Showing all posts written by Alistair McIntyre
Alistair received his J.D. from UC Berkeley Law, where he was a member of and contributor to the Berkeley Technology Law Journal and involved with the Samuelson Law, Technology & Public Policy Clinic. Prior, Alistair received a Bachelor’s degree in Biomedical Engineering at the University of Minnesota and a Master’s degree in Bioengineering from UC San Diego.
Cambridge Cognition Acquires eClinicalHealth, Targets Improved Virtual Clinical Trial Offerings
Cambridge Cognition Holdings PLC announced on October 12, 2022 that it acquired eClinicalHealth Ltd. (eCH) for about $1.9 million. eCH offers the Clinpal platform, which facilitates virtual clinical studies. Per the announcement, Cambridge Cognition acquired eCH to “enhance” Cambridge Cognition’s capabilities within the virtual clinical study space. According to Cambridge Cognition, the addition of eCH allows coverage of “all modules from recruitment through to clinical reporting.”
Founded in 2012, eCH is a digital technology provider. eCH’s Clinpal is an end-to-end clinical study platform. Clinpal allows researchers to configure a study, market to and recruit potential study patients, gather data from enrolled patients, and store and access study data. According to eCH, several studies involving a “top 10 pharma” company have already used Clinpal.
Cambridge Cognition is a tech company that develops digital solutions for clinical cognitive studies. More specifically, the company offers several different digital platforms intended for use at various stages of a clinical study, such as patient recruitment, study design, and data analysis. According to Cambridge Cognition, virtual clinical study is suitable for many different central nervous system disorders—for example, depression or Alzheimer’s disease. Such studies can run regular cognitive assessments at home. In this vein, Cambridge Cognition’s CANTAB platform enables remote assessment. CANTAB can administer cognitive tests to a patient via a mobile device.
Zooming out, the expansion of the virtual clinical trial market may have been accelerated by the COVID-19 pandemic. As of 2022, 89% of clinical study sponsors use decentralized technologies and methods in their studies.
Boston Scientific Acquires Embolization Gel Developer Obsidio, Inc.
Boston Scientific announced on August 15, 2022, that it acquired Obsidio, Inc. for an undisclosed fee. Obsidio has technology called the Gel Embolic Material (GEM™), which is used in minimally invasive blood vessel embolization. According to its press release, Boston Scientific intends to expand its interventional oncology and embolization portfolios.
An embolization treatment procedure uses a material to obstruct or reduce blood flow through a blood vessel. The treatment may be used to stop hemorrhaging, to stabilize blood vessel malformations, or to reduce blood flow to tumors, which are often highly vascularized.
Founded in 2019, Obsidio initially sought to commercialize technology relating to NIH-funded research on hemorrhage control and aneurysm treatment. Obsidio subsequently obtained FDA approval for GEM™ on July 1, 2022, claiming equivalence to Biosphere Medical’s EmboCube™ Embolization Gelatin. According to Obsidio, GEM™ is a semi-solid made up of bioresorbable gelatin, layered silicate, and tantalum powder. The material is delivered to a target vessel via catheter. As a semi-solid, the material is supposed to conform to the shape of the target vessel. Additionally, GEM™ is supposed to be shipped in a ready-to-use form, which, according to Boston Scientific, may save some preparation time relative to other embolization materials.
Boston Scientific is a multinational biomedical engineering company. In 2021, Boston Scientific spent over $4 billion across five acquisitions. Obsidio is the second of Boston Scientific’s acquisitions in 2022, the other being a $230 million deal for Synergy Innovation’s majority stake in M.I.Tech, a developer of a conformable, self-expanding metal stent called HANAROSTENT®.
Cancer Drug Patent Not Dead Yet
(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR Immunoconjugate Dosing Regimens”:
A federal judge in Virginia ruled it unpatentable, but the Federal Circuit overturned that decision.
The ‘809 application relates to dosing for the cancer drug mirvetuximab, an immunoconjugate. Generally, immunoconjugates include (1) an antibody portion typically targeting a cell of interest, and (2) a drug coupled to the antibody through a chemical linker. The antibody portion of mirvetuximab targets a folate receptor often overexpressed in ovarian and peritoneal cancer cells.
Early clinical trials for mirvetuximab were mixed. The drug was effective, but caused ocular toxicity if dosage exceeded a certain threshold. The ‘809 application claimed dosing below this threshold: “a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.” AIBW accounts for a patient’s sex, total body weight, and height.
The district court had ruled on summary judgment that the ‘809 application was indefinite and obvious. However, the Federal Circuit held this violated proper procedure by resolving factual disputes against ImmunoGen, the non-moving party.
In one such dispute, the district court had found the ‘809 application indefinite partly because “for example” preceded the AIBW formula in the specification. It held this example did not fall within the claims and declined to hear expert testimony regarding whether a skilled artisan would use the formula. But the Federal Circuit pointed to a particular claimed dosing regimen for a specific immunoconjugate, reasoning this could lead one of skill in the art to choose a specific corresponding AIBW formula. This undermined the district court’s finding of indefiniteness.
In another factual dispute, the district court had held the claims obvious because based on prior art, a skilled artisan would have known to use AIBW dosing to address mirvetuximab’s side effects. The district court found ocular toxicity was a known side effect of immunoconjugates, even though there was no directly supportive expert testimony. The Federal Circuit pointed to contrary evidence in the record: that side effects were not well understood and that it is difficult to generalize the pharmacological effects of immunoconjugates.
Accordingly, the Federal Circuit overturned the indefiniteness and obviousness findings and sent the case back to the district court. Now ImmunoGen has another opportunity to pursue grant of the ‘809 application.