Xinjing Zhiyuan completed Series A financing, focusing on TCR-T immune cell therapy in the field of solid tumors

On October 14, 2021 Neowise Biotechnology reported the company had completed Series A financing (Press release, Neowise Biotechnology, OCT 14, 2021, View Source [SID1234638951]). This round of financing was led by Taifu Capital and followed by Sinopharm Capital. This round of financing will be mainly used for the research and development of TCR-T immune cell therapy products, process development and the construction of GMP production workshops. Previously, Xinjing Zhiyuan has received angel round financing from Baidu Venture Capital and Baitu Biotechnology. In the one year since its establishment, Xinjing Zhiyuan’s cumulative financing amount has exceeded 100 million yuan.

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In recent years, cellular immunotherapy technology has developed rapidly, setting off a wave of cancer treatment. T cell immunotherapy is a hot field in cellular immunotherapy. In particular, CAR-T therapy has achieved remarkable results in the clinical treatment of blood cancer diseases. However, for solid tumors, which account for more than 90% of cancers, the industry generally believes that TCR-T cell therapy that can specifically recognize tumor intracellular antigens has greater therapeutic potential. However , how to provide patients with TCR-T cell therapy drugs quickly, accurately and effectively is a major pain point that plagues the development of the industry.

Against this background, Xinjingzhiyuan came into being in Suzhou BioBAY at the end of 2020, focusing on the development and industrialization of TCR-T cell therapy drugs for solid tumors . The company was co-founded by three Ph.D.s in the biomedical field who returned from the United States to start their own businesses full-time. The team members come from top universities such as California Institute of Technology, Carnegie Mellon University and Cornell University.

Dr. Peng Songming, founder and CEO of Xinjing Zhiyuan, was the first to directly isolate T cells capable of identifying the patient’s tumor from a tumor patient’s blood sample in 2016 while working at the California Institute of Technology, and participated in the founding of the company as one of the scientific founders. PACT Pharma, a tumor neoantigen cell therapy company, leads the R&D team to carry out personalized immunotherapy product development, IND filing and phase I clinical work. The company has received more than US$200 million in financing.

Relying on the rich experience of the founding team, Xinjing Zhiyuan hopes to analyze a large number of patient samples through independently developed high-throughput antigen-antigen receptor screening technology, thereby establishing the world’s largest antigen-antigen receptor paired relationship database (Paired Antigen- TCR library). Based on this database, Xinjing Zhiyuan can quickly select antigen receptors (TCRs) that accurately recognize solid tumors, edit, amplify and functionally identify tumor patients’ T cells, and infuse back the highly specific antigen receptors that recognize the patient’s tumor surface antigens. T cells, thereby achieving the goal of treating tumors and bringing good news to the majority of patients with solid tumors.

At present, Xinjing Zhiyuan has formed an experienced R&D team and established a R&D base in Suzhou. It has initially completed the verification of the high-throughput antigen-antigen receptor screening technology platform and begun to accumulate TCR sequences that specifically recognize tumor antigens. It has established close cooperative relationships with several well-known tertiary hospitals; at the same time, the company is also actively developing TCR-T production processes and preparing to build GMP plants to support the clinical development of subsequent pipelines.

Jiang Xiangren, managing partner of Taifu Capital , said: "Cell therapy is bringing more breakthrough therapies to patients at an unprecedented speed. The founding team of Xinjing Zhiyuan has built the world’s leading discovery platform for TCR-T cell therapy drugs. And it can well solve some key common problems in the current industrialization of TCR-T cell therapy. Taifu Capital highly recognizes Xinjing Zhiyuan’s innovative capabilities and company vision, and hopes to combine Taifu’s industrial resources and industry understanding to help the company’s development development to bring new breakthrough therapies to patients with solid tumors as quickly as possible."

Wu Aimin, founding partner of Sinopharm Capital, said: "TCR-T cell therapy has shown good potential in the treatment of solid tumors and has considerable clinical and commercial value. However, its screening barriers are high and the technology is difficult. We are highly optimistic about Xinjing Zhiyuan. The team’s global vision and R&D capabilities in this field integrate upstream bioinformatics analysis, midstream high-throughput screening, and downstream platform verification, greatly improving the success rate of R&D. We are confident that it will benefit patients in the future!"

Liu Wei, CEO of Baitu Biotechnology, said: "The breakthroughs achieved by Xinjing Zhiyuan in the past year have exceeded our expectations. Focusing on the highly expressed HLA subtypes in the Chinese population, the company has completed hundreds of pMHC-TCR tests in the past year. pairs, and in the process establish a high-throughput computing and experimental platform from discovery to verification. As an investor and strategic partner, we look forward to bringing more clinical resources and computing resources to the company, and strive to work with the company Build the world’s largest T cell antigen-antigen receptor database, improve the accuracy of current TCR-T AI design, and turn the "needle in the haystack" of solid tumor TCR-T drug discovery into "finding the picture."

