On May 20, 2021 Indica Labs, an industry leader in quantitative digital pathology & image management solutions, and Ibex Medical Analytics, a pioneer in artificial intelligence (AI) based cancer diagnostics, reported an agreement to integrate the Galen AI-based cancer diagnostics platform into the HALO AP digital pathology workflow platform (Press release, Lifescience Newswire, MAY 20, 2021, View Source [SID1234580466]).

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The HALO AP platform was developed by Indica Labs to address the needs of digital Anatomic Pathology labs. The platform can be fully integrated within existing LIS or HIS solutions or can operate as a standalone case and image management system for anatomic pathology. Furthermore, HALO AP supports a full range of tissue-based assays and workflows, including synoptic reporting, tumour boards, secondary consults, quantitative analysis, and AI-assisted workflows. HALO AP is used by some of the largest anatomic pathology laboratories in the world, including NeoGenomics and the National Cancer Institute (NCI).

Ibex’s Galen platform uses strong-AI algorithms that support pathologists in improving the quality of cancer diagnosis and providing productivity-enhancing insights that help reduce turnaround times. Installed in labs worldwide and used as part of everyday clinical practice, Galen routinely detects misdiagnosed and mis-graded cancers in digitized slides, guiding pathologists to areas of cancer in support of a prompt review. In recent clinical studies, the Galen platform demonstrated outstanding clinical outcomes, including the highest accuracy levels reported in the field for prostate cancer, 1- to 2-day reductions in total turnaround time, and 37% productivity gain for pathologists, compared to conventional microscope viewing.
The integration between HALO AP and the Galen platform is designed to enable a seamless experience for the end-user. Galen adds AI-powered cancer detection, case prioritization, grading and other productivity-enhancing insights displayed directly within the HALO AP Platform, so there is no need to use a separate viewer. Where applicable, the data will be communicated with the LIS or HIS system automatically.

"While Indica Labs continues to grow our state-of-the-art AI application pipeline, we also recognize the importance of interoperability with other leaders in this growing field," commented Steven Hashagen, Indica Labs CEO. "A truly seamless integration with Ibex will allow customers to make best-of-breed AI selections without compromising usability."

"Integrated digital pathology and AI workflows are a major driver in supporting pathologists, as they are challenged by ever-increasing workloads and complexity of cancer diagnosis," said Joseph Mossel, CEO and Co-founder of Ibex Medical Analytics. "By joining forces with Indica Labs, we can jointly offer end-to-end solutions enabling pathologists to accelerate adoption of new technologies, strengthen the business case for digitization and improve the quality of cancer care."

On May 20, 2021 Tyligand Bioscience, which is committed to the research and development of new small molecule anti-tumor drugs, reported the completion of the A round of financing of about US$20 million jointly participated by Hongli Venture Capital, Yijing Capital, and China Medical System (Press release, Tyligand Bioscience, MAY 20, 2021, View Source [SID1234644993]). This round of financing will be used to promote the transformation of the company’s pipeline to the clinical stage, including the phase II clinical trials of onapristone in China, the preclinical research and IND declaration of 3 innovative molecules, and several First-in-class research projects compound optimization. BFC Capital acted as the exclusive financial advisor to Tyrex in this transaction.

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Dr. Zhang Yantao, chairman of Tyligand Bioscience, said: I am very grateful to new and old investors for their recognition and support of Tyligand’s original creativity. We should live up to high expectations, strive to efficiently promote the progress of the pipeline, develop high-quality first-class new drugs that can stand the test of time, and provide patients and medical staff with more accessible and reliable treatment options.

Dr. Xu Tianhong, managing partner of Holly Ventures, said: Holly Ventures is committed to discovering and investing in original innovations in the field of biomedicine at home and abroad, as well as first-class entrepreneurial teams of scientists with a solid style and deep foundation. Tyligand’s unique First-in-class and Best-in-class R&D pipeline is the best proof of its team’s creativity and execution ability in drug molecule design. We look forward to working closely with the company in the field of life sciences to provide safe and effective treatment options for cancer patients.

Yijing Capital said: Tyligand team has become one of the most innovative companies in the field of small molecules with its global vision in risk management and control, decision-making power in target selection, and efficient capital utilization. Yijing Capital is very optimistic about the company’s R&D platform built around the selective regulation of molecular phosphorylation levels, and is also very honored to support the advancement of Tyrena’s pipeline and the realization of clinical value. It looks forward to the smooth progress of the company’s products under research and the early benefit of patients around the world.

