Pharmaceutical Technology Editors

Celularity Inc., a clinical-stage cellular medicine company developing off-the-shelf allogeneic therapies derived from the postpartum human placenta, announced in a July 16, 2021, press statement the closing of a merger with GX Acquisition Corp. (GXGX).

Proceeds from the transaction totaled approximately $138 million. The combined, publicly traded company will be named Celularity, Inc., and its common stock will commence trading on the Nasdaq Capital Market on July 19, 2021, under the ticker symbol “CELU.” Celularity’s management team will continue leading the merged company following this transaction.

“Celularity aims to transform the way we approach the treatment of cancer and other diseases by harnessing the versatility, unique immune biology and innate stemness of placental-derived cells,” said Robert J. Hariri, founder, chairperson and chief executive officer of Celularity in the press statement. “We are immensely proud of our clinical development results so far as well as the state-of-the-art manufacturing capabilities we built to support rapid scaling and a competitive cost structure for our placental-derived cell therapeutics. We believe off-the-shelf, allogeneic cell therapies will drive a paradigm shift in how clinicians approach the treatment of cancer and other serious diseases.”

“Our PIPE is led by existing Celularity investors, who understand the company’s pipeline and clinical development program and took advantage of the opportunity to add to their investment in Celularity.”Hariri also noted, “ Celularity has entered into important strategic and commercial partnerships with leaders like Palantir and Arthrex which we believe will strengthen our intellectual property and grow revenues from its existing marketed products.”

Dean C. Kehler, co-chairman and CEO of GX Acquisition Corp. and new board member of Celularity, added, “We are excited to see Celularity take this very important next step in its evolution as a transformative biotechnology company by becoming a publicly-traded company, listed on The Nasdaq Capital Market under the symbol “CELU”. This step will enable Celularity to continue to leverage the company’s commercial and clinical stage assets to treat diseases of high unmet need, like cancer, infectious diseases and degenerative diseases.”

The company reported the following details about the transaction in the press statement: “On January 8, 2021, Celularity, a clinical-stage biotechnology company leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum placenta, entered into a definitive business combination agreement with GX Acquisition Corp., a special purpose acquisition company (SPAC). Under the terms of the business combination agreement, the SPAC Sponsors and certain current equity holders, officers and directors of Celularity have agreed to be subject to a one-year lockup in respect of their common stock, in each case subject to certain customary exceptions, which will provide important stability to the leadership and governance of the combined entity.”

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Common stock of Celularity to commence trading on the Nasdaq Capital Market as “CELU” on July 19, 2021.

Celularity Closes Merger with GX Acquisition Corp 

A new report by Radnor Capital Partners and commissioned by the UK BioIndustry Association (BIA) has shown that international investors are being drawn toward the biotech sector of the United Kingdom.

According to the analysis, biotech shares on the London Stock Exchange have continued to outperform the wider market in the first half of 2021. Strong demand has been seen from North American investors and European investors for UK-quoted biotech’s, with UK larger institutions continuing to be material net sellers in value terms.

“These findings are further evidence that the UK is on the cusp of a golden age for biotech. Global investors, particularly from the US and Europe, can see the huge value in the sector and are flocking in,” said Martin Turner, head of Policy and Public Affairs at the BIA, in a July 13, 2021 press release. “There is a great opportunity here to capitalize on the UK’s position as an international hub for finance, combined with our world-leading biotech sector, to put the UK at the heart of a global industry that will dominate the 21st Century.”

“The capital raising element of our analysis is perhaps the most profound as 2020 saw a clear break from the previously established trend of declining fundraising activity,” added Iain Daly, director and co-founder at Radnor Capital Partners, in the press release. “The evidence from 2021 to date is that fundraising volumes are tracking below 2020 but well ahead of 2019. With a number of potentially material [initial product offerings] to come in [second half of the year], this picture is likely to remain positive.”

A new report by Radnor Capital Partners and commissioned by the BIA has shown that international investors are being drawn toward the biotech sector of the UK.

UK Biotech Attracts International Investment, According to New Analysis

Aptamer Group has signed a contract with a global pharmaceutical company to use Optimers (the company’s optimized aptamers) to support innovative vaccine development for neurodegenerative disease. The partnership was announced in a July 14, 2021 press release.

