Deaths, ac­cu­sa­tions of in­sid­er trad­ing and an ear­ly warn­ing from Boehringer stir Han­mi con­tro­ver­sy

Con­tro­ver­sy over a lethal can­cer drug de­vel­oped by Han­mi and Boehringer In­gel­heim con­tin­ues to bub­ble up in Ko­rea.

In re­cent days a mem­ber of the op­po­si­tion Min­joo par­ty — Rep. Jung Choun-sook — cir­cu­lat­ed a let­ter from Boehringer In­gel­heim dat­ing back to Au­gust 23rd stat­ing that they were halt­ing en­roll­ment and stud­ies of ol­mu­tinib at the rec­om­men­da­tion of the Da­ta Mon­i­tor­ing Com­mit­tee, ac­cord­ing to a re­port in the Ko­rea Her­ald. And he ac­cused the coun­try’s food and drug safe­ty min­istry of al­low­ing tri­als to con­tin­ue even af­ter the dan­gers be­came ap­par­ent.

That was more than a month be­fore Boehringer an­nounced that it was wash­ing its hands of their part­ner­ship with Han­mi — though the Ger­man com­pa­ny on­ly lat­er ac­knowl­edged that Ko­re­an of­fi­cials had cit­ed at least one death and two se­vere ad­verse events in stud­ies of the drug. An­oth­er re­port cit­ed by the op­po­si­tion said three pa­tients had died.

As Boehringer ear­li­er ac­knowl­edged to me, there were “two cas­es of tox­ic epi­der­mal necrol­y­sis, one of them fa­tal, and one case of Stevens-John­son-Syn­drome in which the pa­tient sub­se­quent­ly died due to dis­ease pro­gres­sion and pneu­mo­nia.”

The drug was ap­proved in Ko­rea on May 17 — an oc­ca­sion that Boehringer trum­pet­ed with con­sid­er­able fan­fare as it pro­mot­ed its own plans for a rapid de­vel­op­ment ef­fort — and is still on the mar­ket.

Boehringer’s an­nounce­ment that it was pulling out of the deal came on Sep­tem­ber 30. But Han­mi is un­der in­ves­ti­ga­tion for de­lay­ing the news to ac­com­mo­date in­sid­er trad­ing. The Na­tion­al Pen­sion Ser­vice, which took a hit when Han­mi stock plunged af­ter the news hit, is threat­en­ing to take ac­tion if the ru­mors of in­sid­er trad­ing are con­firmed. Some re­ports from Ko­rea say that word of the set­back was spread by a mo­bile mes­sen­ger ser­vice ahead of the for­mal an­nounce­ment.

Rep. Kim Myung-yeon of the Saenuri Par­ty told the Ko­rea Times that six funds sold Han­mi shares from 9 am to 9:13 am. The news broke at 9:28 am on Sep­tem­ber 30.

At that point, the ink had bare­ly dried on a new pact that Genen­tech signed with Han­mi to part­ner on HM95573, a pan-RAF in­hibitor now in Phase I. The big Roche sub­sidiary struck their deal on Sep­tem­ber 28, pay­ing $80 mil­lion up­front to part­ner on the drug, the lat­est in a long line­up of mar­quee part­ners who have signed with Han­mi as the Ko­re­an com­pa­ny mount­ed a big ef­fort to de­vel­op brand­ed ther­a­pies. And a com­pa­ny spokesper­son at Genen­tech said that they’re stick­ing with the deal.

“Our de­ci­sion to col­lab­o­rate with Han­mi was based on a rig­or­ous re­view of the sci­en­tif­ic da­ta and our be­lief in the po­ten­tial of the in­ves­ti­ga­tion­al med­i­cine HM95573,” Genen­tech said in an email to me. “Genen­tech be­came aware of the re­cent news re­gard­ing the Han­mi/BI col­lab­o­ra­tion (ol­mu­tinib EGFR in­hibitor), as well as al­le­ga­tions of in­sid­er trad­ing when they were re­port­ed in the news in the past week. While the al­le­ga­tions against Han­mi are se­ri­ous, they have noth­ing to do with our agree­ment.”

Boehringer didn’t an­swer queries about the doc­u­ment con­cern­ing the Da­ta Mon­i­tor­ing Com­mit­tee or when it first be­came aware of the ad­verse events re­port­ed in the stud­ies. Nei­ther did Pasi A. Jänne, a promi­nent re­searcher at Dana-Far­ber who’s list­ed on clin­i­cal­tri­ as one of the pri­ma­ry in­ves­ti­ga­tors on one of the stud­ies for ol­mu­tinib.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Cedric Ververken, Confo Therapeutics CEO

Dai­ichi Sankyo inks $183M dis­cov­ery deal with GPCR biotech for CNS tar­get

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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