onilcamotide (RV001) / Chosa Oncology - LARVOL DELTA

Vaccination Against RhoC in Prostate Cancer Patients Induces Potent and Long-Lasting CD4+ T Cell Responses with Cytolytic Potential in the Absence of Clinical Efficacy: A Randomized Phase II Trial. (PubMed, Vaccines (Basel)) - P2 | " Men randomized to active treatment with RV001V demonstrated the induction of potent, functionally capable, anti RhoC-CD4+ T cell responses. However, there was no benefit in time to biochemical progression, and no difference in time to the initiation of second-line therapies."

Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • RHOC

RhoVac's phase IIb study in prostate cancer , BRaVac, failed to meet its primary endpoint (PRNewswire) - "RhoVac AB...regrets to announce today on May 29th, 2022, that its phase IIb study in prostate cancer, BRaVac, in spite of the previous positive results related to the compound, failed to demonstrate RV001 (onilcamotide) superiority over placebo in preventing progression in patients with biochemical recurrence (a rise in PSA) after curative intent therapy. Progression was defined as either a doubling of PSA, clinical recurrence, or death. RhoVac will undertake a more thorough analysis of the results, and a clear plan on how to proceed will be communicated end June. The primary outcome analysis, however, regrettably offers little hope of a license or acquisition deal based on the results of this study alone."

P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Pre-clinical findings support the potential use of RhoVac's drug candidate, onilcamotide, across several cancers (PRNewswire) - "The findings identify the crucial MHC-II expression in more tumour cells than was previously known, and they also show co-localisation of the MHC-II receptors and onilcamotide's target protein, RhoC....The data suggests that onilcamotide is tissue agnostic, i.e., that it could be used across cancer types. The data has even documented the presence of MHC-II receptors in more types of cancer than previously known."

Preclinical • Oncology • Solid Tumor

RhoVac AB announces Database Lock in its clinical phase IIb trial of onilcamotide (PRNewswire-Asia) - "RhoVac AB...announced on May 10th, 2022, that its phase IIb study in prostate cancer, BRaVac, has reached 'Database Lock'. This means that all data from the trial is now finally reported, cleaned and 'locked' in the data base. The next step will be analysis to produce the results. As previously stated, RhoVac anticipates having its primary results no later than at the beginning of June....All results, including subgroup analyses, will be available in the summer."

P2b data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

"RhoVac AB tillkännager databasstängning (”Database Lock”) i sin kliniska fas IIb-studie med onilcamotide https://t.co/jQ9V6LCkL7" (@CisionNews)

The Canadian Intellectual Property Office intends to grant RhoVac's patent application for RV001 (onilcamotide) cancer vaccine (PRNewswire) - "RhoVac AB...announces today, 24th January 2022, that the Canadian Intellectual Property Office ('CIPO') has issued a 'Notice of Allowance', which means that it intends to grant RhoVac's patent application for RV001 (onilcamotide) cancer vaccine. The company has previously been granted patents relating to onilcamotide in USA, Europe and Japan. The Canadian patent will provide RhoVac's onilcamotide vaccine with broad protection in a key market and significantly strengthens the company's patent portfolio....The patent term will then extend to December 2028, potentially longer if an application for a Certificate of Supplementary Protection is filed and granted in Canada."

Patent • Oncology

"Kanadensiska patentverket avser bevilja RhoVacs patentansökan för cancervaccinet (RV001) onilcamotide https://t.co/ipH6KDMB5e" (@CisionNews)

Clinical • Oncology

"BioStock: RhoVac gives guidance on new indications for RV001 https://t.co/j8OvnLdvOQ" (@CisionNews)

Another clean interim safety review of RhoVac's clinical phase IIb study in prostate cancer (PRNewswire) - “RhoVac AB…announces today on December 9th, 2021, that its Data & Safety Monitoring Committee (DSMC) has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac. All patients have now been recruited into the study. The safety profile of RV001 (onilcamotide) was considered excellent, and the DSMC concluded that the trial can continue without modifications….RhoVac currently estimates finalising the study and presenting results in the first half of the 2022.”

