On November 10, 2020 HitGen Inc. (HitGen, 688222.SH) reported it has entered into a collaboration and licensing agreement with Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd (Baiyunshan, 600332.SH/00874.HK) to develop and commercialise its HG030 programme in mainland China (Press release, HitGen, NOV 10, 2020, View Source [SID1234571035]). Baiyunshan is a publically listed company in Shanghai and Hong Kong engaged in the pharmaceutical and healthcare industry. HG030 is a novel inhibitor for Trk/ROS1 discovered by HitGen, which received IND approval from China’s National Medical Products Administration (NMPA) in March 2020, and is entering Phase I clinical trial in China for patients with NTRK/ ROS1 gene fusion-positive cancers.

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Under the terms of the agreement, Baiyunshan will receive exclusive rights for the development and commercialisation of HG030 in the mainland China, and will pay HitGen an upfront licensing fee of RMB 38M, followed by a series of milestones and royalty of sales as the product progresses through clinical trials and product launches in the mainland China. HitGen retains all rights of the product in all territories outside the mainland China.

HG030 is a second-generation small molecule Trk inhibitor designed to treat patients with NTRK gene fusion-positive cancers, regardless of cancer type. Most patients with NTRK-rearranged advanced cancer are sensitive to tyrosine kinase inhibitor (TKI) therapy. These TKIs have dramatically improved outcomes for patients with advanced Trk-positive cancer, yet these cancers remain incurable. Resistance invariably develops, such as acquired mutations G595R and G667C. HG030 is a novel, highly potent, selective, second-generation Trk inhibitor with clear activities in preclinical models against most known resistance mutations in patients with advanced Trk-positive cancer. Therefore, HG030 might be an effective therapeutic strategy for patients with Trk-positive advanced cancer who were naive or had become resistant to currently available TKIs.

"We are very pleased to enter this licensing agreement with Baiyunshan. Over the past few years, HitGen has been developing an innovative drug discovery technology platform centred on DNA-encoded libraries (DELs), and has entered into a number of research collaborations with leading pharmaceutical and biotechnology companies worldwide utilising this technology. In addition to the development and applications of DELs technology, we have also been applying our discovery research capabilities to build a portfolio of innovative drug discovery projects for collaboration and licensing. HG030 is the first out-licensing result of such an effort. This collaboration and licensing demonstrates HitGen’s capability in progressing discovery projects from target nomination to early clinical trials, as well as the quality of the programme. We hope our effort of this type will contribute to the discovery and development of innovative medicines for patients. With their tremendous clinical development, manufacturing and commercialisation capabilities and track record, I look forward to seeing further progress of HG030 in clinical development and ultimate successful product launch by Baiyunshan", said Dr Jin Li, Chairman and CEO of HitGen Inc.

On November 10, 2020 BrickBio reported that in site-specific bioconjugation for improved therapeutics via its unnatural amino acid incorporation technology platform, reported that it has expanded on three therapeutic programs and received positive data on its first preclinical novel antibody-drug conjugate, BRKB-28, for breast cancer and gastric cancer (Press release, BrickBio, NOV 10, 2020, View Source [SID1234570981]). The data from a leading CRO that conducted the in vitro testing reported that BRKB-28 did not target nor adversely affect healthy cells, and at the same time eradicated the cancerous targets.

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BrickBio’s platform has the ability to precisely control the DAR (drug to antibody ratio) while producing a homogenous product. The tight control of the DAR contributed to a significantly improved performance profile of BRKB-28 over the leading breast and gastric cancer biologic, which resulted in significant death of healthy cells. Having the broadest and most diverse toolkit of bioconjugation handles, BrickBio is able to site-specifically modify any protein at any site, improving key therapeutic characteristics, such as increased half-life, increased efficacy, decreased dosage and decreased toxicity. Furthermore, the flexible BrickBio platform is payload and linker agnostic, expression host agnostic and produces an entirely homogenous product in every conjugation.

Preclinical Antibody for Breast and Gastric Cancer

The flexibility of the BrickBio platform has enabled the expansion of the company’s therapeutic programs, including "Antibody Drug Conjugates", "Novel Bispecific Antibody Conjugates", and "Novel Scaffolds".

