With mon­ey flow­ing, Pli­ant Ther­a­peu­tics heads to pub­lic well

Fresh off rais­ing a $100 mil­lion Se­ries C and send­ing their sec­ond com­pound in­to the clin­ic, Pli­ant Ther­a­peu­tics is head­ed for Wall Street.

The South San Fran­cis­co-based biotech filed this morn­ing for an $86 mil­lion IPO. The mon­ey will help fund clin­i­cal de­vel­op­ment of their lead pro­gram for a rare lung dis­ease and rare liv­er dis­ease and boost pre­clin­i­cal re­search for on­col­o­gy and mus­cu­lar dy­s­tro­phy.

The IPO comes amid a se­ries of large pub­lic fi­nanc­ings for biotechs, as in­vestors fun­nel dol­lars out of in­dus­tries strug­gling dur­ing the pan­dem­ic. Small can­cer biotechs Zen­tal­is and ORIC raised $165 mil­lion and $125 mil­lion a piece, while ADC filed for $125 mil­lion. Yes­ter­day, al­ready pub­lic Im­munomedics was able to raise $459 mil­lion in a new of­fer­ing.

Bernard Coulie

For Pli­ant, the deal comes just two months af­ter a $100-mil­lion No­var­tis-led raise, af­ter which CEO Bernard Coulie ac­knowl­edged an IPO could be com­ing but re­fused to com­ment to Xcon­o­my on when.

Al­though Pli­ant is rais­ing mon­ey in part to push for­ward a lead pro­gram they’ve had since their found­ing, the com­pa­ny’s S-1 al­so sig­nals a shift for the group. Third Rock found­ed the group around tech­nol­o­gy meant to block TGF-β ac­ti­va­tion, a key path­way in fi­bro­sis, and while they long em­pha­sized the ap­pli­ca­tions across dif­fer­ent dis­eases, their first tar­gets were rare dis­eases and liv­er dis­eases.

They de­vel­oped an TGF-β in­hibitor called PLN-74809 and brought it in­to the clin­ic for id­io­path­ic pul­monary fi­bro­sis (IPF), a con­di­tion that in­volves ir­re­versible scar­ring of the lungs, and pri­ma­ry scle­ros­ing cholan­gi­tis (PSC), a pro­gres­sive form of in­flam­ma­tion in the lung and gall­blad­der.

Pli­ant al­so de­vel­oped PLN-1474, an in­hibitor of the same path­way that No­var­tis will try to de­vel­op for NASH. The col­lab­o­ra­tion, an­nounced in Oc­to­ber, paid Pli­ant $80 mil­lion up­front, cov­ered costs for Phase I and sub­se­quent de­vel­op­ment, and al­so grant­ed No­var­tis ac­cess to up to 3 oth­er pre­clin­i­cal can­di­dates. Al­though NASH has seen a slew of fail­ures — most re­cent­ly with Gen­Fit’s Phase III loss yes­ter­day — the dis­ease still rep­re­sents an enor­mous mar­ket for drug com­pa­nies.

Go­ing for­ward, though, the com­pa­ny’s new ex­per­i­men­tal com­pounds will come in can­cer and mus­cu­lar dy­s­tro­phy.

For can­cer, the idea is based in im­muno-on­col­o­gy. The com­pa­ny cit­ed re­search in­di­cat­ing that TGF-β plays a role in a tu­mor’s abil­i­ty to turn down in­flam­ma­tion in its mi­cro-en­vi­ron­ment and evade the im­mune sys­tem. They will try to use an in­hibitor to turn down that an­ti-in­flam­ma­to­ry re­sponse and make tu­mors more sus­cep­ti­ble to check­point ther­a­pies — a com­mon goal for can­cer biotechs.

In mus­cu­lar dy­s­tro­phy, the com­pa­ny is de­vel­op­ing an an­ti­body to al­loster­i­cal­ly in­hib­it an undis­closed in­te­grin they say is up­reg­u­lat­ed in mus­cle cells across dif­fer­ent mus­cu­lar dy­s­tro­phies, in­clud­ing Duchenne mus­cu­lar dy­s­tro­phy.

But both those pro­grams are in the pre­clin­i­cal stage. And for now, most eyes will rest on PLN-74809 and how it per­forms in the clin­ic. The com­pa­ny is re­cruit­ing for a pair of Phase IIa tri­als in IPF and they re­cent­ly were cleared for a Phase IIa in PSC. Covid-19, though, could throw time­lines com­plete­ly in the air. The re­sults could al­so be mud­died:

As a re­sult of the COVID-19 pan­dem­ic and shel­ter-in-place re­stric­tions, com­mence­ment of en­roll­ment of our clin­i­cal tri­als of PLN-74809 in IPF and PSC has been de­layed. We an­tic­i­pate de­lays in site start-up ac­tiv­i­ties of one to two quar­ters for both the PLN-74809 IPF and PSC Phase 2a tri­als, and we could ex­pe­ri­ence slow­er than ex­pect­ed en­roll­ment. In ad­di­tion, af­ter en­roll­ment in these tri­als, if pa­tients con­tract COVID-19 dur­ing par­tic­i­pa­tion in our tri­als or are sub­ject to iso­la­tion or shel­ter in place re­stric­tions, this may cause them to drop out of our tri­als, miss sched­uled dos­es or fol­low-up vis­its or oth­er­wise fail to fol­low tri­al pro­to­cols. If pa­tients are un­able to fol­low the tri­al pro­to­cols or if our tri­al re­sults are oth­er­wise dis­put­ed due to the ef­fects of the COVID-19 pan­dem­ic or ac­tions tak­en to mit­i­gate its spread, the in­tegri­ty of da­ta from our tri­als may be com­pro­mised or not ac­cept­ed by the FDA or oth­er reg­u­la­to­ry au­thor­i­ties, which would rep­re­sent a sig­nif­i­cant set­back for the ap­plic­a­ble pro­gram.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.