On February 8, 2021 Enzychem Lifesciences (KOSDAQ: 183490), a biopharmaceutical company developing innovative medicines to improve the lives of patients with cancer and inflammatory diseases, reported it will present new study data regarding its lead drug candidate, EC-18 in combination with immune checkpoint inhibitor (ICI) therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, held virtually, April 10-15 and May 17-21 (Press release, Enzychem Lifesciences, FEB 8, 2021, View Source [SID1234574763]).

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ICI is approved and used in the treatment of various cancers. However, some carcinomas are refractory to ICI and the treatment effect diminishes through drug resistance. Adenosine-induced tumor progression and drug resistance are major obstacles to ICI therapy. Effective removal of adenosine surrounding the tumor can improve the ICI effect and suppress tumor progression.

"We are excited to present our in vitro cell analysis results at AACR (Free AACR Whitepaper), that support EC-18’s unique mechanism of action and synergistic therapeutic effect in combination with immune checkpoint inhibitors," said Ki Young Sohn, CEO & Chairman, Enzychem Lifesciences. "Based on these results, EC-18 has an anti-tumor effect by quickly eliminating eAdo extracellular adenosine (eAdo), which is a key factor for successful ICI therapy. PLAG, the active pharmaceutical ingredient of EC-18, may help cancer cells absorb and remove eAdo, thereby, effectively inhibiting tumor growth and changing the tumor microenvironment. PLAG may enhance the therapeutic effect of ICI in the treatment of LLC-1 lung carcinoma cells."

Details of the virtual poster presentation are below:
Abstract Title: Suppressive effect of PLAG on tumor progression and its synergistic therapeutic effect with ICI therapy through adenosine clearance.
Date: Saturday, April 10, 2021
Abstract Number: 1447
Session: Targeting the Tumor Microenvironment in Drug Development

The virtual abstract is available in the program section of the virtual AACR (Free AACR Whitepaper) annual meeting website: View Source

On February 8, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported that having successfully closed an additional financing round, raising CNY63m (~USD10m), it has already achieved positive animal data in its small molecule program targeting MYC overexpression (Press release, Anticancer Bioscience, FEB 8, 2021, View Source [SID1234574730]).

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The financing, by a small syndicate of undisclosed, experienced Chinese angel investors adds to the previous seed financing of CNY68.75m (~USD11m) and is being used to support further expansion of ACB’s proprietary screening libraries and discovery platforms, with the goal of progressing two of its programs towards IND enabling studies this year.

ACB is an international private company, commercialising discoveries emerging from China’s world-leading cancer research at the J. Michael Bishop Institute of Cancer Research.

The Company is using its unique screening libraries and discovery platforms in cancer biology to uncover novel mechanisms to induce cancer cell death, without harming healthy cells. Synthetic lethality is possible when the same genetic changes that enable carcinogenesis also make the cancer cell overly dependent on specific pathways and proteins. Attacking these dependencies with drugs can yield dramatic anti-cancer effects, while leaving normal cells healthy. Synthetic lethality enables targeting of drivers of carcinogenesis that are not currently amenable to drug development.

The Company has five distinct synthetic lethality programs in drug development. These include:

Oncogene enabled synthetic lethality (focused on MYC inhibition)

Tumour suppressor synthetic lethality

Polyploid cell synthetic lethality

Centrosome amplification/delustering therapy

Restoration of contact inhibition

ACB has invested in proprietary small molecule and natural product libraries, that comprise novel scaffolds of drug-like molecules and natural medicinal botanicals, with over 20,000 botanical samples already collected and curated. ACB’s small molecule libraries are based on novel scaffolds upon which further diversity can be assembled. These general-utility new scaffold-drug fragment (GUNS-DF) libraries, are being expanded and evolved through iterative screening/optimization processes for multiple phenotypic screening projects.

In the company’s lead MYC inhibition program, a novel chemical series with low nM activity has been identified in model cell lines. Already, functional activity of ACB’s lead ‘HJ’ compound series has been demonstrated in vitro that mimics inhibition of Aurora B kinase. Inhibition of Aurora B kinase is known to elicit synthetic lethality in cells overexpressing MYC. The synthetic lethal phenotype includes the induction of cell cycle arrest early in mitosis followed by accumulation of polyploid cells. ACB is further exploring a second MYC inhibitory compound series.

Founder, President, and CEO of ACB, Dr. Dun Yang, said, "With the additional financing, we are well placed to accelerate our synthetic lethal approach and to maximise the value of our libraries and pipeline. Already a provisional filing covering the novel library of HJ compounds has been completed and this is the first GUNS-DF library for which ACB has filed for PCT patent protection, testifying to the utility of our library technology platform. We expect to follow this with additional composition of matter filings as we progress our MYC and other discovery programs."

