Pharmaceutical Technology Editors

BAT, a multi-category consumer goods business, has launched a biotech company, KBio Holdings, for the acceleration of research, development, and production of novel medicines that leverage plant-based technology.

According to a Jan. 7, 2022 press release, KBio will be focused on the delivery of treatments for rare and infectious diseases by realizing and expanding on the potential of the plant-based technology platform from BAT and its existing plant biologics organization, Kentucky BioProcessing (KBP), along with the existing clinical and pre-clinical vaccines and antibody pipeline. The new biotech will be seeking out innovative R&D collaborations and financing to expand its therapy pipeline and future portfolio. The ultimate aim will be for KBio to become financially self-sufficient.

“I am excited by the opportunity to build on the significant accomplishments made by BAT and KBP. I am confident in the potential of KBio’s powerful plant-based platform, capabilities and emerging early-stage pipeline,” said Patrick Doyle, the newly appointed CEO of KBio, in the press release. “To-date, the technology has demonstrated its ability to produce novel antibody and vaccine candidates with high purity at a fraction of the time and cost of current technologies. The speed and efficiency demonstrated by the KBio platform has significant potential. This could enable us to progress to clinical studies faster than industry norms, in the hope of delivering treatment solutions more quickly.”

“Science and innovation are fundamental to BAT and delivering on our purpose of building A Better Tomorrow. We recognize the potential of our innovative plant-based technology and have established KBio to maximise that potential,” added David O’Reilly, BAT’s director of Scientific Research, in the press release. “We are excited to see what the future holds.”

Articles

BAT has launched KBio Holdings—a biotech focused on the acceleration of research, development, and production of novel medicines that leverage plant-based technology.

BAT Launches Biotech Company to Accelerate the Development of Novel Medicines

BBI Solutions, an independent provider of immune-diagnostic reagents and contract services, has announced on Jan. 4, 2022 that it has completed the acquisition of BioTeZ Berlin-Buch—a Germany-based manufacturer of reagents and finished tests for the 

Through the acquisition, which also includes Steffens Biotechnische Analysen, BBI Solutions will increase its capabilities and will enhance its portfolio and position as a ‘complete’ immunoassay reagent supplier. Adding to BBI Solutions’ existing portfolio will be the BioTeZ’s Streptavidin-based portfolio, as well as immunoassay development services that will complement the company’s existing service offering.

“This latest acquisition of BioTeZ and Steffens-Biotec further enhances our portfolio and positions BBI as a leading immunoassay reagent supplier,” said Mario Gualano, CEO of BBI Group in the press release. “It enables us to provide additional products and services in the fight against the COVID pandemic. The combined research and development capability will provide customers of both BioTeZ and BBI with new, innovative products and a broader portfolio for greater choice.”

“We are very proud to become part of the BBI family and to be able to reach many more customers worldwide,” added Uwe Ahnert, CEO of BioTeZ, in the press release. “In doing so, we will be able to support them in the production and development of innovative diagnostics.”

BBI Solutions has completed the acquisition of BioTeZ Berlin-Buch—a Germany-based manufacturer of reagents and finished tests for the in-vitro diagnostics market.

BBI Solutions Acquires BioTeZ Berlin-Buch

Dutch vaccine specialist, Intravacc, is partnering with Leiden University Medical Center (LUMC) for the development and evaluation of a new intranasal coronavirus vaccine candidate in a clinical Phase I/II study. The partnership was announced in a Jan. 5, 2022 press release.

The nasal spray vaccine, NANOVAC, has been based on soluble nano-spheres with synthetic corona proteins that protect the upper respiratory tract and prevent the virus from entering the lungs. As a result of the vaccine’s design, it is expected to be broadly protective and able to protect against multiple corona viruses.

Preclinical studies performed by LUMC’s Translational Nanomaterials and Imaging department have shown positive results with the nasal spray vaccine. The Phase I/II clinical study will involve healthy volunteers so that the safety and tolerability of the vaccine can be evaluated. It is expected that the clinical trial will start at the end of 2022 with preliminary data available early in 2023.

“I am particularly pleased with Intravacc's input in the development of this new nasal spray vaccine. This concept and Intravacc's own AVACC-10 vaccine are potential game-changers in the fight against COVID,” said Jan Groen, PhD, CEO of Intravacc in the press release. “According to renowned immunologist Professor Ed Lavelle, of Trinity College Dublin, transmission of the virus is best blocked where it enters the body. It is therefore preferable to administer the vaccine via a spray in the nose for direct immunization of the throat and nasal mucosa (2022 nose spray interview).”

Intravacc is partnering with Leiden University Medical Center for the development and evaluation of a new intranasal coronavirus vaccine candidate in a clinical Phase I/II study. 

