Archive for the ‘News’ Category

First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects

Monday, January 10th, 2022
Brief Summary:

To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In healthy subjects

Detailed Description:

The study will be conducted at 1 site in NZ. Patients who sign an Informed Consent and meet all eligibility criteria will be administered oral doses of 50mcg, 100mcg and 200mcg CoV2-OGEN1 on Day 1 and Day 15 during Cohort 1-3 respectively.

Follow up visit in all the 3 cohorts will be performed at 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months. One sentinel subject will be dosed at the start of each cohort and will be monitored for 24 hours post administration before the remainder of the cohort can be recruited. Each cohort will include one sentinel subject.

Follow up visit in all the 3 cohorts will be performed at 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months. One sentinel subject will be dosed at the start of each cohort and will be monitored for 24 hours post administration before the remainder of the cohort can be recruited. Each cohort will include one sentinel subject.

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Husband Of Vice President Kamala Harris Meets With Manufacturers And Business Owners At AEDC’s Bridgeworks Center

Tuesday, May 18th, 2021

US Specialty Formulations owner Kyle Flanigan offered remarks about his own challenges supporting employees during the pandemic before discussing his company’s coronavirus vaccine development and rollout. Bridgeworks Incubation Program Manager David Dunn worked closely with Flanigan in securing financing for his company through AEDC’s Urban Made program. Dunn was extremely pleased to see Flanigan as a part of the roundtable discussion.

During the listening session, the Second Gentleman commented on the impressive entrepreneurial spirit present within the facility and the strong sense of hope and community.

Strong Entrepreneurial Spirit Inside Bridgeworks Facility

Once thanking the participants, Emhoff informed them that he’d be able to share their individual stories at home that night and discuss them over dinner with his wife, Vice President Kamala Harris.

“In our roles at AEDC, we talk every day about the impactful work done by our local manufacturers,” said Erin Hudson, Marketing and Communications Specialist. Following the conclusion of the roundtable, Emhoff conducted brief interviews with the media and posed for photos before departing the Bridgeworks facility.

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Pharmaceutical company expanding Allentown operations

Monday, December 7th, 2020

U.S. Specialty Formulations (USSF), a pharmaceutical manufacturing company, plans to expand its Allentown operations to develop a COVID-19 vaccine with its partner VaxForm, USSF is using VaxForm’s oral vaccine platform technology to adapt an emergent that will act as a vaccine for SARS-CoV-2 (COVID-19). The platform will use proteins to produce an immune response.

Clinical materials from the Allentown plant will be used in phase one clinical safety trials in February. The company is seeking an emergency use authorization approval from the U.S. Food and Drug Administration for its oral and injectable COVID-19 vaccine. To meet the demand for the vaccine, the company will need to expand its facility, purchase equipment, and hire at least 97 employees.

“Completion of the USSF expansion will add a significant capability and capacity for our offerings and specifically to the oral Vaccine Platforms,” Dr. Kyle Flanigan, USSF CEO, said. “As we continue the ramp for our Generation 1 and Generation 2 oral platforms, USSF will have the manufacturing space and human resources to deploy vaccines throughout PA and the world.

This is expected to have a dramatic positive impact on world health.” The Department of Community and Economic Development awarded USSF with more than $225,000 through the COVID-19 Vaccines, Treatments, and Therapies program.

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Oral COVID-19 Vaccine Developed In PA May Be Ready In Early 2021

Friday, December 4th, 2020

PENNSYLVANIA — Two Pennsylvania companies are working together on groundbreaking, orally-administered coronavirus vaccines and hope to have their vaccines available by early to mid 2021. Clinical evaluations in humans are slated to begin in February 2021.During a news conference Thursday, US Specialty Formulations (USSF) CEO Dr.

Kyle Flanigan and VaxForm President Dr. Garry Morefield described the two versions of the vaccines their companies are teaming up to develop and produce at an Allentown plant. The vaccines will be offered in a liquid form and a capsule form. Morefield said the oral vaccines are anticipated to be equally as effective as injectable vaccines.

Flanigan said the trials should be completed by May, and at that point the companies will apply for an emergency use authorization from the Food and Drug Administration. However, exact timelines for vaccine production, approval, and distribution are difficult to establish.

About oral vaccines

Oral vaccines are not dependent on cold chain or the same material supply sets standard pharmaceuticals do, Flanigan said. Additionally, injectable vaccines need to have very high safety and sterility levels compared to what is needed for an oral system, Flanigan noted.

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Allentown pharmaceutical firm expanding to help create COVID-19 vaccines

Thursday, December 3rd, 2020
Garry Morefield of VaxForm, left, and Kyle Flanigan of US Specialty Formulations at Ben Franklin Tech Ventures in Bethlehem. PHOTO/FILE

An Allentown pharmaceutical manufacturing company, U.S. Specialty Formulations, is expanding again to continue its work developing a COVID-19 vaccine in partnership with VaxForm of Bethlehem. The expansion is expected to create at least 97 high-paying jobs at the company.USSF will expand its current 41,000-square-foot facility and request an FDA Emergency Use Approval for the release of a COVID-19 oral and injectable vaccine that should be available by mid-2021.

The company will be making renovations and acquiring new equipment to bolster its efforts. USSF is receiving funding from the state Department of Community and Economic Development in the form of a $291,000 Pennsylvania First grant and was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority loan to help with the expansion.

The governor’s office noted that the company has committed to investing at least $5.2 million into the project.

