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Kincell Bio to acquire Imugene’s North Carolina manufacturing facility for up to $6M USD in upfront and milestone-driven payments over three years
Kincell will expand its capacity and commitment to provide high-quality development and manufacturing support for the immunocellular therapy market
As a result of the transfer, Imugene will recognize $32M USD in staff cost reductions, manufacturing efficiencies and overhead savings over the next three years
With the transfer of the manufacturing facility and staff and the outsourcing of Azer-cel process development to Kincell, Imugene reduces staff by 50% and extends its cash runway to 2026
The strategic manufacturing and process development partnership will support Imugene’s Azer-cel clinical study supply

Sydney, Australia and Gainesville, FL USA, 16 April 2024: Imugene, Ltd. (“Imugene”)(ASX: IMU) and Kincell Bio, LLC (“Kincell”), announce a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina Current Good Manufacturing Practice (CGMP) manufacturing facility and the transfer of process and analytical development activities to Kincell.

Under the terms of an asset purchase agreement between Imugene and Kincell, Kincell will acquire Imugene’s CGMP compliant cell therapy manufacturing facility in North Carolina for a total consideration of up to $6M USD in upfront and milestone-driven payments. Both parties have entered into a manufacturing supply agreement whereby Kincell will manufacture Imugene’s Azer-cel to support ongoing clinical trials. Imugene will also transfer process and analytical development of Azer-cel to Kincell in order to support process and method optimization for commercial readiness.

Leslie Chong, Managing Director and Chief Executive Officer of Imugene, commented, “We are delighted to have found a strong partner for the development and manufacturing of our CAR T Azer-cel program. We are confident that this strategic partnership with Kincell will enable Imugene to reach key upcoming data inflection points and extend the company’s cash runway to 2026. Moreover, this partnership allows us to focus on our key capabilities, namely the development of novel cancer treatments. With the transaction, we look forward to continuing to work with many of our former manufacturing colleagues in a new relationship as our contract development and manufacturing organization partner.”

Bruce Thompson, CEO of Kincell, said, “The acquisition of this facility and experienced team, which is actively manufacturing CGMP-compliant products that can support late-stage and/or pivotal clinical trials, accelerates our ability to expand our service offerings for cell therapy developers. The facility’s location in Research Triangle Park (RTP) will facilitate access to talent in a fast-growing and attractive biotech hub. Additionally, we’re excited that the manufacturing supply agreement enables us to partner with Imugene, an innovative immunotherapy company, to optimize and progress an allogeneic CAR T product candidate into later-stage development for patients with significant unmet medical needs.”

The 32,800-square-foot, state-of-the-art, CGMP-compliant facility is designed with the flexibility to expand in capacity and scope to support the manufacture of cell-based therapies. Kincell intends to evolve the site capabilities while leveraging enterprise-wide expertise to manufacture a broad portfolio of autologous and allogeneic products.

For more information please contact:

Imugene

Leslie Chong
Managing Director and Chief Executive Officer
info@imugene.com

Investor Enquiries
shareholderenquiries@imugene.com

Media Enquiries
Matt Wright
matt@nwrcommunications.com.au

US Investor and Media Enquiries
Heather Armstrong
harmstrong@imugene.com

Connect with us on LinkedIn @ImugeneLimited
Follow us on Twitter @TeamImugene
Watch us on YouTube @ImugeneLimited

Kincell Bio

Business Enquiries
Bruce Thompson
Chief Executive Officer
contactus@kincellbio.com

Media Enquiries
Annie Spinetta
aspinetta@6degreespr.com

About Imugene (ASX:IMU)

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumours. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.

Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.

About Kincell Bio

Kincell Bio engineers cells into therapies. Headquartered in Gainesville, Fla., Kincell is a technology-forward contract development and manufacturing organization (CDMO) formed to streamline analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing. Kincell’s initial focus is on manufacturing commercially viable immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs. For more information, visit www.kincellbio.com.

Release authorised by the Managing Director and Chief Executive Officer Imugene Limited and Chief Executive Officer Kincell Bio.

eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, and Kincell Bio, a contract development and manufacturing organization (CDMO) focused on cell therapies, today announced the formation of a new global partnership for a breadth of advanced therapy manufacturing services. This partnership seamlessly brings together both companies’ CGT manufacturing capabilities in Europe and the US. Customers can now access a global development and manufacturing footprint in combination with the boutique customer-focused offerings of both companies.

Key collaboration features include:

Vast Capabilities: The partnership promises a seamless fusion of their distinctive strengths, presenting a suite of services for both the U.S. and international CGT developers, such as:
- Viral vector manufacturing
- Autologous cell therapy (CAR-T, CAR-NK, CAR-M, iPSC-derived) manufacturing
- Allogeneic cell therapy (iPSC-derived and MSC) manufacturing
- Process and analytical development
- Facility development consulting based on eXmoor’s experience designing over 30 CGT sites globally, providing customers the option to seamlessly transfer manufacturing in house
- CMC development consulting, providing customers the right-first-time strategy for their clinical and commercial development
Global Reach: Leveraging eXmoor’s and Kincell’s expansive networks and strategic locations, the alliance aims to swiftly penetrate global markets, meeting the increasing demand for cell and gene therapies.
Innovative Facilities: This synergy is underscored by eXmoor’s state-of-the-art 65,000 sq. ft Cell and Gene Therapy Centre in the UK and Kincell’s 29,000 sq. ft. campus in Gainesville, Florida. These facilities will enable the manufacture of vectors in the UK, and of autologous and allogeneic cells in both the US and UK.

