Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

More allogeneic therapy growth is likely in 2022: Here’s why

By Brian Buntz | December 16, 2021

stem cell

Stem cell image from Pixabay

The market for allogeneic stem-cell transplants continues to grow. “We’re seeing an increased interest in allogeneic approaches and being able to have something readily available off the shelf,” said Joy Aho, senior product manager at Be The Match BioTherapies.

The momentum of this growth is likely to continue for allogeneic therapies into 2022 as researchers continue work on allogeneic chimeric antigen receptor (CAR)-T cells, CAR-NK (natural killer) cells and other therapies.

By contrast, the supply chain for autologous therapies is more complicated. “You’re also harvesting material from very sick patients, which is not ideal from a manufacturing standpoint,” Aho said.

If there is an autologous manufacturing failure, it becomes necessary to collect blood stem cells from the patient. In some cases, a patient may be too sick for another blood draw.

Such factors could put the brakes on the growth of autologous therapies, which still

Joy Aho

Joy Aho

“There’s a lot of those issues in autologous even with all of the upside,” Aho said.

Consistent growth likely for cell and gene therapy, too

The cell and gene therapy market has grown steadily, even during the pandemic. “In general, you saw continued development — you saw continued trials being initiated,” Aho said.

“We saw pauses and slowdowns in some of the existing trials,” Aho said. Such slowdowns were partly the result of drops in patient accrual resulting from the pandemic. Early trials tended to face more of a slowdown than Phase 3 studies. “For the bulk of these therapies, [sponsors] are treating patients with a final line of therapy.”

Expect continued regulatory scrutiny for allogeneic therapy

There have been a couple of examples of potential safety signals in allogeneic therapy. In October, Allogene Therapeutics announced that FDA had placed a hold on its AlloCAR T clinical trials after identifying a chromosomal abnormality in a patient enrolled in its ALPHA2 study. FDA is aiming to ensure there is a clear “characterization of those cells and understanding the potential risks going into that therapy,” Aho said.

Recently, Nature Medicine described the case report of a multiple myeloma patient who developed Parkinsonism symptoms three months after receiving a form of CAR T-cell therapy. The study used autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector used to express a CAR targeting the human B cell maturation antigen.

“When it’s autologous therapy, it’s your own cells. So there’s a lot of areas where there’s much less risk,” Aho said. “When you get to allogeneic therapies, then, there are a lot more considerations there in making sure that that starter material is properly characterized and everything happening, and that bar goes even higher.”

The risk is also potentially higher in therapies like induced pluripotent stem cells (iPSC) and regenerative medicine therapies when researchers aim to place a cell in the body that permanently resides there. “You could be doing something regenerative with diabetes treatment or something like that, then that bar has to be really high — those cells can’t go off the rails versus a lot of the therapies today,” Aho said. “When you think of T cells and NK cells, they’re not designed to stay there forever. They’re in there to do a job, and then they go away.”

Induced pluripotent stem cells remain a promising, if early, experimental therapy

Induced pluripotent stem (iPS) cell-based therapy offers significant potential for various diseases. For diabetes, for instance, researchers have explored differentiating the primitive stem cell-like cells into islet-like cells for diabetes patients. “It would be a cell replacement therapy,” Aho said.

BlueRock Therapeutics has a regenerative program for Parkinson’s disease. “They generated neurons in a dish. They’re frozen down, and then they’re put back into the brains of Parkinsonian patients.”

BlueRock got the Fast Track designation from the FDA for DA01, a pluripotent stem cell-derived dopaminergic neuron therapy. Blue Rock is also raised $225 million to develop potential stem cell therapies for heart damage.

Similarly, Fate Therapeutics (NSDQ:FATE) is developing NK cell therapies from iPS. Sana Biotechnology also has made a significant investment in developing similar therapies.

While such potential therapies offer considerable promise, there likely will be few tangible breakthroughs in the near term. “It’s not like going to be in the next couple of years,” Aho said. When you’re putting something in the body that’s meant to stay, you know, for the rest of your life, then that bar has got to be really high in terms of how you’re characterizing the cells,” she added. “It will be interesting to see what the FDA is going to require from that perspective.”


Filed Under: clinical trials, Drug Discovery
Tagged With: allogeneic, autologous, Be The Match BioTherapies, FDA, stem cells
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE