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Dealmaking in a pandemic: partnerships speeding COVID-19 countermeasures

COVID-19 makes new and old bedfellows as dealmaking centers on countermeasures

COVID-19 may be putting the brakes on a broad swath of biopharma deals, but it has also triggered a host of partnerships for coronavirus countermeasures, pushing vaccine deals to their highest numbers in years. Many of these arrangements knit together actors from across the development spectrum in hopes of a quick and seamless path to market.

Government agencies and non-profits have been stepping up to provide the financial fuel to get these COVID-19 countermeasures off the ground.

The Coalition for Epidemic Preparedness Innovations (CEPI) and HHS’s Biomedical Advanced Research and Development Authority (BARDA) have been particularly prolific. CEPI has granted funding to eight vaccine programs; BARDA has funded at least seven programs across diagnostics, therapeutics and vaccines.

The Bill and Melinda Gates Foundation, Wellcome Trust and Mastercard teamed up to create the COVID-19 Therapeutics Accelerator with $125 million; the Chan Zuckerberg Initiative added $25 million (see “Funding Flows for COVID-19”).

Figure: Funders step up to support COVID-19 countermeasures

Funding arrangements for COVID-19 programs announced through March 31. The European Commission announced March 6 that it had selected 17 projects to fund; only the recipients of one have been disclosed. Additional funders, such as Europe's Innovative Medicine's Initiative (IMI), have issued calls for proposals.

Source: BioCentury's BCIQ database and the organizations' websites

Biotechs and academics from all over the globe are prioritizing COVID-19 programs.

The past three months have seen at least 78 partnerships announced for COVID-19 vaccines, therapeutics and diagnostics involving at least 128 groups from over a dozen countries, according to BioCentury’s BCIQ database (see “COVID-19 Deals Table”).

Over half of those deals (48) cover vaccines, amounting to almost as many vaccine deals as the aggregate number of deals in 2019, 2018 and 2017, and marking a turnaround from what’s largely been a downward trend over the past decade (see “Vaccine Deals Surge in Response to COVID-19”).

Figure: Vaccine deals surge in response to COVID-19

The number of COVID-19 deals for vaccines and adjuvants in 2020 (red line) through March 31 outpaces the number of deals per year for vaccines and adjuvants in all infectious disease indications since 2012, except for 2015, the height of the Ebola epidemic. At least two deals in 2020 were for other diseases (not shown).

Source: BioCentury's BCIQ database and archives

In many cases, the urgency of the situation is prompting funding organizations, development and commercialization partners to line up manufacturing well before a compound is demonstrated to be effective: at least 16 vaccine makers have secured manufacturing partners early in preclinical development (see “COVID-19 Deals: Manufacturing”).

Figure: COVID-19 deals: manufacturing

The manufacturing component of most of the deals covers production for clinical testing, but some companies are already gearing up for market. For example, on Monday, Johnson & Johnson (NYSE:JNJ) and HHS’ Biomedical Advanced Research and Development Authority (BARDA) announced they were committing $1 billion to fund manufacturing of one billion doses of the pharma’s preclinical COVID-19 vaccine, which is expected to enter the clinic in September (see “J&J to Dramatically Scale Up Vaccine Manufacturing”).

Modality breakdown

Although protein and peptide vaccines represent the most common modality among the vaccine deals, mRNA vaccines come in a close second, even though the modality has yet to reach the market (see “COVID-19 Deals by Vaccine Modality”).

The advantage of mRNA vaccines is that they are faster to develop and manufacture, because they bypass the need for cell-based production systems, which can take over a year to optimize. By encoding viral antigens in nucleic acids, these vaccines enlist the patient’s cells to make the antigenic proteins. Seeing an opportunity for a rapid response platform for pandemics, the U.S. Defense Research Advanced Projects Agency (DARPA) funded early R&D of mRNA companies Moderna Inc. (NASDAQ:MRNA) and CureVac AG at a time when the technology was deemed too risky by others (see “DARPA’s Gambles”).

