Fo­cus­ing on next-gen can­cer drugs, GSK touts a ‘break­through’ at FDA; Ais­ling rais­es $280M fund

Ax­el Hoos

→ Any­one look­ing for fresh signs of Glax­o­SmithK­line’s plans to go much deep­er in­to on­col­o­gy should check out the phar­ma gi­ant’s no­tice that its mul­ti­ple myelo­ma drug GSK2857916 just won the FDA’s break­through des­ig­na­tion. GSK’s Ax­el Hoos, who’s been run­ning the ear­ly-stage on­col­o­gy ef­fort af­ter the big as­set swap with No­var­tis, said this drug could be a trans­for­ma­tion­al ther­a­py.  “On­col­o­gy R&D at GSK is fo­cused on de­vel­op­ing med­i­cines with trans­for­ma­tion­al po­ten­tial for pa­tients and we are pleased that our in­ves­ti­ga­tion­al an­ti­body-drug con­ju­gate is the first BC­MA tar­get­ing agent to re­ceive Break­through Ther­a­py and PRIME des­ig­na­tion,” he not­ed. “GSK plans to rapid­ly ad­vance clin­i­cal tri­als with this promis­ing ther­a­py, alone and in com­bi­na­tion with oth­er ther­a­pies, to fur­ther in­ves­ti­gate how GSK2857916 could ben­e­fit pa­tients with mul­ti­ple myelo­ma.”

→ Less than 2 months af­ter help­ing Bridge­Bio raise $135 mil­lion to build a port­fo­lio of drug de­vel­op­ers, 17-year-old Ais­ling Cap­i­tal has rolled out a rel­a­tive­ly mod­est $280 mil­lion biotech fund, the lat­est in a string of ven­ture funds to de­but this year. They’re a pure-play biotech in­vestor, mak­ing fre­quent ap­pear­ances among the syn­di­cates com­ing to­geth­er to back the up­starts in the busi­ness. “To­day, every biotech com­pa­ny must de­vel­op treat­ments that gen­er­ate sig­nif­i­cant up­side for pa­tient care through pro­found im­pact on dis­ease, few­er side ef­fects, and a shift away from tox­ic ther­a­pies to­ward a per­son­al­ized ap­proach,” said Steve Elms, man­ag­ing part­ner, Ais­ling Cap­i­tal. “We are pleased to have the re­sources to con­tin­ue to be a sig­nif­i­cant par­tic­i­pant in our mar­ket and help the com­pa­nies we in­vest in achieve this goal.”

→ Cam­bridge, MA-based mi­cro­bio­me play­er Vedan­ta is jump­ing in­to im­muno-on­col­o­gy with new tech­nol­o­gy to ac­ti­vate CD8-pos­i­tive cells. The biotech sub-li­censed in­tel­lec­tu­al prop­er­ty from JSR Cor­po­ra­tion to de­vel­op and com­mer­cial­ize mi­cro­bio­me-de­rived can­cer im­munother­a­pies. Kenya Hon­da, a pro­fes­sor at Keio Uni­ver­si­ty School of Med­i­cine, and his col­lab­o­ra­tors in the Uni­ver­si­ty of Tokyo in Japan de­vel­oped the IP.

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

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.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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.

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.

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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David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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