"In addition to ongoing partnerships for technology licensing and co-development of partners’ preferred molecules, we are rapidly building on the breadth of capabilities of the BrickBio platform and expanding our internal pipeline for novel biologics," said Audrey Warner, Head of Business Development at BrickBio and Vice President of Investments at Tiger Gene. "BrickBio will partner on its novel-specific pipeline assets as it continues to expand its therapeutic programs," Warner concluded.

"It is very promising to see the facile integration of our unique bioconjugation platform into any protein scaffold, as validated with our BRKB-28 candidate," said James Italia, VP of Commercial Development at BrickBio. "Our team is able to quickly generate and screen candidates with a variety of scaffolds, linkers, and payloads with exquisite control over their biophysical characteristics. We are already witnessing the benefit of the BrickBio advantage and look forward to future candidates in our other internal programs."

"The robustness and flexibility of the BrickBio platform has enabled the company to progress at a much faster rate than initially forecasted, in terms of developing novel antibody drug conjugates, protein therapeutics, and novel bispecific antibody conjugates," said John Boyce, Co-Founder, Chairman, President and CEO of BrickBio, and Co-Founder of Tiger Gene. "We are not only excited about our first pre-clinical candidate for breast and gastric cancer, but also about the continued work with our pharmaceutical partners to rapidly expand the pipeline across a number of indications," Boyce concluded.

On November 10, 2020 Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company focuses on developing novel cellular immunotherapy, reported that their preliminary data including the pre-clinical development, manufacturing, and investigator initiated trial (IIT) results for CTA101, a CRISPR/Cas9-engineered off-the-shelf CD19/CD22 dual-targeted CAR-T cell product, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held virtually on December 5-8, 2020 (Press release, Bioheng Biotech, NOV 10, 2020, View Source [SID1234570980]). The study was designed to evaluate the feasibility of CTA101 in patients with relapsed/refractory B-cell acute Lymphoblastic Leukemia (r/r B-ALL).

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"CTA101, a CRISPR-engineered allogeneic dual-targeted CAR-T, has showed manageable safety and promising efficacy in the treatment of r/r B-ALL patients," said the PI of this study, He Huang, MD, PhD, Professor of hematology, President of The First Affiliated Hospital, Zhejiang University School of Medicine. "It has preliminarily verified the feasibility of generating allogeneic CAR-T by CRISPR gene editing and provided evidence for extended application in the future. As an allogeneic CAR-T, CTA101 tackles several limitations associated with conventional CAR-T therapy, such as possible manufacturing failures, undesirable waiting period between leukapheresis and CAR-T infusion, poor product consistency due to bespoke manufacturing process for individual patient, and unaffordable cost. In addition, its dual-targeted design may be a viable solution to reduce the relapse rate of B-ALL. I would like to expect more allogeneic CAR T cell products for clinical use, which certainly provide more choices to address the unmet medical needs."

Oral Presentation

Title: 499 The Safety and Efficacy of a CRISPR/Cas9-Engineered Universal CAR-T Cell Product (CTA101) in Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Session: 801. Gene Editing, Therapy and Transfer I
Date: Sunday, December 6, 2020
Time: 2:30 p.m. ET (11:30 a.m. PT)
View Source

"We are looking forward to sharing initial data on the feasibility, safety and efficacy of our first allogeneic CAR T cell product, CTA101, at the ASH (Free ASH Whitepaper) 2020 annual meeting," said Xiaohong He, PhD, CEO of Bioheng Biotech. "CTA101 is based on our first-generation allogeneic CAR T technology platform, which can be timely infused to patients without HLA matching. Bioheng has always been committed to the development and commercialization of allogeneic CAR-T cell technologies and products. The positive results of CTA101 will further promote the development and translation of our multiple allogeneic CAR T pipelines."

On November 10, 2020 Anaveon, an immuno-oncology company, reported that it will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting being held from Monday, November 9, 2020 to Saturday, November 14, 2020 (Press release, Anaveon, NOV 10, 2020, View Source [SID1234570895]).

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The abstract is available on the SITC (Free SITC Whitepaper) website and the accompanying poster will be available in the Virtual Poster Hall open from 8.00 a.m. EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 and is also available on Anaveon’s website.

