Analyst Balaji Prasad initiates coverage
Monday, June 10, 2019
Genmab Signs Agreement with Janssen for Next-Generation CD38 Antibody
- Genmab signs agreement with Janssen Biotech, Inc. to collaborate exclusively on next-generation CD38 antibody product, HexaBody®-CD38, incorporating Genmab’s proprietary HexaBody technology
- New agreement builds on Genmab’s successful DARZALEX® collaboration with Janssen
- Next-generation HexaBody-CD38 could potentially add to the DARZALEX multiple myeloma franchise and expand the potential of CD38-targeted therapies in further indications
Genmab A/S (Nasdaq Copenhagen: GEN) announced today it has entered into an exclusive worldwide license and option agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab’s proprietary HexaBody technology. Under the terms of the agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and development activities until completion of clinical proof of concept studies in multiple myeloma and diffuse large B-cell lymphoma. Based on the data from these studies, Janssen may exercise its option and receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38. Should this occur, Janssen will pay Genmab a USD 150 million option exercise fee and up to USD 125 million in development milestones, as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13-20% tiered royalties on sales thereafter. Should Janssen not exercise its option, the terms of the agreement allow Genmab to continue to develop and commercialize HexaBody-CD38 for DARZALEX-resistant patients, and in all other indications except those multiple myeloma or amyloidosis indications where DARZALEX is either approved or is being actively developed.
The agreement is the outcome of pre-clinical research on novel CD38 targeting concepts conducted by Genmab. For HexaBody-CD38, Genmab obtained promising pre-clinical data in a panel of multiple myeloma, lymphoma and leukemia models.
Smith & Nephew acquires innovator in surgical optical tracking technology
Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces that it has agreed to acquire Atracsys Sàrl, the Switzerland-based provider of optical tracking technology used in computer-assisted surgery.
Atracsys’ fusionTrack 500 optical tracking camera will be a core enabling technology for Smith & Nephew’s multi-asset digital surgery and robotic ecosystem, including initially in its next-generation robotics platform due for commercial release in 2020. The fusionTrack 500 offers superior measurement speed and latency performance, supporting reduced procedure times, as well as increased accuracy resulting in finer precision surgical tasks, such as bone cuts, compared to existing tracking technology.
‘The promise of computer assisted surgery with robotics is to provide faster, more accurate, reproducible results that enable surgeons to restore quality of life to more patients,’ said Skip Kiil, Global President of Orthopaedics at Smith & Nephew. ‘With the acquisition of Atracsys, we are securing what we believe to be the best-in-class position tracking technology for our next-generation robotic-assisted surgical system.’
Atracsys’ portfolio includes open platform optical navigation and robotic tracking components with applications in orthopaedics, neurosurgery, spine and dental. Smith & Nephew plans for the business to continue serving these markets.
‘Our aim is to continuously contribute to the improvements in healthcare all around the world, guiding surgical instruments with sub-millimetric precision,’ said Gaëtan Marti, co-founder and Chief Executive Officer of Atracsys. ‘Smith & Nephew’s commitment to offer significant advancements in enabling technology across multiple surgical specialities will open breakthrough opportunities for robotics and computer-assisted surgery,’ added Maurice Hälg, co-founder and Chief Technology Officer.
The acquisition is expected to complete during the third quarter of 2019. The commercial terms have not been disclosed.
Genentech: Positive Topline Results for Phase 2 Lupus Study
- NOBILITY showed that Gazyva helped more patients achieve a complete renal response when added to standard of care
- The Phase II study met both primary and key secondary endpoints
- There are currently no FDA-approved therapies for lupus nephritis
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met its primary endpoint, showing Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year. In addition, Gazyva met key secondary endpoints showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo.
“There are no FDA-approved treatments for lupus nephritis, a potentially life-threatening condition in which patients are at high risk for progressing to end-stage renal disease or death,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We have been investigating a possible treatment for lupus nephritis for more than a decade and have integrated key learnings from that experience in how we study the condition. We are encouraged by the NOBILITY results, which showed a statistically significant difference in achievement of complete renal response, overall renal response, and other measures of disease activity and support the potential for a new treatment option for people living with lupus nephritis.”
Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus (SLE) resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with the highest risk of end-stage renal disease and death.1,2 In addition to meeting the primary endpoint, the study’s key secondary endpoint, defined as achievement of overall renal response (complete or partial renal response) at one year, was also met. No new safety signals were observed with Gazyva in the study at the time of this analysis. The full results from the study will be presented at a future medical meeting.
Presumed positive effect of cannabis consumption on opioid deaths not there
A just-published study has contradicted the findings of an early one that implied a connection between the availability of legal marijuana and opioid overdose deaths.
The earlier study, published in 2014 in JAMA Internal Medicine, showed that, between 1999 and 2010, states with medical cannabis laws had almost a 25% lower average rate of opioid overdose deaths compared to states without legal cannabis.
The new study, published today in PNAS, showed that the link reversed when the period was extended through 2017. The updated data showed that the rate of opioid overdose deaths was 23% higher in states with medical cannabis laws compared to states without.
