Pharmaceutical Technology Editors

FDA announced that it has issued an Emergency Use Authorization on June 17, 2022 for both the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old. The decision was made following an evaluation from FDA’s independent Vaccines and Related Biological Products Advisory Committee, who voted in support of the authorization.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to [six] months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said Robert Califf, FDA commissioner, in an agency press release. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

Previously, the Moderna vaccine had only been authorized for adults 18 and older. An FDA analysis of clinical trial data from Moderna found that the vaccine was 50.6% effective in preventing COVID-19 in children aged six months to 23 months two months after their second dose, and 36.8% effective in children aged six months to five years old. Individuals in the age six to 11 and 12 to 17 were found to have immune responses comparable to adults.

The Pfizer-BioNTech vaccine had previously been authorized for individuals five and older. An FDA analysis of clinical trial data from Pfizer found that the immune responses in children five months through four years old was comparable to the immune responses among individuals aged 16 to 25 who received two higher doses of the vaccine.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, [FDA] ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the release. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”

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FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.

FDA Authorizes COVID-19 Vaccines for Individuals Six Months and Older

Batavia Biosciences announced the expansion of its headquarters and R&D capacity in its Netherlands facility on June 14, 2022. The 22,500-ft² expansion will increase R&D activities for viral vector-based product development, including Lentivirus, adeno-associated virus (AAV), adenovirus, and measles virus vectors. The expansion is expected to be finalized by June 2023.

“The new laboratory floor space for R&D and analytical capabilities will aid the development capacity for customer projects,” said Chris Yallop, chief scientific officer, Batavia Biosciences, in a company press release. “The increased allocation for R&D capacity better positions Batavia Biosciences to serve as pacemakers to the community and to continue to bring promising candidate biopharmaceuticals from bench to clinic.”

According to a company press release, the increased R&D infrastructure is intended to meet increased global development for vaccine development, including live-attenuated, whole killed, vectored, or subunit vaccines.

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands

Aptamer Group and Flip Gene Therapeutics have negotiated a deal to use Aptamer Group’s Optimer technology to support Flip Gene Therapeutics’ gene therapy platform. Under the agreement, Aptamer Group will develop Optimer binders to several small-molecule targets, which will be incorporated into Flip Gene Therapeutics’ gene therapy platform with the goal of developing pharmacologically inducible gene therapeutics that are controllable with a gene switch.

The agreement includes initial upfront payments for Optimer development, with the potential for further licensing payments for the developed Optimer binders, and development and commercial milestone payments upon clinical and commercial success.

Optimer binders are oligonucleotide-based affinity ligands. They offer a solution to support novel gene therapy development through their potential for increased success in discovery over a broader target range and the ability to tune their half-life.

“I am delighted to have established this agreement to develop Optimer binders to enable inducible treatments in this exciting field of gene therapy,” said Dr. Arron Tolley, CEO of Aptamer Group, in a press release. “We will be working closely with our partner Flip Gene Therapeutics on developing and assessing the Optimer binders to function as part of their gene therapy platform. The interest in pursuing Optimer binders as part of their therapeutic modality offers a strong endorsement of the technology.”

Aptamer Group has signed a deal with Flip Gene Therapeutics to support the development of inducible gene therapies.

Aptamer Group Signs Deal with Flip Gene Therapeutics

SCHOTT has announced plans to triple its ready-to-use vial production capacity at its site in Lebanon, PA, to meet increasing demand for storing injectable drugs. The company currently provides a comprehensive product portfolio for ready-to-use vials with more than 750 product combinations.

Ready-to-use vials are particularly suitable for drugs, such as biologics and vaccines. The vials are pre-washed and sterilized and packaged in a standardized tub to simplify the filling process for pharmaceutical companies. The solution enables pharma companies to efficiently perform pre-clinical and clinical trials as well as commercial filling.

“With our investment, we are underlining our commitment to the global pharma industry and particularly the U.S. market. Additionally, we are enhancing our regional manufacturing footprint in Lebanon, Pennsylvania, where we are proudly celebrating our site’s 30th anniversary,” said Andreas Reisse, executive vice president of SCHOTT Pharma, in a press release.

“We are increasing our production capacity intending to meet the growing need for this product category and contribute to bringing the latest life-saving treatments to patients faster,” said Hakan Gerdan, who was appointed as SCHOTT’s new Plant Manager in Lebanon, PA at the start of 2022, in the release.

SCHOTT is planning to triple its ready-to-use vial production capacity in the United States to meet increasing demand for storing injectable drugs.

SCHOTT to Triple Vial Production Capacity in the US

Boehringer Ingelheim announced on June 14, 2022 that it has signed an option to acquire Trutino Biosciences, a San Diego-based biotech company.

Trutino Biosciences is a pre-clinical stage biotech company that focuses on the discovery and development of cytokine therapies to treat immuno-oncology and autoimmune diseases. The acquisition will advance Boehringer Ingelheim’s effort to mobilize a patient’s immune system to fight cancer through cancer cell-directed and immune cell-targeting compounds.

Under the agreement, Boehringer Ingelheim reserves the rights to purchase all shares of Trutino Biosciences once specified program milestones have been achieved within a given timeframe. Trutino will continue to operate as an independent company until that time.

“Boehringer Ingelheim is excited to extend our partnership with Dr. Kim and his outstanding team at Trutino Biosciences. Our existing collaboration has made rapid and impressive progress in a short time frame, and we expect this field to have potential combination benefits with our existing immune-targeting assets,” said Clive R. Wood, PhD, corporate senior vice president and global head of discovery research, Boehringer Ingelheim, in a press release. “The selective activation of specific cytokines localized in the tumor microenvironment holds enormous promise and has the potential to be a key element in fully harnessing the power of the immune system to fight cancer.”

Boehringer Ingelheim has signed an option to acquire Trutino Biosciences.

Boehringer Ingelheim to Acquire Trutino Biosciences

Late-stage clinical biopharmaceutical company, Humanigen, and global contract development and manufacturing organization (CDMO), PCI Pharma Services, have entered into an agreement for the commercialization of lenzilumab, it was announced on June 16, 2022.

Lenzilumab is a first-in-class monoclonal antibody that has been shown to neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF) associated with COVID-19 and other indications. Results from a Phase III study (LIVE-AIR) have suggested that when using lenzilumab as an early intervention it has the potential to prevent the consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

“We continue our commercial preparation in the UK [United Kingdom] and in parallel are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to address regulatory requirements for a potential Conditional Marketing Authorization. With its global reach, PCI will provide a critical function in the supply chain, by directly purchasing lenzilumab for further distribution in the UK and facilitating this key process for Humanigen,”saidEdward Jordan, chief commercial officer, Humanigen.“It is anticipated that we will complete our response to MHRA soon after the top-line results from the ACTIV-5/BET-B clinical trial with lenzilumab are received.”

Humanigen and PCI Pharma Servicesare partnering up for the commercialization of lenzilumab.