ANV419, Anaveon’s lead programme, is a powerful and selective interleukin-2 (IL-2) agonist that is in late stage preclinical development for the treatment of cancer. It represents a unique approach to no-alpha IL-2 agonists by taking advantage of a highly selective antibody which binds to the same site as the IL-2 alpha receptor and is able to completely abolish its binding.

The data demonstrates that ANV419 presents IL-2 to the beta/gamma IL-2 receptor with similar potency as native IL-2 and thus provides a natural growth signal to anti-tumor CD8+ T cells and natural killer (NK) cells while it avoids promoting pro-tumor regulatory T cells. The compound is a high molecular weight biologic that behaves like an antibody and has an outstanding safety profile in non-human primates.

"We are excited by the data demonstrating that ANV419 has a unique approach to no-alpha IL-2 agonists by taking advantage of a highly selective antibody which binds the same site as the alpha receptor and is able to completely abolish its binding," said Christoph Huber, Chief Scientific Officer of Anaveon. "With its high level of activity on anti-tumor immune cells and excellent safety profile we look forward to starting our first clinical study in Q1 2021 and to exploring ANV419’s applicability in a range of cancer indications, as well as in combination with other therapeutics."

Details of the poster presentation:

Title: ANV419 is a novel CD122-selective IL-2/anti-IL-2 antibody fusion protein with potent CD8 T cell and NK cell stimulatory function in vitro and in vivo

Live Q&A: Poster #571 – Wednesday, Nov. 11 from 5:15-5:45 p.m. EST and Friday, Nov. 13 from 4:40-5:10 p.m. EST

Anaveon was founded in December 2017 by Andreas Katopodis, previously Director at the Autoimmunity, Transplantation & Inflammation Group at the Novartis Institutes for BioMedical Research and Onur Boyman, Professor and Chair in the Department of Immunology at the University of Zurich. The Company is developing selective IL-2 Receptor Agonists, a type of protein that could therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Under certain situations, T-cells are able to attack tumors and, consistent with this, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer. The lead compound, ANV419, is designed to overcome known challenges with human IL-2. These include severe, dose-limiting side effects and a short half-life that requires frequent infusions. This type of drug, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.

On November 10, 2020 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing a pipeline of novel T cell therapies for patients suffering from cancer, reported that the Company has established a manufacturing partnership with ElevateBio, LLC, to leverage the extensive technical capabilities at ElevateBio BaseCamp, a world-class cell and gene therapy manufacturing facility based in Waltham, MA (Press release, TCR2 Therapeutics, NOV 10, 2020, View Source [SID1234570870]). The strategic partnership will focus on the production of TC-210, TCR2’s TRuC-T cell targeting advanced mesothelin-expressing cancer, to support demand for the anticipated Phase 2 clinical trial.

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"After observing meaningful tumor regression in patients at our first, and presumably suboptimal, TC-210 dose, we are pleased to announce a manufacturing partnership with ElevateBio, an innovative organization that has significant technical expertise in the cell and gene therapy field," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "To date, we have successfully manufactured T cell products for all patients treated. In anticipation of expanding our Phase 1/2 clinical trial, manufacturing with ElevateBio BaseCamp will increase both our capacity and technical capabilities to meet potential demand for clinical material for larger cancer patient populations."

Elevate BaseCamp was established as a center of innovation dedicated to cell and gene therapy research and development, process development and cGMP manufacturing operations, using state-of-the-art facilities designed to rapidly develop single and multi-product cell and gene therapies, regenerative medicine and immunotherapies. The BaseCamp partnership enables TCR2 Therapeutics to establish additional manufacturing capacity and technical capabilities in the U.S., in addition to its existing Stevenage, UK, manufacturing facility, and will support the Phase 2 expansion portion of the TC-210 Phase 1/2 clinical trial once a recommended Phase 2 dose is defined.

"We are excited to have entered this partnership, enabling TCR2 to leverage our cell therapy expertise and state-of-the-art center of innovation to expand their manufacturing capacity as their lead TRuC-T cell targeting solid tumors advances through the clinic," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "BaseCamp is a world-class facility designed to support the manufacturing of cutting-edge cell therapies for our portfolio companies and for selective partners with highly innovative therapies like TCR2, allowing high-quality production at scale. We look forward to working with TCR2 and enabling their vision to cure cancer patients."