ADA 2019 – a good start for Beta Bionics
The iLet system showed decent blood sugar control in its first trial, but the highly automated system is far from proven.
Data from the first human trial of Beta Bionics’ so-called bionic pancreas suggest that the device, which aims to be even more hands-off than other artificial pancreas-type systems, can improve blood sugar control compared with insulin injections or other insulin pumps.
The device worked well when used with glucose monitors from either Dexcom or Senseonics. But Medtronic’s status as the only company with a marketed artificial pancreas is safe for a little while yet: Beta Bionics intends to start a pivotal US trial of a newer version of the iLet next year.
The trial assessed the third-generation form of the iLet. The device’s USP is that patients only need to enter their weight and the machine calculates insulin doses from there, with no need to enter the other information, such as meal sizes and times, that is required by other closed-loop systems (Beta Bionics brings machine learning to insulin delivery, June 21, 2018).
The iLet system can administer insulin, glucagon or both to modulate blood sugar levels. In this trial, data from which were presented at the meeting of the American Diabetes Association on Saturday, the device was used to deliver insulin only.
Time in range
The trial enrolled 12 type 1 patients who usually treated their condition with multiple daily injections of insulin and 22 who used insulin pumps. It had a crossover design in which patients used their usual treatment method for seven days and iLet for seven days. 17 of the enrollees used Dexcom’s G5 continuous glucose monitor as the data input for the iLet, and the other 17 used the Eversense CGM from Senseonics.
Use of the iLet significantly increased the percentage of time patients had glucose levels in the target range of 70-180mg/dl compared with their usual care, and there was no statistically significant difference in time spent in hypoglycaemia between the two groups.
| DATA FROM THE FIRST HUMAN TRIAL OF BETA BIONICS’ ILET | |||
|---|---|---|---|
| iLet | Usual care | P | |
| Time spent in target blood sugar range (70-180mg/dl) | 70.1% | 61.5% | 0.006 |
| Time spent in hypoglycaemia (<54mg/dl) | 0.6% | 0.6% | 0.87 |
| Mean blood sugar level | 155mg/dl | 162mg/dl | 0.097 |
| Mean total daily dose of insulin | 44units/day | 42units/day | Not sig |
| Source: ADA abstract #77-OR; company communications. | |||
The amount of time spent in hypoglycaemia when on the iLet was lower when it was used with Dexcom’s G5 glucose monitor than with Senseonics’ Eversense; however, the researchers noted that it is unclear whether this represents an actual difference in hypoglycaemia or a difference in the detection of hypoglycaemia between the two sensors.
According to the abstract, “several device issues” occurred, prompting Beta Bionics to make changes to the design of the fourth-generation iLet to improve safety and usability. It is this version that will enter pivotal studies.
Bihormonal
The ADA data add to results from a different study assessing the use of the iLet to deliver both insulin and glucagon which reported last week. This dual-hormone configuration is one of the key stages in the development of a more advanced artificial pancreas, since it enables more sensitive control of blood sugar levels than an insulin-only system.
Also a crossover trial, this study compared the iLet in its insulin-only configuration for one week versus the bihormonal configuration, using Zealand Pharma’s dasiglucagon, for one week in 10 adults with type 1 disease.
When delivering both hormones the system allowed a mean glucose level of 139mg/dl, versus 149mg/dl during the insulin-only period. During the bihormonal period, participants spent 79% of the time with their glucose level in range, vs 71% during the insulin-only period. Neither difference was statistically significant, however.
| DATA FROM BIHORMONAL TRIAL OF BETA BIONICS’ ILET | |||
|---|---|---|---|
| Bihorminal iLet | Insulin-only iLet | P | |
| Time spent in target blood sugar range (70-180mg/dl) | 79% | 71% | <0.01 |
| Time spent in hypoglycaemia (<54mg/dl) | 0.3% | 0.6% | Not given |
| Mean blood sugar level | 139mg/dl | 149mg/dl | <0.01 |
| Source: company communications. | |||
These results are encouraging, though of course both trials are small. The dual-hormone configuration is behind the insulin-only form, not least because dasiglucagon is not yet approved. If the pivotal trial of the fourth-gen insulin-only version succeeds, iLet could hit the market in 2021, though 2022 might be more likely. The bihormonal version could arrive a year or two after that.
Beta vs alpha
The device would go up against Medtronic’s MiniMed 670G, the only approved closed-loop system in which a blood glucose sensor is linked to an insulin pump. It might also go up against Medtronic’s next-generation version, the 780G.
The 780G is designed to automate the delivery of insulin boluses when the user experiences, or is predicted to experience, prolonged high blood sugar. The pivotal study will enrol 250-350 adults and children with type 1 diabetes and is expected to conclude in January.
Beta Bionics’ single-hormone system stands little chance of knocking Medtronic’s tech into second place on the market. Medtronic, though, does not have a means of delivering glucagon as well as insulin, so if and when Beta Bionics can bring its dual-hormone system to market it will have an advantage. But that interesting situation will take some years to come about, if indeed it ever does.
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