On November 9, 2023 March Biosciences (March Bio), a clinical stage biotechnology company committed to combating challenging cancers unresponsive to existing immunotherapies, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, reported that Cancer Focus Fund is investing $4.8 million in funding and providing clinical support for March Bio’s upcoming Phase 2 clinical trial of MB-105 for the treatment of relapsed T-cell leukemias and lymphomas (Press release, March Biosciences, NOV 9, 2023, View Source [SID1234637449]).

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MB-105 is a chimeric antigen receptor-T cell ("CAR-T") therapy targeting CD5, a protein that is widely expressed in both normal and malignant T-cells, including T-cell associated leukemias and lymphomas. This has limited its use as a target for cancer therapies, since healthy T-cells needed for normal immune system functioning would be destroyed along with the malignant T-cells. MB-105 has been specially engineered to preserve healthy T-cells while maintaining its potency against CD5 positive tumor cells. In an ongoing Phase 1 trial conducted by the Baylor College of Medicine Cell and Gene Therapy Center, MB-105 has demonstrated a favorable safety profile and encouraging early efficacy results in both relapsed T-cell lymphoma and T-cell acute lymphoblastic leukemia patients.

The prognosis is poor for patients with relapsed or refractory T-cell leukemias and lymphomas, with more than 85% dying within months of relapse. The use of later lines of salvage therapies and advances in targeted cancer therapies has not affected these dismal outcomes, with long-term survival of less than 10%. Relapsed patients who are able to achieve a second remission and proceed to a subsequent stem cell transplant have better results, but therapeutic options for achieving a second remission are severely limited, underscoring the urgent need for innovative solutions.

Sarah Hein, co-founder and CEO of March Biosciences, commented, "As a Houston-invented and headquartered biotech developing an innovative cancer therapy manufactured in collaboration with Houston’s CTMC, we are delighted that the Cancer Focus Fund is investing in our upcoming clinical trial. We believe MB-105 has the potential to become the foremost, first-in-class life-saving therapy for relapsed T-cell lymphoma patients, who have limited treatment options. We also welcome the opportunity to work with Cancer Focus Fund and MD Anderson to advance the clinical program for MB-105. The breadth and quality of the support we are receiving from our local partners and institutions underscore Houston’s increasing prominence as a worldwide leader in cancer R&D and clinical research."

The Phase 2, open label, multi-center trial will assess MB-105 in patients with CD5-positive relapsed/refractory T-cell lymphoma. Patients will receive one dose of MB-105 and will be followed for a minimum of 12 months.

"March Bio’s highly innovative approach to overcoming a key limitation of CAR-T therapy is emblematic of the breakthrough science that Cancer Focus Fund was established to support," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "This young company impresses with the strength of its management and science teams, including global leaders in the development of CAR-T therapies. It has already forged valuable partnerships and is advancing MB-105 with the urgency we prize in our portfolio companies. We also are pleased to be investing in a promising biotech firm with such strong roots in our Houston life sciences community."

On November 9, 2023 Bayer and US-based Recursion Pharmaceuticals, Inc., a clinical stage TechBio company decoding biology to industrialize drug discovery, reported that they have updated the focus of their research collaboration to precision oncology (Press release, Bayer, NOV 9, 2023, View Source [SID1234637450]).

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The oncology-focused collaboration will leverage Bayer’s small molecule compound library and expertise in biology and medicinal chemistry as well as Recursion’s purpose-built artificial intelligence-guided drug discovery platform. This strategic shift will enable Bayer to utilize Recursion’s capabilities to initiate and advance the identification of novel therapeutic targets for challenging oncology indications with high unmet need.

"The methodology in which Recursion uses artificial intelligence (AI) in drug discovery, could be one of the most disruptive technologies of our time," said Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division, Head of Business Development, Licensing & Open Innovation and Head of Leaps by Bayer. "As our collaboration and the usage of AI continue to evolve, we look forward to continuing to work with industry innovators to identify novel targets for oncology indications."

Bayer’s strategic approach in oncology is based on precision drug development which enables fast identification of the most promising targets and commercially viable programs. The company is continuously working to find new ways of treating cancer, so that patients do not necessarily need to undergo life-changing and invasive treatments. Artificial intelligence and the use of machine learning methods allow the processing of enormous amounts of data – including high-resolution imaging – and offers unprecedented potential for the discovery of new drug candidates for cancer and other complex diseases.

"Every cancer is different and requires an individual approach," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG. "At Bayer, we are committed to driving breakthrough innovations for patients with diseases of high unmet medical need. Nearly half of our entire pharma pipeline is dedicated to cancer therapies, and we have a strong foundation to build on to bring these innovative treatment approaches to patients."

Recursion’s drug discovery platform navigates over five trillion biological and chemical relationships within one of the world’s largest proprietary datasets. The system integrates scaled ‘wet-lab’ biology and chemistry data with computational tools, using advanced machine learning technologies to industrialize drug discovery by validating and advancing therapeutic programs efficiently and with minimal bias. Their dataset, which includes information from 50 different human cell types and a ~1.7 million small molecule library, is supported by BioHive-1, a TOP500 ranked supercomputer.

"We believe that the next generation of biopharma leaders will operate at the convergence of rigorous science, scaled datasets and accelerated computing," said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. "Today, we are thrilled to announce the evolution of our collaboration with Bayer, highlighting the flexibility and broad-scale applicability of our platform, as we turn our focus together on challenging targets in oncology with the goal of bringing better medicines to patients more efficiently."

Under the terms of the agreement, the companies may initiate up to seven oncology programs and Recursion is eligible to receive potential, success-based, future payments of up to $1.5 billion plus royalties on net sales. Bayer will gain the option to exclusively license novel therapeutics derived from the research activities.

Leaps by Bayer, the impact investment arm of Bayer AG, led Recursion’s Series D financing in 2020 with an investment of USD 50 million.

On November 9, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported results for the quarter ended September 30, 2023 and highlighted recent corporate events (Press release, MEI Pharma, NOV 9, 2023, View Source [SID1234637448]).

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"Our ongoing clinical studies evaluating the combination of voruciclib, our CDK9 inhibitor, with Venclexta in relapsed/refractory AML patients and ME-344, our mitochondrial inhibitor, combined with Avastin in metastatic colorectal cancer patients, continue to have strong investigator support and cohort enrollment remains on track in each program," said David M. Urso, president and chief executive officer of MEI Pharma. "We expect to report data from the dose escalation portion of the Phase 1 clinical trial evaluating voruciclib in combination with venetoclax in early calendar 2024, and data from the first cohort of patients in Phase 1b clinical trial evaluating ME-344 in the first half of 2024."

First Quarter Fiscal Year 2024 and Recent Highlights

In August 2023, MEI announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, inhibit energy production through glycolysis and, thereby, increase tumor reliance on mitochondrial energy production, providing an opportunity to evaluate a combination with ME-344 to inhibit energy production in tumor cells and induce an antitumor effect. The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
In November 2023, MEI announced that an abstract highlighting clinical data from the monotherapy dose escalation stage of the ongoing Phase 1 study evaluating voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies, will be presented during a poster session at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 9 – 12, 2023.
Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study

Report clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial evaluating voruciclib plus Venclexta (venetoclax) in patients with AML early in calendar 2024.
ME-344 – Mitochondrial inhibitor in Phase 1b Study

Report clinical data from Cohort 1 of the Phase 1b clinical trial evaluating ME-344 plus Avastin (bevacizumab) in patients with relapsed colorectal cancer in the first half of calendar-year 2024.
First Quarter Fiscal Year 2024 Financial Results

As of September 30, 2023, MEI had $82.2 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended September 30, 2023, cash used in operations was $18.5 million, compared to $14.8 million during the quarter ended September 30, 2022. The increase in cash used in operations was primarily due to changes in working capital associated with the wind down of zandelisib activities with Kyowa Kirin and professional services primarily related to advisory and legal fees associated with various stockholder-related activities, including stockholder-initiated consent solicitations.

