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China NMPA Approves Phase III Clinical Trial of ASC40 Combined with Bevacizumab for Treatment of Patients with Recurrent Glioblastoma

On July 21, 2021 Ascletis Pharma Inc. (HKEX code: 1672) reported that China National Medical Products Administration (NMPA) has approved the Phase III clinical trial application of ASC40 combined with Bevacizumab for treatment of patients with recurrent glioblastoma (rGBM) (Press release, Ascletis, JUL 21, 2021, View Source [SID1234585037]).

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The Phase III registrational study is a randomized, double-blind, placebo-controlled, multi-center clinical trial in China to evaluate progression-free survival (PFS), overall survival (OS) and safety of patients with rGBM. Approximately 180 patients will be 1:1 randomized to Cohort 1 (oral ASC40 tablet QD + Bevacizumab) and Cohort 2 (matching placebo tablet QD + Bevacizumab).

On May 25, 2021, the Company announced that the clinical trial application for rGBM was accepted for review by China NMPA (Details referring to press release: View Source).

Based on published data, in China, glioblastoma (GBM) represents 46.1% of gliomas and has an incidence rate of approximately 2.85 to 4.56 per 100,000 population per year, suggesting approximately 40,000 to 64,000 new cases of GBM per year. More than 90% GBM patients will relapse after surgery, radiation and chemotherapies. In the United States, GBM represents 56.6% of gliomas and has an incidence rate of approximately 3.21 per 100,000 population per year.

Bevacizumab is the only drug which has been approved for rGMB indication in China as of September, 2020. The data of BELOB Trial indicated that median PFS was three months for patients with rGBM after Bevacizumab treatment.

Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including rGBM, non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.

ASC40 (known as TVB-2640 outside China) is a potent, selective and safe oral small molecule inhibitor of FASN. The data from the Phase II trial have shown that the overall response rate (ORR) for ASC40 (TVB-2640) plus Bevacizumab was 65% including a complete response (CR) of 20% and a partial response (PR) of 45%. Furthermore, the Phase II data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus Bevacizumab was 47%, representing a statistically significant improvement in PFS6 over the historical Bevacizumab monotherapy PFS6 of 16% (BELOB Trial) (P=0.01). ASC40 (TVB-2640) in combination with Bevacizumab was safe and well tolerated in such patient population (ClinicalTrials.gov Identifier: NCT03032484).

"I am thrilled to be the principal investigator leading the ASC40 Phase III trial for rGBM," said Dr. Wenbin Li, Vice Chairman and Secretary General of Glioma Committee of Chinese Cancer Association, Director of the Comprehensive Tumor Treatment Center, Beijing Tiantan Hospital, Capital Medical University, "Based on strong Phase II data, I hope and expect that targeting tumor lipid metabolism with ASC40 will offer a promising therapeutic approach to treat rGBM which is one of the most devastating cancers."

"ASC40 Phase III clinical trial approval by NMPA is a significant milestone for our oncology pipeline since the Company announced, in March this year, an investment escalation in R&D of cancer lipid metabolism and oral checkpoint inhibitors." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "With the strong momentum from the ASC40 Phase III approval, our talented R&D team is accelerating the clinical development programs of ASC40 for other oncology indications as well as oral PD-L1 small molecule inhibitor programs."

A Phase I clinical trial was completed on 136 patients with advanced tumor from the United States and United Kingdom. The patients were treated with ASC40 (TVB-2640) alone and with a taxane. The data from this Phase I trial have demonstrated FASN target engagement, good safety, pharmacokinetics as well as promising responses of ASC40 (TVB-2640) in patients with advanced solid tumors, particularly in lung cancer with KRAS mutations, ovarian cancer, and breast cancer (ClinicalTrials.gov Identifier: NCT02223247).

There are additional clinical trials of ASC40 (TVB-2640) ongoing in the United States in patients with KRAS mutation non-small cell lung cancer (ClinicalTrials.gov Identifier: NCT03808558) and breast cancer (ClinicalTrials.gov Identifier

Exscientia and GT Apeiron Therapeutics Enter Oncology Joint Venture

On July 21, 2021 Exscientia, an AI-driven pharmatech company with a mission to revolutionise how drugs are discovered, and GT Apeiron Therapeutics （Apeiron）, a Shanghai based company focused on novel oncology drugs, reported a strategic research and development collaboration agreement (Press release, Exscientia, JUL 21, 2021, View Source [SID1234585035]). The collaboration will leverage the patient-centric AI-first capabilities of Exscientia to accelerate the discovery of multiple small molecule therapeutic drug candidates designed to selectively treat aberrant cell cycle driven cancers and build a pipeline of CDK novel therapies. All pipeline products will be equally owned and Exscientia holds an equity stake in Apeiron.

This expanded collaboration follows the successful design of multiple selective CDK7 compounds. The potent, highly selective, non-covalent CDK7 compounds have demonstrated consistent tumour responses in xenograft models as well as exceptional pharmacokinetics. In addition, using live primary tissue samples from ovarian cancer patients, the CDK7 inhibitors showed both enhanced tumour cell cytotoxicity as well as selectivity over immune cells in the same microenvironment.

"Based on what they have already achieved, Exscientia is clearly the leader in AI-driven drug discovery, and we have witnessed this first-hand in our collaboration so far," stated Dr. Mingxi Li, President of GT Apeiron Therapeutics. "We have been incredibly impressed by the combined power of the AI design and use of patient data to optimize and select molecules that are more likely to give positive effects in the clinic. This joint venture is a significant step in building GT Apeiron’s valuable and robust pipeline of CDK inhibitor drugs and substantially accelerates our early-stage output and progression towards being a clinical stage biotech company."

