Century Therapeutics Strengthens Position in Autoimmune Disease with Strategic Pipeline Expansion Supported by $60 Million Private Placement and Acquisition of Clade Therapeutics
- Century Therapeutics plans to expand CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications beyond the CALiPSO-1 trial in SLE.
- A $60 million private placement of common stock supports Century's increased research and development activities in autoimmune diseases, extending the cash runway into 2026.
- The acquisition of Clade Therapeutics strengthens Century's position in allogeneic, iPSC-derived cell therapy by enhancing its pipeline with new programs in cancer and autoimmune diseases.
- Century's expanded pipeline includes three additional preclinical-stage programs from Clade's αβ iT platform, broadening its therapeutic offerings in autoimmune diseases and cancer.
- Century's strategic expansion into autoimmune diseases aims to address significant unmet needs for patients with treatment options.
- CNTY-101 demonstrates promising preclinical data supporting its efficacy in autoimmune diseases, with plans to evaluate it in moderate to severe SLE in the CALiPSO-1 trial.
- The $60 million private placement led by institutional investors like Bain Capital Life Sciences reinforces Century's financial position to drive further research and development in autoimmune diseases.
- The acquisition of Clade Therapeutics for approximately $35 million in upfront consideration adds value to Century's platform with new pipeline programs and technology enhancements.
- Century's acquisition of Clade Therapeutics includes a mix of cash and shares of Century common stock, with an additional milestone payment of $10 million upon future clinical achievements.
- Century's diversified pipeline now includes next-generation iNK and iT cell programs targeting cancer and autoimmune diseases, expanding its therapeutic capabilities.
- None.
Insights
The recent announcement by Century Therapeutics regarding the expansion of its iPSC-derived iNK cell therapy, CNTY-101, into additional autoimmune disease indications represents a strategic move that could significantly impact its financial outlook. The $60 million private placement led by Bain Capital Life Sciences and others underscores strong investor confidence in Century's approach and provides a reinforced cash runway into 2026. This financial injection is important for the company's aggressive R&D expansion, particularly as it transitions from preclinical to clinical stages which are capital-intensive.
Furthermore, the acquisition of Clade Therapeutics for $35 million in upfront consideration plus potential milestone payments enriches Century's pipeline and technological capabilities, potentially enhancing its market positioning and future revenue streams. The investment in the Allo-EvasionTM platform, aimed at reducing the need for lymphodepletion, could lower treatment-related risks and costs, potentially improving the commercial viability of CNTY-101. However, it's important to monitor how these strategic moves translate into clinical successes and regulatory approvals, which are key value drivers in biotech.
Century's strategic focus on expanding the indications for CNTY-101 beyond the initial B-cell malignancies to autoimmune diseases could address a significant unmet medical need, given the limited treatment options currently available for conditions like SLE. The preclinical data suggesting more potent B-cell killing by CNTY-101 compared to primary CAR-T cells, if corroborated by clinical trials, may lead to a paradigm shift in the treatment of autoimmune diseases.
However, the success of this approach hinges on the clinical outcomes of the CALiPSO-1 trial and subsequent studies. The technology's potential to enable repeat dosing without continuous lymphodepletion could be a game-changer, improving patient outcomes and compliance. The acquisition of Clade Therapeutics adds further value by incorporating novel αβ iT cell programs, which could diversify Century's therapeutic offerings and mitigate risks associated with the iNK cell therapy development.
From a market perspective, Century Therapeutics' strategic initiatives appear to be well-aligned with the growing demand for innovative treatments in the autoimmune disease space, which is projected to expand due to increasing prevalence and a push for personalized medicine. The iPSC-derived cell therapy market is still in its nascent stage, with significant growth potential. Century's early-mover advantage, particularly in the use of Allo-EvasionTM technology, could set a new industry standard if successful.
However, the competitive landscape includes several biotech firms investing in similar technologies and the market's response to Century's expanded pipeline will depend on the differentiation and efficacy of its therapies. The pricing strategy for these therapies upon approval will also be a critical factor, given the cost sensitivity in the healthcare sector. Investors will closely watch the progress of clinical trials and regulatory filings for cues on the company's growth trajectory and market potential.
Century is pursuing additional autoimmune disease regulatory filings for its iPSC derived iNK cell therapy, CNTY-101, beyond CALiPSO-1 trial in SLE, based on the potential of its differentiated profile
Private placement of
Acquisition of Clade Therapeutics strengthens Century’s position as a leader in allogeneic, iPSC-derived cell therapy through enhancement of pipeline and next generation Allo-EvasionTM platform
Newly expanded pipeline incorporates three additional preclinical-stage programs from Clade’s αβ iT platform spanning across cancer and autoimmune diseases
PHILADELPHIA, April 11, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, today announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a
“Today’s news signifies a transformative milestone for Century, as we accelerate and broaden our research and development initiatives in autoimmune diseases and iPSC-derived cell therapy on a larger scale. With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century. “We believe this strategic expansion of CNTY-101 into additional autoimmune disease indications, coupled with the incorporation of multiple new next-generation assets into our pipeline, represents an important step forward in our goal to address significant unmet need for patients across these serious diseases. We look forward to initiating CALiPSO-1 in SLE in the first half of this year, as well as the near-term pursuit of additional regulatory filings in autoimmune disease for CNTY-101, and presenting additional clinical data from ELiPSE-1 trial in the middle of this year.”
