On December 9, 2020 Grand Pharmaceutical and Healthcare Holdings Limited reported that Group’s associate Sirtex Medical US Holding, Inc. ("Sirtex") has entered into several transactions and strategic cooperation with two U.S. based innovative companies Nanospectra Biosciences, Inc. and BlackSwan Vascular, Inc. respectively with an aim to enrich the Group’s highly innovative and high-barrier pipeline, and therefore will acquire certain shares of the two investees and carry out cooperation on related products, which helps to expand Sirtex’s and the Group’s strategic planning in the field of precision interventional diagnostics and treatment (Press release, Grand Pharmaceutical, DEC 9, 2020, View Source [SID1234653968]).
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Precision interventional diagnostics and treatment is one of the Group’s focus areas in strategic planning, which can be further divided into three sub-fields: precision anti-tumor intervention, precision vascular intervention and precision neurointervention. In the field of precision anti-tumor intervention, Sirtex, plus OncoSec Medical Incorporated (NASDAQ: ONCS), another associate of the Group in the US specializing in anti-tumor intervention and DNA immunotherapy, are both important associates and international research and development ("R&D") and production platforms of the Group. The Group together with Sirtex owns or has access to six world-class innovative products for treatment of five solid tumors including colorectal cancer, prostate cancer, melanoma, triple negative breast cancer and squamous cell carcinoma in this field.
1) Subscribe Shares of Nanospectra and Entered into Cooperation Agreement
Sirtex entered into a strategic investment arrangement (the "Nanospectra Agreement") with Nanospectra, pursuant to which Sirtex has made US$1.5 million equity investment for approximately 6% of first round series B-1 preferred shares in Nanospectra. In addition, Sirtex can appoint a member in the board of director of Nanospectra, and has a limited duration exclusive right to negotiate for access to Nanospectra’s world-class innovative product AuroLase in regions outside the U.S. Sirtex also has the exclusive right of first negotiation should Nanospectra seek to transfer a controlling interest in the future. In the event of declaration of dividend (subject to the conditions stated in the articles of Nanospectra) or liquidation, Sirtex, along with holders of other Preferred series B-1 shares will carry a dividend or entitle to the assets respectively in preference to the holders of other classes of shares. The preferred series B-1 shares also carry the same voting rights as other classes of shares of Nanospectra.
Based in Houston, Texas, Nanospectra is an innovative medical device company, of which the lead product AuroLase was initially developed by a team composed of scientists led by Professor Naomi Halas, a member of the National Academy of Sciences and the National Academy of Engineering and Jennifer West, also a member of the National Academy of Engineering. Nanospectra launched a pivotal trial in prostate tissue ablation in the first quarter of this year. Professor Naomi Halas is the founding director of the Laboratory for Nanophotonics at Rice University and Director of the Smalley-Curl Institute. As one of the pioneering researchers in the field of plasmonics, Professor Naomi Halas created the concept of the "tunable plasmon" and invented a family of nanoparticles with the applications in biomedicine, optoelectronics, chemical sensing, photocatalysis, and most recently in solar energy. In conjunction with Professor West, they co-founded Nanospectra to advance the clinical development of targeted photothermal treatment of soft tissue using nanoparticles.
AuroLase, Nanospectra’s innovative medical device, for the ablation of solid tumors, utilizes the unique "optical tunability" of a new class of nanoparticles. AuroLase for prostate tissue ablation is expected to the world’s first and only ultra-focal tissue ablation therapy. Compared with surgery, radiotherapy or alternative focal therapy approaches, AuroLase therapy can maximize treatment effectiveness while minimize side effects typically associated with surgery, radiation, and alternative focal therapies. The AuroLase project for the treatment of prostate cancer tissue ablation is conducting a multi-site pivotal clinical trial in the US, with clinical safety and effectiveness among patients being demonstrated preliminarily. It is expected to become the first marketed innovative product in the field of ultra-focal thermal ablation to treat prostate cancer tissue ablation. AuroLase technology is highly scalable and is expected to be applied to various solid tumors such as thyroid cancer and breast cancer.
2) Purchase Certain Shares of BlackSwan and Obtain the Rights of Full Acquisition
Sirtex and BlackSwan have entered into a shares purchase agreement. Under the agreement, Sirtex will invest US$5 million in exchange for approximately 12.5% preferred shares in BlackSwan and Sirtex will appoint an observer member to the board of directors. In addition, Sirtex has an option to purchase the remaining shares of BlackSwan at a consideration of no more than US$41.5 million in aggregate, within a certain period of time upon the submission of pre-market approval ("PMA") application of BlackSwan’s products.
BlackSwan’s core product LavaTM is a global leading innovative medical device in the field of precision vascular intervention, and is indicated for peripheral vascular applications. LavaTM has radiopacity with low imaging artifact. Its rapid mixing leads to a short 3 minutes preparation time, increasing its ease of use and enabling emergent procedures to improve patients’ chances of survival.
In the future, it also has the potential to expand into other indications in anti-tumor field in combination with SIR-Spheres Y-90. The potential of radiolabeling LavaTM with radioisotopes creates synergies for additional brachytherapy and interventional therapies for Y-90 and other radioisotopes. LavaTM received an investigational device exemption ("IDE") approval from the United States Food and Drug Administration ("FDA") in September this year, and it has the potential to become the first liquid embolic approved for commercialization in the US for peripheral vascular applications.
KonaTM, BlackSwan’s second liquid embolic product candidate, has a target indication for neurovascular applications. It has potential to become drug loadable with chemotherapeutics or radioisotopes for controlled drug delivery in multiple treatment, providing the ability to compete with particle-based transcatheter arterial chemoembolization ("TACE"), ablation and brachytherapy combined with surgery. In addition, KonaTM also has the potential to be used in combination with SIR-Spheres Y-90 and chemical drugs.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "Sirtex’s cooperation with Nanospectra and BlackSwan and acquiring multiple world-class high-tech innovative products have expanded its product portfolio in oncology and precise intervention and enhanced its connection to research and development capabilities in tumor treatment and precision interventional diagnostics and treatment, strengthened its core competitiveness and propelled the Group’s technological innovation and global planning process."
"Sticking to patients-centered and innovation-driven, the Group has increased its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs in recent year. After years of development, the Group has built its global ‘precision diagnostics + treatment’ strategic platform integrating ‘oncological, vascular, and neurological’. It also becomes a rare innovative global pharmaceutical company that exhibits rapid development with interventional products covering ‘oncological, vascular, and neurological’ in China. The Group will continue to develop world-class innovative products and advanced technologies in the field of precision interventional diagnostics and treatment, striving to build a leading ‘paninterventional diagnostic and therapeutic platform’ in China as well as the world."
"With the continuous expansion of global innovative product portfolio, the Group’s technological advancements have shown their effects. Multiple progresses have demonstrated the Group’s hardcore advantages, which is, in the first step stable operations laying a solid foundation of capital and resource for global expansion. Then in turn the innovative products with high barriers and high added value which are developed by the Group’s multiple global R&D centers generate momentum for future business growth once these products are launched to the market. Meanwhile, through adopting the strategy of ‘global expansion and dual-cycle operation’, the Group has gradually formed a new pattern of domestic and international cycles that synergize with each other. With synergistic effects from multiple global R&D centers, the Group will provide patients with more advanced and diverse treatment options in the world.