Biotech SPAC takes IPO goal down a notch; Africa’s top health agency warns against mon­key­pox vac­cine hoard­ing

A blank check SPAC was gun­ning to raise $100 mil­lion when it filed an S-1 in April. Now, it has set its sights a lit­tle bit low­er.

Biotech Group Ac­qui­si­tion Corp an­nounced Thurs­day that in­stead of of­fer­ing 10 mil­lion units for $10 a piece, it is now plan­ning on of­fer­ing on­ly 7.5 mil­lion shares at that price, which would net the com­pa­ny $75 mil­lion. Each unit con­tains one share of com­mon stock and one war­rant, ex­er­cis­able at $11.50.

The SPAC, found­ed ear­li­er this year, is led by Melody Shi, who is joined by Manu Ohri, the CFO of I/O on­col­o­gy biotech GT Bio­phar­ma. While the SPAC has not ex­plic­it­ly list­ed what com­pa­ny it wants to merge with, it not­ed in an SEC fil­ing that it is look­ing at the biotech­nol­o­gy sec­tor in North Amer­i­ca and the Asia-Pa­cif­ic re­gion out­side of cer­tain Asian mar­kets such as Chi­na, Tai­wan, Hong Kong and Macau. It plans to list on the Nas­daq un­der the sym­bol $BGACU.  — Paul Schloess­er

Africa’s top health agency warns against mon­key­pox vac­cine hoard­ing by wealth­i­er na­tions 

A di­rec­tor at one of Africa’s top pub­lic health agen­cies has is­sued a warn­ing about any hoard­ing of small­pox vac­cines that can be used to treat the cur­rent mon­key­pox out­break.

Ahmed Og­well Ouma, the deputy di­rec­tor of the Africa Cen­tres for Dis­ease Con­trol and Pre­ven­tion, said on Thurs­day that he hoped vac­cine hoard­ing, as seen by wealth­i­er na­tions dur­ing the Covid-19 pan­dem­ic, would not be re­peat­ed with the cur­rent mon­key­pox out­break, ac­cord­ing to a re­port from Reuters,

Mon­key­pox, an en­dem­ic dis­ease in west­ern Africa and the Con­go Riv­er Basin, has caused alarm as 200 sus­pect­ed and con­firmed cas­es of the virus were de­tect­ed in at least 19 coun­tries since ear­ly May, most­ly in Eu­rope and some in North Amer­i­ca, caus­ing sev­er­al na­tions to start mak­ing large pur­chas­es of small­pox vac­cine from man­u­fac­tur­ers.

How­ev­er, Og­well Ouma is adamant that the vac­cines should not be hoard­ed and should in­stead go to those who need them on an eq­ui­table ba­sis, not just to na­tions that can af­ford them out­right.

“We know how to deal with it… and we are hap­py to share that knowl­edge, the ex­pe­ri­ence, and the skills we have built over time with coun­tries that are see­ing mon­key­pox now,” Og­well Ouma said in a news con­fer­ence. — Tyler Patchen

J&J’s BC­MA CAR-T lands con­di­tion­al OK in Eu­rope

Back in 2017, Leg­end Biotech and J&J’s Janssen en­tered an ex­clu­sive li­cense and col­lab­o­ra­tion deal for cli­ta-cel, a BC­MA CAR-T ther­a­py to treat pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma (RRMM) who re­ceived at least three pri­or ther­a­pies, such as a pro­tea­some in­hibitor (PI), an im­munomod­u­la­to­ry agent and an an­ti-CD38 an­ti­body, and demon­strat­ed dis­ease pro­gres­sion on the last ther­a­py.

And as of ear­ly Thurs­day morn­ing, the Eu­ro­pean Com­mis­sion gave Leg­end the thumbs up in the form of a con­di­tion­al mar­ket­ing au­tho­riza­tion. This con­di­tion­al au­tho­riza­tion fol­lows FDA ap­proval grant­ed ear­li­er this year, set­ting up a show­down with the on­ly oth­er BC­MA CAR-T ap­proved in the US, Bris­tol My­ers and blue­bird’s Abec­ma.

“The ap­proval of Carvyk­ti by the Eu­ro­pean Com­mis­sion marks Leg­end’s first ap­proval in the re­gion and is a sig­nif­i­cant mile­stone,” Leg­end Biotech CEO Ying Huang said in a state­ment. “We look for­ward to work­ing with Janssen to bring this new op­tion to pa­tients across Eu­rope.” — Paul Schloess­er

Rea­ta Phar­ma­ceu­ti­cals wins pri­or­i­ty re­view for Friedrich’s atax­ia drug can­di­date

Texas biotech Rea­ta Phar­ma­ceu­ti­cals an­nounced Thurs­day that the FDA grant­ed pri­or­i­ty re­view for the biotech’s NDA on omavelox­olone.

The drug can­di­date, which tar­gets Nrf2, a reg­u­la­tor of an­tiox­i­dant and cel­lu­lar pro­tec­tive genes, has been test­ed for use in pa­tients with Friedrich’s atax­ia, a ge­net­ic, pro­gres­sive, neu­rode­gen­er­a­tive move­ment dis­or­der. Rea­ta said in a state­ment the FDA in­di­cat­ed that at this time, it has not iden­ti­fied any po­ten­tial re­view is­sues.  Omavelox­olone pre­vi­ous­ly re­ceived Fast Track Des­ig­na­tion last No­vem­ber, and then Rare Pe­di­atric Dis­ease Des­ig­na­tion ear­li­er this month.

The FDA gave a PDU­FA date of No­vem­ber 30, and ac­cord­ing to Rea­ta, the fed­er­al reg­u­la­tor is plan­ning on hold­ing an ad­comm to dis­cuss the ap­pli­ca­tion.

Rea­ta CEO War­ren Huff said in a state­ment the biotech is pleased with the de­ci­sion for Pri­or­i­ty Re­view, adding that “We look for­ward to work­ing with the FDA dur­ing the re­view process, and if ap­proved, we are look­ing for­ward to a com­mer­cial launch in ear­ly 2023.” — Paul Schloess­er

So­sei Hep­tares ex­pands its UK-based R&D op­er­a­tions

The GPCR spe­cial­ists at So­sei Hep­tares are ex­pand­ing their op­er­a­tion in the Unit­ed King­dom with a sec­ond site with­in Gran­ta Park, in Cam­bridge, to The Cori Build­ing, pre­vi­ous­ly oc­cu­pied by Can­cer Re­search UK.

Ac­cord­ing to the com­pa­ny, the re­quire­ment for ad­di­tion­al R&D space is be­ing dri­ven by its strat­e­gy to be­come a mul­ti-pro­gram, ear­ly clin­i­cal stage busi­ness, and as part of this strat­e­gy, So­sei Hep­tares is con­tin­u­ing to in­vest in en­hanc­ing its dis­cov­ery plat­form and ex­pand­ing its R&D ca­pa­bil­i­ties to sup­port the ad­vance­ment of its in-house pipeline and part­nered pro­grams. The ex­ist­ing fa­cil­i­ty will un­der­go re­mod­el­ing to con­vert it ex­clu­sive­ly to lab­o­ra­to­ry space.

The new fa­cil­i­ties in The Cori Build­ing will be­come home to So­sei’s ex­pand­ed trans­la­tion­al med­i­cine team. CEO Chris Cargill said in a state­ment that the com­pa­ny’s R&D team has ex­pand­ed to 200 mem­bers, up from 130 when the com­pa­ny first moved to Gran­ta Park in 2018. — Tyler Patchen

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.