Astel­las signs on pluripo­tent stem cell part­ners at Ex­CellThera; Lit­tle Uni­cy­cive brings home $25M af­ter float­ing a small IPO

Astel­las has signed up on rights for a batch of pluripo­tent stem cells from Mon­tre­al-based Ex­CellThera, cen­ter­ing on the in vit­ro use of their UM171 com­pound.

Astel­las is hand­ing over an un­spec­i­fied up­front pay­ment and promis­ing a slate of mile­stones to get the col­lab­o­ra­tion un­der­way.

Guy Sauvageau, CEO and founder of Ex­CellThera, not­ed:

While Ex­CellThera has fo­cused on de­vel­op­ing our core strength in oth­er ther­a­peu­tic ar­eas, Astel­las has in­vest­ed sig­nif­i­cant­ly in PSC-re­lat­ed pro­grams and is ab­solute­ly the right part­ner for us in that re­gard.

John Car­roll

Lit­tle Uni­cy­cive brings home $25M af­ter float­ing a small IPO

Not all biotech IPOs in­volve big, up­sized of­fer­ings and mega­cash win­nings. Take the case of Uni­cy­cive Ther­a­peu­tics.

The biotech has just raised $25 mil­lion gross by sell­ing 5 mil­lion shares at $5 a pop. That comes in at the low end of the range.

Uni­cy­cive is de­vel­op­ing drugs for kid­ney dis­ease, and gave “un­der­writ­ers a 45-day op­tion to pur­chase up to an ad­di­tion­al 750,000 shares of its com­mon stock and/or war­rants to pur­chase up to an ad­di­tion­al 600,000 shares of its com­mon stock, at the ini­tial pub­lic of­fer­ing price, less the un­der­writ­ing dis­counts and com­mis­sions.” — John Car­roll

Aslan gets a $45M loan to pay for a loom­ing PhII study

Af­ter ex­pe­ri­enc­ing a host of prob­lems with its ear­ly can­cer drugs, Sin­ga­pore-based Aslan Phar­ma­ceu­ti­cals is now tak­ing out a $45 mil­lion loan to fund mid-stage work on ASLAN003. They’ll start with a fo­cus on in­flam­ma­to­ry bow­el dis­ease with a Phase II planned for ear­ly 2022.

Aslan has been in plen­ty of hot wa­ter with in­vestors, es­pe­cial­ly af­ter a 2019 tri­al fail­ure. So they’ve turned to K2 HealthVen­tures for the first $20 mil­lion loan with the rest of the mon­ey sub­ject to “cer­tain terms and con­di­tions.”

“These re­sources pro­vide ad­di­tion­al work­ing cap­i­tal, strength­en our bal­ance sheet, and en­hance our fi­nan­cial flex­i­bil­i­ty by ex­tend­ing our ex­pect­ed cash run­way through late 2023, as we look for­ward to ex­pand­ing our clin­i­cal ac­tiv­i­ties for ASLAN003,” said Aslan CEO Carl Firth. — John Car­roll

Cure­Vac ex­ec­u­tives ditched shares be­fore vac­cine flop news broke: re­port

On Tues­day, Busi­ness In­sid­er re­port­ed that four mem­bers of Cure­Vac’s board ditched large blocks of shares worth more than $38 mil­lion as the com­pa­ny’s Covid-19 vac­cine can­di­date floppedWednes­day, the com­pa­ny clapped back, deem­ing the re­ports un­true.

The price of the Ger­man biotech dropped around 50% af­ter the dis­ap­point­ing ef­fi­ca­cy re­sults were an­nounced. But board mem­bers sold near­ly all of their re­main­ing shares, in­clud­ing com­pa­ny co-founder Flo­ri­an von der Mülbe, who ditched about half of his by June 21, when the four ex­ec­u­tives re­port­ed such to the SEC. Cur­rent chief tech­nol­o­gy of­fi­cer Mar­i­o­la Fotin-Mleczek sold 99% of shares, Busi­ness In­sid­er re­ports.

In a state­ment emailed to End­points News, a Cure­Vac spokesper­son said:

The re­ports that in­di­vid­ual mem­bers of the Board of Man­age­ment have sold al­most all of their blocks of shares is not true. We con­tra­dict this re­port­ing, the fol­low­ing is cor­rect: As stat­ed in the rel­e­vant SEC doc­u­ments, the Cure­Vac NV board mem­bers have blocks of shares in the form of vir­tu­al shares (Vir­tu­al Share Own­er­ship) as part of their com­pen­sa­tion. Parts of these vir­tu­al shares are con­vert­ed in­to re­al shares and made avail­able ac­cord­ing to de­fined de­vel­op­ment mile­stones for build­ing up the com­pa­ny – e.g. an IPO, start of a clin­i­cal ap­proval study for the first phar­ma­ceu­ti­cal prod­uct, etc. For the IPO on the New York tech­nol­o­gy com­pa­ny ex­change NAS­DAQ, this part was 10%. In our 20F doc­u­ment, you can see how that per­cent­age, af­ter tax, trans­lates in­to re­al­iz­able shares for the board mem­bers. Even if these shares were com­plete­ly sold, they would on­ly rep­re­sent a small pro­por­tion of the re­spec­tive block of shares held per board mem­ber. The rep­re­sen­ta­tion that an al­most com­plete sale of com­pa­ny shares by the board of di­rec­tors due to a lack of faith in Cure­Vac is not ap­plic­a­ble – we dis­agree.

Josh Sul­li­van

NASH liv­er dis­ease drug deemed safe in PhI­Ia

He­p­i­on Phar­ma­ceu­ti­cals an­nounced that its Phase IIa tri­al of a liv­er dis­ease drug for the treat­ment of non-al­co­holic steato­hep­ati­tis was safe and well-tol­er­at­ed, with few side ef­fects.

The drug — dubbed CRV431 — was pro­vid­ed in ei­ther a 75 mg or 225 mg oral dose once dai­ly, and reached max­i­mum con­cen­tra­tions with­in 30 hours.

“Sta­tis­ti­cal sig­nif­i­cance in a dose re­sponse on ALT is very en­cour­ag­ing, sug­gest­ing a rapid drug ef­fect. A thor­ough re­view of lit­er­a­ture by our group sug­gest­ed that a 10% to 15% de­cline in ALT in four weeks over place­bo would in­di­cate a ben­e­fi­cial drug ef­fect,” SVP of clin­i­cal phar­ma­col­o­gy Patrick Mayo said in a state­ment. “Our clin­i­cal phar­ma­col­o­gy group has al­ready de­vel­oped a pop­u­la­tion phar­ma­co­ki­net­ic-phar­ma­co­dy­nam­ic, or PK-PD, mod­el which pre­dicts CRV431 blood con­cen­tra­tion ef­fect on ALT re­duc­tions, which is not usu­al­ly pos­si­ble at this ear­ly stage in drug de­vel­op­ment.” — Josh Sul­li­van

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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