CEO Carmine Stengone (Pipeline Therapeutics)

Ver­sant spin­out lands $80M to go 'much broad­er' than the old Roche part­ner­ship that birthed it

About three years af­ter split­ting from Ver­sant Ven­tures’ dis­cov­ery group, Pipeline Ther­a­peu­tics has land­ed an $80 mil­lion Se­ries C round to go “much broad­er” than the Roche-part­nered pro­gram that birthed it.

Daniel Lor­rain

Ver­sant an­nounced Pipeline’s launch in 2018, four years af­ter Roche agreed to pay the re­search tab at Ver­sant’s In­cep­tion Sci­ences for re­myeli­na­tion work in mul­ti­ple scle­ro­sis. Re­myeli­na­tion in­volves a re­pair to the nerve dam­age that caus­es MS. Roche took over one of the pro­grams, called In­cep­tion 5, and the team that helped de­vel­op it was spun out in­to Pipeline, in­clud­ing cur­rent CSO Daniel Lor­rain.

“When that was done, the as­pi­ra­tions for Pipeline were broad­er than that,” CEO Carmine Sten­gone said of Roche’s In­cep­tion 5 ac­qui­si­tion. “The frame­work was around re­myeli­na­tion to start, but the vi­sion for the com­pa­ny was much broad­er.”

Pipeline is con­tin­u­ing the re­myeli­na­tion work in MS, but al­so ex­pand­ing in­to ax­on­al re­pair and synap­to­ge­n­e­sis. Their lead can­di­date, PIPE-505, fo­cus­es on the lat­ter.

PIPE-505 is cur­rent­ly en­rolling pa­tients in a Phase I/IIa study for sen­sorineur­al hear­ing loss, which af­fects up­wards of 40 to 45 mil­lion peo­ple in the US, ac­cord­ing to Sten­gone. The neu­rode­gen­er­a­tive con­di­tion is char­ac­ter­ized by two main hear­ing prob­lems, the first of which is out­er hair cell de­gen­er­a­tion.

As you lose out­er hair cells, you lose vol­ume con­trol, mean­ing every­thing’s qui­eter, Sten­gone said. There’s less speech clar­i­ty and less am­pli­fi­ca­tion. But in Sten­gone’s opin­ion, that’s not where the most un­met need is. The biggest com­plaint pa­tients have is that they can’t hear when there’s back­ground noise. And to ad­dress that, one must look to the cochlear synapse.

The cochlear synapse con­nects the au­di­to­ry nerve fibers to the in­ner hair cells, and over time — ei­ther due to age or pro­longed noise ex­po­sure — there’s a re­trac­tion of that synapse, Sten­gone ex­plained.

“What we’re do­ing with PIPE-505 is re-en­gag­ing guid­ance cues that al­low for that synapse to reach out that 500 mi­crons to ful­ly form that cir­cuit. And once you re­store the cochlear synapse, you should have an im­prove­ment in speech and noise pro­cess­ing,” the CEO said.

There are cur­rent­ly no drugs ap­proved for SNHL, mean­ing pa­tients are lim­it­ed to hear­ing aids and cochlear im­plants, which don’t quite ad­dress the un­der­pin­nings of hear­ing loss. The bur­geon­ing field in­cludes Fre­quen­cy Ther­a­peu­tics, which read out longer-term dura­bil­i­ty da­ta to back its SNHL can­di­date, which us­es prog­en­i­tor cells, in Sep­tem­ber. The new da­ta build on Phase I/II re­sults re­leased in 2019. Then there’s Ak­ou­os, which scored a $105 mil­lion Se­ries B a year ago to take its lead SNHL can­di­date to the clin­ic. And Deci­bel Ther­a­peu­tics, an­oth­er Boston-based com­pa­ny, has an SNHL pro­gram in the dis­cov­ery phase.

Pipeline’s sec­ond can­di­date, a re­myeli­na­tion pro­gram for MS dubbed PIPE-307, re­cent­ly en­tered Phase I. They’ve al­so got an LPA1 re­cep­tor an­tag­o­nist pro­gram for re­myeli­na­tion and neu­roin­flam­ma­tion, for which they’re look­ing to nom­i­nate a de­vel­op­ment can­di­date in mid-2021.

In ad­di­tion to ad­vanc­ing the pipeline, Sten­gone plans on us­ing Se­ries C funds to bulk up Pipeline’s staff. The 22-per­son com­pa­ny is look­ing at four new hires in the near term, he said.

As for the pos­si­bil­i­ty of go­ing pub­lic in the near fu­ture, Sten­gone said, “We’ll con­sid­er all fi­nanc­ing op­tions go­ing for­ward, but noth­ing that we would lock our­selves down to at this point.”

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Ali Madani, Profluent founder and CEO

Proflu­ent de­buts to de­sign pro­teins with ma­chine learn­ing in bid to move past 'AI sprin­kled on top'

While OpenAI’s Microsoft-allied ChatGPT takes the world by storm, a fledgling startup in Berkeley, CA is debuting to take a similar language-learning model approach, but with the goal of designing new proteins.

Profluent, founded by a former Salesforce AI research leader, has secured $9 million to kick-start its work, with proceeds going toward building out an integrated wet lab and recruiting machine learning scientists and biologists. Insight Partners led the seed round. The investor base also includes Air Street Capital, AIX Ventures and Phoenix Venture Partners.

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In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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#JPM23: What's re­al­ly dri­ving the cost of health­care and drugs in 2023?

Executive Editor Drew Armstrong spoke with PhRMA CEO Steve Ubl, EmsanaRx CEO Greg Baker and ICER President Steve Pearson about how the debate over drug costs has changed (or not) in the last decade, the shifting payer landscape and why there seems to be so little movement on drug rebates. This transcript has been edited for brevity and clarity.

Drew Armstrong:

So first of all, thank you to everybody for being here and for our panel for being here. Incredibly excited to have this discussion on the cost of healthcare and drugs and what’s driving that. We’re here with Steve Ubl, the head of PhRMA. Thank you so much. Steve Pearson from ICER, and Greg Baker from EmsanaRx. I want to start this conversation with a little bit of a personal reminiscence. So about almost 10 years exactly. I was a reporter back in my previous job and I was covering drug pricing and Gilead had just launched their hepatitis C drug and I was having a conversation with another Steve over at Express Scripts and he made some comments essentially about how they intended to launch a price war over hepatitis C therapies.

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Peter Joyce, Grey Wolf Therapeutics co-founder and CEO

Grey Wolf reels in $49M to en­ter the clin­ic for new im­munother­a­py tar­get

When he finds the time to go fly fishing, Peter Joyce says gray wulffs, or mayfly mimics, are his good luck charm — he always catches a fish when he uses them. Joyce has now brought in $49 million in a Series B round for his biotech company Grey Wolf Therapeutics.

The Oxford, UK cancer biotech plans to use the funds to bring its first asset into human trials in the coming month or two, according to Joyce. Pfizer Ventures and Earlybird Venture Capital co-led the round, which the startup disclosed Thursday.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.