Jazz, Codiak in alliance with $76M ante and up to $1B-plus in milestones

Codiak CEO Doug Williams has notched his first collaboration deal.

The biotech exec and his team are collecting a $56 million upfront from Jazz Pharmaceuticals $JAZZ as Codiak ramps up 5 translational programs using its exosome platform, with two of the cancer targets in public sight — NRAS and STAT3. There’s another $20 million on the table for near-term preclinical goals, with a $200 million package of milestones per target and a royalty arrangement for success.
Significantly, Williams says that the alliance includes an opt-in on 2 programs that Codiak can co-commercialize, which would mark a major change for the biotech.

Williams, a longtime biotech exec who managed Biogen’s R&D ops for one stretch, says he’s known Jazz CFO Matt Young for quite awhile now, which helped opened the door to this deal.

“There’s a growing realization in Jazz and globally that exosomes are an interesting approach to developing therapeutics,” he notes. And it’s a good add-on for Jazz as they explore new ways to “drug the undruggable” in oncology and other therapeutic fields.

It’s a good development for Codiak, Williams adds, allowing some extra financing on top of the $168.5 million he’s already raised for the company, expanding the pipeline and staff — which now sits at 60.

They’ve been working on using exosomes as a kind of cellular freight service, carrying payloads of nucleic acids, proteins, small molecules and more through the various roadblocks your body uses to check the spread of threatening substances. By hijacking the system, Codiak is looking to create a whole new way to drug the currently undruggable. And their first in-house effort focused on jumping on board these nanoparticles with an siRNA targeting KRAS that has shown promise in a variety of models for pancreatic cancer.

That should set up a move into the clinic with their own product in 2020.

The deal with Jazz, meanwhile, leaves Codiak in charge of maneuvering the 5 programs through Phase I/II studies, with Jazz left in charge of any additional clinical work they elect to pursue.

https://endpts.com/jazz-triggers-codiaks-first-exosome-alliance-with-a-76m-ante-and-up-to-1b-plus-in-milestones/

No-Baseline-Needed Concussion Test OK’d

An eye-tracking test for concussion that requires no baseline assessment is cleared for U.S. marketing, said neurodiagnostics company Oculogica.

To be sold as EyeBOX, the 4-minute, non-invasive test is approved for use in patients ages 5 to 67. Oculogica said it’s the first such test to win FDA marketing authorization. Patients watch a short video with their heads placed in a chin-and-forehead rest similar to those commonly used in optometry clinics. Eye movements are analyzed with a proprietary algorithm.

Initial distribution will be limited to “select, qualified sites,” the firm said.

Approval (via the FDA’s “de novo” authorization pathway for novel, low- to moderate-risk devices) was based primarily on a 282-patient clinical study involving children and adults presenting to emergency departments and concussion clinics with head injuries. Patients were evaluated within 2 weeks of injury. Full results have not yet been published.

One journal paper involving another Oculogica study indicated that, in children with suspected concussion, the test achieved 72% sensitivity with 84% specificity when patients were evaluated an average of 22 weeks after injury.

https://www.medpagetoday.com/neurology/headtrauma/77235

Which Bariatric Surgery Needs Most Revisions Over the Decades?

Over the course of 20 years, just over one-quarter of bariatric surgery patients underwent revisional procedures, researchers reported.

In a follow-up analysis of participants from the Swedish Obese Subjects (SOS) study, 27.8% of adult patients underwent a first-time revisional surgery — accounting for 559 patients out of 2,010 — Stephan Hjorth, PhD, of the University of Gothenburg, and colleagues wrote in JAMA Surgery.

Among these revisional surgeries, conversions to other bariatric procedures were the most common, making up nearly 18% of these surgeries. This was followed by around 6% of revisions accounting for corrective surgeries, while 4.5% were reversals back to normal gastrointestinal anatomy.

The reasons for revisional surgery included weight-associated indications; band- or staple-related technical complications; and surgical-associated complications including infection, stoma stenosis, stoma dilatation, pouch enlargement, reflux, and nausea.

Between the three surgeries assessed — banding, vertical banded gastroplasty (VBG), and gastric bypass (GBP) — people who underwent banding were the most likely to undergo any type of revisional surgery over the maximum 26-year follow-up period. Nearly 41% of patients who underwent banding had a revisional surgery.

Revisions were less common for vertical banded gastroplasty patients, occurring in around 28% of patients. Revisions were the least common among those who underwent gastric bypass, with only 7.5% of these patients undergoing revisions.

As for reversal surgeries, those with banding were five times more likely to have a surgery reversal compared with those with VBG (40.7% vs 7.5%; HR 5.19, 95% CI 3.43-7.87, P<0.001). Banding and VBG patients were most likely to undergo a reversal or a conversion to gastric bypass.

However, when it came specifically to corrective surgeries — which mostly occurred within the first 10 years postoperatively — these generally had similar rates of incidence between all three types of surgeries, ranging from 5.3% of those with VBG to 7.1% of GBP patients.

