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Plus Therapeutics and Biocept Announce Comprehensive Laboratory Services Agreement for the ReSPECT-LM Trial

On June 22, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, and Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a multi-year agreement to employ Biocept’s cerebrospinal fluid (CSF) assay CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of patients with leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord (Press release, Cytori Therapeutics, JUN 22, 2022, View Source [SID1234616164]).

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CNSide is an assay based on Biocept’s proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer which are leading causes of LM. CNSide provides a robust quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or radiologic monitoring.

"LM and the therapeutic response to 186RNL can theoretically be assessed through periodic sampling of tumor cells in the CSF," said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. "Every LM patient in the ReSPECT-LM trial will have permanent access to the CSF via an intraventricular catheter placed in the cerebral ventricles before treatment, permitting medical staff to draw CSF as easily as blood. The CNSide technology is the most sophisticated and powerful technology available for monitoring tumor status and therapeutic response and can be seamlessly implemented into the ReSPECT-LM trial for the potential benefit of patients with LM."

"We see a significant opportunity for Plus Therapeutics to use our CNSide assay to monitor tumor burden in the CSF and response to treatment, and to profile specific cellular biomarkers which may inform their cancer radiotherapeutic drug development activities," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide has the potential to improve our understanding of therapy response in patients with LM treated with novel therapeutic approaches. This represents an area of very high unmet need in the care of cancer patients with certain forms of brain metastasis that are life-threatening."

Biomea Fusion Announces First Patient Dosed in Multiple Myeloma Cohort of COVALENT-101 Trial

On June 22, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), reported that the first patient has been dosed in the MM cohort of COVALENT-101, the company’s Phase I clinical trial evaluating BMF-219, Biomea’s covalent menin inhibitor, in patients with R/R AML, ALL, DLBCL, and MM (Press release, Biomea Fusion, JUN 22, 2022, View Source [SID1234616163]).

"From the very beginning of our journey, we have been exploring and validating the broad potential of covalently inhibiting the scaffold protein, menin, in a host of liquid and solid tumors. Menin’s broad role in a variety of tumor types is rather striking. Based on the outstanding translational work of our team, we have seen compelling preclinical activity using BMF-219 in MM subtypes, especially those that are driven by MYC, a protein essential to the growth of numerous tumor types," said Steve Morris, MD, Chief Medical Officer of Biomea Fusion.

"Today, we have taken the first step to explore the clinical potential of BMF-219, a single-agent covalent menin inhibitor, in treating relapsed / refractory multiple myeloma patients. This represents the second cancer type, as well as the first cancer type outside of AML, to be studied with BMF-219. We are committed to delivering innovative medicine to patients in need, including those with R/R MM. I am incredibly proud of our team for their dedication as they continue to explore the boundaries of where science is leading us. Our mission is fundamentally driven by the wish to help cure patients of their disease. I would like to thank the entire Biomea team, including our participating clinical sites and wonderful collaborators, for their work quality and brilliance in achieving this very important milestone," said Thomas Butler, CEO, Chairman of the Board and Co-Founder of Biomea.

About COVALENT-101

A Phase I, open-label, multi-center, dose escalation and dose expansion study designed to assess the safety, tolerability, and pharmacokinetics / pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias —including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). The study has been expanded to include cohorts for patients with R/R multiple myeloma and R/R diffuse large B-cell lymphoma. Additional information about the Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

About Multiple Myeloma (MM)

MM is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow. As cancerous cells proliferate and migrate from the bone marrow, organ damage occurs due to excess immunoglobulins in bones and blood and the general weakening of bones. Approximately 35,000 people in the U.S. are diagnosed with MM each year and the 5-year relative survival rate is ~56% (Source: NCI SEER Data). The need is greatest among patients with relapsed or refractory disease, with overall survival as low as 6 months in some patients. Additionally, it is estimated that more than 60% of MM patients have menin dependent genetic drivers (MYC addicted or driven) and that these drivers are more common in the relapsed or refractory setting.

BIO-TECHNE TO ACQUIRE NAMOCELL

On June 22, 2022 Bio-Techne Corporation (NASDAQ:TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported it has reached an agreement to acquire Namocell, Inc (Press release, Bio-Techne, JUN 22, 2022, View Source [SID1234616162]). Bio-Techne anticipates the acquisition to close in the first quarter of its fiscal 2023.

Founded in 2014 and headquartered in Mountain View, California, Namocell is a leading provider of fast and easy to use single cell sorting and dispensing platforms that are gentle to cells, and preserve cell viability and integrity. Single cell selection and sorting is a critical technology in various workflows in both biotherapeutics and diagnostics, including cell and gene therapy development and commercialization, cell engineering, cell line development, single cell genomics, antibody discovery, synthetic biology, and rare cell isolation.

