On June 4, 2020 Rakuten Medical, Inc. (Rakuten Medical) and The University of Texas MD Anderson Cancer Center (MD Anderson) reported a strategic alliance collaboration agreement to advance the development of new cancer therapies based on Rakuten Medical’s proprietary Illuminox technology platform (Press release, Rakuten Medical, JUN 4, 2020, View Source [SID1234560819]).

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Under the terms of the agreement, Rakuten Medical and MD Anderson will collaborate to conduct studies based on the Illuminox technology platform and to determine study designs, combination therapies, and target patient populations for future clinical trials. The alliance is designed to expand development of the technology and bring a novel therapeutic approach to patients with cancer, with an initial focus on those with head and neck cancers. This agreement expands upon an existing sponsored research agreement between Rakuten Medical and MD Anderson.

"We are honored that MD Anderson has recognized the exciting potential of our Illuminox technology by entering into this strategic alliance agreement," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "We believe our collaboration will allow us to develop novel treatments for different cancer types. We are energized by MD Anderson’s shared optimism and conviction to bring treatments to patients in need."

The Illuminox technology platform is based on a cancer therapy called photoimmunotherapy, developed by Dr. Hisataka Kobayashi and colleagues from the National Cancer Institute. Illuminox is a technology combining drugs and laser device systems being evaluated for the treatment of different cancers.

"The Illuminox technology represents a new form of therapy with the potential to selectively target cancer cells while sparing surrounding normal tissues through light-activatable antibody-dye conjugates," said Jeffrey Myers, M.D., Ph.D., chair of Head and Neck Surgery at MD Anderson. "We are pleased to build upon our collaborative relationship with Rakuten Medical to work toward bringing investigational treatment options forward with the goal of providing the best options for our patients."

On June 4, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that the Independent Data Monitoring Committee (IDMC) of the FRUTIGA study of fruquintinib has completed a planned interim data review (Press release, Hutchison China MediTech, JUN 4, 2020, https://www.chi-med.com/chi-med-announces-the-continuation-of-phase-iii-frutiga-study/ [SID1234560818]). Based on the preset criteria, the IDMC recommended that the trial continue.

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FRUTIGA is a Phase III trial in China of fruquintinib in combination with paclitaxel (Taxol) in the treatment of patients with advanced gastric adenocarcinoma or gastroesophageal junction ("GEJ") adenocarcinoma who have progressed after first-line standard chemotherapy.

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.

About FRUTIGA in Gastric Cancer
FRUTIGA is a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored.

Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376.

FRUTIGA was initiated following the results of an open label, multi-center Phase Ib dose finding/expansion study of fruquintinib in combination with paclitaxel (Taxol) as a second-line treatment in patients with advanced gastric cancer (clinicaltrials.gov identifier NCT02415023).

Other Fruquintinib Development
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with colorectal cancer ("CRC") in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.

Global development of fruquintinib in CRC: We are initiating a Phase III registration study, known as the FRESCO-2 study, in the U.S., Europe and Japan in CRC. FRESCO-2 is expected to start enrolling patients in mid-2020. Based on our agreement with the U.S. Food and Drug Administration (FDA), the FRESCO and FRESCO-2 studies, if positive, could support our New Drug Application (NDA).

Immunotherapy combinations: We have entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).

On June 4, 2020 Accent Therapeutics and AstraZeneca (LSE/STO/NYSE: AZN) reported that it will collaborate to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer (Press release, Accent Therapeutics, JUN 4, 2020, View Source [SID1234560817]). The collaboration combines Accent’s expertise as a leader in the biology, target identification and drug discovery of RMP-targeting therapies with AstraZeneca’s industry leading expertise in oncology.

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Inhibition of RMPs is a new approach for addressing RNA pathobiology by targeting proteins that control many aspects of RNA biology. This class of targets represents a vast field of potentially important targets for cancer and other diseases.

José Baselga, Executive Vice President, Oncology R&D, AstraZeneca said: "The promise of RMP inhibition is a compelling area of exploration for AstraZeneca. With this collaboration, we will seek to identify novel targets and unlock the full potential of our medicines. We believe that the Accent team’s expertise in RNA-modifying protein biology and drug discovery complements AstraZeneca’s extensive research and development portfolio."

Shakti Narayan, Chief Executive Officer, Accent Therapeutics said: "This collaboration leverages both AstraZeneca’s vast cancer expertise and resources and Accent’s rich pipeline of RMP therapeutic programs to bring new and potentially life-changing medicines to patients. This collaborative effort will enable us to rapidly advance and achieve the rich therapeutic potential of these exciting programs."

Under the terms of the collaboration agreement, Accent will be responsible for research and development activities for a nominated preclinical program through to the end of Phase I clinical trials. Following completion of Phase I, AstraZeneca will lead development and commercialization activities for the nominated program, with Accent having the option to jointly develop and commercialize with AstraZeneca in the US. AstraZeneca will also have the exclusive option to license worldwide rights to two further preclinical discovery programs, for which Accent will conduct certain preclinical activities.

Accent will receive an upfront payment of $55 million and, in the event that Accent elects to jointly develop the nominated program, is eligible to receive up to $1.1 billion in additional success-based payments across all programs in the form of option fees and milestone payments, as well as tiered royalties on net sales ranging from mid-single digit to low-double digits. In the event Accent opts into co-developing and co-commercializing the nominated program, profits and losses will be split in the US.

