On September 13, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that Management will participate in the upcoming investor events set out below (Press release, Transgene, SEP 13, 2021, View Source [SID1234587622]):

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– Investor Access Forum – Physical event (Paris, France)
September 27 & 28, 2021

– HealthTech Innovation Days 2021 – Digital & physical event (Paris, France)
October 4 & 5, 2021

-European Midcap Event – Digital & physical event (Paris, France)

October 21 & 22, 2021

– EigenKapitalForum – Digital event

November 22, 2021

-Investir Day – Physical event (Paris, France)

November 23, 2021

On September 13, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of the next generation minimally invasive cryoablation technology that destroys tumors by freezing, reported that the first peer reviewed article "Cryoablation Without Excision for Low-Risk, Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial" was published in the Annals of Surgical Oncology with Dr. Richard Fine, MD, FACS, an ICE3 investigator who serves as Program Director of the Breast Surgical Oncology Fellowship and as Director of Research and Education at the West Comprehensive Breast Center in Germantown, TN, as the lead author (Press release, IceCure Medical, SEP 13, 2021, View Source [SID1234587654]).

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"Having a peer reviewed publication of the ICE3 Clinical Study[1] interim results in a well-respected medical journal represents a major milestone for IceCure in solidifying the efficacy and adaptation of its minimally invasive solution by the broader medical community for the treatment of certain breast cancers," stated IceCure CEO, Eyal Shamir. The article reports the results previously announced on April 29, 2021 at the American Society of Breast Surgeons Annual Meeting, that at a mean of 34.83 months following treatment with ProSense Cryoablation System, only 2.06% (4 of 194 patients) experienced cancer recurrence.

The journal article concludes that "breast cryoablation presents a promising alternative to surgery while offering the benefits of a minimally-invasive procedure with minimal risks."[2] Study author Dr. Fine stated that "the 3-year ICE3 trial results highlighting the efficacy and safety of the procedure in this patient group are extremely promising for breast cryoablation. Being able to provide a minimally-invasive option for treating appropriate low risk patients represents a dramatic improvement in care – the procedure is quick, painless and can be delivered with local anesthesia in doctor’s office, with minimal recovery time and excellent cosmetic outcomes."

Dr. Richard Fine will be presenting his findings on cryoablation at the upcoming Mayo Clinic School of Continuous Professional Development Conference "Breast Cancer Care: Innovation, Disruptive Technologies and Early Adopters 2021" in Rochester, MN on Friday, September 17, 2021. Scott Peairs, IceCure US Commericial Director, will be on site at the exhibit.

On September 13, 2021 ITM AG, a leading radiopharmaceutical biotech company, reported that it has signed a strategic long-term agreement to create a Joint Venture with Chengdu Gaotong Isotope Co. Ltd., the leading provider of radiopharmaceuticals and nuclear services in China and a subsidiary of ITM’s collaboration partner China Isotope and Radiation Corporation (CIRC) (Press release, ITM Isotopen Technologien Munchen, SEP 13, 2021, View Source [SID1234587673]). The newly formed company is planned to start operations in Q4 2021 and will be located in Chengdu, China. It will focus its operations on the supply of ITM’s EndolucinBeta (n.c.a. 177Lu) and Gallium Generators to the rapidly emerging Chinese radiopharmaceutical industry. ITM hereby also increases its footprint in China with a second in country location after having established its first subsidiary in Shanghai earlier this year. The Joint Venture will be led by both companies with the goal of scaling and securing access to ITM’s state-of-the-art medical radioisotopes in China.

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"China is an important market for us and this Joint Venture represents our commitment to the region as well as our global efforts to bring a new generation of targeted radiopharmaceuticals to patients with hard-to-treat cancers worldwide," said Steffen Schuster, CEO of ITM. "We are committed to further expanding our successful, long-term partnership with CIRC and are looking forward to increasing our global footprint in China. Next to our own clinical development of targeted radiotherapeutics and diagnostics through our Chinese subsidiary, the new Joint Venture with Gaotong will also help facilitate market access and build new partnerships for our therapeutic radioisotope EndolucinBeta and our Gallium generators for precision oncology treatments with the growing Chinese radiopharmaceutical industry as a whole."

