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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.