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 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that the company will be presenting interim clinical data in a virtual poster on BDC-1001, starting on December 6, 2021 in conjunction with the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021 taking place on December 8 – 11, 2021 (Press release, Bolt Biotherapeutics, DEC 2, 2021, View Source [SID1234618692]). BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated to a TLR7/8 agonist with a non-cleavable linker.

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"The data we will be presenting at ESMO (Free ESMO Whitepaper) I-O includes more than 50 patients at increasing exposures and builds upon the data presented at ASCO (Free ASCO Whitepaper) 2021. We will be presenting additional insights into BDC-1001’s safety and tolerability profile, pharmacokinetics, tumor and serum biomarkers, and early signs of clinical activity. These interim results support continued investigation towards an optimal dosing regimen, as well as the initiation of a combination dose-escalation study with Opdivo by year-end," said Edith A. Perez, M.D, Chief Medical Officer of Bolt Biotherapeutics.

The poster will be available in the e-Posters section of the conference virtual platform as of December 6 at 12 p.m. CET:

Abstract Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Presenter: Manish R. Sharma, M.D., Associate Director of Clinical Research, START Midwest
Presentation Number: 164P
Timing: On-Demand Access

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study at 8:00 a.m. ET/5 a.m. PT on Monday, December 6, 2021.

A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

Opdivo is a trademark of Bristol-Myers Squibb Company.

On December 2nd, 2021 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") reported that the first patient with Primary immunologic thrombocytopenic purpura (ITP) had been dosed in the Phase II Clinical trial of self-developed Zuberitamab (development code: HS006) (Press release, Zhejiang Hisun Pharmaceutical, DEC 2, 2021, View Source;a=index&classid=43&id=3 [SID1234634620]). The study aims to evaluate the safety and efficacy of Zuberitamab (HS006) in subjects with primary persistent or chronic ITP who failed from prior therapy(ies). The leading entity of the clinical trial is Tongji Medical College, Union Hospital, Huazhong University of Science and Technology and the principal investigator is Prof.Yu Hu.

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Zuberitamab (HS006) is a human-mouse chimeric monoclonal antibody that specifically binds to B-lymphocyte antigen CD20 and can kill B cells via ADCC and CDC action. Zuberitamab (HS006) has demonstrated a favorable safety and efficacy profile in B-cell lymphoma in clinical trials. As B cells play an important role in the pathogenesis of autoimmune diseases such as primary immunologic thrombocytopenic purpura (ITP), rheumatoid arthritis (RA), and multiple sclerosis (MS), Zuberitamab (HS006) has the potential to be used in the treatment of autoimmune diseases.

Primary immunologic thrombocytopenic purpura (ITP) is an acquired autoimmune disease characterized by thrombocytopenia. The pathogenesis of ITP is mainly due to the loss of immune tolerance to the patient’s platelet membrane antigens. The patient’s B cells produce antibodies against different platelet antigens, leading to the formation of antigen-antibody complexes, and resulting in excessive destruction of platelets in the spleen or liver. Meanwhile, thrombopoiesis is impaired. Zuberitamab (HS006) specifically clears B-lymphocytes, thereby reducing autoantibody production and platelet destruction. Zuberitamab (HS006) is expected to bring an alternative treatment optionfor ITP patients and improve their quality of life.

"Zuberitamab (HS006) is a self-developed monoclonal antibody that targets the CD20 protein on the surface of B cells. It can rapidly, thoroughly and durably remove CD20+ B cells, and this effect is reversible after drug withdrawal, " said by Dr. Haibin Wang, the Chief Medical Officer (CEO) of BioRay, "The Phase III Clinical trial of Zuberitamab (HS006) for primary treatment of diffuse large B-cell lymphoma has completed the observation of the primary endpoint, and the study results confirmed its good safety, tolerability and efficacy, which provides strong support for the subsequent clinical development of ITP. Based on the existing achievements, BioRay will make every effort to promote its clinical research in ITP and other diseases and promote the early launch of this product in China to benefit more patients."

On December 2, 2021 Integra Therapeutics, a biotechnology company that is creating next-generation gene writing tools to boost the efficiency and safety of advanced therapies, reported the company has completed its first round of funding for €4.5 million with Advent France Biotechnology (France), Invivo Capital (Spain) and Takeda Ventures (USA) (Press release, Integra Therapeutics, DEC 2, 2021, View Source [SID1234654526]).

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Integra Tx was founded in late 2020 as a spin-off of Pompeu Fabra University (UPF) based on technology developed in the Translational Synthetic Biology Lab led by Dr Marc Güell (EMBO Young Investigator, National Research Award for Young Talent and co-founder of two biotech firms).

The great potential of this novel gene writing technology lies in the fact that it resolves some of the main technical limitations of gene therapy: it can be used to paste DNA sequences of any size gene with high precision. Advanced therapies are one of the pillars of the medicine of the future and are aimed at both preventing and treating genetic and oncological diseases that, for now, are incurable.

The funds raised in this round will allow Integra Tx to complete the prototype of the new gene writing technology platform, carry out preclinical validation using in vivo and ex vivo models, and manage its patent portfolio in 2022 and 2023. After that, the company plans to open a Series A round to seek regulatory approval and carry out clinical trials with patients.

"We’re very proud to be transferring our scientific knowledge and technological skills in gene editing from the lab to society. We thank all our investors for their commitment to Integra Tx and to making advanced therapies safer and more effective, and getting them to patients that urgently need them," says Dr Avencia Sánchez-Mejías, co-founder and CEO of Integra Tx. Sánchez-Mejías joined the UPF Translational Synthetic Biology Lab in 2018 after doing research at the Institute of Biomedicine of Seville, the National University of Singapore and the University of Miami Miller School of Medicine.

Dr Marc Güell, co-founder and CSO of Integra Tx, explains, "the Integra Tx technology platform is very promising because it is an evolution of the CRISPR-Cas techniques. We’ve found a way to merge them with transposase and integrase proteins that have a great capacity for gene transfer and to not depend on viral vectors for transporting the components into the cell, which is a step forward in making these therapies safer." Plus, it has applications both in vivo (directly in patients) and ex vivo (outside of patients).

Matthieu Coutet, Managing Partner at Advent France Biotechnology, adds: "We decided to invest in Integra Tx because we believe in its seasoned scientific and management team. Its founders have shown a strong passion and ambition to move Integra Tx’s technology forward, combined with a proven expertise in gene editing and advanced therapies."

Dr Luis Pareras, Managing Partner at Invivo Capital, says: "We’re thrilled with the possibilities Integra Tx’s plataform can develop to solve the problem of cargo size in gene therapy. We’re also very pleased with the international syndicate supporting this seed round, in yet another example of technology transfer opportunity and the competitiveness of the biotech ecosystem in Spain."

Miles Gerson, Takeda Ventures Partner and Senior Investment Director, says: "Takeda Ventures is very excited to support Integra Tx and their next generation gene writing platform with many potential applications to benefit patients."