“We are responding to our customers’ desire to access the deep domain expertise and hands-on engagement from a specialist CGT CDMO while contracting with a single partner, for a global program,” said Angela Osborne, CEO of eXmoor. “Partners will have access to services associated with larger companies, like launching cross-Atlantic clinical trials, without sacrificing the personal attention each of our teams is known for.”

“We are thrilled to partner with eXmoor to support global opportunities. Through seamless interaction across two different geographies, we will leverage our combined expertise to help advanced therapy developers solve for a broad range of manufacturing requirements,” said Bruce Thompson, CEO of Kincell Bio. “This is an exciting time of growth for us, following our exit from stealth last month. As we have pivoted the team in Gainesville to manufacturing services, Kincell Bio has retained an innovative mindset. This will enable us to partner with clients across both geographies to accelerate product development, and give therapeutic innovator companies the best opportunity to get their live-saving therapies to market.”

About eXmoor pharma

eXmoor pharma is a one-stop cell-and-gene-therapy partner accelerating the manufacturing journey from research to patients. Founded in 2004, eXmoor has specialized in the CGT sector since 2007, helping organizations to understand, plan and implement the appropriate CMC strategy. eXmoor does this via its combination of GMP manufacturing capability and its translation and capital consulting groups, including process and analytical development labs. eXmoor has completed over 500 projects for 150 organisations and is headquartered in Bristol, UK, with 80 current employees, growing to 200 by 2027. To learn more: exmoorpharma.com.

About Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs, as well as developing expertise in stem cell products and iPSCs. For more information, visit www.kincellbio.com.

For further information, please contact info@kincellbio.com

A small CDMO called Kincell Bio launched Wednesday, with its CEO hoping to fill a niche offering cell therapy manufacturing for early-stage biotech startups.

Kincell Bio, a technology-forward contract development and manufacturing organization (CDMO) focused on cell therapies, today emerged from stealth with $36 million in new funding. Kineticos Ventures led Kincell’s launch funding.

Kincell is a spinout of Inceptor Bio’s CMC, manufacturing and quality organizations formed to accelerate innovator research and clinical trials. Kincell acquires a facility and a fully staffed team based at its Gainesville site, with plans to grow in Gainesville, as well as in additional key markets, such as Research Triangle Park (RTP), Boston and other customer locations.

Kincell offers analytical development, process development, CMC consulting and early-stage GMP manufacturing focusing on immune cell therapies, including autologous and allogeneic Chimeric Antigen Receptor (CAR)-T, CAR-NK and CAR-M programs. The Company plans to establish in-house mRNA development and additional GMP manufacturing capacity while forging trusted partnerships for viral vector and plasmid DNA supply to support all cell engineering processes.

Shailesh Maingi, founder of Kineticos Ventures and of Inceptor Bio, will serve as chair of the Kincell Board of Directors.

“Kincell represents a significant step forward in bridging the gap between laboratory research and clinical development of cell therapies,” said Mr. Maingi. “By addressing the manufacturing challenges faced by early-stage innovators, Kincell is playing a vital role in accelerating the progress of cell therapy innovation. We are excited to support their mission to make cell therapy manufacturing more accessible and streamlined, ultimately bringing life-changing treatments to patients in need.”

Kincell will be led by Chief Executive Officer Bruce Thompson, Ph.D., who will also serve on the Board of Directors. Dr. Thompson brings over 20 years of CMC strategy, product development and cell therapy manufacturing experience, with previous cell and gene therapy manufacturing and development leadership positions at National Resilience, Inc. (Resilience), Lyell Immunopharma, Fred Hutchinson Cancer Center and Pfizer.

“Kincell is at the forefront of innovative cell therapy manufacturing, and I am honored to lead this exceptional team. Our mission is to enable early-stage biotech companies to bring their life-changing therapies to patients by providing accessible and high-quality manufacturing services,” said Dr. Thompson. “With our technology-forward approach and focus on immune cell therapies, we are poised to accelerate the advancement of cell therapies from bench to bedside. I am excited about the potential impact we can make in the field and look forward to collaborating with our partners to drive innovation and improve patients’ lives.”

For more information, visit www.kincellbio.com.

About Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs, as well as developing expertise in stem cell products and iPSCs. For more information, visit www.kincellbio.com.

About Kineticos Ventures
Kineticos Ventures’ portfolio of investments is made up of biotechs and life science services companies striving to disrupt how drugs are developed, diseases are diagnosed, and patients are treated. The Kineticos Ventures fund focuses on significant, unmet medical needs in oncology, neurosciences, and rare diseases. In addition to targeting these disease states with patients in need, we look for companies utilizing disruptive technologies such as cell and gene therapy, gene editing, and mRNA/RNAi, all technologies dramatically changing how medicine is practiced.

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Media Contact
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6 Degrees
handerson@6degreespr.com

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