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Manufacture of Carina’s LGR5 CAR-T has begun with CellVec contracted to produce GMP-grade lentivirus constructs

On November 9, 2021 Singapore-based CellVec reported that it will manufacture clinical-grade lentivirus – the first critical step in making LGR5 CAR-T cells for a first-in-human clinical trial for patients with advanced colorectal (bowel) cancer in late 2022 (Press release, Carina Biotech, NOV 9, 2021, View Source [SID1234594853]).

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Lentiviruses are widely used as a tool to deliver genes of interest to cells. In this case, the lentivirus transduces (or inserts) a group of genes to a patient’s T cells (immune cells), which turn the T cells into cancer-killing CAR-T cells targeting LGR5, a cancer stem cell marker found on colorectal cancer and other cancers.

Professor Simon Barry, Carina’s Vice President of Cell Therapy Manufacturing, said: "We are delighted to be working with CellVec because of their outstanding track record and expertise. Their flexibility and willingness to incorporate Carina’s proprietary manufacturing process was an important consideration in the selection of CellVec as our service provider."

"The partnership with Carina Biotech marks a significant milestone for us to facilitate the furtherance of gene therapies. We look forward to supporting Carina in the successful development of its LGR5 CAR-T cells," said Dr Ang Peng Tiam, Chairman of CellVec and Medical Director of Parkway Cancer Centre.

Carina’s LGR5 CAR-T cells are targeted at LGR5, a cancer stem cell marker that is highly expressed on colorectal cancer (and other cancers). Colorectal (bowel) cancer is the deadliest cancer for Australians aged 25-34 and Australia’s second deadliest cancer overall.

Young-onset colorectal cancer is often diagnosed at later stages, which have a much poorer prognosis.

Carina Biotech CEO, Dr Deborah Rathjen, said:

"We are continuing to see impressive results with our LGR5 CAR-T cell in pre-clinical testing. After our recent successful capital raise and welcoming new impact investors to our company, we are on track for a pre-IND submission in Q2 of 2022 and an IND submission to the FDA in the second half of 2022. These are important milestones towards the initiation of a Phase I/II clinical trial in patients with advanced colorectal cancer."

About LGR5
LGR5 is a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5+ expression has been correlated with a particularly poor prognosis.

Cancer stem cells are a small sub-population of cells within a tumour with the ability to self-renew, differentiate into the many cell types of a tumour, initiate new tumours, and resist chemotherapy and radiotherapy (leading to relapses).

By targeting cancer stem cells, it is hoped that this therapy will reduce the tumour’s ability to generate new cancer cells, resulting in durable tumour suppression and preventing the relapses that are very common in patients with colorectal cancer.

Carina’s pre-clinical studies of the LGR5-targeted CAR-T cell have shown highly promising results with complete tumour regression and no tumour recurrence. They have also demonstrated impressive tumour access and prolonged CAR-T cell survival.

There are five approved CAR-T therapies available in the US today – all for blood cancers. One of these has been approved for use in Australia (Kymriah for the treatment of relapsed/refractory B cell acute lymphoblastic leukemia and large B cell lymphoma).

All five CAR-T therapies are generating transformational outcomes for patients with blood cancers that have failed multiple prior lines of therapy.

ADC Therapeutics to Participate in the Jefferies London Healthcare Conference

On November 9, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that Chris Martin, PhD, Chief Executive Officer, will participate in a fireside chat at the Jefferies London Healthcare Conference on Tuesday, November 16th at 11:20 a.m. GMT / 6:20 a.m. EST (Press release, ADC Therapeutics, NOV 9, 2021, View Source [SID1234594852]).

A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

Chemomab to Present at Stifel 2021 Virtual Healthcare Conference

On November 9, 2021 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported it will host a live presentation and participate in 1-on-1 investor meetings at Stifel’s 2021 Virtual Healthcare Conference (Press release, Chemomab, NOV 9, 2021, View Source [SID1234594851]).

Plus Therapeutics Receives FDA Fast Track Designation for 186RNL Targeted Radiotherapeutic for Leptomeningeal Metastases

On November 9, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track designation for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM), a rare complication in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord, affecting nearly 5% of people living with cancer (Press release, Cytori Therapeutics, NOV 9, 2021, View Source [SID1234594850]). The Company recently announced clearance of its Investigational New Drug (IND) application from the FDA, and expects to initiate patient accrual in the ReSPECT-LM Phase 1 dose escalation clinical trial of 186RNL in the fourth quarter of 2021.

"The incidence of LM is rising and represents a rapidly progressing and fatal complication of several cancer types," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Based on our clinical experience with 186RNL in glioma and preclinical studies in LM models, we are optimistic that 186RNL may have a therapeutic role in management of this increasingly common cancer."

Fast Track designation confers several benefits to the drug development program including 1) more frequent meetings with FDA to discuss the drug’s development plan, 2) more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, 3) eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

About the ReSPECT-LM Study

The ReSPECT-LM clinical trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately 2-3 months following treatment. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.

Bio-Techne To Present At The Stifel 2021 Virtual Healthcare Conference

On November 9, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16, 2021 at 10:00 a.m. EDT (Press release, Bio-Techne, NOV 9, 2021, View Source [SID1234594849]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source