On September 22, 2022 Keymed Biosciences (HKEX:02162) reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted CMG901 the Breakthrough Therapy Designation for the treatment of advanced gastric and gastroesophageal junction(GEJ) cancer which have relapsed and/or are intolerant to prior therapies (Press release, Keymed Biosciences, SEP 22, 2022, View Source;gastroesophageal-junction-cancer-301630843.html [SID1234621373]).

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About CMG901

CMG901 is a Claudin 18.2-targeted antibody-drug conjugate (ADC) developed for the treatment of Claudin 18.2-expressing solid tumors. In April 2022, the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation[i] and Orphan Drug Designation[ii] as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancer which are resistant/refractory to prior therapies.

About CDE’s Breakthrough Therapy Designation

CDE’s Breakthrough Therapy Designation is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, BTD provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.

On September 22, 2022 Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, reported the first findings by researchers using its new Tapestri Single-cell Multi-omics Measurable Residual Disease (scMRD) assay, as researchers from Memorial Sloan Kettering Cancer Center (MSK) discovered subclonal co-mutations and immunophenotypic profiles that can distinguish individual cells indicative of future acute myeloid leukemia (AML) relapse from others present after treatment (Press release, Memorial Sloan-Kettering Cancer Center, SEP 22, 2022, View Source [SID1234621372]). Because it is uniquely capable of both high sensitivity and specificity, the scMRD assay can distinguish between leukemic, preleukemic, and hematopoietic clones, and between donor and host cells following bone marrow transplantation. The findings have the potential to be applied to improve treatment prognostics, guiding doctors on patient need for a hematopoietic stem cell transplant, with future implications for both patient stratification in clinical trials and patient care — impacting disease surveillance, therapeutic selection, and patient outcomes.

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About half of all patients with AML relapse within a few years of their first treatments1. Currently, flow cytometry and single gene testing and/or bulk next-generation sequencing are used to detect the presence of measurable residual disease (MRD). However, even if both tests come back negative, many patients will still relapse. Mission Bio’s scMRD technology is designed to improve upon these assays by integrating DNA mutation and immunophenotypic signatures for each cell individually, enabling quantitative analysis of leukemia cells that may have gained new mutations causing treatment resistance or changed their immunophenotype from the start of the disease.

Researchers from the lab of Ross Levine, MD, Deputy Physician in Chief for Translational Research at MSK, used the assay to study the clonal architecture of cells that survived initial AML therapy. In data presented at Mission Bio’s Tapestri scMRD for AML Summit, the researchers illustrated several findings that could impact the predictive power of scMRD. For example, in patient samples drawn following chemotherapy, Levine’s team found the scMRD assay detected clinically relevant variants missed by bulk next-generation sequencing. Additionally, the researchers tapped the multi-omic capabilities of the assay to characterize both the mutational profile and immunophenotype of single cells and to illustrate the clonal architecture distinguishing leukemic clones from preleukemic clones and hematopoietic clones. Full publication of the data is forthcoming.

"We believe these findings are key to improving how patients are treated for leukemias and other cancers where MRD is relevant," said Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio. "Partnering with both top academics like Ross’s team at MSK and industry partners for studies like this will be critical in establishing MRD as a surrogate endpoint, to one day incorporate into clinical trials and practice. It paves the way for not just predicting relapse but preventing it, by identifying high-risk clones for early eradication."

This summer, Mission Bio announced a program to give pioneering cancer researchers and biopharma partners early access to its research-use-only scMRD assay for AML, which uses the Tapestri Platform to identify single point mutations, copy number variants and structural lesions in DNA and immunophenotype data from the same cells. Through Mission Bio’s early access program, researchers, contract research organizations, and biopharma companies can utilize the scMRD assay for AML for proof-of-concept study research programs ahead of full-scale commercialization. For more information, visit View Source

On September 22, 2022 Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating promising treatments to market with its transformative AnovaOS technology platform, and the industry’s first collaborative ‘learning system’, reported a partnership with the Mary Crowley Cancer Research (Mary Crowley) to establish and support a technology enabled approach to extend early Phase clinical trials to cancer patients in the Southern and Southwestern United States (Press release, Anova Enterprises, SEP 22, 2022, View Source [SID1234621371]).

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Mary Crowley is a nonprofit cancer research center of excellence that has been delivering the highest quality research for more than 25 years. Their disciplined approach to conducting innovative clinical trials brings hope to cancer patients today while advancing development of treatment for patients in the future. In partnership, Anova and Mary Crowley are accelerating that work.

"Mary Crowley has built a reputation of delivering the highest quality research. We are a leading provider of complex oncology clinical trials in Texas because of the partnerships we serve and our dedicated and patient centric focus to care," said Jon Friedenberg, CEO at Mary Crowley. "Our work with Anova will expand those relationships and enable further growth in the number of patients we serve."

