Jim Mel­lon's Ju­ve­nes­cence takes a chance on tiny up­start run by for­mer Pfiz­er ex­ec

When Mar­garet Jack­son was do­ing some con­sult­ing work for Ju­ve­nes­cence CEO Greg Bai­ley last year, she did not an­tic­i­pate the an­ti-ag­ing biotech ven­ture would even­tu­al­ly in­vest in her new­ly in­cor­po­rat­ed pre­clin­i­cal meta­bol­ic dis­ease biotech BY­OMass.

The com­pa­ny, run by Jack­son who is the on­ly full-time em­ploy­ee, has been in stealth mode — it is so ear­ly stage, it doesn’t even have a web­site yet.

Ju­ve­nes­cence on Wednes­day said it had pledged up to $6.5 mil­lion in eq­ui­ty fi­nanc­ing in BY­OMass and will col­lab­o­rate with the com­pa­ny to de­vel­op ther­a­peu­tics de­signed to mod­u­late me­tab­o­lism as­so­ci­at­ed with ag­ing and age-re­lat­ed chron­ic ill­ness­es.

Mar­garet Jack­son

With­in the field of meta­bol­ic dis­eases, drug­mak­ers gen­er­al­ly tend to tar­get tis­sues like the liv­er, the mus­cle, the fat and the pan­creas, Jack­son said in an in­ter­view with End­points News.

“My group is go­ing to be fo­cus­ing on the brain and how it con­trols me­tab­o­lism, more specif­i­cal­ly how the hy­po­thal­a­mus and the brain stem per­form…to help main­tain food in­take, body weight and blood pres­sure.”

Ju­ve­nes­cence’s cap­i­tal in­jec­tion will help take the three pro­grams she is cur­rent­ly work­ing on clos­er to the clin­i­cal can­di­date nom­i­na­tion stage, she said. “I ex­pect to do an­i­mal test­ing by the end of this year.”

For now, BY­OMass is a one woman show, as­sist­ed by a large co­hort of ex­pe­ri­enced con­sul­tants. The goal is to build a team as the pro­grams ad­vance.

Mean­while, Jack­son has joined the Ju­ve­nes­cence team as VP, head of pre­clin­i­cal R&D. She has led mul­ti­ple teams and drug dis­cov­ery ef­forts in her 20-year ca­reer — the bulk of which was spent at Pfiz­er.

Two months ago, Ju­ve­nes­cence said it had raised $46 mil­lion to in­vest in the sci­ence of an­ti-ag­ing, as part of a promised $100 mil­lion raise. The 15-mem­ber team works with re­searchers far and wide, in­vest­ing in their col­lab­o­ra­tors and set­ting up JVs with AI groups, such as Alex Zha­voronkov’s AI shop at In­sil­i­co Med­i­cine — while gain­ing con­trol­ling in­ter­ests in firms in­clud­ing AgeX and Ly­Ge­n­e­sis. Last month, Ju­ve­nes­cence de­buted an an­ti-ag­ing joint ven­ture with the Buck In­sti­tute ded­i­cat­ed to in­duc­ing ke­to­sis.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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