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Tuesday, June 23, 2020

Sanofi’s third Translate collaboration sees big bucks at last

The deal-hungry French big pharma gives Translate’s mRNA vaccine technology a massive boost.
When in March a Covid-19 vaccine deal between Sanofi and Translate Bio included no up-front fee some eyebrows were raised. Doubts over Sanofi’s commitment were surely blown away today when a broad new transaction between the companies saw the senior partner hand across $300m on signing, plus $125m for a 7% equity stake in Translate.
Today’s tie-up has a broad focus on developing mRNA vaccines for infectious diseases, including Covid-19 and beyond. The deal effectively formalises and updates the first collaboration between the companies, struck back in 2018, before Translate was a Nasdaq-listed entity.
That 2018 deal had an initial three-year term, and included $45m up front, with a focus on mRNA vaccines for up to five undisclosed infectious disease pathogens. The March pact added one year to the timeline and Covid-19 to the focus; a lead vaccine is to enter human trials in the fourth quarter.
Closer ties
Now Sanofi has seen enough to focus those earlier efforts in a transaction that ties it closer still to its partner.
However, little has been disclosed about the assets involved. In addition to the Covid-19 vaccine Sanofi singled out work on an influenza candidate now in preclinical trials, saying this should enter the clinic in mid-2021. Other mRNA vaccines in the works target “another viral pathogen and a bacterial pathogen”.
At close of play yesterday Translate was trading a modest 25% above its mid-2018 IPO price. With the equity stake Sanofi is buying priced at a 50% premium the stock this morning surged 54%, giving Translate a $1.6bn market cap.
Some might ask why, if Translation’s approach is so promising, Sanofi has not simply bought out its partner.
Coronavirus
While the new deal clearly has a broad, largely undisclosed focus, investor attention will no doubt continue to fall on efforts to tackle the new coronavirus.
A clinical trial for a Covid-19 vaccine might not be starting until late this year, but the project is being fast-tracked for a possible launch in the second half of 2021, assuming positive data, Sanofi said today. The group also highlighted Translate’s established mRNA manufacturing, which could have capacity to supply 90-360 million doses a year.
Various technology approaches are being taken to develop a coronavirus vaccine, but mRNA “is considered among the most promising”, Sanofi said. One of its advantages is that it can be manufactured more easily than traditional egg-based vaccines, though of course no mRNA vaccine has yet reached the market.
Sanofi and Translate have been working together for years, but they will find themselves behind Moderna, whose Covid-19 mRNA vaccine mRNA-1273 has brought huge amounts of funding and already yielded anecdotal snippets of clinical data (Moderna reminds the markets of biotech’s dual purpose, May 19, 2020).
Other companies developing mRNA vaccines against Covid-19 include: Biontech/Pfizer, whose four vaccines coded BNT162 have entered a volunteer study; Arcturus; and Curevac, in which the German government recently bought a 23% stake.
Sanofi today claimed that through Translate it had the only large-scale mRNA manufacturing capacity. Perhaps in time this will allow it to catch up to the sector’s leaders.
https://www.evaluate.com/vantage/articles/news/deals/sanofis-third-translate-collaboration-sees-big-bucks-last

NanoViricides working on COVID-19 drug, eyes government backing if data positive

NanoViricides (NYSEMKT:NNVC) has reported ~$6.44M of current assets and current cash liabilities of ~$1.14M.
The net cash used in operating activities during the nine months period was ~$5.11M. The Company’s expenditures were in line with budget estimates.
NNVC had previously raised capital from public and direct offering.
With these cash inflows, the Company believes it has sufficient funding for its planned expenditures.
NanoViricides is working on developing a therapeutic drug for the treatment of COVID-19.
If the COVID-19 drug program produces positive results, the Company anticipates obtaining assistance from US government and international agencies for further testing and potential exploratory clinical use.
NNVC continues to advance its first drug candidate, namely NV-HHV-101 skin cream, for the treatment of shingles rash as its first indication, towards human clinical trials.
The Company is in the process of identifying and selecting appropriate partners and collaborators for the intended Phase1/2a human clinical studies for this drug candidate.
https://seekingalpha.com/news/3585268-nanoviricides-working-on-covidminus-19-drug-will-seek-government-backing-data-positive

