Asia Deal Watch: China’s BravoVax, US-based GeoVax Team Up On Coronavirus Vaccine

Deal news from GeoVax/BravoVax, Onconova/HanX, Zydus Cadila/China Medical System Holdings, EyePoint/Ocumension, Ningbo NewBay Medical/Genentech, Otsuka/PhoreMost, Almirall/WuXi Biologics

Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Strategic Transactions.

US, Chinese Vaccine Developers Link For Coronavirus Product

On 27 January, US firm GeoVax Labs Inc. and Chinese vaccine developer BravoVax Co. Ltd. said they had signed a letter of intent to jointly develop a vaccine against the new Wuhan coronavirus (2019-nCoV). GeoVax will use its MVA-VLP vaccine platform and expertise to design and construct the vaccine candidate using genetic sequences from the ongoing coronavirus outbreak, while privately held BravoVax, which is based in Wuhan, will provide further development, including testing and manufacturing support, as well as direct interactions with Chinese public health and regulatory authorities.

GeoVax’s Modified Vaccinia Ankara (MVA) platform technology, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP (virus-like particle) immunogens within the person receiving the vaccine. The VLPs mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system (protective T-cell as well as antibody responses) to recognize, prevent and control the target infection. The MVA-VLP-derived vaccines elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector and allowing full protection at single doses.

The vector system is improved for high expression and stable transgenes during manufacture and offers the advantage of being a live replication-competent vector in avian cells. Single-dose protection is a favorable characteristic of preventive vaccines for an emerging infectious disease outbreak response, given the speed of spread of pathogens and the impracticality of multi-dose regimens in the under-resourced settings where outbreaks often occur, the companies noted.

Onconova Reacquires Chinese Rights To Rigosertib From HanX

Onconova Therapeutics Inc. reacquired rights in Greater China to its Phase III cancer candidate rigosertib on 23 January, terminating a license agreement signed with HanX Biopharmaceuticals Inc. in May 2019. The agreement was cancelled after HanX failed to make payments outlined under the transaction – the Chinese firm still could realize some milestone and royalty payments pegged to rigosertib in exchange for transition assistance with the drug, a blocker of RAS effector pathway signaling. [See Deal]

The Philadelphia-area biotech noted that it may attempt to re-partner Chinese rights to rigosertib after it reports top-line data from the pivotal INSPIRE trial in myelodysplastic syndromes during the first half of 2020. It previously has failed Phase III studies in MDS as well as pancreatic cancer. (Also see "Onconova sinks on 2nd Phase III rigosertib bust" - Scrip, 20 Feb, 2014.)

Rigosertib also is being investigated in leukemia and lung cancer. Onconova holds US and EU rights to its drug, and has out-licensed rights in Canada, Australia, New Zealand, Latin America, Japan and South Korea to various partners. Baxter Healthcare Corp. relinquished its rights to rigosertib in 2015 after multiple trial failures. (Also see "Onconova sinks as Baxter backs away from oral rigosertib" - Scrip, 4 Feb, 2015.)

Zydus Cadila Licenses Desidustat To China Medical System Holdings

Joining the band of Indian companies making forays into China, Cadila Healthcare Ltd., part of the Zydus Cadila group, has entered into a licensing agreement with China Medical System Holdings Ltd. (CMS) to develop and commercialize desidustat, a novel oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Greater China.

Desidustat is being explored for the treatment of anemia in patients with chronic kidney disease (CKD), a serious medical condition that leads to gradual loss of kidney function and, eventually, to failure. Cadila said CKD patients can be treated with this drug, whether they are on dialysis or not.

As part of the agreement announced on 20 January, CMS will be responsible for development, registration and commercialization of desidustat in Greater China, which comprises China, Hong Kong, Macao and Taiwan. While the commercial terms were not disclosed, Cadila will get an initial upfront payment, regulatory milestones, sales milestones and royalties on net sales of the product.

Cadila is conducting two Phase III trials of the drug – a DREAM-ND a trial for CKD patients who are not on dialysis and the DREAM-D trial for CKD patients on dialysis. Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed a good safety profile. The Phase I trials were earlier completed in Australia.

Cadila said more than 120 million people are estimated to be living with CKD in China and anemia is one of the frequent complications of CKD. A survey in China showed that the prevalence of anemia in patients at CKD stage one through five were 22.0%, 37.0%, 45.4%, 85.1% and 98.2%, respectively. The target-achieving rate was only 8.2% for anemia patients in non-dialysis CKD and 35.2% for dialysis CKD, showing an unmet health care need.

Cadila now joins companies like Sun Pharmaceutical Industries Ltd., Cipla Ltd., Aurobindo Pharma Ltd. and Biocon Ltd. in entering the Chinese market. While Cipla and Aurobindo have set up joint ventures with other companies, Sun has licensed its lead psoriasis asset tildrakizumab and dry eye therapy cyclosporine A 0.09% (CsA) to a subsidiary of CMS for Greater China. (Also see "China Ho! Sun Strikes Deals For Ilumya, Cequa" - Scrip, 27 Jun, 2019.) Biocon also has a license-and-supply deal with CMS to sell three generic formulation products, which it has declined to identify. (Also see "Biocon Joins March Into China With CMS" - Generics Bulletin, 19 Sep, 2019.)

