On May 30, 2022 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported 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 (Press release, RhoVac, MAY 30, 2022, View Source;bravac-failed-to-meet-its-primary-endpoint-301557156.html [SID1234615221]). 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.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001 (onilcamotide) late 2019, in prostate cancer patients with biochemical recurrence (a rise in PSA) after curative intent therapy. Positive phase I/II data offered significant hope, and in November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. The objective of the BRaVac study was to show that onilcamotide could significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted, and no unexpected adverse events have been identified, and the end trial results also confirm the anticipated safety of the drug candidate.

On efficacy however, BRaVac, the first placebo controlled study of the drug candidate, failed to deliver on its primary endpoint, which was to demonstrate drug candidate superiority over placebo in reducing the risk of progression, and the primary results did not indicate any significant finding on improved outcomes for the studied patients. RhoVac will now undertake a more thorough analysis of the study results, but the primary outcome analysis obviously offers little hope of a license or acquisition deal based on the results of this study alone. RhoVac will now execute on a cost minimisation contingency plan, while conducting further analyses of the results, aiming to come up with clear recommendations on the future of the project and next steps end June.

RhoVac CEO, Anders Månsson, comments: "Even though we know that benchmarks state that the probability of success for a phase II project in oncology is less than 50% and that clinical development is always a calculated risk, we are surprised and deeply saddened to find that BRaVac failed to meet its primary endpoint. We will immediately minimise expenditure, while further assessing the study data, with the aim of coming up with firm recommendations on how to proceed, and to communicate this end June."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 29-05-2022 19:53 CET.

On May 30, 2022 Amplia Therapeutics Limited (ASX: ATX) reported the following (Press release, Amplia Therapeutics, MAY 30, 2022, View Source [SID1234615220]):

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• Appendix 4E Preliminary Final Report YE 31 March 2022
• Annual Report – Year Ended 31 March 2022
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

On May 29, 2022 InxMed Co., Ltd, a clinical-stage biotechnology company dedicates on developing innovative therapies targeting stroma microenvironment and drug resistance for hard-to-treat solid tumors, reported that the clinical data from an open-label phase Ib trial evaluating the efficacy and safety of IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant recurrent ovarian cancer (PROC), will be presented in the form of poster at the upcoming 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) from June 3, 2022 to June 7, 2022 (Press release, InxMed, MAY 29, 2022, View Source [SID1234615222]). Abstract was published on the ASCO (Free ASCO Whitepaper)’s website（Abstract #：5567）. The data showed that patients receiving combination of IN10018 with PLD demonstrated promising antitumor activities and manageable safety profile in PROC patients, with a high overall response rate (ORR) of 56.7%（Poster #：445）.

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This phase Ib study is to evaluate the safety, tolerability, and antitumor activities of IN10018 in combination with PLD in patients with platinum-resistant recurrent ovarian cancer. The primary endpoint for the study is objective response rate (ORR), and key secondary endpoint include disease control rate (DCR), duration of response (DOR) and progress-free survival (PFS).

As of cutoff data of December 31, 2021, a total of 42 patients were enrolled. Antitumor response was evaluated in 30 efficacy evaluable patients who had at least one post-baseline tumor assessments per investigator’s assessment. 17 PRs and 9 SDs were reported and none of the patients had CR. The ORR was 56.7%, the DCR was 86.7%, and the median DOR was 4.5 months (95% confidence interval [CI]: 2.7 months – NA) and still maturing. The ORR and DCR were 65.0% (13/20) and 90.0% (18/20), respectively, in 20 efficacy evaluable patients who had at least 6 months follow-up. In all 42 enrolled patients, the median PFS were 6.2 months (95% CI: 6.2 months – NA) and still maturing.

The safety profile of the combination is comparable to these single agents alone without additive toxicities. No IN10018 related death observed and only 9.5% (4/42) patients reported SAEs which were related to both IN10018 and PLD. The most frequently reported IN10018 related AEs were proteinuria, decreased appetite, fatigue, and AEs of gastrointestinal origin such as nausea, diarrhea, vomiting. Majority of these drug related AEs were CTCAE grade 1 and 2, no drug related grade 4 or 5 AE reported. Proteinuria was noted asymptomatic, reversible and could be managed with appropriate dose interruption/reduction and only one proteinuria event resulted in IN10018 dose reduction.

