On December 2, 2021 InnoCare Pharma (HKEX: 09969), a commercial-stage biotech company, reported that its BTK inhibitor orelabrutinib has been included in the updated National Reimbursement Drug List (NRDL) by the China National Healthcare Security Administration (NHSA) (Press release, InnoCare Pharma, DEC 2, 2021, View Source [SID1234596419]). Orelabrutinib is an oral, once-daily BTK inhibitor with national Category 1 designation. It is included in the NDRL as the treatment of patients with r/r Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL), and the treatment of patients with r/r Mantle Cell Lymphoma (MCL).

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"Lymphoma is one of the malignant tumors with the fastest growth of incidence rate and one of the top ten malignant tumors with the highest mortality rate in China. The inclusion of orelabrutinib in the NRDL could significantly improve access of this innovative drug in China, which can benefit more patients," said Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare.

"We are grateful that orelabrutinib has been included in the NRDL. We will continue to fulfil our mission — ‘Science drives innovation for the benefit of patients’, and accelerate exploring more indications for orelabrutinib," said Dr. Cui.

Orelabrutinib has excellent target selectivity with near 100% BTK occupancy. Orelabrutinib’s once-daily oral administration is convenient for continued treatment.

About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and autoimmune diseases.

Orelabrutinib had received approval on Dec. 25, 2020 from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with r/r Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL), and the treatment of patients with r/r Mantle Cell Lymphoma (MCL). In addition, multi-center, multi-indication clinical trials are underway in the US and China for orelabrutinib as monotherapy or in combination therapies for the treatment of Marginal Zone Lymphoma (MZL), Central Nervous System Lymphoma (CNSL), Waldenstrom’s Macroglobulinemia (WM), Diffuse large B-cell lymphoma (DLBCL), etc.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

Attributed to its excellent selectivity and clinical safety profiles, orelabrutinib is also evaluated in the global phase II studies for the treatment of Multiple Sclerosis (MS), phase II clinical trials for the treatment of Systemic Lupus Erythematosus (SLE) and Primary Immune Thrombocytopenia (ITP) in China.

On 2 December 2021 Oncology One Pty Ltd, reported a partnership with WEHI (Walter and Eliza Hall Institute of Medical Research) to develop new drugs for the treatment of cancer, in collaboration with Curtin University (Press release, Oncology One, DEC 2, 2021, View Source [SID1234629324]).

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The collaboration centres on the development of novel small molecule drugs to treat solid tumours, initially focusing on breast cancer.

The project will seek to identify small molecule compounds that specifically inhibit a novel target in breast cancer that drives tumour growth. If successful, further work will need to be undertaken to refine these compounds towards candidate therapies, which could enter clinical trials in due course.

Chair of Oncology One’s Scientific Advisory Board, Dr Ian Street, said: "This project represents an important next step for Oncology One in building a pipeline of drug discovery programs that are highly differentiated and address unmet clinical needs. We have made great progress in early breast cancer detection, and this has had a dramatic effect on reducing mortality. However, if early disease is missed and the cancer metastasises, then unfortunately prognosis is poor. We are very much looking forward to a productive collaboration with David and Pieter, and the drug discovery and research teams at WEHI and Curtin".

This transcontinental project originated in the research labs of Professor David Komander at WEHI and Associate Professor Pieter Eichhorn at Curtin University. The objective is to develop a new therapeutic for treating metastatic ER+ breast cancers that have escaped current treatments. The new therapeutic also has the potential to address unmet clinical needs in other cancers such as colorectal and brain.

WEHI Ubiquitin Signalling Division Head, Professor David Komander, said: "The ubiquitin system offers many opportunities for innovative cancer treatments. We are delighted to work with Oncology One on this exciting project and to translate our research to benefit cancer patients. The project was initially born in a collaboration with Curtin University, and we are excited to draw upon our strengths and to work with industry to improve treatments for a disease that continues to impact so many lives."

Breast cancer is the most prevalent form of cancer in women and accounts for over 2 million cases and over 600,000 deaths per year worldwide according to the World Health Organisation (WHO). The emergence of resistance to existing therapies is a major challenge in the treatment of many people with breast cancer, and new treatment modalities are urgently required to improve patient outcomes.

Curtin University Associate, Professor Pieter Eichorn, said: "While breast cancer survival rates have improved, there are millions of patients who don’t respond to current treatments. Through this collaboration drawing on the expertise of WEHI in drug discovery and Oncology One in drug development, we can find the best way to bring our cancer treatment discoveries to patients, and make a real difference to them and to their loved ones and families."

On December 2, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported its presentation at the TIGIT Therapies Digital Summit 2021 being held virtually December 7 – 9, 2021 (Press release, Shattuck Labs, DEC 2, 2021, View Source [SID1234596402]).

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Presentation Details
Presentation Title: LIGHTing the Way for TIGIT Blockade in CPI Refractory Tumors
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: December 9, 2021
Time: 9:30 a.m. EST
Location: View Source

The presentation will be available for download on the Events & Presentations section of the company’s website and also will be available to registered participants of the TIGIT Therapies Digital Summit 2021.

On December 2, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported that interim data from the ICE3 Clinical Trial on cryoablation of small, low-risk breast cancer was featured by Co-Primary Investigator, Dr. Kenneth Tomkovich at the Radiologists Society of North America (RSNA), which was held from November 29th through December 2nd (Press release, IceCure Medical, DEC 2, 2021, View Source [SID1234596420]). Dr. Tomkovich’s presentation, "Primary Treatment of Low Risk Breast Cancers Using Image-Guided Cryoablation: A 6 Year Update of the ICE3 Trial" was selected to be featured in a daily bulletin by RSNA, the largest radiology society in the world with over 48,000 members in the United States, representing 31 radiologic sub-specialties sharing state-of-the-art radiological innovations.

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Dr. Tomkovich featured the ICE3 interim results on Tuesday, November 30th as part of the larger "Breast Imaging (Breast Intervention and PET/Breast Imaging in Neoadjuvant Chemotherapy" session.

Eyal Shamir, Chief Executive Officer of IceCure, noted, "We are proud that our data was recognized by the Radiology Society of North America,(RSNA), the largest radiology society in the world and a highly regarded medical association. We believe this recognition by this prestigious society is further supportive of the ICE3 data."

Dr. Tomkovich commented, "The acceptance of cryoablation as a treatment for breast cancer is becoming more wide-spread in the radiological medical community and the interim ICE3 trial results continue to validate this approach. It is an option that could be much more convenient than a mastectomy or lumpectomy surgery, in terms of requiring less office time, as well as less stress and a quick recovery for the patient."

On December 2, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported it had licensed exclusive worldwide ex-China rights to the KRAS inhibitor, JMKX1899, from Shanghai Jemincare Pharmaceutical Co., Ltd. Jemincare will retain the relevant rights in the greater China area (Press release, HUYA Bioscience, DEC 2, 2021, View Source [SID1234596454]).

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Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program outlicensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

KRAS is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of KRAS in the switch-II region, which has made KRAS druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare filed the IND with the NMPA in October 2021. The parties will work closely to file the IND with the US FDA in 2021 to move towards clinical development.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage KRAS inhibitor to our oncology pipeline especially to test in combination with our SHP2 inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."