On May 31, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its introduction of the first cryo-electron microscopy (Cryo-EM) system in the Japanese pharmaceutical industry to further accelerate drug discovery research (Press release, Chugai, MAY 31, 2021, View Source [SID1234583291]).

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The cryo-EM, for which the Nobel Prize in Chemistry 2017 was awarded, has been drawing attentions as an innovative technology. The system was introduced for the structural analysis of drug candidate molecules bound to target proteins, which is an essential process in drug discovery research.

Chugai places great emphasis on Structure-Based Drug Design in its drug discovery research, and aims to create quality drug candidate compounds by pursuing precise structure design. X-ray crystallographic analysis, which we have primarily used to obtain molecular structure, requires crystallization of the intracellular protein which a drug candidate targets. The mid-size molecule drug which Chugai focuses on mainly targets such proteins that are difficult to crystallize, which has posed a challenge in the refinement of compound design.

As the cryo-EM does not require the crystallization process, it enables structure analysis of a wider range of molecules including intracellular proteins that are difficult to crystallize, as well as significantly improving research efficiency. We hope that it will enhance our Structure Based Drug Design capability and increase the success rate of compound development. This system we introduced is provided by Thermo Fisher Scientific, and installed at Kamakura research laboratories for the structural analysis of a variety of drug candidate compounds including mid-size molecule drugs.

"The introduction of cryo-EM is expected to greatly transform Chugai’s drug discovery process. It will further enhance the quality and speed of Structure Based Drug Design, and accelerate the discovery of mid-size molecule drugs which we aim to establish as the third modality," said Dr. Osamu Okuda, Chugai’s President and CEO. "Chugai’s drug discovery is supported by its unique scientific and technological capabilities. We will continue to rigorously adopt advanced technologies to realize innovations that contribute to resolve unmet medical needs."

About cryo electron microscopy (Cryo-EM)

Cryo-electron microscopy (Cryo-EM) is a powerful biophysical technique that allows researchers to visualize molecular assemblies at near-atomic resolution. With the rapid technological advancements, structural elucidation of biological molecules such as protein has been rapidly increased, in particular for intractable biological molecules by existing methods such as X-ray crystallography and NMR technique.

Cryo-EM has been recently applied in the pharmaceutical industry around the world due to its ability to accurately and rapidly visualize the intricate interactions between drug and receptor, enabling informed, accelerated drug discovery and structure based drug design.

On May 30, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets reported that its abstract reporting pre-clinical results from its V-domain immunoglobulin suppressor of T cell activation (VISTA) antibody, HMBD-002, has been selected for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8, 2021 (Press release, Hummingbird Bioscience, MAY 30, 2021, View Source [SID1234583287]).

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The abstract reports pre-clinical studies that demonstrate HMBD-002’s ability to induce an effective anti-tumor immune response, both as a monotherapy and in combination with the checkpoint inhibitor pembrolizumab in multiple syngeneic and humanized xenograft models.

HMBD-002 is the only IgG4 isotype anti-VISTA antibody currently in development for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer and non-small cell lung cancer. The Phase 1 clinical trial for HMBD-002 is anticipated to commence later this year.

The full abstract is now available on ASCO (Free ASCO Whitepaper)’s Meeting Library: View Source

Details of the publication are as follows:

Abstract Title:

HMBD-002 is a novel, neutralizing, anti-VISTA antibody exhibiting strong preclinical efficacy and safety, being developed as a monotherapy and in combination with pembrolizumab

Abstract Number:

e14569

About HMBD-002

HMBD-002 is a unique anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody is advancing to clinical trials with support from a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

On May 30, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets reported that its abstract reporting pre-clinical results from its V-domain immunoglobulin suppressor of T cell activation (VISTA) antibody, HMBD-002, has been selected for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8, 2021 (Press release, Hummingbird Bioscience, MAY 30, 2021, View Source [SID1234583287]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The abstract reports pre-clinical studies that demonstrate HMBD-002’s ability to induce an effective anti-tumor immune response, both as a monotherapy and in combination with the checkpoint inhibitor pembrolizumab in multiple syngeneic and humanized xenograft models.

HMBD-002 is the only IgG4 isotype anti-VISTA antibody currently in development for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer and non-small cell lung cancer. The Phase 1 clinical trial for HMBD-002 is anticipated to commence later this year.