Figure: COVID-19 deals by vaccine modality

Moderna and CureVac are both now developing mRNA vaccines for COVID-19. On March 16, Moderna’s mRNA-1273 became the first vaccine -- of any modality -- to begin clinical testing for COVID-19. CureVac expects to enter the clinic this summer.

COVID-19 may therefore become the first approved indication for the new modality of vaccines. Moreover, if successful, mRNA vaccines may become the modality of choice for future outbreaks.

Encoding antigens in DNA could have many of the same benefits, although expression in patient cells requires entry to the nucleus. mRNA can be translated in the cytoplasm and doesn’t have to cross two membranes.

At least a dozen partnerships have been formed to create DNA vaccines; five use non-viral vectors and seven use viral vectors for delivery. In five cases the vaccine modality was not disclosed.

Neutralizing mAbs was by far the modality of choice for COVID-19 therapies, representing more than two thirds of the 23 deals that disclosed a modality, dwarfing the numbers for small molecules and other newer modalities.

A benefit of mAbs is that they can both treat symptomatic patients and provide temporary protection against becoming infected. The latter could be especially useful for frontline medical workers at high risk of infection. mAbs also exert their effects quicker than vaccines. (see “COVID-19 Deals by Therapeutic Modality”).

Figure: COVID-19 deals by therapeutic modality

Expanding web of partners and funders

While only five pharmas have announced COVID-19 deals, behind the scenes a group of at least 10 has begun organizing a large-scale response to the pandemic involving clinical phase repurposing, novel small molecule antivirals, novel antibodies, preventive vaccines and preclinical repurposing (see “Pharmas on One Page”).

Broadly, the web of partners continues to expand, both through deals around additional COVID-19 programs and partnerships that bring additional capabilities to existing programs.

Vir Biotechnology Inc. (NASDAQ:VIR), which has the most COVID-19 deals to date, has been leveraging partnerships to accelerate its mAb programs and to access additional modalities.

Vir has tapped both WuXi Biologics Inc. (HKEX:2269) and Biogen Inc. (NASDAQ:BIIB) for mAb manufacturing capacity, and in the case of WuXi, also for co-development expertise. The biotech is also working with NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center to characterize its mAbs and with Xencor Inc. (NASDAQ:XNCR) to increase the mAbs’ half-lives.

In parallel, Vir has partnered with Generation Bio Co. to encode its mAbs in gene therapies, and it has expanded an existing deal with Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) to add siRNAs as a therapeutic option.

Two pharmas with disclosed deals, J&J and Sanofi (Euronext:SAN; NASDAQ:SNY), are each receiving funding from BARDA to develop internal programs.

Eli Lilly and Co. (NYSE:LLY) and Pfizer Inc. (NYSE:PFE) are serving as development partners for biotechs. Lilly partnered with AbCellera Biologics Inc. to develop and commercialize mAbs against COVID-19; Pfizer Inc. (NYSE:PFE) partnered with BioNTech SE (NASDAQ:BNTX) to co-develop mRNA vaccine candidate BNT162.

The fifth pharma, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), is contributing its vaccine adjuvants via a partnership with Coalition for Epidemic Preparedness Innovations (CEPI) (see “GSK to Provide Adjuvant”).

Several developers of COVID-19 countermeasures have yet to announce partnerships. At least 86 vaccines and therapeutics are in preclinical testing for COVID-19, and over 50 approved and investigational agents are being repurposed for the indication (see “COVID-19 Vaccines and Therapies: Preclinical” and “COVID-19 Vaccines and Therapies: Clinical”).

Table: COVID-19 deals Table

Table lists partnerships announced in the first three months of the year to develop, manufacture and commercialize COVID-19 therapeutics, vaccines and diagnostics.

Source: BioCentury's BCIQ database and organization websites

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