"The demand for innovative, precise and high-quality treatment options for cancer patients in China continues to increase. Together with ITM, we are working toward addressing this need," said Mr. Wang Suohui, the General Manager of CIRC. "We established a collaboration with ITM over ten years ago and strengthened our partnership in 2019 to locally manufacture and distribute ITM’s EndolucinBeta and Gallium Generators. We are excited to establish this Joint Venture as the next step in our common development and look forward to working with ITM in providing increasing quantities of high-quality medical radioisotopes to Chinese hospitals and industry and to further improving access for precise cancer radiotherapeutics and diagnostics for patients."

The Joint Venture follows the existing strategic partnership between ITM and CIRC which was initially formed in 2010 and further extended in November 2019. As part of the newly-formed Joint Venture, ITM and CIRC will also work on securing and scaling the supply of diagnostic and therapeutic radioisotopes as a robust basis for the clinical development and commercialization of targeted radiotherapeutics and diagnostics in China both independently and together with local pharmaceutical partners. Further details of the agreement were not disclosed.

On September 13, 2021 Cytovia Therapeutics, Inc. ("Cytovia"), a biopharmaceutical company developing allogeneic "off-the-shelf" gene-edited iNK and CAR (Chimeric Antigen Receptor)-iNK cells derived from induced pluripotent stem cells (iPSCs) and NK cell engager multifunctional antibodies, and CytoLynx Therapeutics ("CytoLynx), its newly-formed China-focused joint venture, reported that they have closed $45 million from institutional investors to finance the IND enabling and initial clinical development of their pipeline (Press release, Cytovia Therapeutics, SEP 13, 2021, View Source [SID1234587918]).

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Cytovia and TF Capital, a leading China-based biotech institutional investor, have formed CytoLynx Therapeutics. TF Capital along with YF Capital, BioTrack Capital, Ruihua Capital, and TG Sino-Dragon Fund (backed by TigerMed) have invested $45 million to support the new venture, as well as Cytovia research and development projects. The collaboration agreements between CytoLynx and Cytovia will advance multiple NK therapeutics through product development in the Greater China region. Additionally, CytoLynx obtained a technology license from Cytovia based on its core technologies to allow in-China development of additional NK therapeutics for global commercialization. Cytovia is eligible to receive up to $400 million in upfront development and commercial milestones under the agreement.

Dr. Daniel Teper, Chairman and CEO of Cytovia commented: "We are excited to accelerate the global development of our lead GPC3 programs for the treatment of hepatocellular carcinoma, a condition with significant unmet medical needs and a very large patient population in Asia, particularly in China, and establish a path to provide these therapies to the Chinese market. CytoLynx will also serve as a development and commercialization platform for additional Cytovia products, as well as in-licensed immuno-oncology assets."

Dr. Wei Cheng, Managing Director at TF Capital added: "We are delighted to partner with Cytovia Therapeutics to bring novel therapeutic options to patients in China. Cytovia has a seasoned entrepreneurial leadership team and best-in-class NK technologies, including iPSC-derived NK cells, gene editing, and NK Engager multifunctional antibodies. We believe that by combining the strengths of the two parties, we can make CytoLynx and Cytovia global leaders in NK cancer therapeutics and benefit patients worldwide."

Dr. Albert Huang, Executive Director at Yunfeng Capital noted: "As the lead investor in this series of financing, Yunfeng Capital believes that Cytovia and CytoLynx are well positioned to become leading players in iPSC NK cell therapy."

On September 12, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical results and subgroup analyses from the Company’s robust lung cancer program will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, BeiGene, SEP 12, 2021, View Source [SID1234587558]).

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"We continue to make meaningful progress with our deep immuno-oncology portfolio, including our lung cancer program of seven Phase 3 trials in NSCLC. Driven by growing clinical insights, we are working to accelerate the development of tislelizumab in novel combinations in lung cancer, including with our internally discovered potent investigational anti-TIGIT antibody ociperlimab and therapeutic agents from collaborations, such as sitravatinib," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "In addition, our scientists are exploring new modalities for potential combinations with tislelizumab in lung cancer and other solid tumors, and with the ongoing Novartis collaboration, tislelizumab can be leveraged with their oncology pipeline for more combination opportunities. We plan to work to realize the therapeutic potential of this differentiated checkpoint inhibitor through combinations in various tumor types for patients worldwide."