On 3rd June 2020 Enara Bio (formerly Ervaxx), a biotechnology company leveraging its proprietary T-cell/T-cell receptor (TCR) discovery and Dark Antigen platforms to deliver targeted cancer immunotherapies, reported its new name – Enara Bio Limited (Press release, Ervaxx, JUN 3, 2020, View Source [SID1234607515]). This new name reflects the company’s expanded product discovery and development strategy beyond its initial focus on endogenous retroviral (ERV) antigens for the development of cancer vaccines (hence "Ervaxx").

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"Enara" is derived from an Arabic word that means illumination, enlightenment and bringing light into darkness. The company believes this new name more closely illustrates Enara Bio’s mission as a science-led organization exploring the genomic dark matter as a source of novel cancer-specific T-cell antigens. The rebrand also recognizes the company’s new TCR research capabilities, including programs that could enable immune recognition of a broad range of tumor cell types in an HLA-independent fashion, and thus offer broadly applicable T-cell therapies. By building discovery efforts on both sides of the T-cell/cancer-cell interface (the "immune synapse"), Enara Bio is building a pipeline of cancer immunotherapies for broad patient populations.

The company was founded as Ervaxx Ltd. in late 2016 with an initial focus on the development of therapeutic cancer vaccines utilizing novel antigens derived from endogenous retroviral (ERV) DNA sequences. Since then, and based on breakthrough science coming from both internally-generated and in-licensed insights, Enara Bio has broadened its horizons to include TCR-based immunotherapies targeting an extended cancer-associated antigenic repertoire derived from the entire genomic dark matter, termed Dark Antigens.

To accelerate this evolution, Enara Bio in-licensed patents covering T cells and TCRs reactive to cancer-specific antigens and ligands from Cardiff University in January 2020. These exciting new technologies, while early research-stage, present compelling opportunities to develop immunotherapies with the potential to address a broad range of tumor types independent of the patient’s genetic background.

Kevin Pojasek, President and CEO of Enara Bio commented:

"Our new name – Enara Bio – reflects the progression of our strategy and capabilities to align more broadly with our purpose of delivering impactful immunotherapies to all cancer patients. Our ground-breaking work in identifying and characterizing Dark Antigens is now joined by other exciting new programs focused on pan-cancer, pan-HLA targets, which greatly expand our opportunities for the development of novel immunotherapies with broad utility across patients with diverse cancers. While we continue to press ahead with these exciting programs internally, we are increasingly seeking partnerships to advance the full diversity of our science and product opportunities."

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About Enara Bio

Enara Bio (formerly Ervaxx) is a science-led company targeting the T-cell/cancer-cell interface (the "immune synapse") to develop new targeted cancer immunotherapies designed to treat a broad patient population.

Enara Bio is exploring the hidden depths of cancer and T-cell biology to discover and characterize novel immunotherapy targets, such as Dark Antigens and MR1-presented ligands. We are pioneering approaches to exploit these targets with TCR-directed T-cell immunotherapy and therapeutic vaccines.

To achieve our mission, we are leveraging our differentiated Dark Antigen and TCR discovery platforms that integrate bioinformatics, immunopeptidomics, metabolomics and immunology in our Oxford, UK-based research lab.

Enara Bio is backed by leading life science investors, including SV Health Investors. We have partnerships with world-class academic institutions, including the Francis Crick Institute, Cardiff University, Johns Hopkins School of Medicine and the University of Oxford, to help drive the leading edge of these new areas of science.

On June 3, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, announced pipeline updates for its robust set of Conditional Bispecific Redirected Activation (COBRA) programs at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Maverick Therapeutics, JUN 3, 2020, View Source [SID1234570575]).

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By nature of its elegant and innovative design, the COBRA platform is the most mature bispecific T cell engaging platform in its class that can safely target solid tumors with highly specific and potent activity. COBRA molecules are prodrugs selected to bind to specific targets, which may be expressed in both tumor and healthy tissue. However, COBRAs are engineered to take advantage of the tumor’s unique microenvironment for T cell activation; triggering T cell mediated killing only at the site of the tumor while sparing damage to patients’ healthy tissues.

"As we continue to advance our pipeline, we look forward to initiating the clinical development of our lead first-in-class COBRA programs, MVC-101 and MVC-280, both of which have generated promising pre-clinical data designed to validate the COBRA mechanism of action and be predictive of translation to patients. Our pipeline reflects our single focus on developing potent and conditionally active T cell engaging therapies for solid tumor cancers. Beyond our two lead programs, we have also generated compelling in vivo data for two additional COBRA molecules," said Jim Scibetta, Chief Executive Officer, Maverick Therapeutics. "The first patient who is safely and effectively treated for a solid tumor cancer with any form of T cell therapy, whether CAR T cell therapy or redirected T cell engagers like our COBRAs, will serve as a major breakthrough in the field of cancer immunotherapy. For us at Maverick, this is an incredibly important and humbling mission."

"Although evidence of anti-tumor activity has been observed in patients with solid cancers, the full potential of T cell engaging therapies against solid tumor cancers continues to be hindered by unacceptable toxicity," said Jim Vasselli, M.D., Senior Vice President, Clinical Development, Maverick Therapeutics. "Underpinning the pre-clinical development of COBRA technology is Maverick’s commitment to using gold standard in vivo and in vitro models to maximize our understanding of the molecules. We are encouraged by the early results generated by these first two programs and are excited to continue development towards the clinic."

MVC-101 Is a Highly Potent COBRA Targeting Tumors that Express EGFR

Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non small cell lung cancers. Maverick expects to initiate a Phase 1 trial in Q1 2021.

MVC-280 Is a Highly Potent COBRA Targeting Tumors that Express B7H3

Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1 trial in H2 2021.

About the COBRA Therapeutics Platform

Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought after trifecta in cancer care; high specificity, high potency and reduced toxicity.