"We are driven to bring drugs to market that make a difference for patients," says Andrew Hopkins, chief executive officer of Exscientia. "Apeiron bring a focus and an expertise on the biological basis of multiple cancers and helps us to create better drugs for better outcomes in the clinic and beyond. This collaboration has already proven to be capable of delivering potential drug candidates with promising patient-relevant data, and we look forward to extending that into a portfolio of multiple clinical assets."

Omniscient Neurotechnology Launches Quicktome™ Brain Mapping Platform for Neurosurgery After Regulatory Clearance in United States, Canada and Australia

On July 21, 2021 Omniscient Neurotechnology ("o8t"), a pioneering brain mapping software company, reported that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Quicktome, a digital brain mapping platform that allows neurosurgeons to visualize and understand a patient’s brain networks prior to performing life-changing brain surgery (Press release, Omniscient Neurotechnology, JUL 21, 2021, View Source [SID1234585033]). This announcement occurs on Glioblastoma Awareness Day, a day dedicated to increasing public understanding of the most common, complex, treatment-resistant, and deadliest type of brain cancer.

In addition to FDA clearance in the United States, Quicktome has also received Health Canada approval as well as regulatory clearance by the Therapeutic Goods Administration (TGA) of Australia.

Quicktome is a neurosurgical planning software which incorporates "connectomics", the field of understanding brain connectivity, into routine neurosurgical planning. Critically, by visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.

Utilizing cloud computing for large-volume data processing, and intuitive browser-based interfaces, Quicktome aims to streamline the process for neurosurgeons. The digital platform furthermore enables multidisciplinary collaboration in hospitals, and greater insight on a patient before and during surgery.

"We are thrilled to receive regulatory clearance for Quicktome. This is the first digital mapping platform designed to incorporate brain connectome data for neurosurgeons to improve patient outcomes," said Stephen Scheeler, CEO, Omniscient Neurotechnology. "Until now, the tools that neurosurgeons have relied on have been no match for the brain’s complexity. Quicktome breaks information down into actionable insights to inform the impact each incision will have on the patient. Since its authorization, physicians are already relying on this technology to guide surgical planning. This is a significant milestone for Omniscient and, more importantly, begins a new era for neurosurgery for patients and physicians."

"I wish I had technology like this when I started practicing," said Dr. Michael Sughrue, Chief Medical Officer, Omniscient Neurotechnology, a neurosurgeon who has completed over 3,000 brain tumor removals. "When I learnt about connectomics, I realized the biggest impact I could make to the field of neurosurgery was to make Quicktome a routine source of insight for all neurosurgeons. With this ground-breaking technology, our hope is for a better quality of life for patients and families after brain surgery."

"Omniscient is the first to harness the power of brain connectomics for use in neurosurgery," said Stephane Doyen, Chief Data Officer at Omniscient Neurotechnology. "Big data is changing everything we know about the brain. Modern neuroscience has shown that we are our brain networks, which control everything from movement to speech. Understanding how the brain is connected and what these connections mean will drastically help us better deliver healthcare, starting with neurosurgery."

Immunomic’s Academic Collaborator Dr. John Sampson Recognized as “World Expert” in Glioblastoma as Part of Glioblastoma Awareness Day

On July 21, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields (Press release, Immunomic Therapeutics, JUL 21, 2021, View Source [SID1234585032]). The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert". Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

"Dr. Sampson’s contributions to advancing the research in glioblastoma is widely known in our scientific community and we are excited that his significant impact is being recognized on a global level by Expertscape," commented Dr. William Hearl, CEO of ITI. "This recognition is especially important today, on Glioblastoma Awareness Day, where we honor the patients, families, and care givers who have faced this complex and deadly type of brain cancer. We look forward to continuing to collaborate with Dr. Sampson to advance our glioblastoma immunotherapy program, ITI-1000, through Phase 2 and toward patients in need."

RefleXion Expands Commercial Reach With Sale to Texas Cancer Center

On July 21, 2021 RefleXion Medical, Inc., a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality that will one day treat all stages of cancer, reported the sale of its RefleXion X1 machine to The Center for Cancer and Blood Disorders, a free-standing cancer treatment center with 15 locations throughout northern Texas (Press release, RefleXion Medical, JUL 21, 2021, View Source [SID1234585031]).

"We are thrilled to bring the promise of biology-guided radiotherapy to the Dallas-Fort Worth Metroplex," said Barry Russo, CEO of The Center for Cancer and Blood Disorders. "We have a long history of offering our patients the latest advances in cancer therapies, clinical trials and cancer research, and BgRT continues this convention. The multi-modality nature of the X1 will allow us to eventually offer advanced radiotherapy for all stages of solid tumor cancers, even in cancers where it has been traditionally infeasible to do so."

The RefleXion X1 machine is cleared for clinical use in stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), intensity modulated radiotherapy (IMRT), and forms of conventional radiotherapy indicated for early-stage cancers, or palliative relief of symptoms for later-stage cancers. BgRT, currently under development, is designed to treat both early and late-stage cancers.

BgRT uses biological emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope known as a PET tracer to guide radiotherapy. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine detects these emissions using PET detectors and responds in real-time to direct radiotherapy to each tumor and destroy it, even in moving tumors.

"We are gratified by the commitment and enthusiasm of the clinicians at The Center for Cancer and Blood Disorders for our RefleXion X1 platform," said Todd Powell, president and CEO at RefleXion. "This sale expands our commercial momentum into the southern United States, a large and growing market known for embracing new technologies that deliver cutting-edge patient care."

Installation of the RefleXion X1 machine, which will be located at the main campus in Fort Worth, is expected to begin in early 2022.