Roche’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma

On October 14, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL) (Press release, Hoffmann-La Roche, OCT 14, 2021, View Source [SID1234591207]). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regular rate of infusion can take approximately three to four hours, so administering over a shorter time period can result in time savings for patients and could also reduce pressure on healthcare systems. This is especially important given the ongoing challenges for healthcare systems around the world brought about by the COVID-19 pandemic.[1]

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"Gazyvaro has improved outcomes for people with follicular lymphoma, and now has the additional benefit of a shorter infusion time," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Reducing the amount of time patients need to be in hospital has the potential to improve their treatment experience whilst also increasing efficiency for institutions and healthcare systems."

The approval is based on the phase IV GAZELLE study and other supportive studies investigating Gazyvaro in previously treated and untreated FL patients. The efficacy and safety of the GAZELLE study were consistent with that demonstrated by Gazyvaro administered at the regular rate of infusion. The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. Following this approval, Gazyvaro’s label update is being implemented immediately and Roche is aiming to launch short duration infusion Gazyvaro for patients in the EU with previously treated and untreated advanced FL as soon as possible. Gazyvaro is already approved for the treatment of FL, and now shorter duration infusion Gazyvaro will offer another more convenient option to enhance FL patients’ treatment experiences.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

About the GAZELLE study
GAZELLE [NCT03817853] is an open-label, international, multicentre, single arm, phase IV study investigating the safety and efficacy of the short duration infusion (SDI; target 90-minute infusion) of Gazyvaro (obinutuzumab) administered in combination with chemotherapy in patients with previously untreated advanced follicular lymphoma (FL). Patients who did not experience Grade 3 or higher infusion-related reactions were eligible to receive short duration infusion Gazyvaro from cycle 2. The primary endpoint of the study was the proportion of patients who experience Grade 3 or higher infusion-related reactions associated with short duration infusion during cycle 2 (the first treatment cycle with short duration infusion).

Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on B-cells, including malignant B-cells, but not on stem cells or plasma cells. Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyvaro is marketed as Gazyva in the US.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

Additional combination studies investigating Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About follicular lymphoma
Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.[2] It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 30,000 people in Europe.[3]

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting FcRH5 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

Fresenius Kabi enters collaboration to enhance the supply of essential medicines for U.S. Patients

On October 14, 2021 Fresenius Kabi reported that it has agreed to collaborate with Phlow Corporation, a public benefit company, to expand access to affordable sterile injectables formulated for U.S. children’s hospitals and to help strengthen the supply chain for U.S.-sourced API and essential medicines (Press release, Fresenius, OCT 14, 2021, View Source [SID1234591230]). The companies will work together to supply private-labelled products, co-develop and manufacture novel products and make essential medicines rapidly available in the event of a public health emergency.

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Anticancer Bioscience Welcomes New Investor into Seed Financing Round Bringing Total Raised to Over $31m to Advance Synthetic Lethality Approaches to Cancer Therapy

On October 14, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported that it had secured an additional CNY 68.4 million (~USD 10.6 million) from new Chinese investors (Press release, Anticancer Bioscience, OCT 14, 2021, View Source [SID1234591246]). The seed extension financing was led by Three Rivers Capital, who joins existing private Chinese investors. The total raised in the seed round is now over USD31 million (around CNY 200 million).

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The proceeds will be mainly used to accelerate the preclinical development of the company’s two most advanced programs, MYC-synthetic lethal and contact inhibition restoration. The funds will also be used to optimize lead compounds for polyploidy-synthetic lethal therapy and to identify additional lead compounds for the company’s contact inhibition restoration approach to combatting cancer.

ACB is applying synthetic lethal approaches to develop targeted cancer therapies. These have the potential to be much safer and more effective than current therapies. ACB has access to world-leading cancer biology expertise and drug discovery platforms that enable the company to identify novel compounds that can target both genetic and epigenetic vulnerabilities of cancer cells. ACB has bespoke chemical compound libraries and has invested in developing one of the world’s largest natural product libraries, providing a rich screening resource for potential cancer therapeutics.

Commenting on the financing, Dun Yang PhD, Founder, President, and CEO of ACB said, "This successful financing round is a further strong endorsement of our innovative approach to identifying first-in-class and best-in-class therapeutics for the treatment of cancer, using synthetic lethal strategies. It underlines our progress over the past months and will help accelerate our five drug discovery programs through optimization to candidate selection and IND enabling studies. We aim to initiate two clinical trials in 2022."

Xiaoyin Chen, Investment Director at Three Rivers Capital said: "ACB is an emerging innovative biotech with global competitiveness. We firmly believe that only revolutionary innovations in drug discovery and development can generate great clinical benefits and value. ACB utilizes its unique small molecule libraries and screening approaches, combined with its multiple proprietary platform technology based on synthetic lethality, to develop broad-spectrum anti-cancer drugs and strives to become the pioneer in developing novel and next-generation cancer therapies."

ACB will be presenting its innovative drug discovery platforms and pipeline at the LSX Inv€$tival Showcase in November.

CEO Eyal Barad and Dr. David Sans from Cannabics Pharmaceuticals in NYC, to Participate at Benzinga’s Cannabis Capital Conference

On October 14, 2021 Cannabics Pharmaceuticals Inc. (OTC: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that CEO Eyal Barad and Dr. David Sans FAARM, PhD, MBA in New York, will participate at the upcoming Benzinga’s Cannabis Capital Conference in NYC on 14-15 of October (Press release, Cannabics Pharmaceuticals, OCT 14, 2021, View Source [SID1234592176]).

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