IceCure Medical Announces Updated Regulatory Strategy in China for the IceSense3® System to Treat Cancerous Tumors with Cryoablation

On October 12, 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 the advancement of its regulatory strategy in China with the submission of an amendment to the registration certificate for the IceSense3 system, which was granted by China’s National Medical Products Administration ("NMPA") (Press release, IceCure Medical, OCT 12, 2021, View Source [SID1234591125]). The amendment, if approved, will allow the Company to sell its disposable IceSense3 Cryoprobes for commercial procedures. The Company expects the NMPA to complete its evaluation of the amendment by the end of 2022. If the amendment is approved, the Company expects to then launch its commercial sales program for the IceSense3 system in China in early 2023.

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"We are excited to announce the advancement of our regulatory strategy for the IceSense3 system in China, as we look to bring our minimally-invasive therapy to more cancer patients around the world. With more than 400,000 new breast cancer cases diagnosed in China in 2020, according to the World Health Organization, breast cancer continues to be a significant health concern in China," commented Eyal Shamir, Chief Executive Officer of IceCure. "As Chinese health providers continue to look for advanced technologies, we expect early adopters in China to provide a base for our commercial launch once the IceSense3 Cryoprobes receive NMPA regulatory clearance. As part of our strategy to gain greater awareness of our systems and cryotherapy as a cancer treatment more broadly with healthcare providers in the region, we have been supportive of an ongoing independent clinical trial with a site in Hong Kong and a site in Shenzhen. Also, we expect another independent trial to start soon in a leading hospital in Shanghai."

BioMarin to Host Third Quarter 2021 Financial Results Conference Call and Webcast on Wednesday, October 27 at 4:30pm ET

On October 12, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, October 27, at 4:30 p.m. ET to discuss third quarter 2021 financial results and provide a general business update (Press release, BioMarin, OCT 12, 2021, View Source [SID1234591123]).

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Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

AUM Biosciences announces closing of $27 million in a "Series A" Round of funding to advance its clinical stage pipeline of precision and targeted cancer therapies

On October 12, 2021 AUM Biosciences (AUM) reported the successful completion of $27 million series A funding round (Press release, AUM BioSciences, OCT 12, 2021, View Source [SID1234591122]). This will fuel AUM’s vision of developing a world class biotech pipeline focused on drugging what many consider as the undruggable targets, as well as addressing the need to delay and overcome resistance to targeted drugs in oncology . The funding will also accelerate pipeline expansion and business growth. This round was led by private equity funds including Singapore-based Everlife and globally focused health sciences investment firm SPRIM Global investments (SGI).

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Through its robust strategic collaborations with leading academic institutions, pharmaceutical and biotech companies globally, AUM is now leading an ecosystem of multi-modality line up of small molecule targeted therapies, including in-house research programs. AUM plans to use the proceeds to advance the clinical development of its portfolio with immediate initiation of two Phase II programs for MNK and TRK inhibitors.

Talking about the impetus Vishal Doshi, CEO and co-founder, AUM Biosciences said, "We are excited about the next phase of growth and value creation. Our blue-chip founders and leaders are proud to have the confidence of and support from Everlife and SPRIM Global Investments. These proven investors share our enthusiasm for developing new therapies for patients who have high unmet needs."

Harish Dave, CMO and co-founder, AUM Biosciences who is gearing up to lead the next phase of this growth journey, expressed, "We are thrilled to see our vision taking root, and the strong support from Everlife and SPRIM Global Investments will certainly accelerate our innovation plans, globally. The synergy in our vision to support the cancer patients with better targeted therapies, has laid the foundation of this association and investment."

Earlier this year, AUM had entered into a strategic collaboration agreement with Handok Inc and CMG Pharmaceutical Co. Ltd. Additionally, AUM Biosciences and Newsoara Biopharma also announced a 5-year transformational strategic partnership in 2020 to co-develop and co-discover next-generation cancer therapeutics (enterprise value of up to USD 135M).

Dr. Arjun Oberoi, Executive Chairman, Everlife said, "We are deeply impressed by AUM’s leadership team and believe that AUM’s unique portfolio holds great promise to address multiple unmet needs in the field of oncology. Everlife has a strong inclination in expanding its presence in the cancer diagnostic arena. This collaboration will help position us more strongly in the overall oncology ecosystem and grants us immediate access to AUM’s network of research laboratories and those of its partners in Southeast Asia".

