On December 7, 2022 Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, and multiple biopharma and academic partners reported that they are presenting data from the company’s Tapestri Platform on a range of topics at the 64th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, beginning this weekend in New Orleans, LA (Press release, Mission Bio, DEC 7, 2022, View Source [SID1234624913]). In all, Mission Bio and its partners will share 15 heme-oncology topics highlighting the use of single-cell DNA + protein multi-omics to better understand resistance mechanisms and drivers of relapse, improve identification of Measurable Residual Disease (MRD), and precisely characterize CAR T cell therapies. These include presentations from Servier Pharmaceuticals and researchers at Memorial Sloan Kettering Cancer Center (MSK) that demonstrate Tapestri’s ability to bridge the gap between translational research and precision therapeutics, providing a deeper understanding of the patient journey and unlocking novel therapeutic approaches. These include the following:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On Saturday, Dec. 10, Servier will share new Phase 3 findings for the combination of its TIBSOVO (ivosidenib tablets) plus azacitidine. Researchers identified potential mechanisms of acquired resistance in patients with IDH1-mutated acute myeloid leukemia (AML) using single-cell DNA sequencing with Tapestri.
On Monday, Dec. 12, researchers from MSK will present data from Mission Bio’s Single-cell Multi-omics MRD (scMRD) Assay for AML, highlighting its ability to detect clinically relevant variants missed by bulk next-generation sequencing in patient samples drawn following chemotherapy. The assay was also used 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.
On Sunday, Dec. 11, Mission Bio’s Senior Director for Clinical Applications, Aaron Llanso, will lead a Company Showcase giving an overview of the predictive power and potential clinical utility of the scMRD Assay, featuring data from the MSK team and researchers from the University of Texas MD Anderson Cancer.
"Mission Bio has led the way into a new era for precision therapeutics with single-cell DNA + protein multi-omics," said Todd Druley, Chief Medical Officer at Mission Bio. "The first step was enabling discoveries in heterogeneous and dynamic diseases with implications for treatment. Today, biopharma partners are increasingly adopting the Tapestri Platform for novel insights that inform late-stage clinical trials, stratifying patient populations and monitoring their disease progression, as well as ensuring product quality in targeted cell and gene therapies. And the latest findings in MRD outline a future where patient single-cell data potentially improves patient outcomes."

Mission Bio’s in-person only Company Showcase, AML single-cell multi-omics minimal residual disease (scMRD) and the horizon of clinical utility, will be held on Sunday, December 11, 2022 at 4:00 p.m. CT at the Ernest N. Morial Convention Center, Hall J, Theater 6.

For a full list of presentations sharing data from Mission Bio’s Tapestri Platform, visit View Source To meet us in person, please visit us all week at Booth 2014.

To learn more about Mission Bio and the Tapestri Platform, please visit www.missionbio.com.

On December 7, 2022 Accord Healthcare, Inc., a leading generic pharmaceutical company, reported it has added Bendamustine Lyo. Injection to its line of chemotherapy drugs (Press release, Accord Healthcare, DEC 7, 2022, View Source [SID1234624912]). Accord’s product is AP rated to Teva’s Treanda and is being offered in both 25-mg and 100-mg vials.

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Bendamustine Lyo. Injection is in a class of medications called alkylating agents1. It works by killing existing cancer cells and limiting the growth of new cancer cells. Bendamustine is indicated for the treatment of adults with chronic lymphocytic leukemia (CLL) or indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or rituximab containing regimen.

"Adding Bendamustine Lyo. Injection to our line of available chemotherapy drugs is an important step in continuing to make oncology therapies more accessible to those who need them," said Accord Healthcare President Jeff Hampton. "The availability of generics expands medication options for patients. When pharmacists have access to additional manufacturers, they are able to offer needed oncology products at a lower cost."

Important Safety Information:

Adverse reactions2 of Bendamustine Injection during infusion and within 24 hours post infusion may include nausea and fatigue (frequency >5%). Other adverse reactions can include myelosuppression, infections, anaphylaxis, tumor lysis syndrome, and skin reactions.

