Bris­tol-My­ers Squib­b's Op­di­vo/Yer­voy com­bo scores col­orec­tal can­cer OK; For­mer Ake­bia, Mer­ri­mack staffers found guilty

→ Bol­stered by pri­or­i­ty re­view and a break­through ther­a­py des­ig­na­tion, Bris­tol-My­ers Squibb’s Op­di­vo/Yer­voy has been ap­proved for a sub­set of col­orec­tal can­cer pa­tients who’ve run out of op­tions. The FDA gave the green light — cov­er­ing mi­crosatel­lite in­sta­bil­i­ty high (MSI-H) or mis­match re­pair de­fi­cient (dMMR) metasta­t­ic col­orec­tal can­cer (mCRC) that has pro­gressed fol­low­ing treat­ment with a flu­o­ropy­rim­i­dine, ox­ali­platin and irinote­can com­bo — based on an on­go­ing Phase II tri­al. Eighty two out of 119 pa­tients re­ceived treat­ment pri­or to the Check­mate-142 study; 46% in that sub-pop­u­la­tion, and 49% over­all, re­spond­ed to the I/O com­bo. Se­ri­ous ad­verse re­ac­tions oc­curred in 47% of all pa­tients — some­what re­flect­ed in the list of safe­ty warn­ings that come with the ap­proval. The rec­om­mend­ed dos­ing sched­ule in­volves an IV in­fu­sion every three weeks for four dos­es, fol­lowed by Op­di­vo main­te­nance ther­a­py.

→ More than a year af­ter two friends charged with in­sid­er trad­ing by swap­ping non­pub­lic in­fo on their re­spec­tive biotech com­pa­nies, the ver­dict is in: guilty — for con­spir­a­cy and se­cu­ri­ties fraud. Schultz Chan, who worked for Ake­bia Ther­a­peu­tics $AK­BA at the time, and Songjiang Wang, a for­mer Mer­ri­mack Phar­ma­ceu­ti­cals $MACK staffer, re­ceived the ver­dict from a ju­ry in Boston fol­low­ing a two-week tri­al.

Ac­cord­ing to a crim­i­nal com­plaint, the duo were work­ing a two-way deal where Chan — then Ake­bia’s di­rec­tor of bio­sta­tis­tics — fed in­sid­er in­fo on Ake­bia’s tri­al da­ta to Wang, the di­rec­tor of sta­tis­ti­cal pro­gram­ming at Mer­ri­mack, who rec­i­p­ro­cat­ed with the scoop on Mer­ri­mack drugs. One of the deals al­leged­ly yield­ed a $288,000 prof­it.

Both men, who have de­nied wrong­do­ing in the past and de­clined to com­ment af­ter the tri­al, are sched­uled to be sen­tenced in ear­ly Oc­to­ber.

Paula Soteropou­los, Akcea CEO

Akcea $AK­CA has scored its first drug ap­proval since spin­ning out of Io­n­is $IONS, as Eu­ro­pean reg­u­la­tors come through with an ap­proval for in­ot­ersen fol­low­ing a thumbs up from the EMA com­mit­tee. To be mar­ket­ed as Tegse­di, the drug treats hered­i­tary TTR amy­loi­do­sis by block­ing pro­duc­tion of the transthyretin (TTR) pro­tein. The green light gives Io­n­is and the ma­jor­i­ty-owned Akcea an im­por­tant leg up against ri­val Al­ny­lam, whose patisir­an has a US PDU­FA date that’s two months ahead of in­ot­ersen’s in Oc­to­ber. “With the EC’s de­ci­sion, TEGSE­DI is now the world’s first and on­ly RNA-tar­get­ed ther­a­peu­tic ap­proved for pa­tients with hAT­TR amy­loi­do­sis,” said Akcea CEO Paula Soteropou­los. “We are ready to launch Tegse­di along with our pa­tient and physi­cian sup­port ser­vices across Eu­rope.”

→ The res­pi­ra­to­ry ex­perts at As­traZeneca are wad­ing in­to gene ther­a­py for a nov­el ap­proach to treat­ing chron­ic lung dis­ease with a new col­lab­o­ra­tion. Emeryville, CA-based 4D Mol­e­c­u­lar Ther­a­peu­tics will con­tribute its dis­cov­ery plat­form to help iden­ti­fy and en­gi­neer the AAV vec­tor that will be best suit­ed to de­liv­er the drug the part­ners will de­vel­op to­geth­er. Med­Im­mune, the bi­o­log­ics arm of the UK phar­ma gi­ant, has com­mit­ted to play­ing a role in the whole process — from ear­ly stage de­vel­op­ment to com­mer­cial­iza­tion (which 4DMT will pre­sum­ably be in­volved in). Fi­nan­cial de­tails were not dis­closed.

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.