“The greater weight loss after GBP is the likely main reason for a lower request for conversions in this subgroup compared with the subgroups that undergo banding and VBG,” wrote the researchers.

When broken down by surgery type, the most common reason for a revisional surgery among those who had banding was band-associated problems, such as migration stenosis or slippage. Among banding patients, nausea and weight-related indications were also common reasons for revision.

As for VBG patients, the most common indication for revisional surgery was staple-related disruptions, accounting for 10% of these patients. Nausea due to stenosis and collar migration were also common indications for revision. The most common indications for revisional surgery for gastric bypass patients were reflux-associated and esophagus-associated complications.

“The dominant reason for corrective revisional surgery was bile reflux (including esophagitis), which occurred only in patients with loop technique GBP,” the researchers noted, adding how “this demonstrates the superiority of the Roux-en-Y technique with regard to the need for secondary interventions.”

In an accompanying commentary, Ricardo Cohen, MD, of Oswaldo Cruz German Hospital in Brazil, praised the study, writing that “although the SOS study started in the 1990s and operative techniques have evolved, it brings answers about bariatric revisional surgery and raises thoughts regarding choosing the best index bariatric procedure.”

Cohen also pointed out that although the small percentage of gastric bypass patients included in the cohort was a limitation, it’s still apparent that this surgery accounted for fewer revisionary surgeries. “Among more than 200 Roux-en-Y gastric bypass procedures, only five (2.3%) required any reoperation,” he said.

“Revisional surgery carries a higher complication rate than the primary procedure, but if needed, it should not be denied,” Cohen added, also noting the growing number of reported revisions with the recently popular sleeve gastrectomy. Ultimately, he said, “maybe a wiser movement is to start with the right choice and curb the need for reoperations.”

The study was funded by the National Institutes of Health, Svenska Vetenskapsrådet, and a Sahlgrenska University Hospital ALF Research grant.

Näslund reported fees for consulting and lectures from Baricol AB, Sweden, outside the study; no other study authors reported disclosures.

Commentator Cohen reported financial relationships with Ethicon-JJ and serving on the scientific advisory board of GI Dynamics.

• Primary Source

  JAMA Surgery

  Source Reference: Hjorth S, et al “Reoperations After Bariatric Surgery in 26 Years of Follow-up of the Swedish Obese Subjects Study” JAMA Surg 2019; DOI: 10.1001/jamasurg.2018.5084.

• Secondary Source

  JAMA Surgery

  Source Reference: Cohen R “Revisional Bariatric Surgery and Choosing the First Procedure” JAMA Surg 2019; DOI: 10.1001/jamasurg.2018.5107.

https://www.medpagetoday.com/endocrinology/obesity/77253

Reata Has Clinical Trial Design for Phase 3 Polycystic Kidney Disease Treatment

Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced that it has completed a successful end-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical trial of bardoxolone methyl (bardoxolone) in patients with autosomal dominant polycystic kidney disease (ADPKD).

The trial, named FALCON, will be an international, double-blind, placebo-controlled, parallel group, Phase 3 trial.  The Company plans to enroll approximately 300 ADPKD patients randomized 1:1 to oral, once-daily bardoxolone or placebo.  The trial will include ADPKD patients from 18 to 70 years old with an estimated glomerular filtration rate (eGFR) between 30 to 90 mL/min/1.73 m².  The primary efficacy endpoint is the change from baseline in eGFR compared to placebo after 48 weeks of treatment followed by a 4-week drug withdrawal period, the retained eGFR benefit.

FALCON is statistically powered to detect a placebo-corrected, retained eGFR benefit of 1.6 mL/min/1.73 m².  Based upon guidance from the FDA, the 52-week retained eGFR benefit data may support accelerated approval under subpart H.  After Week 52, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year.  The second-year retained eGFR benefit will be measured at Week 104 after withdrawal of drug for four weeks.  Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval.

The Company expects to initiate enrollment in the FALCON trial during mid-2019.

https://www.marketscreener.com/REATA-PHARMACEUTICALS-INC-28377265/news/Reata-Announces-Clinical-Trial-Design-for-FALCON-a-Phase-3-Trial-of-Bardoxolone-Methyl-for-the-Trea-27820155/

Senseonics 1st Study Participant Implanted in Monitor Study

Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced that the extended life Eversense® XL sensor that lasts up to 180 days has been implanted in the first U.S. study participant as part of the clinical trial for pre-market application submission to the Food and Drug Administration.

The PROMISE Clinical Study is intended to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes over a 180-day period. Approximately 180 study participants at up to 15 locations across the United States are planned to enroll in the study. The Eversense XL sensor previously received the CE Mark and is currently marketed to patients across the European Union.