Bayer said near glyphosate settlement worth up to $10B

Bayer (OTCPK:BAYRY) +5.5% in Frankfurt after Germany’s Handelsblatt reports the company is close to reaching a settlement worth $8B-$10B with plaintiffs in the dispute over its glyphosate-based weedkiller.
Bayer’s supervisory board is due to discuss and vote on the settlement in the coming days, according to the report, which also says all plaintiff attorneys representing Roundup cases appear to have signed onto the deal.
Last month, Bayer reportedly reached verbal agreements to resolve many of the ~125K U.S. lawsuits over Roundup but supervisory board approval was still needed.
https://seekingalpha.com/news/3585278-bayer-near-glyphosate-settlement-worth-up-to-10b-report

Schrödinger expands COVID-19 drug discovery efforts

Physics-based software platform developer Schrödinger (NASDAQ:SDGR) announces a “significant” expansion of its work to discover novel antivirals for COVID-19 under its partnership with a philanthropic global initiative. The accelerated pace, evaluating “billions” of molecules each week, is supported by Google Cloud.
It is leading the computational design work in an alliance with major biopharma firms, including Takeda (NYSE:TAK), Novartis (NYSE:NVS), Gilead Sciences (NASDAQ:GILD) and WuXi AppTec (OTCPK:WUXIF).
Thus far, it has evaluated four protein targets and has used Google Cloud to support ultra-large virtual screens for two.
Alliance partners will be responsible for acquiring and testing the most promising candidates and advancing them to lead optimization with Schrödinger’s assistance.
On another note, the company will partner with Thermo Fisher Scientific (NYSE:TMO) on extending the use of the latter’s cryo-EM technology to a wider range of targets that may not be amenable to structure prediction via x-ray crystallography. Financial terms are not disclosed.
https://seekingalpha.com/news/3585291-schrodinger-expands-covidminus-19-drug-discovery-efforts

Kitov Pharma up on collaboration with Bristol Myers in lung cancer

Kitov Pharma (NASDAQ:KTOV) is up premarket on the heels of providing updates on clinical progress of CM-24 and NT-219.
The company will collaborate with Bristol-Myers Squibb (NYSE:BMY) on a Phase 1 study of CM-24 in combination with BMY’s Opdivo (nivolumab) for non-small-cell lung carcinoma and pancreatic cancer. The study is expected to begin in Q4 with data expected in H1 2021.
The FDA has signed off on its IND for NT-219, as monotherapy or in combination with Erbitux, for the treatment of recurrent or metastatic solid tumors and head and neck cancer. Phase 1 data are expected in H1 2021.
Multiple data readouts are expected within 15 months.
https://seekingalpha.com/news/3585299-kitov-pharmaplus-49-on-collaboration-bristol-myers-in-lung-cancer

FDA to review AbbVie application to update Imbruvica labeling

The FDA has agreed to review a supplemental marketing application from AbbVie (NYSE:ABBV) related to the use of Imbruvica (ibrutinib) and Roche’s (OTCQX:RHHBY) Rituxan (rituximab) to treat Waldenström’s macroglobulinemia, a rare and incurable type of non-Hodgkin lymphoma (NHL).
The filing seeks to update Imbruvica’s U.S. prescribing information based on an analysis of more than five years of data from the Phase 3 INNOVATE study.
Related ticker: Johnson & Johnson (NYSE:JNJ)
https://seekingalpha.com/news/3585322-fda-to-review-abbvie-application-to-update-imbruvica-labeling

Dosing underway in Oncolytics Bio combo study in breast cancer

Oncolytics Biotech (NASDAQ:ONCY) doses first patient in its phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC).
The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA (OTCPK:MKGAY) and Pfizer (NYSE:PFE).
Participants will receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck and Pfizer’s anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio). The BRACELET-1 study will enroll 45 patients randomized into three cohorts.
The primary endpoint is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.
https://seekingalpha.com/news/3585332-dosing-underway-in-oncolytics-bio-combo-study-in-breast-cancer