VXM01 / Vaximm - LARVOL DELTA

OSR Holdings, Inc..today announced that Vaximm AG, an OSR Company, has entered into a non-binding term sheet with BCM Europe AG ("BCME"), a Swiss-based life sciences investment group and OSRH's largest shareholder, to explore a potential exclusive global licensing agreement for VXM01, Vaximm's first-in-class oral cancer immunotherapy platform. (PRNewswire) - "Under the contemplated terms (which remain subject to final negotiation and execution of definitive agreements): Vaximm would receive a $20 million upfront payment; Up to $815 million in clinical, regulatory, and commercial milestone payments, and a pass-through of commercial royalties that BCME may receive from any future pharmaceutical partner after BCME recovers any milestone differential under a defined delta-recovery mechanism."

Licensing / partnership • Oral Cancer

Vaximm AG, an OSR Company, Announces Results from Phase 2a Trial of VXM01 and Avelumab Combination Therapy in Glioblastoma (PRNewswire) - P1/2a | N=30 | NCT03750071 | Sponsor: Vaximm GmbH | "The non-resected patient cohort showed a 12.0% objective response rate (ORR). 12.0% of these patients showed a partial remission and 4.0% had stable disease. This suggests that, with further investigation, VXM01 in combination with PD-L1 inhibition (e.g. avelumab) could offer meaningful clinical benefit for this challenging patient population....Despite the small size of this open-label trial (n=25), the observed median time to progression of 2.7 months (95% CI: 2.7 – 2.7, range 0.3 - 22.1 months), and median OS of 11.1 months (95% CI: 8.5 – 16.3, range 3.8- 38.2 months), are encouraging initial results in the context of prognosis for patients with recurrent glioblastoma, reported to have a median PFS of 1.5 to 6 months and median OS of 2 to 9 months."

P2a data • Glioblastoma

VXM01 phase I study in patients with progressive glioblastoma: Final results. (ASCO 2018) - P1; "...This trial examined safety and tolerability, clinical and immunogenic response to VXM01 after at least four vaccinations [106 or 107 colony-forming units (CFU)] in patients with progressive glioblastoma who have failed at least radiochemotherapy with temozolomide...Three out of them with additional nivolumab... VXM01 was safe and produces detectable specific peripheral immune responses as well as CD8/Treg ratio increase in post-vaccine tumor tissue. There was one patient with an objective response. As a next step, a combination study of VXM01 and anti-PD-L1 checkpoint inhibitor has been launched."

Clinical • P1 data • Solid Tumor

VXM01 phase I study in patients with resectable progression of a glioblastoma. (ASCO 2017) - P1; "This trial was set up to examine safety and tolerability, clinical and immunogenic response to VXM01 after treatment with at least four vaccinations [106 or 107colony-forming units (CFU)] in patients with recurrent glioblastoma who have failed at least radiochemotherapy with temozolomide. VXM01 was safe and produces specific peripheral immune responses as well as enumeration of tumor-infiltrating T-cells in post-vaccine tumor tissue. Post treatment MRI imply vascular normalization and there was one patient with an objective response. As a consequence of this data, an expansion cohort of this trial has been launched."

P1 data • Biosimilar • Oncology

VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Vaximm GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Dec 2022

Combination therapy • Enrollment closed • Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Oral DNA vaccination targeting VEGFR2 combined with the anti-PD-L1 antibody avelumab in patients with progressive glioblastoma - final results. NCT03750071 (EANO 2022) - P1/2 | "VXM01 in combination with avelumab was safe and produced detectable peripheral VEGFR-2-specific immune responses. Three non-resected patients had an objective response, three more patients experienced best response stable disease. For future studies a patient enrichment strategy based on immune biomarkers might be envisaged."

Clinical • IO biomarker • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD8 • KDR

NEC OncoImmunity Acquires VAXIMM’s Neoantigen Vaccine Development Assets (GlobeNewswire) - “VAXIMM technology enables fast generation and delivery of personalized T-cell cancer vaccines and may overcome key issues faced by the neoantigen field. NEC OncoImmunity to initiate first clinical trial with lead program from acquisition in 2022. NEC OncoImmunity (NOI)…and VAXIMM AG…announced that the companies have signed an agreement under which NOI will acquire all of VAXIMM’s neoantigen program assets….Under the agreement, NOI will acquire VAXIMM’s neoantigen vaccine-related patents, license the requisite manufacturing patents, and will take over several existing contracts with key collaborators and partners. Financial terms of the agreement have not been disclosed….VAXIMM retains rights to its first-in-class oral T-cell activation platform technology and all other product candidates, including VXM01, which is being developed for the treatment of glioblastoma.”

