Vipin Garg, Altimmune CEO

Al­tim­mune aban­dons ship on in­tranasal Covid-19 vac­cine, re­fo­cus­ing on liv­er, obe­si­ty pro­grams af­ter tri­al flop

Among the al­so-rans in the Covid-19 vac­cine race, small biotech Al­tim­mune hoped to ride a nov­el in­tranasal for­mu­la­tion for its own can­di­date to mar­ket but ran in­to an FDA clin­i­cal hold along the way. Now, af­ter the vac­cine turned out a dud in an ear­ly-stage test, Al­tim­mune is bail­ing out and re­fo­cus­ing around its oth­er pro­grams.

Al­tim­mune’s sin­gle-dose vac­cine, dubbed Ad­COVID, didn’t spur an ad­e­quate im­mune re­sponse in a Phase I test in 80 healthy vol­un­teers, the biotech said Tues­day. Mean­while, the vac­cine was well tol­er­at­ed, but the lack of re­sults was good enough for Al­tim­mune to walk away.

Al­tim­mune CEO Vipin Garg called the re­sults “dis­ap­point­ing” in a state­ment, par­tic­u­lar­ly af­ter the biotech thought it saw promise in pre­clin­i­cal stud­ies. Shares of the biotech $ALT were trad­ing down near­ly 33% af­ter the bell at around $10.

Al­so on Tues­day, Al­tim­mune re­vealed it would hit the pause but­ton on its less­er-known im­munomod­u­la­to­ry can­di­date for Covid-19, dubbed T-COVID, af­ter run­ning in­to dif­fi­cul­ty en­rolling high-risk Covid-19 pa­tients above the age of 65. The com­pa­ny at­trib­uted that chal­lenge to the suc­cess­ful roll­out of Covid-19 vac­cines in the US and said they would end de­vel­op­ment in the high-risk co­hort while feel­ing out a po­ten­tial path in low-risk pa­tients.

Ad­COVID’s road to the clin­ic was de­layed back in De­cem­ber af­ter the FDA put a halt on the com­pa­ny’s IND ap­pli­ca­tion af­ter cit­ing is­sues with the vac­cine’s tri­al pro­to­col and CMC is­sues. Af­ter agree­ing to the FDA’s de­mands, Al­tim­mune opened en­roll­ment in Phase I in Feb­ru­ary, giv­ing pa­tients ei­ther one or two dos­es of the vac­cine at three sep­a­rate dose lev­els.

The biotech said its vac­cine did spur some an­ti­body re­sponse but not enough to keep pace with the vac­cines al­ready ap­proved for emer­gency use.

Mean­while, Al­tim­mune said it plans to piv­ot fo­cus back to ALT-801, a can­di­date for obe­si­ty, and Hep­T­cell, a pep­tide-based ther­a­py for obe­si­ty and liv­er dis­eases.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Nader Pourhassan, CytoDyn CEO (Photo by Jeff Kravitz/FilmMagic for CytoDyn’s Pro)

Cy­to­Dyn faces DOJ, SEC sub­poe­nas af­ter pro­mot­ing failed Covid-19 drug

The little, PR-happy drug company publicly called out by the FDA is now getting attention from both the SEC and the Department of Justice.

CytoDyn, a one-time penny stock that has gained both money and notoriety for aggressively pushing an old HIV drug as a treatment for Covid-19, disclosed in a regulatory filing Friday the SEC and DOJ have separately subpoenaed the company and “certain of its executives” as part of investigations into the company’s promotion and marketing practices.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Lan Huang, BeyondSpring CEO

Shares of Be­yond­Spring sky­rock­et on new, pos­i­tive can­cer drug tri­al re­sults

Sometimes results come along that shock even a biotech’s believers.

On Wednesday, BeyondSpring, a small New York biotech with an offbeat approach to immunotherapy, announced its lead drug significantly extended non-small cell lung cancer patients’ lives in a large trial. Although the company did not release the exact survival data, it said that nearly twice as many patients were alive after two years on the drug arm than on the standard-of-care arm.

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Pfiz­er puts the pres­sure on Eli Lil­ly's JAK in­hibitor Olu­mi­ant with new da­ta in alope­cia area­ta

As Eli Lilly looks to secure a win for its blockbuster Olumiant in alopecia areata, going where no JAK inhibitor has gone before, Pfizer is coming up from behind with Phase IIb/III results suggesting its own candidate can help regrow hair lost due to the autoimmune disease.

On Wednesday, Pfizer unveiled topline results from the ALLEGRO trial, which enrolled 718 patients 12 years and older with alopecia areata, a condition that can cause sudden, severe and patchy hair loss. While the patients’ episodes of alopecia areata varied in length, they all had one thing in common: They had lost at least half the hair on their scalps.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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