Autoimmune Expansion
Century is pursuing additional regulatory filings for CNTY-101 in autoimmune disease indications with limited current treatment options and high unmet need. CNTY-101 is a CD19 targeting allogeneic iNK cell therapy with 6 precision gene edits powered by Century’s Allo-EvasionTM technology, which enables repeat dosing without the need for continued lymphodepletion. This provides the opportunity to create tighter control over drug exposure and potentially enable B-cell depletion without causing prolonged B-cell aplasia. Use in autoimmune disease is also supported by Century’s preclinical data demonstrating CNTY-101’s ability to elicit more potent in vitro killing of B-cells from healthy donors and SLE patients as compared to primary CAR-T cells, as well as the encouraging initial safety, efficacy, and translational data from Century’s Phase 1 ELiPSE-1 trial in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).
Century plans to evaluate CNTY-101 in moderate to severe SLE in the Phase 1 CALiPSO-1 trial (NCT06255028), the first autoimmune disease indication for its platform. CALiPSO-1 will assess CNTY-101 in patients who have been exposed to two or more standard immunosuppressive therapies. The trial is on track to be initiated in the first half of 2024 with preliminary data expected by the end of 2024. Additional regulatory filings in other prioritized autoimmune disease indications are expected in the second half of 2024.
Private Placement
Century entered into a securities purchase agreement with a select group of institutional investors and accredited investors for an approximately
Century will issue approximately 15,873,011 shares of common stock in the private placement. The shares are being sold at a price of
The shares of common stock were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (Securities Act), and have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Century has agreed to file a registration Statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement.
The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules).
BofA Securities acted as the sole placement agent for the private placement made to institutional investors.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the shares offered in the private placement, nor shall there be any sale of such shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
Clade Therapeutics Acquisition
The acquisition of Clade strengthens Century’s position as a leader in allogeneic, iPSC-derived cell therapy through the enhancement of its next generation platform – including novel technology enhancing Century’s efforts on Allo-EvasionTM – and a newly expanded pipeline incorporating three additional preclinical-stage programs from Clade’s αβ iT platform spanning across cancer and autoimmune diseases. With favorable terms and synergies between these respective platforms, Century is well-positioned to drive further value in the cell therapy space in the near and long term.
“Under the leadership of a pioneering team of scientists and senior leaders with decades of experience in stem cell biology and iPSC differentiation enabled by significant capital investment from their investors, Clade has established a discovery engine with industry-changing potential,” said Hy Levitsky, M.D., President of R&D of Century. “These efforts have delivered a process capable of exquisitely controlling iPSC differentiation toward definitive hematopoiesis and the generation of adaptive αβ CD4+ and CD8+ T cells for the treatment of cancer and autoimmune diseases. This landmark achievement has been widely sought after in the field, replicating the events occurring during T cell development in the thymus to overcome key functional limitations of earlier generation cell therapies and unlock this modality’s seemingly limitless potential. Clade’s impressive achievements also include the creation of three lead therapeutic candidates, which will further enhance Century’s pipeline. Together with Century’s iPSC derived γδ T cells and NK cells, these platform advances provide industry-leading capabilities relevant across a range of applications.”
Century’s newly expanded and diversified pipeline incorporates additional next-generation iNK and iT programs spanning targets in cancer, and autoimmune diseases. These programs include CLDE-308, an αβ iT cell program targeting CD19 in autoimmune disease and B-cell malignancies, CLDE-361, an αβ iT cell program targeting BCMA in myasthenia gravis, and an undisclosed iT cell focused research program in solid tumors.
The aggregate purchase price of the Clade acquisition is approximately
Goodwin Procter LLP is acting as legal counsel and Lazard acted as financial advisor to Century. Cooley, LLP is acting as legal counsel to Clade Therapeutics.
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune and inflammatory diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived cell product candidates are designed to specifically target hematologic and solid tumor cancers, with a broadening application to autoimmune and inflammatory diseases. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer and autoimmune and inflammatory disease care. For more information on Century Therapeutics please visit www.centurytx.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the satisfaction of customary closing conditions with respect to the private placement and the Clade acquisition, the anticipated use of proceeds of the private placement, and our clinical development plans and timelines, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: changes in market conditions prior to the closing of the private offering or the Clade acquisition; our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our dependence on the success of our lead product candidate, CNTY-101; the ability of CNTY-101 to be administered as part of a multi-dose strategy and to enable responses without lymphodepletion; uncertainties inherent in the results of preliminary data, preclinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; the timing of and our ability to initiate and successfully enroll the Phase 1 SLE trial; our ability to successfully integrate operations with Clade Therapeutics; our ability to obtain FDA clearance of our future IND submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
For More Information:
Investors/Media: Julie Seidel/ Noor Pahlavi – century@argotpartners.com
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