Covid-19 roundup: Temasek leads a $250M raise for BioN­Tech as first Covid-19 mR­NA vac­cine da­ta looms; Chi­na's mil­i­tary OKs first use of coro­n­avirus vac­cine

Singapore’s giant fund run by Temasek is putting some financial muscle behind BioNTech $BNTX as the Pfizer partner prepares to post the first cut of its data on their mRNA vaccine to combat Covid-19.

Temasek is leading a $250 million injection into the German biotech, one of a small pack of mRNA players attempting to field a vaccine to fight the global pandemic that’s been rattling the world. Moderna is in front of the mRNA pack with Phase III plans.

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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Covid-19 roundup: UP­DAT­ED: Amid calls for trans­paren­cy, Mod­er­na re­leas­es full PhI­II pro­to­col; As­traZeneca tri­al halt thought to be 'con­firmed trans­verse myelitis,' per CNN

Prominent scientists, public health experts and industry critics have been calling for more transparency from vaccine makers, including the release of the companies’ Phase III trial protocols. On Thursday, Moderna became the first major developer to do so.

“It is usually not what industry does,” CEO Stéphane Bancel told Endpoints News in an interview in advance of their R&D day today. “But given the need there is for the scientific community and the medical community and the media to understand how the vaccine is being developed, to make sure people are confident in the safety of the process, in the governance with scientific independence in the medical world and the like, we’re dropping tomorrow the full protocol. It is unredacted.”

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Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

UP­DAT­ED: A mi­cro-cap with a po­ten­tial­ly promis­ing coro­n­avirus drug en­lists mask-skep­tic con­gress­man for DSMB

A small biotech that has talked up a potentially promising but unproven treatment for Covid-19 enlisted an unusual member for its study’s Data and Safety Monitoring Board: a sitting Republican congressman with close ties to the CEO and a history of mask skepticism.

NeuroRx, an Israeli biotech testing a lung inflammation drug in Covid-19 patients, tapped Maryland Rep. Andy Harris for the DSMB, Politico reported. Harris is an anesthesiologist but not a biostatistician, and he has questioned the CDC about a “cult of masks” in the US. Harris has known NeuroRx CEO Jonathan Javitt since the two worked at Johns Hopkins together over 20 years ago.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Covid-19 roundup: AlloVir snags IND ap­proval for po­ten­tial T cell ther­a­py; Sanofi and GSK strike 300 mil­lion-dose deal with the EU 

After snagging IND approval for its off-the-shelf virus-specific T cell Covid-19 therapy, AlloVir is now racing toward a proof-of-concept study.

The candidate, ALVR109,  is designed to halt the progression of Covid-19 by destroying SARS-CoV-2-infected cells.

In March, AlloVir expanded its partnership with the Baylor College of Medicine to develop treatments that restore T-cell immunity in immune-compromised patients. In addition to Covid-19, the program pursues SARS classic, MERS and four other coronaviruses.

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Roche says a sec­ond tri­al of Actem­ra re­vives hopes for IL-6. What now?

Roche’s Actemra — and the IL-6 drug class by extension — may have a role in the fight against Covid-19 after all.

Data from a new Phase III study showed that adding the drug to standard of care could reduce hospitalized patients’ likelihood of needing mechanism ventilation, the Swiss pharma giant reported. Importantly, the majority of the 389 enrolled patients are from minority racial and ethnic groups who are often underrepresented in clinical trials but bear the brunt of the pandemic.

Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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