Clostridioides difficile, commonly known as C. diff, is a significant health threat in the U.S. Recent estimates suggest that C. diff, a common bacteria, can cause infection in roughly 500,000 patients annually in the U.S., with around 30,000 of these cases resulting in death. “Actually, it’s more like 5 million when you think about it in terms of people at risk,” estimated Brian Finrow, founder and CEO of Lumen Bioscience, a biotech specializing in developing novel biologics. C. diff infection (CDI) is especially prevalent and dangerous in the immunocompromised elderly patients who are hospitalized or have been in nursing homes for long periods. “It’s a huge cost driver,” Finrow. Annual U.S. costs tied to CDI have eclipsed $6 billion per year. The infection is especially prevalent and dangerous in the elderly. Complicating matters further, recurrent CDI infections are common, affecting anywhere from 20% to 35% of patients with an initial infection.A s…
Oncolytic adenoviruses have won significant attention in recent years as a novel approach to cancer treatment. One example of the trend is AdAPT-001 TGF-ß Trap, an engineered variant of the common cold virus equipped with a transforming growth factor-beta (TGF-β) “trap.” This mechanism is designed to latch onto and neutralize TGF-β, an immunosuppressive cytokine involved in cancer cell growth and disease progression.
At the 2023 ASCO Annual Meeting, the developer of AdAPT-001, EpicentRx, shared initial findings from a phase 1 trial on AdAPT-001. The initial data indicates that patients generally tolerate AdAPT-001 well.
So far, the study has enrolled 28 patients for treatment with AdAPT-001 as a single agent. EpicentRx plans to enroll an additional roughly 50 patients for a phase 2 portion where AdAPT-001 will be combined with immunotherapy.
In the phase 1 por…
Dr. Judy Wang, Associate Director of Drug Development at the Florida Cancer Specialists and Research Institute, explained the science behind the therapy. “CLN-619 is a human IgG1 monoclonal antibody that binds to cell surface ligands called MICA and MICB. These new immune therapies are trying to overcome t…
The VC-backed microrobotics startup Bionaut Labs has entered into a strategic collaboration with Candel Therapeutics.
Candel (NSDQ:CADL) — a biopharma focused on oncolytic viral immunotherapies — will explore the use of Bionaut Labs’ miniature remote-controlled robots. Could the robots help deliver Candel’s oncolytic viral immunotherapy agents to certain brain tumors?
Founded in 2016, Bionaut Labs has focused on developing new modalities for treating central nervous system disorders since its inception.
Now, Bionaut will work with Candel to further the preclinical development of a micro-robotic system that can deliver oncolytic viruses directly to brain tumors, including high-grade gliomas.
“Bionaut designed its platform to provide accurate and safe access to hard-to-reach locations in the CNS,” said Michael Shpigelmacher, Bionaut Labs’ CEO.
Executives at Bionaut were impressed with Candel’s presence in …
Takeda Pharmaceutical Company Ltd. (TSE:4502/NYSE:TAK) is moving forward with its plan to acquire its collaborator GammaDelta Therapeutics Ltd. (London).
The acquisition is subject to customary closing conditions. Takeda projects that the deal will close in the first quarter of its fiscal year, which will end on June 30, 2022.
The acquisition would bolster Takeda’s immuno-oncology and immunotherapy portfolio, given GammaDelta’s experience working with gamma delta (γδ) T cells as potential therapies for solid tumors hematological malignancies.
GammaDelta had developed allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms. Those platforms encompass blood-derived and tissue-derived cells.
“We’re committed to developing cell therapies that will have an impact on large segments of patients by focusing on off-the-shelf, allogeneic cell therapies that are highly accessible and have the potential to address solid tumors,” Christopher…
Amgen (NSDQ:AMGN) has acquired privately-held immunotherapy specialist Teneobio (Newark, California).
The transaction includes an upfront $900 million upfront payment and future contingent milestone payments worth up to an additional $1.6 billion.
Tenebio’s stated mission was to tap human heavy-chain antibodies to “redirect the immune system to safely fight disease.”
Earlier this year, it had three drug candidates—TNB-383B, TNB-486 and TNB-58—in Phase 1 trials. The company had 11 additional candidates in earlier stages of discovery and development.
Amgen believes that the acquisition will complement its work on T-cell engagers and bi- and multispecific biologics. “Teneobio’s expertise and technologies will further expand our repertoire of multispecific architectures and advance our overarching mission to develop transformative innovation to bring to market best-in-class products to serve our patients,” said Dr. …
With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications, we face the dawn of a new era in anticancer research. New therapeutic targets, novel classes of products, booming and competing pipelines, innovative statistical methods, and a changing regulatory environment are all features of this new era.
More than ever, we need clinical trials that can incorporate the required innovations into their design, conduct, infrastructure and analysis. Fortunately, specialist CROs stand ready to take what they have learned from the past 10 years of oncology drug development and apply it to the new world in which we find ourselves.
These CROs already know how to meet the challenges of segmented study populations and an increasingly competitive development landscape, how to implement complex and adaptive…
An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica.
Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results.
In previous years, the scientific community established that immunotherapy can rarely cause interstitial lung disease (ILD). An umbrella term covering several conditions such as pulmonary fibrosis that lead to scarring of the lungs, ILD also arises in some patients with COVID-19.
The fact that ILD can arise from COVID-19 and cancer immunotherapies complicated oncology clinical trials, recalled Gebow at Bioclinica, which provides clinical trial adjudication products and services. “Patients in immunotherapy clinical trials were showing up at the emergency room with some type of lung infection,” Gebow said. “You can imagine if you’re the pharmaceutical company…
After living through the COVID-19 pandemic over the past year, it’s understandable that most people consider viruses to be our enemies causing illness and harm to humans. However, this outlook fails to consider the many surprising advantages these submicroscopic collections of genetic code afford scientists in pushing the boundaries of medicine.
Viruses have honed advantageous skills over billions of years of evolution to invade and hijack the cellular machinery of living organisms, including bacteria, fungi, animals and, importantly, humans. As such, this ability to manipulate life has enabled researchers to gain insights into how best to exploit this advantage for good. This effort has already yielded new biological therapies to treat a wide range of diseases, including rare, inherited disorders treated with gene and…
Dr. Michael Gross, a disgruntled shareholder of immunotherapy specialist IMV (NSDQ:IMV), has launched an offensive intended to cause a leadership shakeup at the company.
Gross released a press release on June 1 announcing his plans to oust the company’s board chair Andy Sheldon and the chair of the board’s compensation committee, Julia Gregory.
The director must receive a majority of shareholder votes to retain his role.
IMV will hold an annual general meeting on June 18.
On June 4, Gross released a new press release stating that he had the support of approximately 25% of the outstanding common shares of IMV.
Gross also stressed that he believes in IMV’s potential.
An IMV spokesperson said the company’s management is aware of the concerned shareholder but had no further comment. The company has made recent changes to its board, installing Dr. Michael Kalos and Kyle Kuvalanka. Kalos is an expert in T-cell therapy and immunotherapy…
A former director of medical and scientific affairs at Merck (NYSE:MRK) faces criminal charges in federal court in New Jersey for allegedly stealing and transmitting trade secrets.
Shafat A. Quadri has been released on $100,000 unsecured bond. He was most recently employed at AstraZeneca (NSDQ:AZN).
The single count of trade secret theft carries a maximum potential penalty of up to 10 years in prison and a fine as high as $250,000, or double the total financial gain or loss, according to Rachael A. Honig, acting U.S. attorney for the District of New Jersey.
The complaint describes Quadri’s former employer as “Company 1,” stating that the organization reached out to the FBI in Oct. 2019 to report suspicious activity regarding its sensitive intellectual property. Quadri had been employed at that company until Sept. 30, 2019.
The suit alleges that Quadri …