Rubius Therapeutics to Participate in Jefferies Virtual Healthcare Conference

On May 20, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported that Pablo J. Cagnoni, M.D., president and chief executive officer, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 4:00 p.m. EDT (Press release, Rubius Therapeutics, MAY 20, 2021, View Source [SID1234584707]).

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A live audio webcast will be available within the Investors & Media section of the Rubius Therapeutics website. An archived replay will be accessible for 90 days following the event.

GeneQuantum Completes C Round for Novel ADC Candidates

On May 20, 2021 GeneQuantum Healthcare (Suzhou) reported that it completed a Series C funding to develop its portfolio of site-specific antibody drug conjugate molecules (Press release, GeneQuantum Healthcare, MAY 20, 2021, View Source [SID1234580472]). According to the company, the C round raised several hundreds of millions of RMB, which puts the funding at least in the $50 million range, but the exact amount was not disclosed. GeneQuantum says it has built a differentiated ADC platform that addresses the major problems of ADC drugs: high heterogeneity, narrow therapeutic window and high manufacturing cost. The Series C was led by China Life Private Equity Investment.

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Indica Labs and Ibex partner to deliver AI-powered clinical workflows for digital pathology

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."

OSE Immunotherapeutics and Boehringer Ingelheim Present Positive Phase 1 Results with First-in-Class SIRPα inhibitor BI 765063 in Advanced Solid Tumors at ASCO 2021

On May 20, 2021 OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) and its development partner Boehringer Ingelheim reported that acceptance of an upcoming poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 4 – 8, 2021, covering promising initial data from Phase 1 dose escalation of selective SIRPα inhibitor BI 765063 in patients with advanced solid tumors (Abstract #2623) (Press release, OSE Immunotherapeutics, MAY 20, 2021, View Source [SID1234580464]).

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The data to be presented at ASCO (Free ASCO Whitepaper) 2021 indicate that OSE Immunotherapeutics’ first-in-class signal regulatory protein α (SIRPα) inhibitor BI 765063 was well-tolerated, showed sustained receptor occupancy (RO) saturation and monotherapy activity. Clinical benefit was observed in 45% of patients evaluable per RECIST* criteria. A durable partial response was observed in an advanced hepatocellular carcinoma (HCC) patient, and the on-treatment biopsy of the responder showed an increase in CD8 T-cell infiltration and activation. Furthermore, the on-treatment biopsy also showed an increase in PD-L1 expression on tumor cells. A BI 765063 dose escalation study in combination with Ezabenlimab (PD-1 antagonist) is ongoing and will help determine the recommended dose for further Phase 2 clinical development in patients with advanced solid tumors.

Alexis Peyroles, CEO of OSE Immunotherapeutics commented: "OSE Immunotherapeutics is moving forward to deliver highly innovative, first-in-class and best-in-class compounds. The promising data presented at ASCO (Free ASCO Whitepaper) includes no serious dose limiting toxicities, as well as early evidence of efficacy, suggesting that selective myeloid cell targeting of SIRPα to modulate CD47-dependent inhibition of anti-tumor immunity including the ‘Don’t Eat Me’ axis is a sound therapeutic strategy in solid tumors. These promising data presented at ASCO (Free ASCO Whitepaper) 2021 on BI 765063 confirm the quality of our science and we look forward to continuing to accelerate our clinical development and pipeline diversification over the coming years."

*RECIST: Response Evaluation Criteria in Solid Tumours

PRESENTATION DETAILS

Title: "Safety, pharmacokinetics, efficacy, and preliminary biomarker data of first-in class
BI 765063, a selective SIRPα inhibitor: results of monotherapy dose escalation in phase 1 study in patients with advanced solid tumors"

The abstract #2623 was posted on ASCO (Free ASCO Whitepaper).org on May 19, 2021 at 5:00PM ET and 11:00PM CEST

From June 4th at 3:00PM CEST:
Virtual poster presentation on demand
Poster session: Developmental Therapeutics – Immunotherapy
Presenting Author: Stéphane Champiat, MD, PhD, Institut de Cancérologie, Gustave Roussy, Villejuif

LEADING CELL THERAPY BIOTECH COMPANY CHOOSES RESEARCH TRIANGLE FOR ITS NORTH AMERICAN R&D AND MANUFACTURING FACILITY

On May 20, 2021 CARsgen Therapeutics Corporation, an innovative biotechnology company pursuing medicines to treat cancer reported that it will create approximately 200 jobs and invest $157 million in Durham, Governor Roy Cooper (Press release, Carsgen Therapeutics, MAY 20, 2021, View Source [SID1234580460]). The company’s selection of the Research Triangle area will establish its first biomanufacturing site in North America. CARsgen Therapeutics currently has its U.S. clinical development operations in Houston, Texas.