The most common non-hematologic adverse reactions for CLL are pyrexia, nausea, and vomiting. The most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.2

Further information about safety and potential side effects can be found on the Products page at Accord Healthcare US.

Bendamustine was approved3 by the US Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) in March 2008 and for the treatment of rituximab-refractory, indolent B-cell non-Hodgkin lymphoma (NHL) in October 2008.

On December 7, 2022 UCLB spinout, Endomag reported that it uses magnetics to remove the need for radioactivity when staging breast cancer, commonly through a procedure called sentinel lymph node biopsy (Press release, UCLB, DEC 7, 2022, View Source [SID1234624906]).

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In 2018, Endomag’s technology, Magtrace was initially approved for patients undergoing a mastectomy procedure. Since that original submission, additional data has been submitted to the FDA which has now validated its use for all breast cancer patients, leading to an expansion to all patients choosing breast conserving surgery too.

This news is a major milestone for both breast cancer patients and physicians across the US, helping to improve access and reduce the reliance on nuclear medicine alternatives.

On December 7, 2022 Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, and Concr, a techbio company with a statistical learning-powered biomarker prediction engine, reported that a partnership to identify biomarkers to improve therapeutic response to inhibitors of cytidine triphosphate synthase 1 (CTPS1), an enzyme to which all cancers appear to be addicted (Press release, Step Pharma, DEC 7, 2022, View Source [SID1234624905]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Concr’s proprietary data modelling will be used to identify biomarkers for Step Pharma’s cancer drug assets, which includes its first-in-class, highly selective, orally bioavailable CTPS1 inhibitor, STP938, by effectively integrating diverse experimental data with patient and tumour-centric datasets. Concr adopts cosmology methods to effectively combine diverse data types into a single holistic tumour model with superior predictive power. The biological insights generated will be utilised by Step Pharma in its pre-clinical and clinical development programmes, with the overall aim of improving patient response and outcomes.

Step Pharma recently entered clinical development with its first in class CTPS1 inhibitor STP938 in a Phase I/II trial for T cell and B cell lymphomas and is the latest company to utilise the potential of data and predictive modelling for translational research. By inhibiting the enzyme CTPS1, Step Pharma can selectively target the de novo pyrimidine synthesis pathway in cancer cells, enabling highly selective treatment of both blood cancers and solid tumours. Concr’s existing partnerships are investigating biomarkers of response in multiple cancer types, including breast cancer and cancer of unknown primary.

On December 7, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that Sanofi has provided notice of termination of the parties’ global SHP2 development and commercialization collaboration (Press release, Revolution Medicines, DEC 7, 2022, View Source [SID1234624904]). Following termination, Revolution Medicines will regain all global rights granted to Sanofi under the agreement, including decision-making regarding research and development, and rights to all commercial proceeds from RMC-4630, a SHP2 inhibitor drug candidate in development for the treatment of patients with certain RAS-addicted cancers. The companies plan to collaborate to transition all Sanofi’s rights and obligations related to RMC-4630 back to Revolution Medicines over the first half of 2023.

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"We remain committed to studying RMC-4630 as a potentially important RAS Companion Inhibitor in our cohesive pipeline focused on novel targeted therapies for RAS-addicted cancers, and fully intend to continue as planned our ongoing Phase 2 clinical trial evaluating RMC-4630 in combination with sotorasib for patients with NSCLC bearing a KRASG12C mutation," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Going forward, our strategy for developing RMC-4630 is unaffected by their decision, and we continue to expect to provide topline data from our RMC-4630-03 study in the second half of 2023."

Sanofi notified Revolution Medicines of its termination of the collaborative research, development and commercialization agreement (the Collaboration Agreement) for convenience on December 6, 2022. During the transition, Revolution Medicines expects that Sanofi will continue to fulfill any obligations under the Collaboration Agreement, including reimbursing Revolution Medicines’ costs, as contemplated by the Collaboration Agreement.

With current cash, cash equivalents and marketable securities, Revolution Medicines continues to project it can fund planned operations through 2024. The company is updating its projected full year 2022 GAAP net loss to be between $245 million to $265 million, including estimated non-cash stock-based compensation expense of $30 million to $35 million.