BerGen­Bio nar­rows R&D to fo­cus on NSCLC and Covid-19; Oral SERDs see an­oth­er set­back as G1 drops pro­gram

BerGen­Bio said it will pri­or­i­tize its pipeline to fo­cus on first-line non-small cell lung can­cer and Covid-19 with its lead drug be­m­cen­tinib. That means work in acute myeloid leukemia, MDS and ovar­i­an can­cer has been put on pause.

The com­pa­ny said the nar­rowed R&D work pro­vides the “op­ti­mal path to­wards trans­lat­ing BerGen­Bio’s strong sci­en­tif­ic foun­da­tion” and the shift comes a month af­ter the biotech named for­mer IQVIA VP of on­col­o­gy Cristi­na Oli­va as its CMO.

“As a small biotech com­pa­ny, there’s on­ly so much we can ef­fi­cient­ly do at the same time,” CEO Mar­tin Olin said on an in­vestor call.

Be­m­cen­tinib has FDA fast track des­ig­na­tion in the first-line NSCLC in­di­ca­tion and the com­pa­ny thinks there’s “po­ten­tial for an ac­cel­er­at­ed ap­proval path­way in this in­di­ca­tion,” Olin said on the Wednes­day morn­ing call.

In Covid-19, the drug met the pri­ma­ry goal in a Phase II study when com­bined with stan­dard of care, in­clud­ing Gilead’s remde­sivir, the com­pa­ny said last month. The drug is be­ing added to a pan-Eu­ro­pean plat­form Covid-19 study, as well, dubbed EU-Sol­i­dAct.

“We were al­so able to pre­vent pa­tients to progress to non in­va­sive ven­ti­la­tion or high flow nasal oxy­gen and we were able to dis­charge the pa­tients much soon­er from the hos­pi­tal than stan­dard of care,” Olin said of the tri­al, which took place in In­dia and South Africa.

“If we are able to re­peat the da­ta, we be­lieve that it could be an op­por­tu­ni­ty to have an ex­pe­dit­ed reg­u­la­to­ry process with the agen­cies for a po­ten­tial ap­proval,” Olin said, re­fer­ring to emer­gency use nods.

Olin said the com­pa­ny is scal­ing up man­u­fac­tur­ing ca­pa­bil­i­ties to “hope­ful­ly al­low us to en­gage in a dis­cus­sion with the au­thor­i­ties about a po­ten­tial launch post-Phase IIb study, if suc­cess­ful.” BerGen­Bio is in part­ner­ship dis­cus­sions on its as­sets, Olin said. — Kyle LaHu­cik

G1 Ther­a­peu­tics drops an oral SERD pro­gram

G1 Ther­a­peu­tics is say­ing farewell to a pipeline pro­gram.

Re­searchers will dis­con­tin­ue de­vel­op­ment for its ex­per­i­men­tal oral SERD drug rin­tode­strant, the North Car­oli­na biotech an­nounced in Wednes­day’s first-quar­ter earn­ings re­port. G1 de­cid­ed to end the pro­gram af­ter re­view­ing part­ner­ship op­tions and re­cent da­ta. The in­tel­lec­tu­al prop­er­ty will be re­turned to the Uni­ver­si­ty of Illi­nois-Chica­go.

Ac­cord­ing to the com­pa­ny, the oral SERD space proved “high­ly com­pet­i­tive,” sug­gest­ing there weren’t any part­ners who want­ed to take on the chal­lenge.

It’s been a tough time for oral SERDs re­cent­ly fol­low­ing big set­backs from Roche and Sanofi. Two weeks ago, Roche in­ves­ti­ga­tors flagged a fail­ure on the pri­ma­ry end­point for progress-free sur­vival among ER-pos­i­tive, HER2-neg­a­tive pa­tients in a Phase II study. And in March, a top Sanofi prospect flunked a ma­jor test in breast can­cer. — Max Gel­man

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Pfiz­er and Sang­amo re-open PhI­II of he­mo­phil­ia A gene ther­a­py; AEON head­ed to PhI­II

A year after voluntarily pausing the Phase III study of their hemophilia A gene therapy program, and four months after FDA lifted the clinical hold, Pfizer and Sangamo Therapeutics say they will resume dosing next month.

The move pushes back the original data readout by two years. At the time of the first patient dosing in October 2020, a Pfizer spokesperson had told Endpoints News that a pivotal readout would come in early 2022. Following the hurdles caused by the clinical hold, Pfizer said Friday morning the new anticipated timeline is the first half of 2024.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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