drug discovery with rigorous machine learning and data science, AbCellera enhances the entire biologics ecosystem, from small biotechs to global pharmaceutical companies.

"AbCellera has embarked on a long-term project to make it possible to solve biological challenges with the speed and urgency that they all too obviously require," said Peter Thiel, entrepreneur and investor.

"AbCellera is at the intersection of biology, technology, and AI, allowing it to make new antibody drug discovery advancements, which we previously couldn’t dream of, possible," said John Hamer, Managing Partner, DCVC Bio. "From developing therapeutics for neurological diseases to COVID-19 and everything in-between, AbCellera is transforming the antibody discovery process, delivering more possibilities in less time and with less expense. We continue to be enthusiastic supporters of its progress."

AbCellera will use the funds to deepen its technology stack, creating and aggregating novel tools to propel the development of new biological modalities, from monoclonal, multi-specific, and single-domain antibodies, to bioconjugates, gene-encoded biologics, and cell therapies.

The funds will also support the growth of AbCellera’s facilities and teams, including:

Expanding its workforce;
Opening a new 48,000-square-foot R&D facility in 2021; and
Building a GMP manufacturing facility for production of biologics for clinical testing.
AbCellera has successfully completed more than 55 programs, delivering high-quality antibody drug candidates for a wide variety of drug targets, including historically challenging multi-pass membrane protein targets, such as GPCRs and ion channels. The company has generated lead therapeutic antibody candidates for unmet needs in various disease areas including cancer, immuno-oncology, neurodegeneration, pain, fibrosis, and metabolic disorders

MiNA Therapeutics Announces Publication of Phase I Liver Cancer Data in Clinical Cancer Research and Provides Update on Clinical Development and Drug Discovery Programs

On May 27, 2020 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported the publication of data from its Phase I liver cancer trial, OUTREACH, in Clinical Cancer Research (Press release, MiNA Therapeutics, MAY 27, 2020, View Source [SID1234558567]). It is the first publication in which a small activating RNA treatment (MTL-CEBPA) demonstrated clinical benefit . In addition, the Company provided an update on its ongoing clinical trials for lead program MTL-CEBPA and its drug discovery programs.

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"This landmark publication in Clinical Cancer Research details for the first time that RNA medicines can activate gene expression, providing clinical benefit to patients," commented Robert Habib, CEO of MiNA Therapeutics. "As we enter into the second half of 2020, we continue to advance our clinical development objectives and uncover the vast opportunities inherent in our unique drug discovery pipeline."

Publication and OUTREACH Study Update

The publication in Clinical Cancer Research summarizes the results from MiNA’s Phase I, open-label, dose escalation and dose expansion trial of MTL-CEBPA, OUTREACH, in adults with advanced Hepatocellular Carcinoma (HCC). Overall, MTL-CEBPA was well-tolerated and demonstrated pharmacodynamic target engagement, meeting the primary endpoint of the study. Furthermore, a reduction of suppressive immune cells in the tumour microenvironment as well as initial signs of potential synergistic efficacy when combined with standard of care tyrosine kinase inhibitors in HCC could be observed. These encouraging Phase I data validate the targeting of C/EBP-α as a novel therapeutic strategy in cancer and prompted a Phase Ib study further evaluating MTL-CEBPA in combination with sorafenib in HCC. Enrolment for the Phase Ib part of the OUTREACH trial was completed in Q1 2020 and initial results will be presented during a poster session at the forthcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on Friday, May 29, 2020. The framework for a subsequent Phase II clinical trial is currently being designed with the objective of initiating this next stage of clinical development in the second half of 2020.

The full Clinical Cancer Research publication is available on the "Publications" page of MiNA’s website. A similar overview of the Phase I data was most recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September 2019.

TIMEPOINT Update

In March 2020, TIMEPOINT, a global Phase I/Ib clinical study of MTL-CEBPA in combination with anti-PD1 checkpoint inhibitor pembrolizumab in patients with advanced solid tumours was initiated and the first patient was treated. The study is designed to assess the safety, tolerability, pharmacology and clinical activity of MTL-CEBPA in combination with pembrolizumab in these patients. Recruitment for the study is expected to continue through 2021.

