Re­genxbio scores $180M vec­tor deal; Bris­tol-My­ers ex­pands agree­ment to test Op­di­vo with In­fin­i­ty's IPI-549

Abeona Ther­a­peu­tics $ABEO has li­censed Re­genxbio’s $RGNX NAV AAV9 vec­tor for four dis­eases: San­fil­ip­po syn­drome type A (MPS II­IA), San­fil­ip­po syn­drome type B (MPS II­IB), In­fan­tile Bat­ten Dis­ease, al­so known as neu­ronal ceroid lipo­fus­ci­nosis type 1 (CLN1 Dis­ease), and Ju­ve­nile Bat­ten Dis­ease, al­so known as neu­ronal ceroid lipo­fus­ci­nosis type 3 (CLN3 Dis­ease). Re­genxbio is guar­an­teed $40 mil­lion in cash for the deal, in­clud­ing $20 mil­lion in near-term pay­ments, with an­oth­er $140 mil­lion in po­ten­tial fees and mile­stones.

With six ap­proved PD-1/L1 drugs on the mar­ket and a pletho­ra of oth­ers in de­vel­op­ment, mak­ers of check­point in­hibitors con­tin­ue to test their of­fer­ings in com­bi­na­tion with oth­er drugs to eke out a big­ger slice of the lu­cra­tive on­col­o­gy mar­ket. On Mon­day, Bris­tol-My­ers $BMY ex­pand­ed its agree­ment with In­fin­i­ty Phar­ma­ceu­ti­cals’ $IN­FI to test Op­di­vo in com­bi­na­tion with In­fin­i­ty’s PI3K-gam­ma in­hibitor, IPI-549, in pa­tients with ad­vanced urothe­lial can­cer. The Phase II tri­al is ex­pect­ed to be­gin in the first half of 2019. A com­bi­na­tion of Op­di­vo and IPI-549 con­tin­ues to be eval­u­at­ed in a Phase I study in pa­tients with ad­vanced sol­id tu­mors.

In oth­er can­cer-re­lat­ed news, Take­da has ex­er­cised its ex­clu­sive op­tion to li­cense Crescen­do Bi­o­log­ics’ hum­a­bod­ies for one of its on­col­o­gy tar­gets, in a move that comes sub­stan­tial­ly ear­li­er than planned, Crescen­do said on Mon­day. The mul­ti-tar­get col­lab­o­ra­tion and li­cense agree­ment was set up in 2016. Crescen­do’s hum­a­body-based prod­ucts are an in­ves­ti­ga­tion­al class of pro­tein ther­a­peu­tics, which are de­signed to pen­e­trate and ac­cu­mu­late in tis­sue/tu­mours whilst clear­ing quick­ly from cir­cu­la­tion to min­imise sys­temic tox­i­c­i­ty.

In a sep­a­rate on­col­o­gy tie-up, lit­tle MEI Phar­ma $MEIP has grant­ed Tokyo-list­ed Ky­owa Hakko Kirin ex­clu­sive rights to de­vel­op and com­mer­cial­ize its ex­per­i­men­tal drug ME-401 in Japan for a $10 mil­lion up­front and po­ten­tial mile­stone pay­ments of up to $87.5 mil­lion. The drug, a PI3K delta in­hibitor, is be­ing de­vel­oped by MEI to treat B-cell ma­lig­nan­cies, and MEI is plan­ning to ini­ti­ate a Phase II study to eval­u­ate the drug in pa­tients with fol­lic­u­lar lym­phoma.

Ger­many’s Grü­nen­thal is now the sole own­er of the der­mal pain patch Quten­za af­ter it ac­quired the re­main­ing rights to the prod­uct from Acor­da Ther­a­peu­tics $ACOR. Back in 2016, Grü­nen­thal ac­quired ex­clu­sive com­mer­cial rights for the patch — which con­tains cap­saicin, the ac­tive in­gre­di­ent in chili pep­pers — in Eu­rope, Mid­dle East and Africa. Grü­nen­thal has made a se­ries of in­vest­ments to ex­pand its ar­se­nal of pain prod­ucts, in­clud­ing ac­quir­ing the Eu­ro­pean rights to Nex­i­um and the glob­al (ex US and Japan) rights to Vi­mo­vo

An­oth­er Ger­man com­pa­ny is al­so in the news. The Mainz-based biotech BioN­Tech has tied up with the Uni­ver­si­ty of Penn­syl­va­nia to de­vel­op mR­NA vac­cines to pre­vent and treat a host of in­fec­tious dis­eases. The com­pa­ny, which al­ready has part­ner­ships with with Roche’s Genen­tech, Pfiz­er, Gen­mab, Eli Lil­ly, Sanofi and Bay­er, is bet­ting that mR­NA-based vac­cines rep­re­sent an op­por­tu­ni­ty to sur­pass con­ven­tion­al vac­cine ap­proach­es be­cause of their ca­pac­i­ty for rapid de­vel­op­ment and their po­ten­tial for low-cost man­u­fac­tur­ing and po­ten­tial­ly safe ad­min­is­tra­tion.

Is­rael’s Mapi Phar­ma has picked up its sec­ond $10 mil­lion eq­ui­ty in­vest­ment from Chi­na’s Zhe­jiang Jingx­in Phar­ma­ceu­ti­cal. The Chi­nese CNS drug­mak­er made its ini­tial in­vest­ment in Mapi back in 2016.

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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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.

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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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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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.