Senseonics also announced that the company has completed its submission of PMA supplements to the FDA to secure an insulin dosing claim and to remove the contraindication related to the Magnetic Resonance Imaging (MRI) exposure on the 90-day system which is currently available in the United States.

https://www.marketscreener.com/SENSEONICS-HOLDINGS-INC-26786073/news/Senseonics-Announces-First-Study-Participant-Implanted-in-the-U-S-as-Part-of-the-PROMISE-180-Day-27820424/

Bausch Health’s Bausch + Lomb Gets Canada OK for Glaucoma Treatment

Bausch + Lomb, part of Bausch Health (BHC), said Thursday that Health Canada issued a notice of compliance for Vyzulta for the treatment of glaucoma.

Vyzulta is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

https://www.marketscreener.com/BAUSCH-HEALTH-COMPANIES-I-44965076/news/Bausch-Health-Lomb-Gets-Canadian-Approval-for-Glaucoma-Treatment-27818120/

Clinical Trial Launches to Develop Breath Test for Multiple Cancers

Owlstone Medical (or the “Company”), a global diagnostics company developing a breathalyzer for applications in early disease detection and precision medicine, and Cancer Research UK, today announces the clinical launch of the PAN Cancer trial for Early Detection of Cancer in Breath¹, with the first patients now being recruited for the 1,500 patient study.

As previously announced on initiation of the collaboration, researchers in the trial are using Owlstone Medical’s² Breath Biopsy^® platform to collect samples, including healthy individuals as trial controls, to analyze volatile organic compounds (VOCs) in the breath.  The trial aims to identify VOCs that can be used as breath-based biomarkers to detect and differentiate different cancer types, thereby improving early detection.

This approach holds great promise as cancer cells display altered metabolism even at the very earliest stage of disease, affecting the pattern of the VOCs exhaled. By identifying the changing pattern of VOCs early, Owlstone Medical’s Breath Biopsy technology could detect cancer at the earliest stage of disease, when treatments are more effective and more lives can be saved.

The trial is recruiting 1,500 patients at Addenbrooke’s Hospital in Cambridge who have been referred from their GP with these specific types of suspected cancer. Prior to other diagnostic tests, breath samples will be collected using Owlstone Medical’s ReCIVA^® Breath Sampler and processed in Owlstone Medical’s Breath Biopsy laboratory in Cambridge, UK.

The clinical trial has initiated in patients with suspected oesophageal and stomach cancers and will expand to prostate, kidney, bladder, liver and pancreatic cancers in the coming months. Research is anticipated to run through 2021, and if the technology proves to accurately identify cancer the team hope that breath biopsy could in the future be used routinely in GP practices to determine whether to refer patients for further diagnostic tests.

Professor Rebecca Fitzgerald, lead trial investigator at the Cancer Research UK Cambridge Centre, said: “We urgently need to develop new tools, like this breath test, which could help to detect and diagnose cancer earlier, giving patients the best chance of surviving their disease. Through this clinical trial we hope to find signatures in breath needed to detect cancers earlier – it’s the crucial next step in developing this technology. Owlstone Medical’s Breath Biopsy technology is the first to test across multiple cancer types, potentially paving the way for a universal breath test.”

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “There is increasing potential for breath-based tests to aid diagnosis, sitting alongside blood and urine tests in an effort to help doctors detect and treat disease. The concept of providing a whole-body snapshot in a completely non-invasive way is very powerful and could reduce harm by sparing patients from more invasive tests that they don’t need.

“Our technology has proven to be extremely effective at detecting VOCs in the breath, and we are proud to be working with Cancer Research UK as we look to apply it towards the incredibly important area of detecting early-stage disease in a range of cancers in patients.”

Almost half of cancers are diagnosed at a late stage in England³. This highlights the importance of early detection, particularly for diseases like oesophageal cancer where only 12% of oesophageal cancer patients survive their disease for 10 years or more. For example, Rebecca Coldrick, 54 from Cambridge, was diagnosed in her early 30s with Barrett’s oesophagus, a condition where the cells lining the oesophagus are abnormal – often caused by acid reflux. Out of 100 people with Barrett’s oesophagus in the UK, up to 13 could go on to develop oesophageal adenocarcinoma⁴.

Rebecca Coldrick said: “About 20 years ago I developed acid reflux, and I began to live on Gaviscon and other indigestion remedies. I went to the doctors and shortly after I was diagnosed with Barrett’s. Every two years I have an endoscopy to monitor my condition.”

Dr David Crosby, head of early detection research at Cancer Research UK, said: “Technologies such as this breath test have the potential to revolutionize the way we detect and diagnose cancer in the future. Early detection research has faced an historic lack of funding and industry interest, and this work is a shining example of Cancer Research UK’s commitment to reverse that trend and drive vital progress in shifting cancer diagnosis towards earlier stages.”

Recognising the importance of early detection in improving cancer survival, Cancer Research UK has made research into this area one of its top priorities and will invest more than £20 million a year in early detection research by 2019.

To find out more about Owlstone Medical’s Breath Biopsy® platform, visit: https://www.owlstonemedical.com/science-technology/breath-biopsy/

https://www.biospace.com/article/clinical-trial-launches-to-develop-breath-test-for-multiple-cancers/