Ocumension Gains Selected Asia Rights To EyePoint’s Dexycu

US company EyePoint Pharmaceuticals Inc. and Ocumension Therapeutics of China on 27 January announced an exclusive license agreement for the development and commercialization of its intraocular product Dexycu (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery in mainland China, Hong Kong, Macau and Taiwan. The product is already marketed by EyePoint in the US.

Watertown, MA-based EyePoint will receive $2m up front and royalties on product sales by Ocumension and is also eligible to receive up to an additional $12m if certain future prespecified development, regulatory and commercial sales milestones are achieved. In exchange, Ocumension will receive exclusive rights to develop and commercialize the product in the territories and Eyepoint will be the exclusive supplier of Dexycu to Ocumension for clinical use and commercial sale.

Dexycu is a single-dose, sustained-release product that provides benefit for up to 22 days, potentially replacing the steroid eye drop regimen prescribed for post-cataract surgery inflammation, which has low patient compliance due to its complex dosing schedule. EyePoint’s proprietary bio-erodible Durasert technology allows for extended intravitreal drug delivery.

Ocumension is controlled by 6 Dimensions Capital, a global life sciences investment firm with a focus on innovative companies in China and the US. EyePoint, established by the merger of Icon Bioscience Inc. and pSivida Inc., obtained US approvals of both Dexycu and posterior uveitis therapy Yutiq (fluocinolone acetonide intravitreal implant) in 2018. (Also see "Early Yutiq Approval Gives EyePoint Two Ophthalmic Drugs To Launch In 2019" - Scrip, 15 Oct, 2018.)

Ningbo Licenses Preclinical Cancer Compound From Genentech

China’s Ningbo NewBay Medical Technology Co. Ltd. announced on 27 January that it has licensed worldwide rights to preclinical GDC-0570 from Genentech Inc. A small molecule Pan-PIM inhibitor, the candidate has shown activity against multiple myeloma and prostate cancer in preclinical models. PIM kinases regulate cell growth, survival and metabolism, Ningbo says. Genentech will receive an undisclosed licensing fee under the deal and can realize clinical, regulatory and commercial milestones as well as potential sales royalties.

Otsuka Links With PhoreMost For Gene Therapy Targets

Japan’s Otsuka Pharmaceutical Co. Ltd. and UK-based PhoreMost Ltd. said on 21 January they had entered into a multi-project collaboration to use PhoreMost’s phenotypic screening platform, SITESEEKER, to identify currently undruggable disease-relevant pathways nominated by Otsuka. Novel targets identified will be validated and characterized by Otsuka as part of its internal development pipeline, with an initial focus on gene therapy applications of identified targets.

The SITESEEKER platform exploits protein-shape diversity to find functionally active peptides and uses proprietary PROTEINi protein-interference technology to probe the entire proteome in a live-cell environment to seek novel druggable targets linked to any particular disease. Financial details of the agreement were not disclosed.

Almirall Uses WuXi’s Antibody Discovery Platform In Dermatology

Almirall SA and WuXi Biologics agreed to collaborate on 9 January on the discovery of multiple bispecific antibodies that target dermatologic diseases using WuXi’s WuXiBody platform. The WuXiBody engineering platform enables the assembly of almost any monoclonal antibody (mAb) sequence pair into a bispecific construct with a structural flexibility that enables the building of various formats with different combinations of valencies (multiple binding sites).

Under the deal, Almirall will gain access to WuXi’s antibody technologies, including WuXiBody, paying WuXi an upfront fee and potentially providing development, regulatory and commercialization milestones and royalties on global sales for each resulting bispecific antibody project generated under the agreement. Almirall’s aim is to discover multiple bispecific antibodies for skin diseases, including atopic dermatitis, to which it will have development rights.

Almirall concurrently announced dermatology-focused transactions with both Bioniz Therapeutics Inc. and 23andMe Inc.  (Also see "Deal Watch: Early 2020 Deal-Making Boom Starts With Third Bayer/Evotec R&D Alliance" - Scrip, 9 Jan, 2020.)

Stay tuned for the next edition of Deal Watch. You can read more about other Asia deals that have been covered in depth by Scrip and Generics Bulletin in recent days below:

(Also see "Glenmark Sells Gynecology Unit" - Generics Bulletin, 23 Jan, 2020.)	Glenmark Pharmaceuticals Ltd. has struck a deal with private equity firm True North for its gynecology business in India and Nepal.
(Also see "Amgen To Buy Out Japan JV With Astellas" - Scrip, 23 Jan, 2020.)	Full, planned acquisition of Tokyo-based operation will give US biotech giant a firmer foothold in key market and new platform for Otezla growth.
(Also see "Piramal Profits As It Sheds DRG To Clarivate For $950m" - Scrip, 20 Jan, 2020.)	An experienced hand at M&A, Ajay Piramal has done it again – this time selling Decision Resources Group to Clarivate Analytics for $950m. Apart from $900m in cash, Piramal Enterprises Ltd. will get a stake in Clarivate while the latter expects the acquisition to be earnings-accretive in 2020.