"More than 75 percent of oncology products in development today targeted to patients whose cancer has one or more genetic drivers," said Chris Beardmore, CEO, Anova. "AnovaOS provides a novel IT infrastructure that enables streamlined matching and enrolment to those targeted therapies no matter where that patient receives care. Its revolutionary. In many cases, Phase I clinical trials must be delivered in a specialty center. Being able to deliver complex study opportunities to patients in real time transforms the way research has been historically accessed."

Research sites and physicians interested in participating in this program should register their profile at www.anovaevidence.com. To find out more contact Wubet Redda, Clinical Trial Project Lead at [email protected]

On September 22, 2022 Emercell SAS (Emercell) and Cell-Easy SAS (Cell-Easy) reported the signing of a strategic agreement for the scale-up and manufacturing of Emercell’s lead product (Press release, EMERCell, SEP 22, 2022, View Source [SID1234621370]).

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Emercell has developed a platform technology to produce off-the-shelf natural killer (NK) cells. NK cells are highly potent immune effectors, used alone as monotherapy, or in combination with therapeutic antibodies, or are genetically engineered to produce Chimeric Antigen Receptor (CAR)-NK cells for the treatment of hematological malignancies and solid tumors. NK-001 is an optimized cell therapy product composed of highly activated and alloreactive allogeneic NK cells. Its patented manufacturing process allows a complete industrialization by using the same batch of NK cells for multiple patients.

Cell-Easy is an analytics-driven Contract Development and Manufacturing Organization (CDMO) specialized in the production of Gene-modified Cell and Cell Therapy products. Cell-Easy’s facilities are located in Toulouse including state-of-the-art controlled environment suites optimized for developing manufacturing and analytical processes, proceed to environmental and material Quality Control, and execute cGMP manufacturing, fill & finish, long-term storage of Advanced Therapy Medicinal Products (ATMPs) compliant with all the requirements of regulatory standards and cGMP guidelines.

Emercell has selected Cell-Easy as a long-term CDMO partner for the scale-up and manufacturing operations of its allogeneic NK cell-based product, with the objective to enter clinical phase in 2023. Emercell has signed a strategic agreement with Cell-Easy specialized in the development and production of ATMP.

"We are very pleased to collaborate with Cell-Easy on the final stages of development and GMP manufacturing of our flagship product, NK-001", said Patrick Henno, President of Emercell." We are looking forward to a successful and long-lasting collaboration as a key element of our development strategy. Moreover, Cell-Easy and Emercell are located in the Occitanic Region and the partnership fits perfectly with the Region’s objectives regarding the development and production of new products in the field of biotherapies, and particularly in the field of immunotherapy.

In a very competitive European landscape, we are delighted that Emercell has chosen us as their privileged CDMO Partner for their first immune-oncology approach using NK-cells", said Guillaume Costecalde, President of Cell-Easy. "Cell-Easy CDMAO’s original approach and the team’s reactivity combined with our state-of-the-art facility allow us once again to convince ambitious ATMP developers such as Emercell to secure their development."

On September 22, 2022 Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications, and OptraSCAN, a leading producer of whole slide scanners, reported a partnership to streamline the adoption of digital pathology technology in the United States, European Union countries and United Kingdom (Press release, Paige AI, SEP 22, 2022, View Source [SID1234621369]). The companies aim to reduce barriers to digitizing glass pathology slides, which will in turn enhance workflows in pathology and oncology.

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Together, the companies will integrate Paige’s clinical AI applications and interoperable enterprise imaging platform with OptraSCAN’s digital pathology scanner to offer advanced end-to-end digital pathology workflow solutions. This provides a streamlined path for pathologists to adopt Paige’s leading suite of digital pathology applications, including the FDA-cleared FullFocus whole-slide image viewer and AI applications including Paige Prostate Suite and Paige Breast Suite alongside OptraSCAN’s affordable digital pathology scanners. OptraSCAN devices have 15 to 480 slide loading capabilities that digitize the glass slides at 40x in less than one minute per slide with patented composite imaging offering.

"We are excited to work with OptraSCAN to make it easier for labs and healthcare networks around the world to adopt digital pathology workflows," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "This collaboration is an important step in our mission to unlock the full potential of AI in routine clinical use and provide healthcare professionals with precise insights to help patients get the most effective care."

Abhi Gholap, Founder and CEO of OptraSCAN said, "OptraSCAN’s mission to enable pathology slide digitization at fractional costs is eventually resulting into higher market demand for digital pathology applications. This partnership with Paige will facilitate adoption of digital infrastructure for global clinical and molecular pathology community in an efficient way."