Historically, researchers relied on flow cytometry sorting methods like FACS (Flourescence-Activated Cell Sorting) or manual pipetting methods for single cell sorting and isolation. Most flow cytometry sorting methods inflict potentially damaging stress on cells, are costly and difficult to operate, and require large numbers of cells. Similarly, manual pipetting methods are inefficient, unreliable and time consuming. Namocell’s proprietary single cell technology uniquely combines microfluidics, flow cytometry and liquid dispensing to achieve sorting and dispensing in a single step, while eliminating the risks associated with traditional FACS such as clogging and cross-contamination.

Namocell’s instrument portfolio includes Pala, a 2-laser system with up to 11 fluorescent detection channels and Hana, a single-laser system with 2 fluorescent detection channels. With unparalleled speed and ease of use, both systems utilize Namocell’s proprietary single-use cell cartridges to deliver single cells from sample to plates in minutes. Namocell’s current installed base is approaching 200 placements, including approximately 60 instruments sold in calendar 2021.

"Namocell is very complementary to Bio-Techne’s existing Cell and Gene Therapy franchise and we anticipate significant commercial synergies as we leverage our existing analytical tools sales force to penetrate this market opportunity," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Emerging technologies in cell-based research as well as next-generation therapeutics have created a need for fast, reliable, easy-to-use, and gentle cell sorting. Namocell’s instruments offer unparalleled performance advantages over traditional flow cytometry and manual techniques and we anticipate continued traction with its leading portfolio of cell sorting technologies. We are excited to welcome Namocell to the Bio-Techne team."

"We are very excited to be joining Bio-Techne," said Dr. Junyu Lin, Chief Executive Officer of Namocell. "Bio-Techne’s global reach and strategic deployment in cell and gene therapy will enable Namocell to accelerate its penetration into the global markets, particularly in cell engineering and cell therapy applications, our biggest and fastest growing sectors. We look forward to beginning the next chapter of growth as part of Bio-Techne."

Fredrikson & Byron, P.A. is serving as Bio-Techne’s legal counsel. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Namocell.

Invectys Inc. to Participate in the 9TH International Conference on HLA-G, July 4-5, 2022

On June 22, 2022 Invectys reported that it will be attending the 9th International Conference on HLA-G (Press release, Invectys, JUN 22, 2022, View Source [SID1234616161]).

Focused on the key immunomodulatory molecule HLA-G, this conference aims to cover the research within this field. Advances in oncology, organ transplantation, autoimmune diseases, virology, etc, will be presented.

Invectys will be giving 2 presentations: « Redirection of immune cells specificity against HLA-G: anti HLA-G CAR T Cells« , on July 4th at 12:10, and « Advances in cancer immunotherapy development: new VHH-based immune checkpoint inhibitors targeting the receptor ILT4« , on July 4th at 12:50.

Sirona Biochem Contracts WuXi AppTec to Manufacture Revolutionary Anti-Aging/Anti-Wrinkle Compound for Clinical Trial

On June 22, 2022 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") reported that it has signed an agreement with Contract Manufacturing Organization (CMO) WuXi AppTec ("WuXi"), Shanghai, for the small-scale production of TFC-1326, a powerful active against the aging effects on skin (Press release, Sirona Biochem, JUN 22, 2022, View Source [SID1234616160]).

Years of groundbreaking research by Sirona’s team of scientists at TFChem has shown in preclinical studies that TFC-1326 has the potential to reverse the effects of aging on skin, including the potential to eliminate fine wrinkles. The scientific data is strong, and we are now preparing for a clinical trial. There are no existing compounds that our scientists are aware of, that have the potential to reverse the effects of the aging process on skin to truly restore its structure and youthful appearance. The anti-aging and anti-wrinkle markets are estimated to be $271 Billion USD globally by 2024.

We are in advanced discussions with a leading clinical trial provider designing the planned clinical trial. Other necessary steps, including formulation and safety work, is being organized. As soon as this is completed and the clinical study starts, we will provide further information on this.

"There are many anti-aging and anti-wrinkle products available on the market currently. But to truly reverse the damage to the skin integrity that occurs naturally with aging is an area of unmet need. Our goal is to demonstrate clinically the potential of TFC-1326 to restore the integrity of the skin and return a more youthful appearance. The treatment of fine wrinkles is also a goal. BOTOX is the most effective on dynamic wrinkles while static wrinkles typically are managed by fillers. TFC-1326 has the potential to replace or supplement dermal filler injections to treat these static wrinkles," said Dr Howard Verrico, CEO of Sirona Biochem. "TFC-1326 with its unique mechanism of action is revolutionary in the aesthetic skin care space. Like our recent success, licensing TFC-1067 and the corresponding compound family globally, we see this as another opportunity to showcase the tremendous potential of our platform technology. And, of course, we are pursuing another lucrative licensing agreement for TFC-1326."