Boehringer In­gel­heim backs Max Planck spin­out in tak­ing a shot at tough class of can­cer tar­gets

Sci­en­tists have long known about tu­mor-as­so­ci­at­ed car­bo­hy­drate anti­gens — those ab­nor­mal sac­cha­rides that are abun­dant on can­cer cell sur­faces and feed them on — but their abil­i­ty to hide from the im­mune sys­tems means they have proved to be eva­sive tar­gets in im­muno-on­col­o­gy.

Two gly­co­sciences ex­perts at the Max Planck In­sti­tute in Ger­many be­lieved syn­the­siz­ing those tar­gets in the first place is key to crack­ing that prob­lem. They have now re­ceived a mod­est seed round to pur­sue that idea at their Berlin-based biotech spin­out, Taca­lyx.

Pe­ter See­berg­er, di­rec­tor at the MPI for Col­loids and In­ter­faces, worked with Oren Moscovitz to de­vel­op au­to­mat­ed gly­can as­sem­bly, which then al­lowed for tar­get­ed an­ti­body gen­er­a­tion.

Oren Moscovitz Max Planck

“The abil­i­ty to syn­the­size pure iso­lates us­ing sol­id phase syn­the­sis rep­re­sents an im­por­tant step for­ward and fa­cil­i­tates the iden­ti­fi­ca­tion of spe­cif­ic an­ti­bod­ies and their sub­se­quent char­ac­ter­i­za­tion,” the com­pa­ny wrote on its web­site. “This ac­cess to gly­cans pre­vi­ous­ly in­ac­ces­si­ble in larg­er amounts is cen­tral to Taca­lyx’s ac­tiv­i­ties.”

Max Planck In­no­va­tion ap­proached Shire vet Pe­ter Son­der­mann al­most two years ago now about launch­ng a ven­ture. In an in­ter­view with End­points News, the CEO said with the help of in­vestors and the re­searchers he’s built a team of four and plans to push the head­count to 10 in a year or so.

While oth­ers have tried a tu­mor vac­cine ap­proach to in­duce im­mune re­spons­es to TACAs, Son­der­mann is con­vinced that a pas­sive im­munother­a­py — syn­thet­ic, clean an­ti­bod­ies gen­er­at­ed in a dif­fer­ent sys­tem — is need­ed in this con­text.

“In a cou­ple of in­di­ca­tions, from vac­ci­na­tion stud­ies, that there seems to be a pret­ty nice cor­re­la­tion be­tween an­ti­body titer and prog­no­sis for the pa­tients,” he said. “So if pa­tients have a high an­ti­body titer against spe­cif­ic TACAs, they have al­so much bet­ter prog­no­sis than pa­tients that do not de­vel­op a titer.”

So far the biotech has elect­ed sev­er­al po­ten­tial TACA tar­gets for fur­ther pre­clin­i­cal val­i­da­tion and con­sult­ed some CROs who can help with the an­ti­bod­ies. The goal is to have one lead struc­ture ready for the clin­ic by the time they burn through the ini­tial fund­ing.

“Be­sides es­tab­lish­ing the com­pa­ny and our dis­cov­ery plat­form for lead gen­er­a­tion, we will use these funds to ex­plore rel­e­vant TACA bi­ol­o­gy in de­tail,” he added in a state­ment.

Boehringer In­gel­heim Ven­ture Fund co-led the €7 mil­lion fund­ing with Kur­ma Part­ners, joined by Id­in­vest Part­ners, High-Tech Grün­der­fonds, co­par­i­on, and Creathor Ven­tures.

Its par­ent drug­mak­er has laid eyes on this class of tar­gets for at least two years. In 2017, the Boehringer In­gel­heim inked a dis­cov­ery al­liance with New­ton, MA-based biotech Siam­ab in search of an­ti­bod­ies hit­ting one spe­cif­ic, but un­named, TACA, with an op­tion to add a sec­ond.

Siam­ab was bagged by a mys­te­ri­ous large play­er last month in a deal worth up to $202 mil­lion.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.