ACB’s goal is to generate first-in-class oncology drugs for a broad range of indications (targeting over 30% of cancer patients), with a focus on therapies disabling previously untargeted mitotic regulators. Overexpression of MYC engenders vulnerability in mitosis and many other cellular processes. It is the most commonly deregulated oncoprotein, making targeting it through synthetic lethality an attractive strategy for cancer therapy.

Since its foundation in 2016, ACB has grown to almost 50 employees in Chengdu China, Hyderabad, India, San Francisco, USA, and St Andrews, UK.

On February 8, 2021 Illumina, Inc. (NASDAQ: ILMN) has selected nine new genomics companies to join the second global funding cycle of Illumina Accelerator in the U.S. and UK (Press release, Illumina, FEB 8, 2021, View Source [SID1234574746]). The global company creation engine, focused on partnering with entrepreneurs to build breakthrough genomics startups, invested in four companies for the second funding cycle of Illumina Accelerator Cambridge, UK and five companies for the twelfth funding cycle of Illumina Accelerator San Francisco Bay Area.

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Today, Illumina also announces over £20 million in initial UK capital commitments have been secured from a select group of investors, including a £10 million commitment from cornerstone investor LifeArc, a leading UK independent medical research charity. The UK commitments will provide pound-for-pound match funding to every Illumina Accelerator Cambridge graduate that secures between £500,000 up to £4 million in qualified new capital, within one year of graduation.

"The UK capital commitments will be instrumental in driving value for our Illumina Accelerator Cambridge startups as they strive to unlock the power of the genome," said Amanda Cashin, Ph.D., co-founder and Global Head of Illumina for Startups.

During two, six-month funding cycles per year, Illumina Accelerator provides the selected startups with access to seed investment, access to Illumina sequencing systems and reagents, as well as business guidance, genomics expertise, and fully operational lab space adjacent to Illumina’s campuses in Cambridge, UK or the San Francisco Bay Area. The newest companies to join Illumina Accelerator’s portfolio of genomics startups include:

Illumina Accelerator Cambridge

BiotaX Labs LTD, a spinoff from Technion Research and Development Foundation (TRDF) Israel, is harnessing the power of the microbiome to diagnose and provide effective, tailored and safe microbial treatments.
Broken String Biosciences Limited, a genomics company from Cardiff, UK, is developing a platform of novel sequencing tools to assess genome stability and to unlock the next generation of innovative medicines, including cell and gene therapies.
Mitra Bio Limited, a skin longevity company from London, UK, is building a non-invasive skin multi-omics platform to unravel skin health and delay ageing.
MultiplAI Health LTD, a diagnostics company from London, UK and Buenos Aires, Argentina, is leveraging advances in genomics and artificial intelligence to develop universal remote screening for cardiovascular diseases.
Illumina Accelerator SF Bay Area

Doloromics Inc., a pain therapeutics discovery company from Dallas, Texas, is building a proprietary platform for discovery of disease-specific pain mechanisms, biomarkers and therapeutics.
Flightpath Biosciences, Inc., a biotechnology company from Berkeley, California is advancing microbiome-targeted therapeutics and diagnostics for the treatment of rare infectious diseases.
Oshun Medical Inc., a women’s health diagnostics company from the SF Bay Area, is working to predict pregnancy complications in women around the world.
Parallel Health Inc., a skin microbiome company from the SF Bay Area, aims to revolutionize skin and body care by providing deep insights and true personalization through best-in-class testing and targeted microbial formulations.
Rubik Therapeutics, Inc., a cancer therapeutics company from Greater Boston, is leveraging computational biology and genome-wide screens to develop engineered cell therapies for solid tumor indications.
"Our newest investments demonstrate the depth and breadth of genomics applications across the globe," said Alex Aravanis, M.D, Ph.D., Chief Technology Officer at Illumina. "These nine genomics startups are focused on discovering breakthrough therapeutics, diagnostics, and direct-to-consumer applications to transform human health and beyond."

Illumina Accelerator is accepting applications for the next global funding cycle, which are due by March 1, 2021. Through a single, global application process, Illumina Accelerator will select up to five companies in each location. To learn more and apply, please visit our website.
(Press release, Illumina, FEB 8, 2021, View Source [SID1234574746])

On February 8, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the effectiveness of the Investigational New Drug (IND) application for a Phase 1 clinical trial to evaluate IDE397, a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor (Press release, Ideaya Biosciences, FEB 8, 2021, View Source [SID1234574764]).

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IDE397 is IDEAYA’s most advanced synthetic lethality program, and being developed in the clinic for cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion, which is prevalent in approximately 15% of all solid tumors. IDEAYA is targeting a Q1 2021 First-Patient-In for the Phase 1 clinical trial of IDE397 in patients having solid tumors harboring MTAP deletion.

IDEAYA also announced that Matthew Maurer, M.D., has joined the company as Vice President, Head of Clinical Oncology and Medical Affairs. "Matt brings extensive clinical development and oncology experience in both the pharmaceutical industry and academia. His background in clinical oncology will be invaluable as we advance IDE397 clinically in MTAP-deletion and target to select the Development Candidate for our wholly-owned PARG program in 2021," said Yujiro S. Hata, President and Chief Executive Officer at IDEAYA Biosciences.

