On December 1, 2021 Shenzhen Chipscreen Biosciences’ licensing partner, HUYABIO International (HUYABIO), reported the regulatory approval for Chidamide (Tucidinostat, also known as Epidaza , Hiyasta, HBI-8000) monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan (Press release, Shenzhen Chipscreen Biosciences, DEC 1, 2021, View Source;huyabio-international-receives-regulatory-approval-for-chidamide-monotherapy-of-peripheral-t-cell-lymphomaptcl-in-japan-301435093.html [SID1234596369]).

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"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of Chidamide has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population", said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of Chidamide Phase 2 study.

The drug was approved based on data from a Phase 2b study that involved 55 patients with aggressive PTCL in Japan and Korea. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed to prior therapies. Chidamide 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Tucidinostat(also known as Hiyasta), in Japan expands our drugs’ indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Tucidinostat that will benefit even more patients."

Dr. Lu Xianping, CEO & President of Chipscreen said, "Tucidinostat, an original new drug independently discovered and developed by Chipscreen, its ex-China rights were licensed out to Huya in 2006. Today, the Japanese approval on Tucidinostat for the treatment to peripheral T-cell lymphoma is another important milestone for the product’s expansion in overseas markets. We sincerely thank our partner Huya International. This new approval enables us to provide Tucidinostat for Japanese patients who are suffering from PTCL. It is also a remarkable step of Chipscreen in the way of providing affordable antitumor drugs for global patients. Via conducting further clinical research of Tucidinostat monotherapy and relevant combination therapies with other antitumor drugs, we are expecting to continuously make new progress to benefit patients all over the world who are suffering from other types of cancers."

About Chidamide (also known as Epidaza, Hiyasta, HBI-8000)

Chidamide is a first-in-class/best-in-class innovative drug which was discovered and developed originally by Shenzhen Chipscreen Biosciences in China. It is an Epigenetic Immunomodulator approved and launched in Chinese market for the treatment of lymphoma and metastatic breast cancer. It also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor Nivolumab. The product’s ex-China rights were licensed out from Chipscreen to HUYABIO. Later on, HUYABIO partnered with Meiji Seika for Japanese market.

On December 1, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that 15 of 30 participants have been recruited in the diagnostic 64Cu SAR-bisPSMA clinical trial (PROPELLER) in patients with untreated, confirmed prostate cancer, scheduled for radical prostatectomy (Press release, Clarity Pharmaceuticals, DEC 1, 2021, View Source [SID1234596315]).

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68Ga PSMA-11 (~200MBq, left) vs. 64Cu SAR-bisPSMA (~200MBq, right) in the same patient; time between serial imaging was 8 days. Standardised Uptake Value (SUVmax)* of the lesions were 6.5 and 6.3 for 68Ga PSMA-11 and 16.5 and 18.5 for 64Cu SAR-bisPSMA

*SUV is a measurement of product uptake in tissue normalised to a distribution volume

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to have quickly and successfully recruited half of the patients planned for the PROPELLER trial with all three sites actively recruiting and imaging prostate cancer patients across Australia. We have been able to not only generate strong preliminary clinical data since the trial commencement in July 2021, but also validate our on-demand distribution model where the 64Cu-SAR-bisPSMA has been shipped to the trial sites across Australia from a central manufacturing facility with minimal delays or interruptions. The pace and quality of work that we were able to achieve during this trial is reflective of the appetite for the new generation of radiopharmaceuticals that can cater to large indications in the oncology space and shift the radiopharmaceutical field towards the "big pharma" model with central manufacture of ready-to-use products. This shift has potential to significantly improve patient care by focusing on the needs of patients and enable their treating staff to access critical treatments that are safe and efficacious, on time and at any treatment centre with a positron emission tomography (PET) camera."

The PROPELLER trial is a Phase I Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using 64Cu SAR-bisPSMA. It is a 30-patient multi-centre, blinded review, dose ranging, non-randomised study of 64Cu-SAR-bisPSMA administered to patients with confirmed prostate cancer prior to radical prostatectomy (NCT04839367)1. The main goals of the PROPELLER trial are to:

Determine the safety and tolerability of 64Cu SAR-bisPSMA in participants with untreated, confirmed prostate cancer and planned for radical prostatectomy;
Examine 64Cu SAR-bisPSMA at different dose levels;
Determine the ability of 64Cu SAR-bisPSMA to detect primary prostate cancer; and
Compare diagnostic properties of 64Cu SAR-bisPSMA against 68Ga PSMA-11, the standard of care for prostate cancer imaging in Australia.
Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the PROPELLER trial commented, "The preliminary data from the patients imaged in the PROPELLER trial to date looks very promising as it supports the evidence of higher uptake of 64Cu SAR-bisPSMA in the tumours that has been shown in the pre-clinical studies. Higher uptake in the tumours means that they are more visible on the PET scans and hence have a higher chance of being detected. These initial results are encouraging for further development of this product as a diagnostic, and the higher uptake and retention also make it an exciting therapeutic target with 67Cu. In addition to the anticipated clinical benefits, having access to centrally manufactured products has the potential to improve patient care by providing an alternative to currently used short-lived diagnostic radioisotopes, such as 68Ga and 18F, the production of which can pose challenges in delivering critical imaging scans to patients with cancer on time. I am very pleased to be working with Clarity on the Targeted Copper Theranostics (TCT) platform of products, having recently completed the C-BOBCAT trial of SAR-Bombesin, in hopes that these products will improve the current treatment paradigm for oncology patients."