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"Global companies know that North Carolina is a world class leader in biotechnology," said Governor Cooper. "Our state’s skilled workers, educational institutions and business environment provide life science companies with the tools they need to succeed."

CARsgen Therapeutics Corporation, a wholly-owned subsidiary of CARsgen Therapeutics Holdings Limited, is a clinical stage biotechnology company specializing in what’s known as chimeric antigen receptor (CAR) T cell therapies, a type of therapy that engages people’s immune systems in a new way. The therapeutic approach can yield medicines for various human cancers, including leukemia, lymphoma, and solid tumors. The company’s project in North Carolina will establish a 37,000 square foot clinical/early-stage commercial manufacturing facility and then a 100,000 square foot cGMP commercial manufacturing facility in Durham that will eventually produce FDA approved cell therapies.

"We are very excited to receive the JDIG grant approval from the State of North Carolina," said Dr. Zonghai Li, CEO, CSO and Chairman of CARsgen Therapeutics. "CARsgen will continuously develop and embed innovations to advance the revolutionary CAR-T cell therapy for unmet clinical needs. The company has launched clinical studies of our leading CT053 and CT041 CAR-T cell therapies in the United States. The new facilities will expand our global cGMP manufacturing capacity to produce the innovative CAR-T cell products for the U.S. patients."

"It’s exciting to see a company at the cutting-edge of science join our growing biotech industry cluster," said North Carolina Commerce Secretary Machelle Baker Sanders. "From companies exploring gene therapies to the innovative work CARsgen is conducting with immune-oncology, there’s no question that North Carolina will continue to play an important role in the future of this industry and the many lives of those impacted by the life sciences sector."

Although wages will vary by job position, the aggregate average salary of the new positions will reach $76,061, bringing a payroll impact of $15.2 million to the region each and every year. The current average wage in Durham County is $75,892.

CARsgen Therapeutics’ project in North Carolina will be facilitated, in part, by a Job Development Investment Grant (JDIG) approved by the state’s Economic Investment Committee earlier today. Over the course of the 12-year term of this grant, the project is estimated to grow the state’s economy by $1.04 billion. Using a formula that takes into account the new tax revenues generated by the 200 new jobs, the JDIG agreement authorizes the potential reimbursement to the company of up to $1,616,250, spread over 12 years. Over the 12 years, those state tax revenues will exceed $31.1 million.

State payments only occur following performance verification by the departments of Commerce and Revenue that the company has met its incremental job creation and investment targets. JDIG projects result in positive net tax revenue to the state treasury, even after taking into consideration the grant’s reimbursement payments to a given company.

CARsgen’s JDIG agreement also could move as much as $538,750 into the state’s Industrial Development Fund – Utility Account for use by rural communities elsewhere in the state. The Utility Account helps finance necessary infrastructure upgrades in more economically challenged areas of the state to attract future business.

"Durham attracts the most innovative companies in the world and today’s decision continues that positive trend," said N.C. Representative Zack Hawkins. "We welcome these new jobs and the talent they will bring to our area and look forward to the life-saving medicines these employees will bring to people in need."

"Research Triangle Park broke records as one of the nation’s first research parks, but I’m proud we didn’t rest on our laurels," said N.C. Senator Natalie Murdock. "It’s great to see this treasured resource continue to grow and renew itself by attracting new ideas and companies to our area."

Partnering with the North Carolina Department of Commerce and the Economic Development Partnership of N.C. on this project were the North Carolina General Assembly, the North Carolina Community College System, the North Carolina Biotechnology Center, Duke Energy, the City of Durham, Durham County and the Greater Durham Chamber of Commerce.