Pharmaceutical Technology Editors

Generate Life Sciences announced the establishment of its good manufacturing practice (GMP) facility in La Jolla, Calif. for newborn stem cell biologics end-to-end manufacturing. This facility will add the role of a personalized therapeutics developer with in-house manufacturing capabilities to the company’s core international donor gamete, genetics service, and newborn stem cell preservation business.

With its bioreactor system, automation, and its meeting cGMP regulations, the new facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.

"The La Jolla GMP facility will be a crucial addition to Generate's vision for our newborn stem cell operation," said Jaime Shamonki, chief medical officer of Generate Life Sciences, in a press release. "As the largest private newborn stem cell biorepository in the world, we believe it is our duty to continually invest in new scientific applications for newborn stem cells with the goal to increase access to novel therapies for families. With this facility, we will have the in-house capability to take these stem cells through the complete process of collection, cryogenic storage, and ultimately biologics manufacturing. This will allow us to power our studies in a much more efficient and streamlined manner and help us better serve the families who have stored over 1.2 million stem cell units with us."

Mesenchymal stem cells (MSCs) can be isolated from the umbilical cord tissue and used in regenerative medicine due to their anti-inflammatory, immune-modulating, and tissue reparative properties. Researchers and scientists are targeting the use of MSCs for the treatment of conditions such as autoimmune disease, acquired neurological diseases, lung disease, and conditions related to infertility. In addition, MSCs are being used in clinical trials for cell therapy, gene therapy, tissue-engineering, and combination products.

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The GMP facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.

Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Facility

MorphoSys AG announced the successful completion of its previously announced cash tender offer for all outstanding shares of Constellation Pharmaceuticals in a July 15, 2021 press release.

All shares that were validly tendered and not validly withdrawn have been accepted for payment. MorphoSys will complete its acquisition of Constellation, and Constellation will be an indirect wholly owned subsidiary of MorphoSys. The merger is expected to close on July 15, 2021, and the value of the transaction is approximately $1.7 billion.

"With Constellation's high-potential product candidates, complementary R&D capabilities, and outstanding team, we can further advance our mission in the fight against cancer," said Jean-Paul Kress, CEO of MorphoSys, in a press release. "This transformational acquisition bolsters our position in hematology-oncology and marks the beginning of an important next chapter in our company's history."

MorphoSys will remain headquartered in Munich, Germany. It will also maintain a commercial and R&D presence in Boston, Mass.

MorphoSys completes the acquisition of Constellation, a clinical-stage biopharmaceutical company. 

MorphoSys to Complete $1.7 Billion Acquisition of Constellation Pharmaceuticals

Kriya Therapeutics announced in a July 14, 2021 press release the closing of a $100 million Series B financing to support the design, development, and manufacturing of gene therapies.

According to the press release, the financing proceeds will be used to further develop Kriya’s core technology platforms, expand its therapeutic pipeline, and advance its current programs in metabolic disease, ophthalmology, and oncology.

“With the support of our new and existing investors, we believe that Kriya is well positioned to deliver transformative improvements in cost, scale, and efficiency that will help the gene therapy field achieve its full potential across a range of therapeutic areas,” said Shankar Ramaswamy, co-founder and CEO of Kriya Therapeutics, in a press release.

The financing was led by Patient Square Capital, with participation from Woodline Partners LP, CAM Capital, Hongkou, Alumni Ventures, and other new investors. All existing institutional investors also participated.

Kriya Therapeutics completes $100 Million Series B financing to advance its platform for designing, developing, and manufacturing gene therapies. 

Kriya Therapeutics to Advance Gene Therapies with $100 Million Financing 

In a July 14, 2021 press release, Biofabri and IAVI announced their partnership on efficacy trials of the tuberculosis (TB) vaccine candidate MTBVAC. MTBVAC is manufactured and developed by Biofabri, a subsidiary of the Zendal Group, in collaboration with University of Zaragoza, IAVI, and the Europe-based Tuberculosis Vaccine Initiative.

To date, Bacille Calmette-Guérin is the only TB vaccine available; it does not prevent primary infection and has limited effectiveness at preventing pulmonary TB in adults.

The Phase II trial of MTBVAC is expected to be completed in 2021. If it is found to be safe and efficacious, MTBVAC will be manufactured and supplied in partnership by Biofabri and IAVI to neonates, infants, adolescents, and adults. The intention is for MTBVAC to be accessible at affordable prices in low- and middle-income countries.

MTBVAC has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.

Zendal and IAVI to Advance Tuberculosis Vaccine Candidate into Efficacy Trials

ImmunityBio announced in a July 14, 2021 press release the authorization from the South Africa Health Products Regulatory Authority (SAHPRA) to proceed with the South Africa sisonke T-cell universal boost trial. Beginning in Q3 2021, the Phase I/II/III trial will evaluate hAd5 spike + nucleocapsid (S+N) as a boost for South African healthcare workers previously vaccinated with an S-only COVID-19 vaccine.

“Several peer-reviewed studies demonstrate that patients who have recovered from SARS-CoV in the 2003 outbreak possess long lasting memory T cells reactive to the nucleocapsid protein of SARS-CoV 17 years after infection,” said Patrick Soon-Shiong, founder and executive chairman of ImmunityBio, in a press release. “While antibodies block infection when present, T cells are vital for long-term immune memory. We are excited to begin this controlled, randomized trial of boosting a previously administered DNA-based viral vector vaccine with our own Ad5 dual-antigen S plus N vaccine to see if it can augment protection in participants who have received the S-based vaccine alone.”

The effect of combining vaccination by two administration routes—subcutaneous and sublingual (SL)—will be assessed in the trial. This combination has the potential to deliver protection from the virus with a single injection followed by droplets placed under the tongue.

In a separate Phase I trial in South Africa, the SL and nasal routes of administration are currently being tested. SL administration results in the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity. This immunity could reduce the chance of infection and potential spread of the virus via the respiratory tract. The three formulations that don’t require an injection—SL, intranasal, and oral capsule—can be administered without a healthcare professional and are easier to transport and store.

According to the press release, this is the first randomized control trial to study a heterologous boost of an S-only vaccine with an Ad5 S+N vaccine boost versus a single S-only prime vaccine as control. The endpoints are to examine whether the boost reduces breakthrough infections currently occurring in South Africa in the sisonke T-cell boost trial.

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

SAHPRA Authorizes ImmunityBio to Proceed with Trial of T-Cell Vaccine as Booster Against COVID-19

Tevogen Bio announced in a July 14, 2021 press release its support of the Yale School of Public Health’s regulatory sciences program expansion, providing students with professional training. This expanded program builds on the current regulatory affairs track in the Yale School of Public Health’s Master of Public Health program, which focuses on the administrative, policy, and legal aspects of product regulation.

Regulatory sciences on the other hand, focuses on the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products made by pharmaceutical, biologic, and medical device organizations, in addition to other industries.

“Stakeholders are searching for talented and emerging leaders in regulatory science, but current educational programs are scarce,” said Sten H. Vermund, Dean of the Yale School of Public Health, in a press release. “With Tevogen Bio’s support, we have an opportunity to reimagine our program and to grow it into one that matriculates students who ultimately become national and international leaders in the field.”

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.