To learn more about BeiGene’s research and development and activities around ESMO (Free ESMO Whitepaper), please visit View Source

Broad Lung Cancer Program Focused on Tislelizumab Combination Treatments

BeiGene is pursuing diverse mechanisms of action in combination with tislelizumab to complement targeting of the PD-1 pathway for potentially improved clinical outcomes or to overcome resistance associated with disease progression.

In NSCLC, many patients who have achieved a response to front-line anti-PD-1 antibody treatment eventually relapse due to resistance. Through its collaboration with Mirati Therapeutics, BeiGene is investigating the combination of tislelizumab and sitravatinib, a spectrum-selective tyrosine kinase inhibitor potentially capable of reversing immunosuppressive tumor microenvironment to overcome immune resistance. BeiGene is conducting a Phase 3 trial of this novel combination in NSCLC, and clinical results from an ongoing Phase 1b trial in patients with metastatic NSCLC, both naïve and refractory or resistance to anti-PD-(L)1 treatment, will be presented at ESMO (Free ESMO Whitepaper) Congress 2021.

Another novel combination of tislelizumab that BeiGene is investigating in lung cancer is with ociperlimab, a potent, Fc-intact investigational anti-TIGIT-antibody in Phase 3 clinical development. TIGIT is a co-inhibitory immune checkpoint receptor expressed on multiple immune cells and has recently emerged as a new therapeutic target that in collaboration with PD-1 has the potential to further suppress antitumor immune response. Tislelizumab’s broad combination portfolio in lung cancer also includes PI3K-delta inhibitor BGB-10188, anti-TIM-3 antibody BGB-A425, and chemotherapy.

Growing NSCLC Program Driven by Scientific Excellence and Clinical Insights

To address the prevalence of NSCLC worldwide and the clinical unmet need despite treatment progress in recent years, BeiGene is currently evaluating tislelizumab in a comprehensive NSCLC program of more than 10 clinical trials covering disease settings from early to late lines.

To gain key insights into how different patient characteristics can impact treatment outcomes, BeiGene’s immuno-oncology team reviews clinical results from NSCLC trials by geography, disease stage, smoking status, and using biomarkers.

Subgroup analyses on BeiGene’s RATIONALE 307 trial recently presented at the 2021 World Conference on Lung Cancer (WCLC) showed that tislelizumab in combination with chemotherapy provided consistent survival benefits in treatment-naïve patients with squamous NSCLC, regardless of PD-L1 expression, blood tumor mutation burden (TMB), tissue TMB, and disease stage (IIIB or IV).

At the ESMO (Free ESMO Whitepaper) Congress 2021, additional analyses on smokers vs. nonsmokers in the two Phase 3 clinical trials in first-line NSCLC, RATIONALE 304 and RATIONALE 307 will be reported.

In addition, the Company is exploring tislelizumab’s potential as an early treatment option, with an ongoing global Phase 3 trial RATIONALE 315 in neoadjuvant or adjuvant settings.

BeiGene’s ePoster Presentations at ESMO (Free ESMO Whitepaper) Congress 2021

Abstract #

Title

Lead Author

3649

Sitravatinib + tislelizumab in patients with anti-PD-(L)1 refractory/resistant metastatic NSCLC

Bo Gao, M.D., Ph.D.
Blacktown Cancer and Hematology Centre (Australia)

3457

Sitravatinib + tislelizumab in patients with metastatic NSCLC

Qing Zhou, M.D., Ph.D.
Guangdong Lung Cancer Institute (China)

2562

Effects of tislelizumab monotherapy on health-related quality of life in patients with previously treated unresectable HCC

Zhenggang Ren, M.D., Ph.D.
Zhongshan Hospital (China)

3786

RATIONALE 304: Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for non-squamous NSCLC in patients who are smokers vs non-smokers

Shun Lu, M.D.
Shanghai Lung Cancer Center (China)

4053

Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients who were smokers vs non-smokers

Xinmin Yu, M.D.
Zhejiang Cancer Hospital (China)

1587

Association between use of antibiotics and clinical outcomes with tislelizumab monotherapy

Zhenggang Ren, M.D., Ph.D.
Zhongshan Hospital (China)

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.