"We are extremely pleased with the data as it demonstrates the superior efficacy and safety of our IN10018, as well as confirming the proof of mechanism of IN10018 regimen. We are excited by this outcome and are working hard on completing this study and determining the further design for a subsequent pivotal study," said Dr Zaiqi Wang, CEO of InxMed. FAK is a non-receptor tyrosine kinase that plays an important role in cell adhesion, migration, and regulation. It exhibits expression upregulation in multiple tumor types. Researchers have found that inhibiting the FAK signaling pathway can effectively reverse previously failed chemotherapy and targeted therapy caused by drug resistance and enhance the response and efficacy of immunotherapy for solid tumors.

InxMed set up a global clinical development program for IN10018, as one of the most advanced FAK inhibitors. Clinical trials currently underway in the US and China are designed for platinum-resistant ovarian cancer, NRAS mutant metastatic melanoma, triple-negative breast cancer, head and neck cancer, pancreatic cancer, and other solid tumors that are still lacking effective treatment. IN10018 received fast track designation from the U.S. Food and Drug Administration (FDA) in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA) for the treatment of patients with platinum-resistant ovarian cancer.

InxMed has the exclusive global development and commercial operation rights of IN10018 and is planning to initiate a pivotal trial in the second half of the year.

On May 28, 2022 FORUS reported that it was a proud sponsor and participant in the Défi Cyclo-Myélome (Press release, FORUS Therapeutics, MAY 28, 2022, View Source;utm_medium=rss&utm_campaign=forus-was-a-proud-sponsor-and-participant-in-the-defi-cyclo-myelome-on-may-28th-2022 [SID1234615259]). This is the 10th year of this important event which aims to increase awareness about multiple myeloma and raise funds for the Myeloma Canada Chair, held by Dr. Richard LeBlanc, at the Université de Montréal at Maisonneuve-Rosemont Hospital (HMR). Funds from this event will support research focused on improving the care of individuals living with multiple myeloma. Special recognition to Marie-Josèphe Champagne who rode on behalf of FORUS alongside other supporters, patients, caregivers and healthcare professionals.

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On May 27, 2022 RemedyBio reported a new collaborative research project with the Thoracic Oncology Research Group (TORG) at the Trinity St James Cancer Institute (TSJCI) to identify novel predictive biomarkers for Non-Small Cell Lung Cancer (Press release, Remedy Biologics, MAY 27, 2022, View Source [SID1234644113]).

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The outputs from this partnership are intended to lay the foundations for next generation diagnostic and prognostic products that could fundamentally change the provision of cancer care.
We are excited to collaborate closely with the talented Trinity & St James’ thoracic team. Despite recent breakthrough advances in the treatment of lung cancer, a huge unmet medical need remains in terms of early detection, minimally invasive monitoring for cancer recurrence and improved precision of patient stratification. This requires us to look at how new and established tools can be best integrated to benefit patients so that they can receive the best medicines for them at the right time. RemedyBio’s transformative immune discovery platform, Nanoreactor, will establish an immune profile for each patient allowing a profound understanding of the interaction between immune, disease, and therapeutic effects.
Dr Colm Galligan, Chief Medical Officer, RemedyBio
We are delighted to collaborate with RemedyBio to advance our translational thoracic oncology research programme at the TSJCI. The immune profiling of lung tumours, using the innovative Nanoreactor, represents a promising approach to improve patient stratification and increase the clinical efficacy of cancer immunotherapy. The group is excited to work with RemedyBio on multiple integrated and truly innovative projects with the potential for near term patient benefit and clinical impact.
Dr Kathy Gately & Prof Stephen Finn, Trinity College Dublin/ St James’ Hospital
We are grateful to Enterprise Ireland for supporting this project through its Innovation Partnership Programme