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 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."

On December 2, 2021 Tune Therapeutics, a biotechnology company pioneering the creation of epi-therapeutic medicines, reported it launched with its powerful and precise genetic tuning platform, TEMPO (Press release, Tune Therapeutics, DEC 2, 2021, View Source [SID1234630692]). This cutting-edge technology dials gene expression up or down to desired levels – with the potential to reverse pathways of cancer, genetic disease, and aging by changing cell fate and function at will.

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"Genetic medicine is at a tipping point," said Matt Kane, CEO of Tune Therapeutics. "We now understand that the driving force of human health and disease is not our genes, but the epigenomic elements that shape and control them. Until now, scientists and bioengineers lacked the combined understanding, clinical expertise, and technology needed to make epigenomic therapies a practical reality. Now, we have all three."

TEMPO Platform

Tune’s proprietary TEMPO platform can rapidly target and adjust the epigenomic machinery of the cell, which shapes DNA and controls gene expression. By varying specific control modules in an iterative process, TEMPO can fine-tune expression toward healthy levels – even in diseases involving multiplex or polygenic interactions.

Unlike genome editing, the tuning process does not generate double- or single-strand breaks in DNA and makes no permanent changes to the DNA sequence. This de-risks the precise targeting of entire gene networks, allowing Tune to simultaneously turn silenced genes on and dial over-expressed genes down, in a practical, therapeutic context.

Tune has already shown that TEMPO can locate epigenomic elements involved in several intractable genetic conditions – revealing targets and networks that would be invisible or inaccessible to gene editing approaches. Moreover, Tune can optimize TEMPO to command expression of individual genes or networks with remarkable specificity and precision. This opens the door to an entirely new class of epi-therapeutics.

"The exciting challenge in front of us is taking these transformative advances in technology and extending their potential for our greater society," said Charlie Gersbach, PhD, Acting Chief Scientific Officer, Tune Therapeutics. "From proof of concept in rare, single-gene disorders to common conditions that aren’t linked to a single gene mutation – but are treatable through epigenomic control and constitute the vast majority of human diseases."

Veteran Genomic Medicine Leadership Team

Tune is launching with a veteran leadership team, endowed with deep expertise in gene and cell therapy, genome editing, and epigenetics.

Matt Kane, Chief Executive Officer
Akira Matsuno, Co-Founder, President and Chief Financial Officer
Charlie Gersbach, Ph.D., Co-Founder, Acting Chief Scientific Officer
Fyodor Urnov, Ph.D., Co-Founder, Scientific Advisory Board
Heidi Zhang, Ph.D., Executive Vice President, Head of Technical Operations
Blythe Sather, Ph.D., Vice President, Head of Research
In addition, Tune’s Board of Directors includes Mr. Kane, Dr. Gersbach, Ali Behbahani, M.D., (New Enterprise Associates), and co-founder Dan McHugh (Emerson Collective).

Drawing upon deep, local talent pools in Durham and Seattle, Tune has assembled two highly seasoned discovery and development teams, secured foundational intellectual property from Duke University, and raised $40 million from top-tier investors – including co-leads New Enterprise Associates and Emerson Collective, with Hatteras Venture Partners, Mission BioCapital, and others joining the round. This financing will enable Tune to rapidly advance its preclinical research, attract top-tier talent, and further develop its therapeutic platform.

"Tune is effectively pioneering a brand-new therapeutic modality," said Dr. Behbahani. "With the unbound potential of this approach, and their collective successes in the field, Tune is primed to become a transformative presence in modern biomedicine."