Dr Alan Taylor further commented, "Clarity is well on track to explore and validate the benefits of the TCT platform, including the logistical, manufacturing and treatment benefits associated with the "perfect pairing" of copper-64 and copper-67. These benefits hold promise of providing a large patient population with early, accurate and precise detection of prostate cancer. As such, we look forward to recruiting the remaining 50% of patients and generating more data to validate the compelling results from our preclinical studies as well as the exciting preliminary results from the PROPELLER trial and our US-based 64/67Cu SAR-bisPSMA theranostic trial (SECuRE trial (NCT04868604)2) in pursuit of our ultimate goal of improving treatment outcomes for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide3. In 2021, the National Cancer Institute estimated 248,530 new cases of prostate cancer in the US and around 34,130 deaths from the disease4. Annually, there are around ~34,000 men in the US who are diagnosed with mCRCP5, ~90% of whom have tumours which express PSMA6.

On December 1, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that Janssen Biotech, Inc. ("Janssen") dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks’ Azymetric and EFECT therapeutic platforms (Press release, Zymeworks, DEC 1, 2021, View Source [SID1234596333]). This is the second Janssen bispecific program utilizing Zymeworks’ proprietary technology platforms to enter the clinic this year, following the announcement in August of Janssen’s dosing of the first patient with JNJ-78278343.

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"At Zymeworks, we are delighted to see our collaborator’s therapies reaching patients in the clinic, and we extend our congratulations to everyone at Janssen on this achievement," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Today, our therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies, with a total of six novel therapeutics having entered clinical development to date."

Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen. Under the terms of that agreement, Zymeworks provided Janssen with a worldwide, royalty-bearing license to research, develop and commercialize up to six bispecific antibodies directed to Janssen therapeutic targets using Zymeworks’ Azymetric and EFECT platforms. Janssen is responsible for all research, development, and commercial activities under the licensing agreement. Zymeworks received an upfront payment of US$50 million and is eligible to potentially receive up to US$282 million in development milestone payments and up to US$1.12 billion in commercial milestone payments, as well as tiered royalties on potential sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific and multispecific antibodies, allowing simultaneous binding to several different disease targets. This unique technology enables the development of multifunctional therapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering and internalization and increase tumor-specific targeting. These features are designed to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric therapeutics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes that deliver high yields and purity, potentially reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to activate or suppress the antibody-mediated immune response. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization and optimization of therapeutic responses for different diseases.

On December 1, 2021 Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, reported the dose administration for the first patient in a Phase 1 study of AC0682, an orally bioavailable, chimeric degrader molecule designed to target and degrade ERα protein with high potency and selectivity (Press release, Accutar Biotechnology, DEC 1, 2021, View Source [SID1234596352]).

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"The initiation of this study represents a significant milestone for Accutar, as it marks the first program from our AI-enabled drug discovery platform and our chimeric degrader portfolio to enter the clinic," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "We look forward to the clinical benefit that AC0682 treatment can potentially provide to ER-positive breast cancer patients."

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer. Additional information on this clinical trial can be found on www.clinicaltrials.gov.

About AC0682

AC0682 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α for the potential treatment of ER-positive / human epidermal growth factor receptor 2 (HER2)-negative breast cancers. In preclinical studies, AC0682 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties and brain penetration, as well as promising anti-tumor activities in ER-positive animal tumor models. AC0682 offers a potential new breast cancer treatment based on a differentiated mechanism of action from fulvestrant and novel SERDs.

On December 1, 2021 ITabMed reported it has completed the spin-off iTAb (immunotherapy antibody) platform and closed $20M Series A-round financing (Press release, ITabMed, DEC 1, 2021, View Source [SID1234596374]). Earlier in this year, Evive Biotech (formerly Generon BioMed Ltd) and Dr. Xiaoqiang Yan formed a joint venture and established ITabMed Ltd. with the full support from Evive and its shareholders . The JV company will focus on continued development of products derived from iTAb platform.

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The iTAb platform has been optimized over the last 10 years aiming to improve the clinical safety windows and to overcome the manufacturing-related challenges. The patented iTAb platform will allow the company to generate bi- or tri-specific T cell engagers. Two leading products, A-319 and A-337 are already in phase I clinical development. Multiple iTAb drug candidates are at different stages of preclinical development.

ITabMed recently closed series A-round financing, co-led by 3E Bioventures Capital and Yonjin Capital, and joined by Binhai Venture Capital. 3E Bioventures and Yonjin Capital are both active biotech investors, with a focus on innovation, with a track-record of success and good reputation.

ITabMed founder and CEO, Dr. Yan said: "We sincerely thank series A-round investors for supporting our continued efforts to bring safe and efficacious products to patients. We share the same mission ‘innovating for life’ and wish to grow together. We also thank the shareholders of Evive Biotech for their help and support."

Dr. Karen Liu, partner of 3E Bioventures commented: "Dr. Yan is a successful serial entrepreneur and a veteran drug developer. He is also a great scientist with a passion for innovation. T-cell engager is an important therapeutic approach in developing immune therapies. There are many drug candidates under development globally, but very few are approved because of issues relating to safety. We see the unique safety advantages of iTAb products and hope they will translate into real human drugs soon." Mr. Wen Chen said: "We are confident in the ITabMed team led by Dr. Yan. They experienced a 20-year path in new drug R&D in China with an outstanding track-record. We are committed to support the company and to bring new immunotherapy drugs to cancer patients."