CELL AND GENE THERAPY, MEDTECH
Pear Therapeutics | January 09, 2023
Pear Therapeutics, Inc., the leader in commercializing and developing software-based medicines known as prescription digital therapeutics (PDTs), announced the expansion of its collaboration with Spero Health, an integrated healthcare services organization.
Spero Health, which has adopted reSET® and reSET-O® at 14 locations in Kentucky, plans to expand access to eligible patients at its remaining 99 locations in Kentucky, Indiana, Ohio, Tennessee, Virginia, and West Virginia. Offering new FDA-approved treatment options is a part of Spero Health's mission to promote patient engagement and retention in recovery.
Steve Priest, Spero Health’s CEO said, “Spero Health continues to find innovative ways with new technologies to bring solutions to our communities that have been devastated by drug overdose, and we are looking forward to our collaboration with Pear Therapeutics to pursue even better outcomes in treatment.”
Adding to this, he further said, “Pear’s technology equips our clinicians with vital measurements via a clinician dashboard that allows us to provide quality care to our patients who suffer from substance use disorders. We believe having access to patient reported data via Pear’s clinician dashboard gives us better insight into patient behaviors. We expect that this approach will help to increase compliance and create efficiencies in how our treatment teams deliver care.” (Source: BusinessWire)
Spero Health's two implemented products, reSET® and reSET-O®, have been measured in real-world use, and their therapeutic content has been evaluated in randomized controlled trials, with the results published in peer-reviewed medical journals. reSET® is used for patients aged 18 or older with substance use disorder as a monotherapy, whereas reSET-O® is used in combination with buprenorphine-based medication-assisted treatment for patients 18 and older with opioid use disorder.
About Pear Therapeutics
Pear Therapeutics, Inc., the parent firm of Pear Therapeutics (US) Inc., is a leader in the development and marketing of software-based pharmaceuticals, also known as prescription digital therapeutics (PDTs). The company intends to transform care through the widespread adoption of clinically validated software-based therapeutics to provide improved patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.
Puma Biotechnology, Inc. | March 16, 2023
Puma Biotechnology, Inc., a biopharmaceutical company, recently announced the online publication of the Phase II TBCRC041 randomized clinical trial results in JAMA Oncology. The trial investigated the use of alisertib, an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A, alone or in combination with fulvestrant in postmenopausal women with endocrine-resistant, HER2-negative metastatic breast cancer who were previously treated with fulvestrant.
The Phase II randomized clinical trial was conducted via the Translational Breast Cancer Research Consortium and included patients previously treated with CDK 4/6 inhibitors and everolimus.
The trial enrolled 91 evaluable patients, with baseline characteristics balanced between the two arms of the trial. However, more patients in the alisertib plus fulvestrant arm had previously received chemotherapy for metastatic disease (47.8% in the alisertib alone arm vs. 68.9% in the alisertib plus fulvestrant arm). In each arm of the trial, all patients had earlier been treated with CDK 4/6 inhibitors. Everolimus was previously administered to 37% of patients in the alisertib alone arm and 57.8% in the alisertib plus fulvestrant arm.
The trial's efficacy results indicated that nine partial responses were observed in the 46 evaluable patients in the alisertib alone arm, leading to an overall response rate of 19.6%. The median duration of response was 15.1 months, with a clinical benefit rate of 41.3% at 24 weeks. The projected median progression-free survival (PFS) was 5.6 months. Nine of the 45 evaluable patients in the alisertib plus fulvestrant arm of the study responded, for an overall response rate of 20.0%. There was one patient who had a complete response and eight patients who showed partial responses. The median duration of response was 8.5 months, with a clinical benefit rate of 28.9% at 24 weeks. The median PFS was expected to be 5.4 months.
The most prevalent grade 3 or higher adverse events in the alisertib alone arm of the trial were neutropenia (43.4%), anemia (19.6%) and leukopenia (17.4%). The most prevalent grade 3 or higher adverse events in the alisertib plus fulvestrant arm of the study were neutropenia (42.2%), leukopenia (31.1%), lymphopenia (15.6%), fatigue (11.1%), and anemia (8.9%).
About Puma Biotechnology, Inc.
Puma Biotechnology, Inc. is a leading biopharmaceutical company specializing in the development and commercialization of innovative treatments for cancer. Its flagship product is Nerlynx (neratinib), an oral tyrosine kinase inhibitor approved by the USFDA for the extended adjuvant treatment of HER2-positive early-stage breast cancer. In addition to Nerlynx, it has a robust pipeline of product candidates in various stages of development. The company is firmly committed to research and development and collaborates with leading academic institutions and research organizations to advance the understanding of cancer and develop new therapies.
MEDTECH, INDUSTRIAL IMPACT
ATUM and Codiak | January 25, 2023
On January 24, 2023, ATUM, a global leader in bioengineering solutions, announced that it has signed a comprehensive licensing agreement with Codiak BioSciences, a clinical-stage biopharmaceutical company, for the Leap-In Transposase® technology.
ATUM will grant Codiak access to its Leap-In Transposase® technology in order to create mammalian cells expressing exosomes engineered to deliver therapeutic payloads under the conditions of the agreement. The Leap-In technology is a comprehensive solution that integrates patented re-coding algorithms, unique genetic vector elements, and a transposon-based mechanism for efficiently inserting genetically stable elements into the genome.
"Through years of rigorous research and clinical validation we have created a platform for engineering and manufacturing therapeutic exosomes with various payloads on the surface or inside the lumen. We believe ATUM's transposase technology has the potential to effectively synergize with Codiak's engEx® Platform to further enhance loading these vesicles, making them more potent and reducing cost of goods," Commented Scott Estes, Ph.D., VP of Cell Line Development at Codiak.
(Source – Business Wire)
"Exosomes are bio vesicles that have the potential to fundamentally change drug delivery. We are proud and excited to license the Leap-In Transposase® technology to Codiak for the engineering of cell lines that enables rapid and robust production of exosomes," said Claes Gustafsson, Ph.D., Chief Commercial Officer and Co-Founder at ATUM.
(Source – Business Wire)
Founded in 2015, Codiak is a clinical-stage biopharmaceutical firm focused on developing exosome-based treatments, a new class of medications with the potential to change the treatment of a variety of diseases with high unmet medical needs. It created a proprietary engEx Platform that uses exosome biology as natural intercellular transfer mechanisms to design, construct, and manufacture innovative exosome therapeutic candidates. By utilizing its engEx Platform, it has produced a rich pipeline of engineered exosomes for neuro-oncology, oncology, neurology, neuromuscular, and infectious diseases.