The Jackson Laboratory Announces Acquisition of Charles River Laboratories Japan

On October 12, 2021 The Jackson Laboratory (JAX), a U.S.-based nonprofit biomedical research institution, reported that it has acquired Charles River Laboratories Japan’s Research Models & Services (RMS) business as a wholly owned subsidiary (Press release, Charles River Laboratories, OCT 12, 2021, View Source [SID1234591120]). The Japan-based organization, which will be called The Jackson Laboratory Japan, has approximately 250 employees and three production sites in Atsugi, Hino and Tsukuba, and an administrative office in Yokohama.

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"This important acquisition resulting in the establishment of The Jackson Laboratory Japan is a critical milestone in further empowering Japanese researchers to make significant scientific advances and improvements in drug discovery and basic research," said Auro Nair, executive vice president of The Jackson Laboratory and president, JAX Mice, Clinical and Research Services.

"We look forward to providing these researchers with direct access to the highest standard of leading-edge animal research models, services, and scientific support that JAX is renowned for. This includes specialty models such as humanized mice and advanced immunodeficient models based on the NSG-platform mouse, as well as services, technical support and scientific expertise. Additionally, this acquisition advances our mission to empower biomedical research worldwide and to play an even more direct role in Japan as well as Korea and Taiwan while advancing our international growth strategy," said Nair.

JAX has the world’s largest and best characterized repository of high-quality models including aged mice, the JAX NSG portfolio, humanized mice, along with important inbred strains like Black 6 and BALB/c and many others in its catalog of 12,000 precision research and therapeutic models. These models have the highest health and genetic quality and have the potential to better provide translatable research insights when precisely applied, benefiting scientists and ultimately, patients around the world. In addition to providing improved access to strains of JAX Mice, the entire JAX NSG portfolio will become available to researchers in Japan.

Nair will serve as the chairman of the Board of Directors and Yukihiro Takemoto will report to Nair while retaining his current role as president and representative director for the new entity, The Jackson Laboratory Japan.

"For over 20 years, we have built a strong partnership with The Jackson Laboratory providing research animal models. We are very pleased to be able to take this new strategic step forward and further contribute to the development of drug discovery and bioscience research in Japan," said Takemoto. "Customers will continue to have full access to all products and services that they currently receive and we look forward to extending our portfolio of offerings to them."

Deepcell Collaborates with the University of Zurich to Deepen the Understanding of Cancer Biology

On October 12, 2021 Deepcell, a life science company pioneering AI-powered cell classification and isolation for basic and translational research, reported a collaboration with the Levesque Lab at the University of Zurich (Press release, Deepcell, OCT 12, 2021, View Source [SID1234591119]). The goals of the collaboration are to use Deepcell’s technology to identify and sort rare melanoma cells, profile melanoma tissues to gain a deeper understanding about tumor microenvironment, and enable molecular analyses of the sorted cells.

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This collaboration brings together one of the leading scientific research institutions in Europe and one of the most innovative life science companies. Deepcell’s AI-powered platform analyzes, classifies and isolates viable cells in a label-free manner based on morphology alone. Through its deep learning-based algorithms and unique cell sorting approach, Deepcell supports a quantitative and mechanistic understanding of cell biology.

"Melanoma cells are difficult to isolate with conventional sorting methods because they lack reliable cell surface markers. By isolating and sorting cells using morphology, we may deepen our understanding of the biology of melanoma progression and, in particular, of cell phenotypes and molecular features of cancerous cells," said Dr Levesque, Associate Professor at the University of Zurich.

The Deepcell platform combines high-resolution imaging of cells in flow with real-time cell classification and sorting, using cell morphology as the only analyte. This label-free, target-agnostic approach overcomes some of the limitations of cell surface marker-based classification and enrichment, including the limited number of available markers and channels for detection, prior knowledge or guesswork required to select surface proteins, and availability of protein-specific antibodies. Importantly, the technology not only analyzes the cellular phenotype, but also enables the isolation of viable, unperturbed cells, allowing for the linkage of cell morphology with molecular data and functional assays.

"We continue to expand our collaborations with world-class researchers, such as teaming up with Dr Levesque and his team at the University of Zurich," said Maddison Masaeli, Co-founder and CEO of Deepcell. "Our unique AI-powered technology transforms cell morphology into a precise, reproducible and unbiased analyte that enables highly accurate cell classification while maintaining cell viability. With the researchers at the University of Zurich, we will be able to generate rich data to help elucidate the complex tumor microenvironment."