Enzychem Lifesciences Announces Poster Presentation At AACR Virtual Annual Meeting 2021

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

Anticancer Bioscience Announces CNY63m (~USD10m) Financing to Advance its Synthetic Lethal Platform and Pre-clinical Oncology Pipeline

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.

Illumina Accelerator Invests in Nine Genomics Startups for Second Global Cycle

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])

IDEAYA Announces IDE397 IND Clearance by U.S. FDA to Initiate Phase 1 and Appointment of Matthew Maurer, M.D., as Vice President, Head of Clinical Oncology and Medical Affairs

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.

Corcept Therapeutics Announces Fourth Quarter, Full-Year 2020 Preliminary Selected Financial Results and 2021 Revenue Guidance; Provides Corporate Update

On February 8, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, reported preliminary fourth quarter revenue of $85.7 million, compared to $87.9 million in the fourth quarter of 2019 (Press release, Corcept Therapeutics, FEB 8, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-full-year-2020 [SID1234574731]). Preliminary 2020 revenue was $353.9 million compared to $306.5 million in 2019. The company expects 2021 revenue of $375 – 405 million.

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Cash and investments increased by $32.7 million in the fourth quarter to $476.9 million. At December 31, 2019 cash and investments totaled $315.3 million. The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program. Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.

These results are prior to completion of the company’s annual independent audit and are subject to adjustment.

"Corcept’s performance during the COVID-19 pandemic demonstrates the durability of our business," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Confronted with unprecedented obstacles, we generated significantly more revenue, more income and more cash than we did in 2019. Having won an important legal victory in our dispute with Teva Pharmaceuticals, we look with confidence to the future. As the pandemic is contained, we expect our commercial growth to resume and have provided 2021 revenue guidance of $375 – 405 million.

"The pandemic’s impact on our clinical activities has been variable. Trials in acutely life-threatening indications, such as advanced ovarian and pancreatic cancer, recruited briskly. Studies of illnesses with a slower course of disease, such as Cushing’s syndrome, castration-resistant prostate cancer ("CRPC"), anti-psychotic-induced weight gain ("AIWG") and non-alcoholic steatohepatitus ("NASH") have proceeded more slowly.

"Despite these challenges, our development team made important advances. They maintained our existing trials, although the pandemic significantly slowed enrollment in many of them. They also started new trials that greatly broadened the scope of our clinical program. In 2020, we initiated trials in Cushing’s syndrome of adrenal origin, metastatic pancreatic cancer, advanced adrenocortical cancer, AIWG and NASH. We also laid the groundwork for further expansion by advancing promising compounds from our portfolio of selective cortisol modulators towards the clinic."

Cushing’s Syndrome

Phase 3 GRACE trial of relacorilant as a treatment for patients with any etiology of
Cushing’s syndrome continues at sites in the United States, Canada, Europe and Israel;
pandemic conditions delay expected timing of NDA submission
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome of adrenal origin, with sites planned in the United States, Europe and Israel
"While our Phase 3 GRACE and GRADIENT trials in patients with Cushing’s syndrome continue to accrue patients and generate valuable data, pandemic-related public health measures, which in many places became even more restrictive in the fourth quarter, continue to slow the pace of enrollment," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "As vaccination campaigns falter – especially in Europe, where many of our most productive clinical sites are located – the retarding effects of the pandemic remain in place. Ultimately, relacorilant’s NDA submission date will depend on the duration and severity of pandemic-related restrictions, which cannot be known with certainty. The delay may be as long as one year, to the second quarter of 2023.

"These delays are especially frustrating because relacorilant’s Phase 2 data were extremely promising. Our team of clinical investigators are enthusiastic. We are confident enrollments will accelerate once conditions improve."

Solid Tumors

Preliminary results in 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel
in patients with metastatic ovarian cancer expected in first half 2021
Preliminary results in first 40 patients enrolled in open-label Phase 3 RELIANT trial
of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer expected
in first half 2021
Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer ("CRPC") expected by third quarter 2021
Patient selection underway in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"Our trials in patients with metastatic ovarian and pancreatic cancer are on track to generate preliminary data in the first half of 2021, as planned," said Dr. Grauer. "These trials are evaluating whether relacorilant can enhance the efficacy of nab-paclitaxel by reducing cortisol’s suppression of apoptosis in patients with advanced disease, many of whom have experienced progression on prior rounds of taxane-based therapies. It would be wonderful to be able to offer a therapy that benefits them.

"The dose-finding trial of our selective cortisol modulator exicorilant with enzalutamide as a treatment for CRPC continues to enroll patients," said Dr. Grauer, "although the pandemic has slowed its pace, pushing selection of an optimum dose to the second or third quarter of this year, depending on how quickly pandemic conditions improve. Our hypothesis, which is well-supported by pre-clinical data, is that combining an androgen receptor antagonist like enzalutamide with a cortisol modulator will block an important tumor escape route.

"Last year, we initiated a Phase 1b trial in patients with adrenal cancer with cortisol excess," said Dr. Grauer. "This study will evaluate whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushing’s syndrome caused by excess cortisol activity."

Metabolic Diseases

Enrollment underway in double-blind, placebo-controlled Phase 2 trial of miricorilant
in patients with NASH
Enrollment continues in GRATITUDE, a double-blind, placebo-controlled, Phase 2 trial
of miricorilant to reverse recent AIWG
Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled
Phase 2 trial of miricorilant to reverse long-standing AIWG
"In the fourth quarter, we initiated a double-blind, placebo-controlled Phase 2 trial of miricorilant as a potential treatment for NASH, a serious liver disorder that affects millions of people," said Dr. Grauer. "We plan to enroll 120 patients, who will receive either 900 mg miricorilant, 600 mg miricorilant or placebo for twelve weeks. The primary endpoint will be reduction in liver fat content, as measured by MRI. Our pre-clinical data suggest miricorilant may be a potent treatment for NASH. We hope to demonstrate similarly encouraging results in patients.

"Our Phase 2 trials in AIWG – GRATITUDE and GRATITUDE II – continue to enroll patients, although the pandemic has slowed the pace," added Dr. Grauer. "AIWG reduces the quality of life and shortens the life expectancy of millions of patients. Results from the Phase 1b trial we completed last year suggest that miricorilant may benefit them. In that study, healthy volunteers given miricorilant plus olanzapine gained less weight and had lower triglycerides and less sharply elevated liver enzymes than those who received olanzapine plus placebo after only two weeks of dosing. These results build on those we achieved in similar trials using mifepristone (see Gross et al, Advances in Therapy (2009); Gross et al, Obesity (2010). Miricorilant, like mifepristone, modulates cortisol activity. Unlike mifepristone, miricorilant does not affect progesterone activity."

Conference Call

We will hold a conference call on February 8, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link (listen-only mode) or dial 1-833-693-0540 (United States) or 1-661-407-1581 (international) approximately ten minutes before the start of the call. The conference ID number is 9289307. A replay will be available on the Investors / Past Events tab of our website.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.