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Moderna Could Have Advantage Over Pfizer’s Cold Chain

Moderna, Inc. has provided details about how its COVID-19 vaccine candidate mRNA-1273 will reach patients if and when it is approved, with cold chain distribution a challenge for it and fellow frontrunner Pfizer.

On its investor call on 26 August, the company disclosed that it is already collecting real time stability data is ongoing to learn more about storage and distribution of MRNA-1273 at -20°C/-4°F - a requirement not shared by many older vaccine platforms, but a less demanding temperature than that required by Pfizer Inc./BioNTech’s candidate, which must be stored at -70°C. (Also see "Coronavirus Update: Moderna’s COVID-19 Vaccine Passes First Test In Elderly Patients" - Scrip, 27 Aug, 2020.)

Moderna revealed that mRNA-1273 could demonstrate 6-12 months of stability at -20°C, with stability at the point of use of around one week at 2-8°C. This could be a clear advantage over Pfizer’s cold chain requirements, which would necessitate special equipment not available beyond major urban centers. 

Analysts at SVB Leerink believe that if Moderna gains an early Emergency Use Authorization (EUA) from the US Food and Drug Administration, it could file amendments allowing for less stringent refrigeration than Pfizer, if its stability data mature as the company’s management expects. 

Nevertheless, the cold chain requirements of both of these leading mRNA- based vaccines could prove to be a downside over time, once vaccine candidates with less burdensome requirements – such as protein subunit vaccines from Sanofi/GSK and Novavax – gain approval.

BioNTech, Fosun Reach Vaccine Supply Deal For Hong Kong, Macau

In the latest planned agreement for the supply of a coronavirus vaccine in China, BioNTech SE has announced an intended collaboration with Shanghai Fosun Pharmaceutical (Group) Co., Ltd. to supply 10 million doses of BioNTech’s BNT162 mRNA-based candidate to the Hong Kong and Macau Special Administrative Regions of China.

A wholly owned Fosun Pharma subsidiary on 27 August signed a Letter of Intent with Hong Kong-listed Jacobson Pharma Corporation Limited for the planned distribution of a total of 10 million doses of the vaccine in the two territories. BioNTech will supply the product from its GMP-certified mRNA manufacturing facilities in Europe. 

The deal “further demonstrates our commitment to provide our vaccine candidate as broadly as possible globally to help end the SARS-CoV-2 pandemic,” BioNTech’s chief business and chief commercial officer Sean Marett said.

The German and Chinese firms had already signed a strategic collaboration in March under which Fosun will commercialize BNT162 in mainland China. A Phase I trial has already been initiated in China and the treatment of the first participants with one of the vaccine candidates from the BNT162 program, BNT162b1, was announced in early August. 

144 participants have already been fully enrolled in the study. (Also see "Coronavirus Update: BioNTech And Fosun Launch Vaccine Trial In China" - Scrip, 6 Aug, 2020.)

Among other western vaccine developers, AstraZeneca PLC has also signed an agreement with Kangtai Biological Products Co. Ltd. to produce and commercialize in China its AZD1222 COVID-19 vaccine candidate, being developed with the UK’s University of Oxford. 

Shenzen-headquartered vaccines specialist Kangtai will be responsible for an annual production capacity of at least 100 million doses of AZD1222 being reached by the end of 2020, which will be expanded to at least 200 million doses by the end of 2021 to meet the needs of the Chinese market. (Also see "Coronavirus Update: Gilead To Meet Global Remdesivir Demand By October" - Scrip, 7 Aug, 2020.)

Many Chinese companies are also advanced in their development of vaccine candidates against SARS-CoV-2, including Sinopharm Group Co. Ltd.Sinovac Biotech Ltd. and CanSino Biologics Inc.  (Also see "Can China Convince World With Its Fast, Cheap COVID Vaccines?" - Pink Sheet, 26 Aug, 2020.)

BeiGene Gains Most Global Rights To Singlomics’ Antibodies

Chinese firm BeiGene, Ltd. has acquired exclusive global development, manufacturing and commercialization rights outside China and other selected Asian territories to Singlomics (Beijing DanXu) Biopharmaceuticals Co., Ltd.’s preclinical anti-COVID-19 antibodies, including DXP-593 and DXP-604 and other antibody sequences. 

A Phase I double-blind, placebo-controlled trial is expected to begin enrolling up to 30 healthy subjects in Australia in September, while another Phase I/II multinational trial in patients with mild to moderate COVID-19 is also expected to begin enrolling by early October. 

Precise financial terms were not disclosed but Singlomics will receive upfront and regulatory and commercial milestone payments and is eligible for tiered, up to double-digit royalties on future sales.

DXP-593 and DXP-604 were identified using high-throughput, single-cell RNA and VDJ sequencing of antigen-enriched B cells from blood samples from over 60 convalescent COVID-19 patients. The companies said DXP-593 showed strong neutralization potency in preclinical testing, with an IC50 of 1.2ng/mL and 15ng/mL against pseudotyped and authentic SARS-CoV-2, respectively, plus strong therapeutic/prophylactic efficacy in rodent models. 

DXP-604 binds to a different epitope but has also demonstrated high potency. Both could potentially be used as part of a cocktail treatment that could help avoid resistance due to viral mutation.

One advantage of the antibody approach, which is being pursued by multiple companies globally, is that production can be scaled up to treat many more patients than convalescent plasma therapy alone. 

Privately held and Beijing-based Singlomics focuses on antibody drug discovery and development and is planning to build a general antibody manufacturing facility in Changping near Beijing.

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