Ab­Cellera ac­quires trans­mem­brane pro­tein pro­duc­er; Com­pass gains psy­che­del­ic IP port­fo­lio

Cana­di­an an­ti­body shop Ab­Cellera ac­quired Mass­a­chu­setts biotech Tetra­Ge­net­ics in an all-cash trans­ac­tion. While more spe­cif­ic de­tails were not made pub­licly avail­able, Ab­Cellera did say in a state­ment that the ac­qui­si­tion in­cludes an up­front pay­ment and po­ten­tial mile­stone pay­ments based on tech­ni­cal achieve­ments, suc­cess­ful R&D and com­mer­cial­iza­tion.

Carl Hansen

Found­ed in 2004, Tetra­Ge­net­ics spe­cial­izes in pro­tein pro­duc­tion — specif­i­cal­ly trans­mem­brane pro­teins, which have proven to be dif­fi­cult to pro­duce in the past. Where Tetra­Ge­net­ics comes in­to the equa­tion with Ab­Cellera is that Tetra­Ge­net­ics can make enough trans­mem­brane pro­teins to sup­port an­ti­body dis­cov­ery.

Hav­ing slow­ly built up a net­work of bio­phar­ma clients in re­cent years, Ab­Cellera shot to fame dur­ing the pan­dem­ic as Eli Lil­ly tapped it for Covid-19 an­ti­body part­ner­ship.

“We look for­ward to wel­com­ing the Tetra­Ge­net­ics team and be­lieve that these new ca­pa­bil­i­ties, once in­te­grat­ed in­to Ab­Cellera’s tech­nol­o­gy stack, will em­pow­er the dis­cov­ery of new an­ti­body ther­a­pies across a range of ther­a­peu­tic ar­eas,” said Ab­Cellera CEO Carl Hansen in a state­ment.

Com­pass Path­ways ac­quires IP port­fo­lio of psy­che­del­ic com­pounds

UK biotech Com­pass Path­ways has gained ac­cess to an in­tel­lec­tu­al prop­er­ty port­fo­lio in­clud­ing patent ap­pli­ca­tions cov­er­ing a va­ri­ety of psy­che­delics, em­pathogens and pro­drugs. The IP was de­vel­oped to­geth­er with Matthias Grill, founder and CEO of MiHKAL. Based in Basel, Switzer­land, Grill will be work­ing with Com­pass to de­vel­op new prod­uct can­di­dates.

Grill has been in­volved in psy­che­del­ic chem­istry re­search for over 15 years, and he has held po­si­tions as head of R&D at Ar­bolea, Lipomed and THC Pharm. He has al­so syn­the­sized psy­che­del­ic sub­stances for a num­ber of hu­man re­search stud­ies, in­clud­ing at the Uni­ver­si­ty of Basel and the Na­tion­al In­sti­tute of Men­tal Health in the Czech Re­pub­lic.

“We are de­light­ed to be work­ing with Matthias and MiHKAL GmbH. This agree­ment will strength­en and ex­pand our IP and de­vel­op­ment port­fo­lio with new com­pounds. We plan to move some of these com­pounds in­to clin­i­cal de­vel­op­ment with­in the next two years,” said Com­pass CBO and pres­i­dent Lars Wilde in a state­ment.

Zai Lab re­ceives BTD ap­proval in Chi­na for be­mar­ituzum­ab

Zai Lab re­ceived a break­through des­ig­na­tion to­day from the Cen­ter for Drug Eval­u­a­tion of NM­PA for be­mar­ituzum­ab — as first-line treat­ment for pa­tients with cer­tain types of mu­tat­ed gas­tric and GEJ can­cers in tan­dem with chemo pro­to­col FOL­FOX6 (flu­o­ropy­rim­i­dine, leu­cov­orin, and ox­ali­platin).

Alan San­dler

The des­ig­na­tion is sup­port­ed by re­sults from the Phase II FIGHT study, which eval­u­at­ed be­mar­ituzum­ab plus chemother­a­py ver­sus chemother­a­py alone in pa­tients with FGFR2b over­ex­pres­sion, HER2-neg­a­tive front­line ad­vanced gas­tric or GEJ can­cer.

All three ef­fi­ca­cy end­points in the FIGHT tri­al — PFS, OS and ORR — achieved pre-spec­i­fied sta­tis­ti­cal sig­nif­i­cance in the be­mar­ituzum­ab arm com­pared to the place­bo arm.

“We look for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties in Chi­na as we ad­vance be­mar­ituzum­ab in­to glob­al, reg­is­tra­tional stud­ies,” Zai Lab pres­i­dent and head of glob­al de­vel­op­ment for on­col­o­gy Alan San­dler said in a state­ment.

Zai Lab li­censed Chi­na rights to be­mar­ituzum­ab from Five Prime be­fore Am­gen bought it in a $2 bil­lion deal.

Novo­cure an­nounces col­lab­o­ra­tion with Roche to eval­u­ate tu­mor treat­ing fields in clin­i­cal tri­al

Novo­cure is col­lab­o­rat­ing with Roche in a Phase II clin­i­cal tri­al to test tu­mor treat­ing fields with Roche’s PD-L1 block­er Tecen­triq (ate­zolizum­ab) in metasta­t­ic pan­cre­at­ic duc­tal ade­no­car­ci­no­ma (mP­DAC).

William Doyle

“We are pleased to col­lab­o­rate with Roche, a glob­al leader in on­col­o­gy, to ex­plore the ef­fi­ca­cy of TTFields to­geth­er with ate­zolizum­ab im­munother­a­py in pan­cre­at­ic can­cer,” said Novo­cure ex­ec­u­tive chair­man William Doyle in a state­ment.

The Phase II study will test safe­ty and ef­fi­ca­cy of TTFields to­geth­er with Tecen­triq, gem­c­itabine and nab-pa­cli­tax­el as a first-line treat­ment for mP­DAC. With plans to en­roll ap­prox­i­mate­ly 75 pa­tients in the EU and Unit­ed States, the pri­ma­ry end­point of the study is dis­ease con­trol rate as de­fined by RE­CIST 1.1 guid­ance.

Novo­cure is the study spon­sor and Roche is pro­vid­ing Tecen­triq for the tri­al.

Biotech rais­es $40M to pay CEO and fund R&D, among oth­er things

Penn­syl­va­nia biotech Vir­pax re­vealed the pric­ing of an un­der­writ­ten pub­lic of­fer­ing of 6,670,000 shares of its com­mon stock. List­ed at a pub­lic of­fer­ing price of $6.00 per share, Vir­pax in­tends to raise gross pro­ceeds of just over $40 mil­lion be­fore de­duct­ing un­der­writ­ing dis­counts and of­fer­ing ex­pens­es.

Un­der­writ­ers have been giv­en a 45-day op­tion to pur­chase up to an ad­di­tion­al 1,000,500 shares of com­mon stock to cov­er over-al­lot­ments at the pub­lic of­fer­ing price, mi­nus the un­der­writ­ing dis­count.

Vir­pax in­tends to use the net pro­ceeds from the of­fer­ing to fund R&D for Epo­la­derm, Probudur, En­velta, An­Qlar and oth­er de­vel­op­ment pro­grams, re­pay out­stand­ing promis­so­ry notes and de­ferred com­pen­sa­tion to Vir­pax CEO An­tho­ny Mack, and then the rest of the funds for work­ing cap­i­tal.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.