May 25, 2022 (Q1 2021)
Creating a solid foundation for the future
The first quarter of 2022 has seen us deliver significant progress, completing the turnaround and, with the recent financing, securing a solid foundation for the future.
Over the last eighteen months, my team and I have rightsized the business and eliminated unnecesary costs to conserve cash, reduced risk by settling legacy litigation, added new development and regulatory capabilites, and initiated our ‘string of pearls’ strategy to build our pipeline through in-licensing and M&A.
Most recently, during the reporting period and despite global geopolitical tensions and a challenging financing environment, we were able to raise SEK 151m through a rights issue, strengthening our balance sheet and securing the short to medium-term finances of the business. This money will be used to fund existing operations and help us achieve potential value inflection points for our development programs.
To mark the completion of the turnaround in the business and the new chapter in our journey, we changed the company name to Vivesto following a vote at an extraordinary general meeting earlier this year. Vivesto comes from Vivo, or to live, in Spanish and Latin, and esto which infers investment. This reflects our focus and commitment to improve survival and quality of life for patients with cancer through investment in R&D and innovation.
Progressing our internal oncology R&D programs
There are still many cancer patients with limited or no treatment options or whose cancers have become resistant to treatment. Our programs, which address these hard to treat cancers, are progressing well in clinical development.
We are preparing for the initation of a Phase 2 trial of our most advanced internal development program, Cantrixil, a potent and selective third generation benzopyran SMETI inhibitor encapsulated in a cyclodextrin, for advanced ovarian cancer. Cantrixil, an intraperitoneally administered drug, was in-licensed from Kazia Therapeutics last year and represents the first program to be brought in-house through our ‘string of pearls’ strategy.
Cantrixil is complicated to manufacture so we have had to engage with multiple parties to secure the supply of clinical trial material. I’m pleased to report that during the quarter we made substantial progress with the signing of an agreement with Lonza, the Swiss multinational manufacturing company, for large-scale production of the main drug intermediate. We also expanded our research facility in Uppsala and broadened our capabilities to develop new Cantrixil formulations using our proprietary drug delivery platform which we believe may provide benefits for patients. Cantrixil is particularly exciting as it is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse.
Docetaxel micellar is currently in an investigator-initiated Phase 1b trial for advanced prostate cancer with the non-profit making Swiss Group for Clinical Cancer Research (SAKK). Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths. Docetaxel micellar is a solvent-free formulation of docetaxel, developed to avoid the need for the solubility enhancers in solvent-based docetaxel, and the mandatory high-dose steroid premedication, while providing an effective treatment option.
The SAKK 67/20 trial is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver, and renal function. The primary objective of this trial is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC and the secondary objectives are to evaluate safety, assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics in this population. During the quarter we announced that the first patient had fully completed the study. Furthermore, the first two of three dosing groups in the trial had been successfully recruited and the first patient for dose group three is in screening phase. We look forward to updating you as the trial progresses.
Maximising value from our partnered commercial oncology program
Our partnered program Apealea® (paclitaxel micellar) for late stage ovarian cancer is an intravenously injectable, non-Cremophor based formulation of paclitaxel using our proprietary drug platform that can be given without premedication such as steroids and with a shorter infusion time. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and oesophageal cancer, as well as other types of solid tumour cancers and is often formulated with Cremophor-EL, which is associated with allergic reactions.
Apealea® is outlicensed globally to Elevar Therapeutics and other regional partners. It is expected to be launched in the UK through Elevar’s European partner Inceptua in the first half of 2022, with the launch in Germany to follow in the second half of 2022. This could lead to us receiving royalties on sales during the second half of 2022. Following feedback from the FDA Elevar has decided to conduct clinical studies prior to filing a registration application for Apealea® in the US. A Phase II/III trial is planned to investigate the safety and efficacy of Apealea in epithelial ovarian cancer. Elevar is working closely with the US Gynecologic Oncology Group (GOG) Foundation through its GOG Partners program. We are in regular contact with Elevar and will keep you informed as the program progresses.
Exploring the full potential of our technologies
Our proprietary drug solubilization technology platform, XR-17™, together with our next-generation, development-stage platform, XR-18, provide a vital constituent of our Apealea® and Docetaxel micellar formulations.
During the quarter we were pleased to announce a significant expansion of our intellectual property (IP) portfolio associated with XR-17™. XMeNa patents were granted in Japan, Singapore, Russia and in several other jurisdictions, protecting an improved method for the manufacturing of the unique XR-17™ components. The XMeNa patent adds to Vivesto’s broad IP portfolio and provides patent protection for the XR‑17™ technology and Apealea® to 2036.
We also announced that we have identified and synthesized a promising novel candidate for use in the XR-18 drug delivery platform, which we believe could offer enhanced capabilities compared with the XR-17™ technology. The next-generation formulation applied in XR-18 is already being tested in combination with a widely used oncology compound, which we cannot disclose for competitive reasons while steps to secure intellectual property are being taken.
Building on these advances post period end, we announced the signing of a research agreement with Visikol Inc., a leading U.S. contract research services provider, to evaluate the cellular effects of new and existing anti-cancer drug formulations developed using Vivesto’s XR-17™ and XR-18 technologies. As a result of this research, we will be able to assess anti-cancer compounds formulated with our XR-17™ drug delivery platform as well as line extensions formulated with our XR-18 technology with regard to their therapeutic properties and underlying biologic effects. This research will allow us to select promising developmental drug candidates and further expand our current and future oncology pipeline.
I am pleased with the progress the business has made during the first quarter of the year in difficult market conditions. We’ve raised finances to secure our short to medium term future and launched a new identity to mark our focus and commitment to improve survival and quality of life for patients with cancer through investment in R&D and innovation.
As our internal development program progresses through the clinic it is vital that we employee the very best capabilities to maximize the chances of success. I am therefore looking forward to welcoming our new Chief Medical Officer, Dr. Daniel Tesfa in the summer. Daniel’s extensive and first-hand experience working in clinical development and oncology makes him a perfect fit for Vivesto.
The next stage in our journey focusses on the execution of our ‘string of pearls’ strategy, in-licensing and M&A to build our oncology pipeline. We remain in discussion with several companies, and I look forward to updating you when I can.
I’d like to thank my team for their continued dedication without whom it would have been impossible to deliver the changes that led to our transformation.
I would also like to thank you all for continuing to invest in a business that is now more streamlined and focused than ever before and which, I believe, is well positioned to deliver value over time.
Dr. Francois Martelet, M.D., CEO of Vivesto