PPD, Schrödinger, Beam set terms for IPO; FDA ex­pands use of Mer­ck­'s Di­fi­cid

→ With slow­er rates of pa­tient en­roll­ment than ex­pect­ed for their Phase III tri­al of its PARP in­hibitor pami­parib vs place­bo — as a ther­a­py in pa­tients with in­op­er­a­ble lo­cal­ly ad­vanced or metasta­t­ic gas­tric can­cer who have re­spond­ed to plat­inum-based first line chemother­a­py — BeiGene is con­vert­ing the tri­al to a Phase II. Pa­tient en­roll­ment be­gan in Ju­ly 2018 and the com­pa­ny has thus far reg­is­tered ap­prox­i­mate­ly 120 pa­tients glob­al­ly.

→ More than 8 years ago in a $3.9 bil­lion deal, PPD was tak­en pri­vate, but now the com­pa­ny has launched its IPO by of­fer­ing 60 mil­lion shares of its com­mon stock. The ex­pect­ed price per share is be­tween $24 and $27. The com­pa­ny plans to list un­der the sym­bol $PPD.

The of­fer­ing is be­ing made through an un­der­writ­ing group led by bookrun­ning man­agers: Bar­clays, JP Mor­gan, Mor­gan Stan­ley and Gold­man Sachs. Bo­fA Se­cu­ri­ties, Cred­it Su­isse, Jef­feries, UBS In­vest­ment Bank, Cit­i­group, Deutsche Bank Se­cu­ri­ties, Ever­core ISI, HS­BC and Mizuho Se­cu­ri­ties are act­ing as joint bookrun­ning man­agers. Baird, William Blair and Drex­el Hamil­ton are act­ing as co-man­agers.

→ Drug dis­cov­ery soft­ware play­er Schrödinger has set the terms for its IPO. The New York-based com­pa­ny is of­fer­ing 10 mil­lion shares at $14 to $16 each — which would see it raise about $160 mil­lion at the top of that range. Mor­gan Stan­ley, Bo­fA Se­cu­ri­ties, Jef­feries and BMO Cap­i­tal Mar­kets are un­der­writ­ing the deal. It plans to list un­der the sym­bol $SG­DR.

→ Fol­low­ing a four-month wait, the gene edit­ing ex­perts at Beam Ther­a­peu­tics fi­nal­ly have the terms for their $100 mil­lion IPO: 6.3 mil­lion shares at a price range of $15 to $17. At the mid­point of that range, the start­up — found­ed by pi­o­neers Feng Zhang, David Liu and Kei­th Joung — would com­mand a ful­ly di­lut­ed mar­ket val­ue of $686 mil­lion, ac­cord­ing to Re­nais­sance Cap­i­tal.

Eli Lil­ly‘s JAK in­hibitor Olu­mi­ant, whose ad­dress­able pa­tient pop­u­la­tion has been nixed by safe­ty con­cerns, helped pa­tients in an atopic der­mati­tis late-stage study, the com­pa­ny re­port­ed on Mon­day. Ini­tial­ly re­ject­ed by the US agency for use in rheuma­toid arthri­tis due to da­ta that showed a clear cor­re­la­tion with throm­bot­ic events or platelet in­creas­es — the drug was even­tu­al­ly giv­en the green light for the low­er dose. Lil­ly’s part­ner, In­cyte, in 2019 elect­ed to walk away from co-fund­ing the drug’s de­vel­op­ment as fears about the ben­e­fit-risk pro­file of the class of drugs ac­cu­mu­lat­ed. “Olu­mi­ant has lim­it­ed po­ten­tial in mod­er­ate-to-se­vere atopic der­mati­tis, giv­en the suc­cess of Re­gen­eron/ Sanofi’s Dupix­ent (which we view as much safer), and the po­ten­tial for oth­er nov­el se­lec­tive JAK in­hibitors (e.g., Pfiz­er’s abroc­i­tinib) which may have a bet­ter risk/ ben­e­fit pro­file,” Cred­it Su­isse an­a­lysts wrote in a note.

→ Near­ly a decade af­ter scor­ing ap­proval for Di­fi­cid to treat C. diff-as­so­ci­at­ed di­ar­rhea in adult pa­tients — Mer­ck, one of the few re­main­ing big phar­ma play­ers to linger in the be­lea­guered field of an­tibi­otics, has con­vinced the FDA to ex­pand the use of the drug in chil­dren aged six months and old­er.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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