UK Supreme Court strikes down Re­gen­eron patents, open­ing door for Kymab

The UK Supreme Court has struck down a pair of Regeneron patents, all but ending a legal dispute between the large US biotech and an upstart British competitor that has raged since 2013.

In a 4-1 ruling, the judges held that the patents Regeneron filed on a technique necessary to make their antibody-producing mice didn’t provide enough information for an expert in the field to reproduce all the inventions covered in the claim. The ruling overturned an appellate court decision that held in favor of Regeneron and against the Cambridge-based Kymab.

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Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months after Seattle Genetics nabbed an accelerated approval for its Astellas-partnered antibody-drug conjugate Padcev, the partners said the therapy has nailed a confirmatory Phase III, proving its worth in locally advanced or metastatic urothelial cancer.

Padcev, which has widely been tapped as a potential blockbuster, scored improvements in both overall survival and progression-free survival compared to chemotherapy, causing a 30% reduction in risk of death (p = 0.001) and 39% reduction in risk of disease progression or death (p<0.00001).

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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#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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Leen Kawas, Athira

Seat­tle-based Athi­ra, aim­ing for tough Alzheimer's and Parkin­son's tar­gets, rais­es $204M for IPO

Following an $85 million Series B round back in June, Athira Pharma is set to become the third biotech in the last three days to go public Friday.

Athira raised $204 million for its IPO after pricing shares at $17 apiece, the high-point of its expected range. Initially pegging $100 million in financing, Athira said it offered 12 million total shares and will trade under the ticker $ATHA.

Now that Athira plans to hit the Nasdaq, there have been more than 50 biotech IPOs this year, more than the total from last year. Combined, the companies have raised more than $11 billion. Over half of those biotechs, including Athira, raised at least $200 million each.

Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado to fo­cus on CSO job at Rain Ther­a­peu­tics

→ A Big Pharma vet has joined Cambridge, MA upstart Vedanta Biosciences to help develop and expand on its microbiome-derived bacteria portfolio.

Jeffrey Silber signed on as CMO of Vedanta after 4 years at EMD Serono as their SVP, global clinical development. Silber worked his way through the ranks at Merck in the late 1990s, eventually becoming their VP and therapeutic area head, vaccine clinical research. And after 16 years at the pharma giant, Silber moved on to AbbVie to be their VP, strategic portfolio development.

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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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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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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