M&A • New trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

[VIRTUAL] Oral DNA vaccination targeting VEGFR2 combined with anti-PDL1 avelumab in patients with progressive glioblastoma: Safety run-in results—NCT03750071. (ASCO 2020) - P1/2 | "Three patients received nivolumab in addition to VXM01, which resulted in one complete and one partial clinical response... A multicentre, open-label phase I/II study (EudraCT 2017-003076-31) in progressive glioblastoma includes 30 patients (24 non-resectable, 6 resectable) previously treated with temozolomide/radiotherapy... VXM01 in combination with avelumab was safe and produces detectable peripheral VEGFR-2 specific immune responses. Three patients had an objective response. Research Funding: Vaximm Gmbh"

Clinical • IO biomarker • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • KDR

VXM01 phase I study in patients with progressive glioblastoma: Final results. (ASCO 2018) - P1; "...This trial examined safety and tolerability, clinical and immunogenic response to VXM01 after at least four vaccinations [106 or 107 colony-forming units (CFU)] in patients with progressive glioblastoma who have failed at least radiochemotherapy with temozolomide...Three out of them with additional nivolumab... VXM01 was safe and produces detectable specific peripheral immune responses as well as CD8/Treg ratio increase in post-vaccine tumor tissue. There was one patient with an objective response. As a next step, a combination study of VXM01 and anti-PD-L1 checkpoint inhibitor has been launched."

Clinical • P1 data • Solid Tumor

Oral DNA vaccination targeting VEGFR-2 combined with anti-PD-L1 avelumab in patients with progressive glioblastoma, A Phase I/II study: NCT03750071. (ASCO 2019) - P1/2; "Background: The vaccine (VXM01) is a VEGFR-2 coding DNA vaccine, using a Salmonella Ty21a carrier for oral application...At least one objective clinical response was attributed to vaccine monotherapy, with one more PR achieved in combination with nivolumab... A multicentre, open-label phase I/II study (EudraCT.gov no.2017-003076-31), will enrol 30 patients with progressive glioblastoma, previously treated with temozolomide/radiotherapy...Objective response rate (ORR), clinical response using iRano criteria, immunological correlates before and after treatment using ELISpot, FACS, TCR-sequencing, IF, and IHC laboratory methods. Clinical trial information: NCT03750071"

Clinical • P1/2 data

VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Vaximm GmbH; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Neutropenia • Oncology • Solid Tumor • MRI

[VIRTUAL] VAXIMM (BIO 2021) - "VXM01 is currently in clinical development for several tumor types, including brain cancer. VAXIMM also has a neoantigen program; the Company’s platform allows for fast generation and delivery of personalized T-cell cancer vaccines."

Brain Cancer • Oncology • Solid Tumor

VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Vaximm GmbH; Active, not recruiting ➔ Completed

Biomarker • Clinical • IO biomarker • Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis (clinicaltrials.gov) - P1; N=6; Active, not recruiting; Sponsor: Vaximm GmbH; Recruiting ➔ Active, not recruiting; N=24 ➔ 6

Biomarker • Clinical • Enrollment change • Enrollment closed • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Vaximm GmbH

Biomarker • Clinical • IO biomarker • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

[VIRTUAL] Vaximm AG (BIO 2020) - "VAXIMM has an ongoing clinical trial evaluating VXM01 in combination with the human anti-PD-L1 antibody, avelumab, as part of a scientific collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. VAXIMM also has a neoantigen program currently in preclinical development in collaboration with NEC; the Company’s platform allows for fast generation and delivery of personalized T-cell cancer vaccines and may overcome key issues faced by other neoantigen approaches. The Vaximm platform is very well suited for targeting viral antigens."

Oncology

VAXIMM announces first results from phase I/II trial in progressive glioblastoma with oral T-cell immunotherapy VXM01 in combination with PD-L1 inhibitor avelumab to be presented at ASCO20 Virtual (PipelineReview) - P1/2, N=30; NCT03750071; Sponsor: Vaximm GmbH; "VAXIMM AG…announced that the safety run-in results from a Phase I/II study in progressive glioblastoma with its lead product candidate, oral VXM01, in combination with the PD-L1 inhibitor avelumab are being presented as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Meeting being held May 29-31, 2020. The trial is part of a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc…Secondary endpoints include objective response rate (ORR), clinical response using immune-response assessment in neuro-oncology (iRANO) criteria and immunological assays. Nine patients treated with VXM01 and avelumab in 2 dose groups had completed the safety run-in phase…Two of these patients have been progression free for more than 6 months"

P1/2 data • Brain Cancer • Glioblastoma • Oncology

VAXIMM announces presentations at ASCO 2019 and other upcoming industry and scientific events (BioSpace) - “VAXIMM AG…announced that the Company will present an abstract about the design of its ongoing trial in patients with glioblastoma with VXM01 oral T-cell immunotherapy in combination with the anti-PD-L1 checkpoint inhibitor avelumab at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.”

Clinical protocol