Biofron­tera will yank shares from Nas­daq; In­tel­lia and ONK col­lab­o­rate on can­cer can­di­dates

Ger­man bio­phar­ma Biofron­tera has de­cid­ed to delist its shares from the Nas­daq and dereg­is­ter its re­port­ing oblig­a­tions with the SEC in an at­tempt to re­duce com­plex­i­ty in fi­nan­cial re­port­ing and ad­min­is­tra­tive costs.

The com­pa­ny’s or­di­nary shares will still be trad­ed in the Prime Stan­dard at the Deutsche Börse un­der the sym­bol B8F. Amer­i­can share­hold­ers can choose to ex­change their Amer­i­can De­posi­tary Shares for or­di­nary shares on the Deutsche Börse, the com­pa­ny said in a re­lease.

In­vestors will be al­lowed to con­tin­ue to hold se­cu­ri­ties in the form of ADS and trade those on the US over-the-counter mar­ket, the com­pa­ny said.

“The ADSs will au­to­mat­i­cal­ly tran­si­tion to the new ADS pro­gram in con­nec­tion with the delist­ing and will be trad­ed un­der a new tick­er to be des­ig­nat­ed,” Biofron­tera said in a state­ment.

In­tel­lia and ONK col­lab­o­rate on can­cer can­di­dates

Ire­land and Mass­a­chu­setts have a long his­to­ry of col­lab­o­ra­tion. In­tel­lia and ONK Ther­a­peu­tics will con­tin­ue that lega­cy, as the two will team up to ad­vance their CRISPR-edit­ed nat­ur­al killer cell ther­a­pies for treat­ing can­cer, the com­pa­nies an­nounced.

In­tel­lia will grant ONK non-ex­clu­sive rights to its ex vi­vo CRISPR/Cas9-based genome edit­ing plat­form and LNP de­liv­ery tech, and ex­clu­sive rights to cer­tain guide RNAs for up to five al­lo­gene­ic ther­a­pies. ONK will be re­spon­si­ble for the R&D and com­mer­cial­iza­tion from the col­lab­o­ra­tion, and In­tel­lia will re­ceive glob­al co-de­vel­op­ment and com­mer­cial­iza­tion op­tions for two ther­a­pies, as well as lead com­mer­cial­iza­tion rights in the US.

The co-de­vel­op­ment deal ex­cludes ONK’s lead prod­uct ONKT-102, de­vel­oped for pa­tients with re­frac­to­ry mul­ti­ple myelo­ma.

In­tel­lia is el­i­gi­ble for a pay­day of up to $184 mil­lion per prod­uct, and com­mer­cial mile­stones and roy­al­ty pay­ments de­scribed as “mid-sin­gle dig­its” as well.

In a state­ment, ONK CEO Chris Now­ers said:

We be­lieve com­bin­ing In­tel­lia’s ex vi­vo genome edit­ing and LNP de­liv­ery plat­forms with our suite of pro­pri­etary NK cell gene ed­its has the po­ten­tial to cre­ate op­ti­mal­ly en­gi­neered NK cells with en­hanced cy­to­tox­i­c­i­ty, per­sis­tence and an im­proved meta­bol­ic pro­file that hold tremen­dous promise to ad­vance the treat­ment of both hema­to­log­ic ma­lig­nan­cies and sol­id tu­mors. We are ex­cit­ed to part­ner with In­tel­lia and are look­ing for­ward to a col­lab­o­ra­tion that al­lows us to con­tin­ue to de­liv­er against our strat­e­gy, as we evolve in­to a clin­i­cal-stage com­pa­ny.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

EU re­port­ed­ly eye­ing vac­cines deal for mon­key­pox out­break; Nas­daq tells Mereo to get stock price up or face delist­ing

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.