FDA sends No­vaVax back to the clin­ic; Stoke Ther­a­peu­tics sets terms for up­sized $101M IPO

→ A be­lea­guered No­vaVax has run in­to a ma­jor hur­dle on its RSV vac­cine’s quest to mar­ket. The FDA is ask­ing the com­pa­ny to con­duct a whole new Phase III tri­al to con­firm that ResVax can pro­tect in­fants from “med­ical­ly sig­nif­i­cant RSV dis­ease” if their moth­ers were vac­ci­nat­ed. While it’s sort­ing out the sit­u­a­tion in the US and Eu­rope, No­vaVax said it will con­tin­ue work­ing with its back­ers at the Bill & Melin­da Gates Foun­da­tion to in­tro­duce the vac­cine in low to mid­dle in­come coun­tries.

Cal­lid­i­tas Ther­a­peu­tics and Ever­est Med­i­cines have en­tered in­to a li­cense agree­ment to de­vel­op and com­mer­cial­ize Cal­lid­i­tas’ lead drug can­di­date, Ne­fe­con — which is cur­rent­ly be­ing run in a glob­al Phase III clin­i­cal tri­al for pa­tients with chron­ic au­toim­mune kid­ney dis­ease IgA Nephropa­thy (IgAN) — in Greater Chi­na and Sin­ga­pore. Swe­den-based Cal­lid­i­tas will re­ceive an up­front pay­ment of $15 mil­lion with po­ten­tial mile­stones up to $106 mil­lion.

Di­a­some Phar­ma­ceu­ti­cals, which is de­vel­op­ing He­pa­to­cyte Di­rect­ed Vesi­cle (HDV) tech­nol­o­gy that is de­signed to be mixed with any com­mer­cial­ly avail­able in­sulin to lessen the in­stances of blood glu­cose highs and lows in pa­tients liv­ing with di­a­betes, on Mon­day post­ed a snap­shot of da­ta from a six-month mid-stage study test­ing the drug, HDV-L, at the Amer­i­can Di­a­betes As­so­ci­a­tion meet­ing.

“In pa­tients with high­er base­line HbA1C, HDV-L led to a HbA1C re­duc­tion equiv­a­lent to con­ven­tion­al Lispro treat­ment, but these HDV-L treat­ed sub­jects re­duced their meal­time in­sulin dose by 25% and ex­pe­ri­enced a trend to­wards a 73% re­duc­tion in time spent in hy­po­glycemia. Pa­tients with low­er base­line HbA1C lev­els did not change their bo­lus meal­time in­sulin dos­es and spent in­creased time in hy­po­glycemia. These re­sults are con­sis­tent with the core hy­poth­e­sis that im­proved liv­er glu­cose stor­age at meal­time should re­duce both pe­riph­er­al glu­cose ex­po­sure and pe­riph­er­al in­sulin re­quire­ments,” said David Klonoff, the prin­ci­pal in­ves­ti­ga­tor of the study, in a state­ment.

→ Pre­clin­i­cal biotech Stoke Ther­a­peu­tics has bro­ken out the terms of its IPO. The Bed­ford, Mass­a­chu­setts-based com­pa­ny plans to of­fer 6.7 mil­lion shares in the price range of $14 to $16 to raise $101 mil­lion, it said in a fil­ing Fri­day. The com­pa­ny plans to list un­der the sym­bol $STOK. 

→ The genome se­quenc­ing ex­perts at Per­son­alis have al­so an­nounced an IPO. The com­pa­ny plans to of­fer 6.7 mil­lion shares in the price range of $14 to $16 to raise $100 mil­lion, it said in a fil­ing Fri­day and will trade as $PSNL. 

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.