Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC For­bion is hop­ping on the ever-length­en­ing SPAC train.

To be led by Jasper Bos, who joined For­bion Growth as a gen­er­al part­ner back in May just af­ter the fund closed at $428 mil­lion, For­bion Eu­ro­pean Ac­qui­si­tion will tar­get late-stage op­por­tu­ni­ties in the life sci­ences in­dus­try in Eu­rope to merge with and bring on­to Nas­daq.

Cyril Less­er, se­nior con­troller at For­bion, will be the CFO while Bos serves as CEO.

Af­ter a record year for biotech SPACs, the craze for blank check com­pa­nies ap­pears to be in a bit of a lull re­cent­ly, al­though it’s clear­ly not stop­ping ex­pe­ri­enced in­vestors who think they will be able to spot a de­cent pri­vate com­pa­ny to flip pub­lic.

As is stan­dard with these types of deals, For­bion Eu­ro­pean Ac­qui­si­tion is pen­cil­ing in a $100 mil­lion raise by sell­ing shares at $10 apiece — a pitch cen­tered around the man­age­ment team’s ex­pe­ri­ence, net­work and ex­per­tise. It may raise an­oth­er $20 mil­lion “at the clos­ing of an ac­qui­si­tion,” the com­pa­ny added. — Am­ber Tong

Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

On­col­o­gy biotech Kro­nos Bio an­nounced da­ta from its on­go­ing Phase I/II clin­i­cal tri­al of its oral CDK9 in­hibitor KB-0742, which is be­ing de­vel­oped to treat MYC-am­pli­fied sol­id tu­mors.

Among the 12 pa­tients treat­ed in the tri­al, KB-0742 had a ter­mi­nal half-life of 24 hours, with ap­prox­i­mate­ly 2 to 2.5-fold ac­cu­mu­la­tion be­tween days 1 and 10. Ac­cord­ing to Kro­nos, this long plas­ma half-life sup­ports the biotech’s ap­proach to defin­ing a ther­a­peu­tic win­dow for CDK9 in­hi­bi­tion.

Fur­ther dose es­ca­la­tion — the first part of the two-stage tri­al — is re­quired to reach de­sired lev­els of CDK9 in­hi­bi­tion.

The na­ture and sever­i­ty of the ad­verse events ob­served have been con­sis­tent with what is typ­i­cal­ly seen among heav­i­ly pre­treat­ed pa­tients with ad­vanced can­cer in Phase I tri­als, and Kro­nos Bio is con­tin­u­ing to en­roll in the tri­al.

“These ear­ly da­ta are en­cour­ag­ing, and we look for­ward to con­tin­u­ing the tri­al and es­tab­lish­ing a rec­om­mend­ed Phase II dose,” said Kro­nos Bio CEO and pres­i­dent Nor­bert Bischof­berg­er.

While the first stage is de­ter­min­ing safe­ty of the drug and find­ing a dosage lev­el for pa­tients, the sec­ond stage of the tri­al will en­roll pa­tients with MYC-am­pli­fied or over-ex­press­ing tu­mors, as well as oth­er tran­scrip­tion­al­ly ad­dict­ed tu­mor types, to as­sess the an­ti-tu­mor ac­tiv­i­ty of KB-0742 at the rec­om­mend­ed Phase II dose. — Paul Schloess­er

Gilead goes with Ama­zon Web Ser­vices as its cloud provider

Gilead had de­cid­ed on Ama­zon for its cloud ser­vices.

Gilead an­nounced this morn­ing that it is go­ing with Ama­zon Web Ser­vices as its cloud provider — cit­ing AWS’s on­line port­fo­lio for in­fra­struc­ture and oth­er ser­vices.

Ac­cord­ing to Gilead, AWS’ ca­pa­bil­i­ties in ma­chine learn­ing and an­a­lyt­ics fu­el de­ci­sion mak­ing across the phar­ma — from bio­mark­er dis­cov­ery to man­u­fac­tur­ing and clin­i­cal tri­al re­cruit­ment.

“With AWS as our pre­ferred cloud provider, our re­searchers can use AWS’s port­fo­lio of ser­vices to gain the in­sights, agili­ty, and se­cu­ri­ty need­ed to de­liv­er new med­i­cines at speed,” said Gilead SVP and CIO Marc Berson in a pre­pared state­ment.

In ad­di­tion, Gilead has moved more than 50% of its da­ta cen­ter foot­print to AWS over the past year through an ac­cel­er­at­ed cloud mi­gra­tion pro­gram with AWS Pro­fes­sion­al Ser­vices. The com­pa­ny al­so plans to mi­grate hun­dreds of ap­pli­ca­tions to AWS, which in­clude ap­pli­ca­tions that sup­port in­dus­try good prac­tice guide­lines and reg­u­la­tions in ar­eas like drug man­u­fac­tur­ing, stor­age and dis­tri­b­u­tion.

As a re­sult, Gilead will be ac­cel­er­at­ing its plans to up­grade its IT op­er­a­tions with AWS, while avoid­ing up­front costs to re­fresh hard­ware and the sus­tained costs of run­ning an “al­ways on,” on-premis­es IT land­scape pro­vi­sioned for peak use. — Paul Schloess­er

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”