With the rapid growth in the global cell and gene therapy (CGT) market, South Korean pharma firms have increasingly been diversifying into the contract manufacturing area for these novel modalities via cross-border acquisitions.
Among these, leading biopharma group GC - which has a strong focus on cell therapies and the US market in particular - acquired the US-based cell therapy contract development and manufacturing organization (CDMO) BioCentriq Inc. in 2022 to broaden its capabilities and scale its platforms. The group's affiliates include GC Biopharma Corp. and GC Cell.
The CGT sector has now reached a new stage with an increasing number of late-phase pipeline assets receiving approval or moving towards commercialization. In 2023 alone, several CGTs were approved by the US Food and Drug Administration, while in the fourth quarter the number of such candidates in Phase III trials increased 10% from the previous quarter.
CGT Landscape: Recent Approvals, Deals And 2024 Catalysts
Flexibility And Autonomy
In this environment, GC’s acquisition has positioned BioCentriq for the next phase of growth. From a CGT landscape perspective, there is an opportunity for CDMOs to provide more solutions, including those that can help get commercialized therapies to patients more quickly.
“When you take a look at where BioCentriq is right now, it has prior experience. It has produced products for patients going into the clinic, but certainly given what the market needs, together with the support of GC, we want to help take it to the next level,” BioCentriq CEO Syed T Husain said in a video interview with Scrip.
The executive, who came on board only recently, said the company is putting together a growth phase plan but ultimately is moving towards the goal of providing solutions to innovators that go all the way through to commercial manufacturing.
From GC's standpoint, the group has a long history and successful track record out of Korea. One of the main reasons that GC Corp., the group holdings firm, acquired BioCentriq was that it wanted to enter the US market and that it is a big believer in cell therapy.
The group also has the US-based pharma firm Artiva Biotherapeutics, Inc. under its wing, whose lead program AlloNK is an allogeneic, non-genetically modified and cryopreserved NK (natural killer) cell therapy.
“I think CDMO businesses, if they're run well, they allow you a lot of diversification and it could be a really exciting platform,” said Husain. “What makes GC a great partner is they're very supportive and they provide us the backing. But they're also very understanding of the fact that a US business and a US company need to have the flexibility and autonomy to operate in that [the US] market.
"It's a different type of market. So, I think it's great to have a parent corporation that thinks like that.”
CGT Manufacturing Outlook
Amid the increasing CGT pipeline globally, the number of commercialized cell therapies is also rising. Once they achieve this stage, the reach is ultimately going to be global - but manufacturing activity for such therapies versus other modalities will require more local capabilities, Husain emphasized.
“Certainly, innovators always want to start with the US. That's where products are always launched first, which is what we're ideally set up for. But then ultimately, as these commercialized cell therapies reach the global network, it's going to require regional manufacturing.”
“And that's where, whether it's a company like BioCentriq that at the right step in its journey expands globally, or it's other CDMOs that are in a position to do that, I think that’s how ultimately the landscape is going to go,” he predicted.
BIOSECURE Validates Strategy
Speaking on the proposed BIOSECURE Act in the US, he believes that this planned legislation and what customers in the pharma/biotech space are focused on validates BioCentriq's and GC's strategy. "They want a US-based CDMO partner that has expertise, capacities and capabilities in the US. It's able to stand on its own two feet and that's why the growth strategy is very much focused on concentrating on the US assets," Husain explained.
“I think the BIOSECURE Act is certainly something that is very real. It's raising the right type of questions in our opinion and it's ensuring that manufacturing, especially for a complex modality like this, is very much based out of the US,” he added.
“Certainly, these products are global so there's going to be a time and place where you need to also have manufacturing across the globe as well. But first and foremost, I think this just supports what we're doing and I think that's why GC has essentially doubled down on BioCentriq. That's why I'm a part of this journey as well and that's why we're looking to grow.”
Video Interview Time Stamps
00:32 Biggest Changes Since Acquisition By GC
02:27 BioCentriq’s Role In GC’s Strategy
04:16 Company Growth Strategy
05:30 Strengths Versus Rival Firms
08:42 Business Priorities For Next Few Years
11:00 CEO’s View, Strategy On US BIOSECURE Act
12:46 Cell/Gene Therapy Manufacturing Market Outlook
14:18 Longer-Term Goals For BioCentriq