“There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Tom Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

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USSF and Vaxform Developing Oral COVID-19 Vaccine

Thursday, December 3rd, 2020

Governor Tom Wolf announced that US Specialty Formulations LLC (USSF), a pharmaceutical manufacturing company, will expand its operations in Allentown, Lehigh County to continue its work developing a COVID-19 vaccine in partnership with VaxForm LLC. Both companies are clients of the Ben Franklin Technology Partners of Northeastern Pennsylvania. This project will create at least 97 new, high-paying positions at the site.

Both USSF and Vaxform started at Ben Franklin TechVentures®, the award-winning business technology incubator owned and managed by BFTP/NEP. The companies’ partnership was facilitated by the proximity they enjoyed as resident companies. Ben Franklin invested a total of $225,000 in USSF. Starting with three staff members, USSF now employs 14 in high-value jobs, and Vaxform employs five.

“There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

USSF will expand its 41,000-square-foot facility in Allentown and will request an FDA Emergency Use Authorization (EUA) approval to release a COVID-19 oral and injectable vaccine in mid-2021. In order to meet its schedule, the company must make renovations, acquire equipment, and hire new employees.

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A COVID-19 vaccine that you drink? That’s what a company expanding in Allentown is working on

Thursday, December 3rd, 2020

Pharmaceutical executives Kyle Flanigan and Garry Morefield first met in 2011 on the sidelines of their daughters’ gymnastics program.“As parents sitting on the sideline watching kids do death-defying feats, we started talking to avert our eyes from what could have been catastrophe,” Flanigan said.

“That’s where the partnership began initially.” Today, the Lehigh Valley duo have their eyes firmly fixed on developing and producing an oral COVID-19 vaccine that people would drink, a formulation that wouldn’t require the same cold storage requirements as the injectable vaccines that appear to be speeding toward market release.

Toward those efforts, the company they co-founded in 2013, US Specialty Formulations LLC, joined with state officials Thursday to announce plans to invest more than $5 million and create nearly 100 high-paying jobs at a 41,000-square-foot facility at 101 E. Lexington St. in Allentown.

USSF and VaxForm LLC, a vaccine consulting firm headed by Morefield, have been partnering on the vaccine since earlier this year, a formulation that produced antibodies in 100% of mice in preclinical trials. Flanigan, USSF CEO, said the human trial is to begin in February.

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Pa. company hopes FDA will authorize oral COVID-19 vaccine

Thursday, December 3rd, 2020

PITTSBURGH, Pa. — Pfizer and Moderna are garnering the lion’s share of the attention when it comes to COVID-19 vaccines. Dozens of other companies are scrambling to find a cure for the virus, including one in Pennsylvania that might not even require a shot. Based in Allentown, which sits between Wilkes-Barre and Philadelphia, US Specialty Formations also hopes to be granted authorization from the FDA to distribute their vaccine.

The company is working alongside VaxForm to create the vaccine. “Starting in January, we’ll be scaling up our production, so we’ll have a stockpile of vaccine available to release as soon as we’re given the okay from the FDA,” said CEO Dr. Kyle Flanigan.

The vaccine would not need special refrigeration like what Pfizer and Moderna are putting out. Those require ultra-cold storage, creating shipping and storage issues all before anyone gets the vaccine.

The company said it anticipates creating nearly 100 new jobs. If everything goes according to plan, the FDA could grant authorization as soon as May for the oral vaccine. “We’re very excited about the progress we’ve made in a short amount of time,” said VaxForm president Dr. Garry Morefield.

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Governor Wolf Announces Life Sciences Partnership to Create Jobs, Develop COVID-19 Vaccine

Thursday, December 3rd, 2020

Harrisburg, PA – Today, Governor Tom Wolf announced that U.S. Specialty Formulations (USSF), LLC, a pharmaceutical manufacturing company, will expand its operations in Allentown, Lehigh County to continue its work developing a COVID-19 vaccine in partnership with VaxForm, LLC. This project will create at least 97 new, high-paying positions at the site. “There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Wolf.

“My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

USSF will expand its 41,000-square-foot facility in Allentown and will request an FDA Emergency Use Authorization (EUA) approval to release a COVID-19 oral and injectable vaccine in mid-2021. In order to meet its schedule, the company must make renovations, acquire equipment, and hire new employees.

There is currently a global shortage of pharmaceutical manufacturing capacity, further exacerbated by the COVID-19 pandemic, and very limited capacity for clinical investigators to obtain appropriately documented clinical grade materials.

USSF has been able to address both of these market challenges. USSF has also partnered with fellow Ben Franklin Technology Partners company VaxForm, LLC, to adapt an emergent oral vaccine platform technology to act as a vaccine for SARS-CoV-2 (COVID-19). This oral platform was originally designed and has been successfully tested to show that it produces the antibodies required to generate immunity to Diphtheria, Tetanus (Lockjaw) and Pertussis (Whooping cough).

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Eastern Pa. companies partner in development of ingestible vaccine

Thursday, December 3rd, 2020

Two Eastern Pennsylvania companies are working on creating ingestible covid-19 vaccines in drinkable and capsule forms, and leaders hope they could be on the market sometime next year.The vaccine work comes from a partnership between VaxForm and U.S. Specialty Formulations, the latter of which plans to expand its Allentown facility, make renovations, hire new employees and buy equipment – all things that are necessary to meet the anticipated timeline of making the vaccine available by mid-2021.

“There will be a global demand for covid-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Tom Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

Funding for USSF’s expansion comes from a Department of Community Economic Development grant worth nearly $300,000 and a $2.4 million Pennsylvania Industrial Development Authority Loan, Wolf said.

Another $225,000 came from the Covid-19 Vaccines, Treatments and Therapies Program, which aims to support the rapid creation of treatments and vaccines against the virus. In return, Wolf said, USSF has pledged to invest at least $5.2 million into the project and create nearly 100 jobs.

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