Discovery Programs

In parallel to the clinical trial developments, MiNA is further expanding its drug discovery pipeline with a focus on developing new drug candidates that can address a range of indications including genetic and metabolic diseases. Most recently in January 2020, MiNA validated its metabolic disease capabilities through the entry into a research collaboration with AstraZeneca, a global leader in the discovery and development of prescription medicines to treat metabolic diseases. MiNA remains well-positioned to build out its early-stage pipeline based on its saRNA approach which, through transcriptional activation, enables the modulation of previously undruggable targets.

About MTL-CEBPA

MTL-CEBPA is the first therapy to specifically up-regulate CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases and identified as a critical barrier for many therapies to induce clinical responses in solid tumour cancers. In pre-clinical studies MTL-CEBPA has been shown to improve the anti-tumour activity of cancer therapies by targeting dysregulated myeloid cells and reducing their suppression in the tumour microenvironment.

OncoSec Strengthens IP Portfolio with Three New Patents Covering TAVO™ and Its Electroporation Gene Delivery System

On May 27, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported Notices of Allowance for three new patent applications covering its interleukin-12 (IL-12) based immunotherapy platform, including its lead product candidate TAVO and next-generation product candidate TAVOPLUS, and electroporation gene delivery system (Press release, OncoSec Medical, MAY 27, 2020, View Source [SID1234558566]).

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The European Patent Office intends to grant a patent covering OncoSec’s gene therapy and electroporation for the treatment of malignancies. The allowed European claims are directed to methods of treating cancer by delivering a plasmid encoding an agonist of GITR, CD137, CD134, CD40L, or CD27 (immune co-stimulators) in combination with a plasmid encoding an immunostimulatory cytokine (such as IL-12 or IL-15) to a tumor by intratumoral electroporation. This patent is significant as it further expands protection of OncoSec’s IL-12 based immunotherapy platform in a key market for various drug combinations.

Additionally, the European Patent Office also intends to grant a second patent protecting OncoSec’s next-generation electroporation gene delivery system focused on the treatment of internal or visceral lesions. Specifically, the allowed claims cover OncoSec’s innovative visceral lesion applicator (VLA) that can be used with the APOLLO electroporation generator, including applicators with two or more electroporation electrodes and a central channel for colocalized drug delivery. These innovative devices allow targeted electroporation and treatment of cells with therapeutic moieties using a single device. The applicator options enable the ability to use a variety of interventional and surgical approaches to access a wide variety of lesions, such as distal lung metastases (catheter-based) and primary and metastatic liver tumors (rigid-based). This is clinically significant because many of these cancers are difficult to reach and treat directly with an immunotherapy.

The Canadian Intellectual Property Office intends to grant a patent protecting OncoSec’s electroporation method for treating microscopic tumors. The allowed claims are directed to delivery of a gene encoding a therapeutic protein, such as a cytokine, including electroporation to reduce tumor growth and metastases in the tumor margin tissue. Tumor resection, if performed, can be done before or after the electroporation. Treatment of tumor margin tissue – prior to and following resection – is a very meaningful treatment advancement for OncoSec, particularly when directed to the prevention of metastases.
"OncoSec continues to prioritize the expansion of its intellectual property portfolio across multiple facets of its technology," said Keir Loiacono, Vice President, Corporate Development at OncoSec Medical Incorporated. "These three new allowances demonstrate OncoSec’s strong patent position in three critical areas: device development, new treatment alternatives and novel adjuvant therapies with previously undescribed combinations. As we look to the future, we believe this will not only help to secure our competitive position in the intratumoral oncology space, but potentially create new opportunities for licensing revenue."

Kadmon to Present at the Jefferies 2020 Virtual Global Healthcare Conference

On May 27, 2020 Kadmon Holdings, Inc. (NYSE:KDMN) reported that Harlan W. Waksal, M.D., President and Chief Executive Officer, will present at the Jefferies 2020 Virtual Global Healthcare Conference on Thursday, June 4, 2020 at 4:00 p.m. ET (Press release, Kadmon, MAY 27, 2020, View Source [SID1234558565]).

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A live audio webcast of the presentation may be accessed on the Investors section of the Kadmon website at www.kadmon.com. A replay of the webcast will be available for 90 days.