P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer

"RhoVacs läkemedelskandidat RV001 har fått sitt vetenskapliga namn https://t.co/u32Kir2SXQ" (@CisionNews)

RhoVac retains international investment bank as advisor for desired RV001 transaction (PRNewswire) - "RhoVac AB...announces...that it has retained the services of Stifel Nicolaus Europe Limited ('Stifel'), a global investment bank, as its exclusive financial adviser in connection with the planning, execution and closing of a potential transaction or partnership deal (a 'transaction'). Such a transaction would be pivotal for further development and commercialisation of the company's lead drug candidate, RV001."

Financing • Genito-urinary Cancer • Oncology • Prostate Cancer

RhoVac announces the completion of patient recruitment for the BRaVac clinical phase IIb study of RV001 in prostate cancer (PRNewswire-Asia) - "RhoVac AB...announces today on Sep 20th , 2021, that its clinical phase IIb study of lead drug candidate RV001 in prostate cancer, BRaVac, is deemed fully recruited and that no additional patients will be screened after this week. Top-line results of the study are estimated to be at hand in the first half of 2022....The objective of the study is to show that RV001 can significantly prevent or delay disease progression in these patients, something for which no standard therapy is currently available."

Enrollment status • P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer • Urothelial Cancer

"RhoVac retains international investment bank as advisor for desired RV001 transaction https://t.co/SQYiZUc9CO" (@CisionNews)

RhoVac presents 3-year follow-up results of the phase I/II study in prostate cancer (PRNewswire) - P1/2, N=22; NCT03199872; Sponsor: RhoVac APS; "The top-line results shows that the vast majority of patients still had undetectable PSA. Furthermore, the RhoC specific immune response has so far been assessed in 15 patients, and in these all but one patient who was a responder in the 1-year follow-up, still had RhoC specific immunity after 3 years. This exceeded expectations...Out of these 19 patients, none of the patients had progressed significantly in terms of PSA nor progressed to other therapy. Indeed, all but three patients had undetectable PSA values (<0.1 ng/ml), and the patients who had a measurable PSA, had a longer PSA doubling time than they did when to entering the original study, indicating a slower progression."

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

BRaVac: Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (clinicaltrials.gov) - P2; N=180; Active, not recruiting; Sponsor: RhoVac APS; Recruiting ➔ Active, not recruiting; Trial primary completion date: Sep 2021 ➔ Apr 2022

Clinical • Enrollment closed • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MRI

Clean interim safety review of RhoVac's clinical phase IIb study in prostate cancer (PRNewswire) - "RhoVac AB...announces today on July 9th 2021, that its Safety Monitoring Committee has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac. The safety profile of RV001 was excellent and the Safety Monitoring Committee concluded the trial can continue without modifications....RhoVac currently estimates finalizing the patient recruitment for the study no later than September this year, and after that the study will run to completion, which is estimated to take 9-12 months after the closing of the recruitment."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

RhoVac receives approval to initiate a long-term follow-up of clinical phase I/II patients (Cision) - “RhoVac…announces today, 9th June 2021, that it has received full approvals to initiate a follow-up study of the patients that took part in the company’s clinical phase I/II trial in prostate cancer in Denmark…The objective of the long-term follow study, to be conducted in the coming months, is to find out to what extent these patients still have the appropriate level of RhoC specific immune response, what their PSA development has been, and to what extent they have progressed to additional therapy…The objective of the clinical phase IIb study, named BRaVac, is to show that RV001 can significantly prevent or procrastinate disease progression in these patients, something for which no standard therapy is available today…further underpinning the best possible partnership deal in 2022.”

European regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

RhoVac Confirms Forecast - BRaVac Phase IIb study recruitment to close in Quarter 3 2021 (PRNewswire) - “RhoVac AB…announces today, May 31, 2021, that it confirms its previous forecast to be able to conclude recruitment for its multi-centre BRaVac Phase IIb study in Quarter 3 2021. Also, all new US clinics have been initiated to boost recruitment in the final months and further raise awareness in the USA…There are less than 50 patients left to recruit and the current recruitment pace points to a close in August; allowing for the impact of summer vacations in hospitals, RhoVac therefore forecasts recruitment closing in September. After closing, finalising the treatment of patients in the study is estimated to take 9-12 months.”