Research and development expenses were $3.5 million for the quarter ended September 30, 2023, compared to $19.5 million for the quarter ended September 30, 2022. The decrease was primarily related to a reduction in zandelisib costs as we continued the wind down of development activities announced in December 2022, as well as reduced personnel and related costs from our fiscal year 2023 reduction in headcount.
General and administrative expenses decreased by $1.0 million to $6.5 million for the quarter ended September 30, 2023, compared to $7.5 million for the quarter ended September 30, 2022. The net decrease was primarily related to reduced personnel and related costs from our fiscal year 2023 reduction in headcount, partially offset by higher external professional services and legal expenses.

MEI recognized revenue of $65.3 million for the quarter ended September 30, 2023, compared to $8.7 million for the quarter ended September 30, 2022. The increase in revenue is due to the recognition of deferred revenue associated primarily with the termination of the Kyowa Kirin Commercialization Agreement in July 2023. As of September 30, 2023, all deferred revenue associated with that agreement has been recognized.
Net income was $56.4 million, or $8.46 per share, for the quarter ended September 30, 2023, compared to net loss of $16.6 million, or $2.49 per share for the quarter ended September 30, 2022. The Company had 6,662,857 shares of common stock outstanding as of September 30, 2023.

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.

On November 9, 2023 Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, reported the initiation of a randomized Phase 2 trial to evaluate the efficacy and safety of TTX-030, a potential first-in-class, anti-CD39 antibody (Press release, Trishula Therapeutics, NOV 9, 2023, View Source [SID1234637447]). The trial will evaluate TTX-030 in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 antibody), compared to chemotherapy alone, as first-line treatment for metastatic pancreatic ductal adenocarcinoma patients.

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"There is significant unmet need for new treatment options for pancreatic cancer," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "We look forward to building on the promising Phase 1 results to potentially advance the treatment landscape with TTX-030, which may bring benefit to patients with advanced pancreatic cancer."

The study is designed to enroll approximately 180 patients globally. Patients will be randomized equally into three study arms, receiving TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 and chemotherapy plus budigalimab; or chemotherapy alone. The primary endpoint of the trial is progression free survival (PFS) in a biomarker-enriched population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link).

Trishula will continue to develop TTX-030 in collaboration with AbbVie Inc. Per the terms of the collaboration agreement, at the conclusion of this Phase 2 study, AbbVie will have an exclusive option to license TTX-030 for further development.

About TTX-030TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity.

On November 9, 2023 Vyriad, Inc., a clinical-stage biotechnology company developing the next generation of targeted genetic therapies, reported that its abstract, In Vivo Generation of Functional CD19 CAR-T Cells Using a Serum-Stable CD3-Targeted Lentiviral Vector, has been selected for an oral presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 9-12, 2023, in San Diego, California (Press release, Vyriad, NOV 9, 2023, View Source [SID1234637445]). Vyriad’s presentation will discuss progress in developing its highly targeted, efficient, serum-stable and durable lentiviral vector technology to deliver genetic payloads directly and specifically to CD3+ T cells.

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Presentation Title: In Vivo Generation of Functional CD19 CAR-T Cells Using a Serum-Stable CD3-Targeted Lentiviral Vector

Session Name: Cellular Immunotherapies: Basic and Translational: Exploring Novel Platforms for Next-Gen CAR-based Therapies

Presentation Date/Time: Monday, December 11, at 11:30 a.m. PT

Presenting Speaker: Stephen J. Russell, M.D., Ph.D., Chief Executive Officer

Full abstracts are available for online viewing via the ASH (Free ASH Whitepaper) Annual Meeting website at www.Hematology.org.