Lin Gang, Chairman of CMS, said: Tyligand has a strong team, and its research pipeline is unique and highly competitive, and it has also attracted first-class collaborators. It is a great pleasure to join hands with investment partners to jointly support original innovations that the market desperately needs.

On May 20, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended March 31, 2021 on Wednesday, May 26, 2021, before the US markets open (Press release, BioLineRx, MAY 20, 2021, View Source [SID1234580351]).

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The Company will host a conference call on Wednesday, May 26, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0610 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 28, 2021; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

On May 20, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company focused on novel immunotherapies for the treatment of solid tumors, reported that it was just awarded "Best Early Stage Product Development Company" within the Life Sciences award category by the Triangle Business Journal (Press release, Istari Oncology, MAY 20, 2021, View Source [SID1234580367]).

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The Triangle Business Journal (TBJ) Life Sciences Awards recognize both individuals and research organizations in the Research Triangle region of North Carolina that are blazing trails and breaking ground in this field. The life sciences award category includes biotechnology, pharmaceuticals, clinical research, human health, medical devices and diagnostics, and many others. This year TBJ honored 16 winners – three individuals and 13 organizations – including Istari, in a ceremony held virtually earlier today.

"I’m really grateful for this award and for the Istari team to be honored by the Triangle Business Journal for all of their contributions," stated President and CEO, Matt Stober. "It serves as recognition of the hardworking team we have here at Istari Oncology and the unique immunotherapy we believe will change the treatment paradigm for cancer patients."

Istari’s lead immunotherapy candidate, PVSRIPO, is based on an attenuated version of the polio vaccine, originally developed through research at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center. The therapy is currently being evaluated in multiple clinical trials across a range of solid tumors including glioblastoma and melanoma. PVSRIPO will also be evaluated in a "basket trial" that includes other solid tumors such as bladder cancer.

On May 20, 2021 GammaDelta Therapeutics ("GammaDelta"), a company focussed on exploiting the unique properties of gamma delta (γδ) T cells for immunotherapy, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company’s allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy, GDX012, to be investigated as a treatment for haematological malignancies (Press release, GammaDelta Therapeutics, MAY 20, 2021, View Source [SID1234580384]). The FDA also granted orphan drug designation to allogeneic Vδ1 γδ T cell therapy (GDX012) for the treatment of Acute Myeloid Leukaemia (AML).

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Dr. Paolo Paoletti, CEO of GammaDelta Therapeutics, commented: "The clearance of our IND application for GDX012 marks an important step for our company in establishing a portfolio of innovative allogeneic cell therapies. The unique properties of Vδ1 γδ T cells will be evaluated for the first time in a clinical study for patients with AML. This important milestone results from our efforts to establish a robust pipeline of cellular immunotherapies derived from our proprietary platforms and processes for the isolation and expansion of Vδ1 γδ T cells from both blood and tissues for targeting haematological malignancies and solid tumours."

GammaDelta plans to initiate a Phase 1 clinical trial for patients with measurable residual disease (MRD) positive AML. Expected to begin later in 2021 as a multicentre study in the US, the trial will evaluate safety, tolerability and anti-leukemic activity of GDX012. GammaDelta Therapeutics is advancing its novel T cell platform under an ongoing collaboration with Takeda Pharmaceutical Company Limited ("Takeda") formed in 2017.

Dr. Michael Koslowski, Head of R&D and Chief Medical Officer of GammaDelta Therapeutics, said: "Although progress has been made in the treatment of AML, the median overall five-year survival rate for patients diagnosed with AML remains under 30 percent. With the development of GDX012 we are aiming to change the treatment paradigm for AML and potentially other haematologic malignancies. The unique biological characteristics of Vδ1 γδ T cells offer a first-in-class Vδ1 γδ T cell therapy for AML, where the development of cell therapies has been historically limited due to the lack of specific targets."

Dr. Chris Arendt, Oncology Therapeutic Area Unit Head of Takeda, commented: "The progression of GammaDelta Therapeutics’ platform technology underscores the potential of γδ T cells and the power of the innate immune system. Through collaboration with pioneers like GammaDelta Therapeutics, we hope to advance next-generation cell therapies and to maximise off-the-shelf treatments in the battle against hard-to-treat cancers."

GammaDelta has developed proprietary technologies to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1 γδ T cells for the treatment of haematologic malignancies and solid tumours. Both platforms have enabled the creation of highly active and selective non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumour cell killing capacity. Vδ1 γδ T cells are a unique subset of T cells that specifically recognise and are activated by molecular patterns of dysregulation on cancer cells. The non-MHC-restricted activity of Vδ1 γδ T cells makes them a unique cell type for the development of fully allogeneic, "off-the-shelf" cell therapies.