Enrollment status • Genito-urinary Cancer • Oncology • Prostate Cancer

Mount Sinai Hospital in New York joins RhoVac's Phase IIb Study in Prostate Cancer (PRNewswire) - "RhoVac AB...announces...that the prestigious Mount Sinai hospital in New York is initiated today as the latest addition to US trial centres in RhoVac's clinical phase IIb study, 'BRaVac', in prostate cancer....In the trial, RhoVac's drug candidate, RV001, will be used in prostate cancer patients that have previously had a prostatectomy or definitive radiation therapy, but that now have suffered a "Biochemical Recurrence" (rising PSA) but who still have not developed detectable metastases."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

Global Covid-19 Vaccination Roll-out causes delay to RhoVac’s Phase IIb study (Cision) - “RhoVac…announces today, March 8th , 2021, that its clinical phase IIb study, ‘BRaVac’, in prostate cancer, will be somewhat further delayed as Covid-19 vaccinations are rolled out to the study population…RV001 treatment initiation deferred until after vaccination. The delay caused by these deferrals is difficult to estimate presently. However, the previous target of having full recruitment by Q2 no longer seems realistic. This tentatively pushes the target for full recruitment to Q3 and the company will communicate a more precise recruitment forecast later in the spring when more data on the handling of the vaccinations is available.”

Clinical • Enrollment status • Genito-urinary Cancer • Oncology • Prostate Cancer

First patient in treatment in RhoVac's clinical phase IIb study in United Kingdom (PRNewswire) - "RhoVac AB...announces...that the first patient in United Kingdom is enrolled in the company's clinical phase IIb study in prostate cancer, a study named RhoVac-002 ('BRaVac')....The clinical phase IIb study is an international, multicenter study, which will recruit over 175 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany and United Kingdom) and the US."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

RhoVac's Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA (PRNewswire) - "RhoVac....announced that the American FDA has granted Fast Track Designation to the company's drug candidate, RV001."

Fast track designation • Genito-urinary Cancer • Oncology • Prostate Cancer

Positive Results from RhoVac's Clinical Phase I/II Study published in Journal of ImmunoTherapy of Cancer (PRNewswire) - P1/2, N=22; NCT03199872; Sponsor: RhoVac APS; "RhoVac announces...that the results of its clinical phase I/II study have been published in the Journal for ImmunoTherapy of Cancer (JITC). The scientifically reviewed article reports that the treatment with RhoVac's drug candidate RV001 was safe and well tolerated, and that a long-lasting immune response could be generated in the vast majority of patients. In the patients who had a measurable PSA when they started the study, a markedly increased PSA doubling time was seen, indicating cancer-specific effectiveness....The study is planned to be completed in early 2022 and it aims to produce results that show a solid clinical 'proof of concept'."

P1/2 data • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer

Article on RhoVac's Phase I/II study to be published in November (PRNewswire) - "...the article elaborating on the results of RhoVac's Phase I/II study in prostate cancer including the 12-month follow-up period, has been accepted for publication in the Journal for ImmunoTherapy of Cancer (JITC). The publication now indicates that the release of the article will take place in November, a few weeks later than previously suggested. The article will feature an elaboration on the mode of action of RV001, but also a discussion on the PSA data findings indicating possibilities of delaying disease progression, for which RhoVac's currently ongoing phase IIb study is aimed at providing substantial evidence."

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

First patient in treatment in RhoVac's clinical phase IIb study in Sweden (PRNewswire) - "hoVac AB ('RhoVac') announces today, on September 17 2020, that the first patient in Sweden is enrolled in the company's clinical phase IIb study in prostate cancer, a study named RhoVac-002 ('BRaVac'). The first patient in Sweden is enrolled in the clinical study, called BRaVac. This clinical trial phase IIb-study is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative intent treatment."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer