On the hunt for the next generation of ‘off-the-shelf’ cell therapies, biotech players like Adicet Bio have looked to leverage some of the less-obvious members of the immune system as potent cancer fighters. In Adicet’s case, scarce gamma delta T cells are on the menu, and an early cut of data is showing some promise.
Adicet’s AD-001, an off-the-shelf cell therapy developed by engineering a CD20-targeting chimeric antigen receptor (CAR) onto a donor’s gamma delta T cells, posted two complete responses across four patients in an early Phase I study testing the drug in patients with heavily pretreated B cell non-Hodgkin’s lymphoma, the biotech said Monday.
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KEY POINTS
Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients. The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers. A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.
Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Bolt Bio CEO Randy Schatzman
Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of ‘clinical activity,’ the biotech said Monday.
BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.
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Geoffrey Porges (SVB Leerink)
All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.
So is all that about to change, big time?
SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.
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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)
As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.
Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.
The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.
The agency’s review team said it ‘does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.’ Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.
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Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.
In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.
Seattle biotech Cyrus Biotechnology announced this morning that it closed an $18 million Series B — and landed an acquisition to boot.
The biotech, which has an in-house software program for biologics discovery, acquired Orthogonal Biologics, a spin-out from the University of Illinois that focuses on using ‘Big Data’ to run deep mutational scanning on proteins and receptors for drug discovery.
Rob Koremans, Recordati CEO
An Italian pharma company engineered a nearly $850 million buyout last week looking to expand its rare disease portfolio and further soak up parts of the US market, but questions remain over the drugs involved and when they could see patient uptake stateside.
Recordati shelled out the cash to acquire EUSA Pharma and its portfolio of four rare disease drugs, the companies announced Friday, allowing Recordati to position itself — by its own account — for growth in the US. EUSA’s top candidate for expansion is ostensibly the neuroblastoma drug Qarziba, approved in the EU for high-risk, newly-diagnosed individuals.
Jonathan Rigby, BioPlus Acquisition Corp board chair and CBO
The biotech sector has been booming throughout the Covid-19 pandemic — and while it has slowed down considerably, there are yet more SPACs at work.
Blank check company BioPlus Acquisition Corp announced last Thursday that it priced its upsized IPO of 20 million units at $10.00 per unit — for $200 million.
The SPAC started trading on Friday at $10.02 under the ticker $BIOSU.
BioPlus didn’t wade into details about its targets, saying only that it planned to merge with ‘Life Sciences Sector,’ according to the company’s S-1 filed back in July.
https://endpts.com/adicet-unveils-early-responses-for-off-the-shelf-drug-leveraging-rare-t-cells-will-durability-hold-up/