Under the terms of the agreement, Aptamer Group will receive an initial upfront payment and will then receive recurring licensing fees for over 10 years upon the implementation of the assay into the vaccine manufacturing processes. Aptamer Group will be required to isolate Optimer reagents and incorporate these into an analytical assay so that the vaccine candidate, currently being evaluated in clinical trials, can achieve regulatory compliance.

Optimer reagents are nucleic acid-based affinity reagents that can specifically bind to a target molecule and act as an antibody alternative. It is expected that the Optimer reagents will help to overcome cross-reactivity issues and allow specific detection and quantification of the active vaccine component within the vaccine additives.

“I am delighted to have established this long-term partnership to further develop the potential of the Optimer platform in biomanufacturing processes that will potentially generate recurring revenues for over 10 years for Aptamer Group. We will be working closely with our partner to support the development and implementation of the Optimer assay to provide effective solutions for vaccine production,” said Arron Tolley, CEO of Aptamer Group, in the press release. “The increased interest in pursuing Optimer technology as a critical part of clinical programs offers a strong endorsement of the technology. Optimer reagents are ideal affinity ligands for the detection and quantitation of biological products within complex mixtures, as they are highly specific and offer advantages in cost-effectiveness and consistency for use at scale.”

Aptamer Group has signed a contract with a global pharmaceutical company to use Optimers to support innovative vaccine development for neurodegenerative disease. 

Aptamer Group Secures Contract with a Global Pharma Company for Vaccine Development

Idifarma, a contract development and manufacturing organization (CDMO), has launched a new service aimed at delivering an accelerated pathway for complex drugs. The launch was announced in a July 14, 2021 press release.

The new service, Simply to Clinic, takes drug projects from pre-formulation to clinical trial implementation guided by Idifarma’s expertise in oral standard and highly potent drugs. Customers can receive tailored services in the development, scale-up, and manufacture of the product at Idifarma’s facility in Pamplona, Spain.

“The technologies and expertise gained by Idifarma across its support of clinical trials of spray dried and oral solid dosage forms for more than 20 years provides the strong foundation needed for this service,” said Idifarma’s head of site, Alfredo Gómez, in the press release. “Innovative products and clinical trials are often complicated because of timelines, regulations, and the use of highly potent active substances. We truly believe that Simply to Clinic will provide many pharma companies with a quick and smooth entry into the challenging clinical program of new drugs. We are experienced in the problems commonly faced and will offer ourintegrated services to achieve a successful, timely, and cost-effective outcome.”

CDMO Idifarma has launched a new service aimed at delivering an accelerated pathway for complex drugs. 

Idifarma Launches New Service for Accelerated Clinical Pathway

According to a July 9, 2021 press release, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax (Pfizer/BioNTech and Moderna vaccines, respectively).

PRAC considered all currently available evidence in reaching its conclusion, which included an in-depth review of 145 cases of myocarditis in the European Economic Area in people who had received Comirnaty and 19 cases in people who had received Spikevax. Additionally, the committee reviewed 138 cases of pericarditis in people who had received Comirnaty and 19 cases in those who had received Spikevax.

As a result of its review, PRAC has recommended that myocarditis and pericarditis are listed in the product information for both vaccines as new side effects. Furthermore, a warning should be included in the product information to raise awareness to healthcare professionals and patients to the risks of the potential side effects.

EMA confirmed that the benefits of all COVID-19 vaccines authorized for use in the European Union continue to outweigh the risks, but it will continue to monitor safety and effectiveness of the vaccines. Any new safety concerns will be communicated to the public and will be tackled via the necessary actions by the regulatory agency.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome, it was announced in a July 9, 2021 press release.

This recommendation has been based on a review of three cases where capillary leak syndrome occurred in people within two days of receiving Janssen’s COVID-19 vaccine. One of the patients had a history of capillary leak syndrome and two of the patients have subsequently died.

Capillary leak syndrome is a very rare and serious condition and as a result of PRAC’s review, it has been recommended that the condition be added to the product information as a new side effect of the vaccine. Additionally, EMA specified in its press release that awareness of the condition should be raised with healthcare professionals and patients.

Signs and symptoms of capillary leak syndrome include rapid swelling of the arms and legs or sudden weight gain, which is a result of the fluid leakage from small blood vessels. Associated symptoms include feeling faint as a result of low blood pressure.

PRAC will continue to review and monitor any further cases of capillary leak syndrome post vaccination. Furthermore, the committee has requested that Janssen provides further information about the possible mechanism for the development of capillary leak syndrome after vaccination.

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.