On November 2, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has now cleared cohort 4 of the intravenous (IV) arm of the monotherapy dose escalation study, as well as IV cohort 2 of the combination study where VAXINIA is administered with blockbuster checkpoint inhibitor drug pembrolizumab (KEYTRUDA) (Press release, Imugene, NOV 2, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/17bdc1de-a079-186b-11e8-6ef4ab6ae92a/Next_cohort_reached_in_IV_arms_of_CF33_hNIS_VAXINIA_study.pdf [SID1234636670]).

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Cohort 5 of the IV arm for the monotherapy dose escalation is now open as is IV cohort 3 of the combination study.

Imugene MD & CEO Leslie Chong said: "As we near closer to opening and completing the final cohorts that were planned at the beginning of the trial, we have an opportunity to expand the trial by enrolling patients in additional cohorts for the monotherapy dose escalation component. This will provide us with a far more robust data set to analyse and speak to at the conclusion of the MAST study, and provide us with a stronger platform as we further the clinical development of CF33 and VAXINIA."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Overall the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.

On November 2, 2023 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it will present preliminary data from its ongoing Phase 1/2a trial of MP0533, a novel tetra-specific T cell engager at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held from December 9–12 in San Diego, California (Press release, Molecular Partners, NOV 2, 2023, View Source [SID1234636664]). MP0533 is in development for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndrome (AML/MDS).

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As of data cut-off (20 July 2023) of the abstract published today, five patients across three dosing regimens had been treated. The preliminary data reported indicate an acceptable safety profile, with no dose-limiting toxicity or Grade ≥3 adverse reactions. Grade 1/2 events considered related to MP0533 included infusion-related reactions and cytokine release syndromes. One of the two patients evaluable for MP0533 antitumor activity in the third treatment cohort achieved a response. The study is currently enrolling its fifth cohort with up to seven dose-escalating cohorts planned and a total enrollment of up to 45 patients. The Company anticipates to present data including from the fourth dose cohort at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December this year.

"The data from the ASH (Free ASH Whitepaper) abstract represent the beginning of an exciting and encouraging clinical journey for the MP0533 program. We are now able to show initial clinical activity of the first tetra-specific, non-antibody-based T cell engager, MP0533, in patients with r/r AML and MDS/AML," said Patrick Amstutz, Ph.D., Molecular Partners’ CEO. "We see both an acceptable tolerability profile at initial doses, as well as the emergence of single-agent anti-tumor activity at relatively low dose levels and we look forward to presenting additional data on MP0533’s potential to treat this particularly intractable blood cancer at the ASH (Free ASH Whitepaper) Annual Meeting in December."

The clonal heterogeneity and lack of single AML-specific target antigens represent major challenges for the development of targeted immune therapies for AML. To overcome these hurdles, Molecular Partners designed MP0533, a novel tetra-specific T cell-engaging, half-life extended DARPin, which simultaneously targets CD33, CD123 and CD70, as well as CD3 on T cells. This unique mode of action is designed to enable avidity-driven, T cell-mediated killing of leukemic stem cells and malignant blast cells, which commonly co-express at least two of the three target antigens, while preserving a therapeutic window that minimizes damage to healthy cells.

The ongoing single-arm, open-label, multicenter Phase 1/2a study of MP0533 is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics, as well as assess preliminary antileukemic activity of MP0533 as a monotherapy for patients with r/r AML and AML/MDS.

The presentation details are as follows:

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster 2
Publication Number: 2921
Title: MP0533, a CD3-Engaging DARPin Targeting CD33, CD123, and CD70 in Patients with Relapsed/Refractory AML or MDS/AML: Preliminary Results of a Phase 1/2a Study
Session Location & Date: San Diego Convention Center, Halls G-H; Sunday, December 10, 2023
Presentation Time: 6:00–8:00 pm PT

The abstract will become available today on the ASH (Free ASH Whitepaper) website at 9:00 am ET.

On November 1, 2023 Oblique Therapeutics reported its Interim report 1 July to 30 September 2023 (Press release, Oblique Therapeutics, NOV 1, 2023, https://obliquet.com/wp-content/uploads/2023/11/delarsrapport-q3-2023-oblique-therapeutics-ab.pdf [SID1234640429]).

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During November 2023, Kinnate Biopharma presented the corporate presentation (Presentation, Kinnate Biopharma, NOV 1, 2023, View Source [SID1234639304]).

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On November 1, 2023 Kyowa Hakko Kirin reported its Consolidated Financial Summary (IFRS) Fiscal 2023 Third Quarter (Press release, Kyowa Hakko Kirin, NOV 1, 2023, View Source [SID1234638996]).

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