Clinical Trial on Intranasal Coronavirus Vaccine Set to Start

Commercial-stage biopharmaceutical company, Pharming Group, has been granted a positive opinion by the European Medicines Agency (EMA) for its Paediatric Investigation Plan (PIP) for leniolisib.

Leniolisib is a phosphoinositide 3-kinase (PI3K) inhibitor that Pharming is currently developing for the treatment of activated PI3K delta syndrome (APDS). So far, patients aged 12 years and older have been included in the ongoing registration of the Phase II/III study evaluating the therapy. However, as APDS affects younger children as well, the PIP, that has been agreed upon by EMA, will enable the company to enroll children as young as one-year old in future studies.

Once the agreed upon PIP has been successfully completed, the market exclusivity for leniolisib could be extended for a further two years in the European Union, which would be on top of the original 10-year market exclusivity the therapy has as a result of its EU Orphan Drug Designation. The company anticipates the top-line data from the Phase II/III registration in the first quarter of 2022.

“We are pleased to have received a positive PIP decision from EMA and accomplish this important regulatory milestone as we continue to advance leniolisib for the treatment of APDS in Europe as well as globally,” said Anurag Relan, chief medical officer of Pharming in a Jan. 6, 2022 press release. “The approval of the PIP further supports our confidence in the potential of leniolisib to address this orphan disease and population and provides us with a pathway towards marketing approval in Europe, in parallel with our [United States] regulatory strategy. Moving forward, we look forward to continuing to work with the regulatory authorities to bring leniolisib to the European market as expeditiously as possible.”

Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.

Pharming Gains Nod from EMA on PIP for Leniolisib

Piramal Pharma Limited (PPL) has invested INR101.77cr (US$13.7 million) in Hyderabad, India-based Yapan Bio to augment its contract development and manufacturing organization (CDMO) business, Piramal Pharma Solutions (PPS). With this investment, PPL holds a 27.78% equity stake in Yapan Bio.

The acquisition adds to PPS’ capabilities in developing and manufacturing large molecules for human clinical trials, the company stated in a Dec. 21, 2021 press release. Yapan Bio adds process development, scale-up, and current good manufacturing practice (CGMP)-compliant manufacturing of vaccines and biologics/biotherapeutics, including high-containment product classes (up to biosafety level-2+ [BSL-2+]), recombinant vaccines, RNA/DNA vaccines, gene therapies, monoclonal antibodies, therapeutic proteins, and other complex biologics.

The biologics capabilities that Yapan Bio offers can be synergistic with PPS’ antibody-drug conjugation capabilities, specifically benefitting customers who prefer an integrated program that includes development, manufacturing, conjugation, and fill/finish. PPS currently offers integrated payload, conjugation, and fill/finish services, which will now be enhanced with the addition of antibody capabilities from Yapan Bio.

“During the past decade, biologics and their accompanying development services are the fastest growing segments of the CDMO market. This investment, coupled with the market-leading capabilities of our Grangemouth, UK, site in antibody-drug conjugations and our sterile fill/finish capabilities in Lexington, [Mass.] [in the United States], demonstrates our commitment to growing our service offerings in the large-molecule CDMO space,” said Peter DeYoung, CEO, Pharma Solutions, Piramal Pharma Limited, in the press release.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Piramal Pharma Invests Minority Stake in India-Based CDMO, Yapan Bio

Thermo Fisher Scientific’s new Invitrogen TrueCut Hifi Cas9 Protein is designed for research applications that require highly precise genome editing, such as the engineering of chimeric antigen receptor (CAR)-T cells and the creation of cellular models for disease discovery. Launched in late November 2021, the new protein significantly minimizes off-target events while retaining maximum on-target editing efficiency.

The Invitrogen TrueCut HiFi Cas9 Protein complements Thermo Fisher’s existing portfolio of clustered regularly interspaced short palindromic repeats (CRISPR) genome-editing solutions by minimizing edits in unintended locations, which the company stated in a Nov. 30, 2021 press release are very disruptive in translational research, drug screening, and drug modeling. According to Thermo Fisher, the protein demonstrates near complete elimination of off-target effects compared to wild-type Cas9 in several cell types, including T cells and induced pluripotent stem cells (iPSCs). The company also stated that it has demonstrated improved off-target profiles relative to other products on the market in the release.

"Our pharma and biotech customers are looking for highly precise, accurate solutions to harness the power of CRISPR genome editing," said Brandon Pence, vice-president and general manager of cell biology at Thermo Fisher Scientific, in the press release. "Nothing is more disappointing than to find out months after an edit that the biological response you are measuring was due to an unintended off-target edit. The new Invitrogen TrueCut HiFi Cas9 Protein offers researchers the confidence that their edits took place where they intended, not somewhere else in the genome."

Thermo Fisher Scientific’s Invitrogen TrueCut HiFi Cas9 Protein offers the advantage of significantly minimizing off-target events while aiming to retain maximum on-target editing efficiency.