Dr. Maurer has over 15 years of experience in oncology and previously worked at Bristol Myers Squibb (BMS) where he most recently led the clinical development of nivolumab and ipilimumab late phase studies in renal cell carcinoma and prostate cancer. Prior to BMS, Dr. Maurer was a physician investigator and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons, where he served as a breast cancer specialist. Dr. Maurer obtained his undergraduate degree from Princeton University and his medical degree from Mount Sinai School of Medicine, and then completed his residency at Columbia University Medical Center.

"I am thrilled to join the IDEAYA team and look forward to advancing the IDE397 clinical program and the broader Synthetic Lethality pipeline, including the PARG program, which has a potential application in breast cancer, an indication in which I have clinical experience as an oncologist," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.

On February 8th, 2021 CStone Pharmaceuticals, a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, reported that anti-PD-L1 antibody sugemalimab has been granted Breakthrough Therapy Designation (BTD) by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) (Press release, CStone Pharmaceauticals, FEB 8, 2021, View Source [SID1234633505]). In addition to this major milestone, sugemalimab was granted Orphan Drug Designation (ODD) for the treatment of T-cell lymphoma and BTD for the treatment of R/R ENKTL by the U.S. Food and Drug Administration (FDA) in October 2020.

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The NMPA’s BTD is designed to facilitate the development and expedite the review of novel medicines to treat serious conditions and fulfill an unmet medical need, specifically for novel or "me-better" candidates at the clinical stage, which has demonstrated significant clinical advantages over the available treatment options. The BTD approval from the China NMPA is expected to substantially accelerate the development and commercialization of sugemalimab in China.

The BTD is supported by the promising CS1001-201 Phase II results in patients with R/R ENKTL, which were presented at the annual meeting of the Chinese Society of Clinical Oncology (CSCO) in 2020. Among 38 evaluable patients, the objective response rate (ORR) was 44.7%, the complete response (CR) rate was 31.6%, and the median duration of response (mDoR) was 16.8 months. Of all 43 patients who received sugemalimab, the median overall survival (mOS) was 19.7 months, and the one-year OS rate was 55.5%. Additionally, sugemalimab demonstrated favorable safety and tolerability.

Professor Huiqiang Huang of Sun Yat-sen University Cancer Center, the Principal Investigator of CS1001-201 study said, "R/R ENKTL is a highly malignant and aggressive disease, in addition to the lack of efficacious treatment options, which often leads to poor prognosis, low cure rate, and severe unmet medical needs of patients. The preliminary results have indicated that sugemalimab could potentially become a new treatment option for patients with R/R ENKTL."

Dr. Jason Yang, Chief Medical Officer of CStone, commented, "We are excited that sugemalimab has been granted BTD by the China NMPA, which also makes sugemalimab one of the very few domestic novel drugs that have obtained BTD from the Agencies in both the U.S. and China. This designation underscores the remarkable clinical value of sugemalimab, and we look forward to working closely with the NMPA in China to maximize the benefit of sugemalimab to patients in the nearest future."

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About ENKTL

Extranodal natural killer/T-cell lymphoma (ENKTL) is a subtype of mature T cell and NK cell lymphoma. There is no existing effective salvage treatment for patients with R/R ENKTL who failed L-asparaginase-based standard regimen. Patients also respond poorly to conventional treatments. Clinicians often have limited treatment options for such patients due to rapid disease progression and poor survival outcomes with a one-year survival rate of less than 20%. In China, the currently available targeted monotherapy for these patients has a complete response (CR) rate of approximately 6%. Thus, there are significant unmet medical needs in patient who failed first-line treatment.

About CS1001-201 Study

CS1001-201 is a single-arm, multicenter, Phase II pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with R/R ENKTL. The primary endpoint of this study is ORR as assessed by the Independent Radiology Review Committee (IRRC). On August 14th, 2020, CS1001-201 has received a Study May Proceed (SMP) letter from the U.S. FDA for the Investigational New Drug (IND) application. CS1001-201 was currently ongoing in the U.S. and China.

About Sugemalimab

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.

Sugemalimab has completed a Phase 1 dose-escalation study in China. During Phase 1a and Phase 1b of the study, sugemalimab showed good antitumor activity and tolerability in multiple tumor types.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase 1 bridging study in the U.S., the clinical program in China includes one multi-arm Phase 1b study for several tumor types, one Phase 2 registration studies for lymphoma, and four Phase 3 registration studies, respectively, for stage III/IV NSCLC, gastric cancer, and esophageal cancer. The phase 3 trial of sugemalimab in the treatment of stage IV non-small cell lung cancer reached the primary endpoint. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to anti-PD-L1 antibody sugemalimab for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma in October 2020. The China National Medical Products Administration has accepted the company’s New Drug Application for sugemalimab.