The full abstract is now available on ASCO (Free ASCO Whitepaper)’s Meeting Library: View Source

Details of the publication are as follows:

Abstract Title:

HMBD-002 is a novel, neutralizing, anti-VISTA antibody exhibiting strong preclinical efficacy and safety, being developed as a monotherapy and in combination with pembrolizumab

Abstract Number:

e14569

About HMBD-002

HMBD-002 is a unique anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody is advancing to clinical trials with support from a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

On May 28, 2021 Accelerator Life Science Partners ("ALSP"), a leading early-stage life science accelerator and investment firm, reported that its portfolio company, Lodo Therapeutics Corporation ("Lodo" or the "Company"), has been acquired by Zymergen Inc. (NASDAQ: ZY) for an undisclosed amount (Press release, Lodo Therapeutics, MAY 28, 2021, View Source [SID1234635821]). The transaction is the third exit from ALSP’s investment fund, Accelerator Life Science Partners I (ALSP I), in the last year.

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Lodo Therapeutics discovered and developed novel therapeutics to address undruggable targets by applying its proprietary platform to tap the vast collections of undiscovered molecules encoded in environmental microbial DNA.

"The Lodo Therapeutics metagenomic platform complements Zymergen’s discovery efforts by expanding their natural product discovery capabilities," said Sean Brady, Ph.D., cofounder, Lodo Therapeutics and professor, Rockefeller University. "I am grateful for the support that the ALSP team provided during Lodo’s development and am eager to incorporate our technology into Zymergen’s platform."

ALSP invested in Lodo as part of the Company’s $17 million Series A financing. ALSP managed the Company business, research, and development (R&D) operations for more than four years. In 2018 ALSP helped Lodo to establish a multi-target collaboration with Genentech worth up to $969 million. ALSP also recruited serial entrepreneur Dale Pfost, Ph.D., as the Company’s Chairman and CEO, and helped to fill key executive leadership positions as the Company graduated from ALSP’s operations.

"We are delighted to see Lodo’s technology, and their talented R&D team become a part of Zymergen’s innovative technology platform," said Thong Q. Le, Senior Managing Director and CEO of Accelerator Life Science Partners. "Combining Lodo’s platform with Zymergen’s growing technology stack will create meaningful opportunities to access unique chemistry and to accelerate biological design and manufacturing. We look forward to the combined team’s continued successes as they work collaboratively to create and commercialize breakthrough products."

On May 28, 2021 PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company reported that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation to its lead product candidate, fimaporfin, for combination treatment with gemcitabine in patients with inoperable locally advanced or metastatic bile duct cancer (cholangiocarcinoma) (Press release, PCI Biotech, MAY 28, 2021, View Source [SID1234585150]). No approved treatment alternatives exist today for the first-line treatment of patients with this disease and fimaChem (fimaporfin) has the potential to play a role in this area of high unmet medical need.

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"The RELEASE trial has in general shown promise with good recruitment activity in South Korea despite the Covid-19 pandemic. Receiving orphan status from the South Korean authorities is a key step in the development of this important new medicine for Asian cancer patients in need of better local treatments. PCI Biotech’s fimaChem treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods." said Dr. Per Walday, CEO of PCI Biotech. "Orphan designation in South Korea, in addition to the already granted orphan designations in EU and USA, are all significant regulatory milestones and recognises the therapeutic benefits we seek to bring to the patients."

About bile duct cancer and the fimaChem technology
The bile duct drains bile from the liver into the small intestine. Bile duct cancer (cholangiocarcinoma) is a cancer that affects the cell lining of the bile duct and represents a patient population with a high unmet medical need. Surgery is the only potential curative option for these patients, but most patients are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. Median survival of inoperable patients is between 11 and 12 months with the current standard of care treatment, which is a chemotherapy combination of gemcitabine and cisplatin. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death, so there is a high need for better locoregional treatments. The locoregional anti-cancer effect of gemcitabine is significantly enhanced by the fimaChem technology in preclinical studies, and early clinical treatment data suggest encouraging tumour response and survival in bile duct cancer patients.

Bile duct cancer is a rare disease with an incidence rate of 1-2 per 100,000 in the western world. The incidence rates are increasing worldwide and are generally higher in Asian countries. The immediate target for PCI Biotech is first-line treatment of inoperable patients with extrahepatic disease. The fimaChem treatment regimen consists of an intravenous injection of fimaporfin, followed four days later by an intravenous infusion of gemcitabine and a laser light application in the bile duct easily administered through endoscopic methods used routinely in these patients. The patients then follow the standard background treatment with up to 8 chemotherapy cycles of gemcitabine + cisplatin. The fimaChem treatment may be repeated during the background chemotherapy treatment cycles.