Day One Expands Pipeline with Potential First-in-Class Clinical-Stage Antibody Drug Conjugate (ADC) Targeting PTK7 in Solid Tumors for Adult and Pediatric Cancers
Day One Biopharmaceuticals (Nasdaq: DAWN) has secured an exclusive license from MabCare Therapeutics for MTX-13 (DAY301), a novel antibody drug conjugate (ADC) targeting PTK7, which is highly expressed in a range of adult and pediatric solid tumors. The investigational new drug (IND) application for DAY301 was cleared by the FDA in April 2024. The agreement includes $55 million upfront payment and up to $1.152 billion in potential milestone payments. Day One aims to dose the first patient in a Phase I study by late 2024 or early 2025.
- Exclusive licensing agreement for MTX-13 (DAY301) secured.
- FDA IND clearance for DAY301 received in April 2024.
- Potential first-in-class ADC targeting PTK7 in solid tumors.
- MTX-13 showed antitumor activity in pre-clinical studies.
- Potential $1.152 billion in milestone payments for MabCare.
- Strategic fit for Day One's mission to advance pediatric and adult cancer treatments.
- First patient dosing for Phase I study expected by late 2024 or early 2025.
- High upfront payment of $55 million for the licensing agreement.
- Additional payments tied to uncertain development, regulatory, and commercial milestones.
- Potential financial risk due to the high cost of development and commercialization.
- Delayed revenue impact as clinical trials are yet to start.
Insights
The exclusive licensing agreement with MabCare Therapeutics involves an initial payment of
The low-to-mid single-digit royalties on net sales will provide a steady revenue stream if DAY301 proves to be successful. However, investors should be aware of the inherent risks in clinical trials, including the possibility of unexpected results or regulatory hurdles that could delay commercialization.
In the near term, investors might see an impact on the company's operating expenses due to the initiation of Phase I trials. Nevertheless, the strategic addition of DAY301 to the pipeline aligns with the company's goal to expand its portfolio, which could enhance its market position and long-term growth prospects.
DAY301's target, PTK7, is a transmembrane protein overexpressed in several solid tumors, making it an attractive target for cancer therapy. PTK7's limited expression in normal tissues implies that the ADC could potentially have a more favorable safety profile compared to other treatments, minimizing damage to healthy cells.
This potential therapeutic framework could offer a new line of attack for difficult-to-treat cancers like esophageal, ovarian, lung and endometrial cancers, as well as pediatric cancers like neuroblastoma and osteosarcoma, which lack effective treatment options. The advancement of DAY301 into clinical trials represents a promising step forward in oncology, potentially expanding the treatment landscape for both adult and pediatric cancer patients.
The linker-payload technology used in DAY301 aims to overcome limitations seen in earlier iterations of PTK7-targeted ADCs, potentially offering a more effective and safer treatment option. This innovation could be a game-changer in the oncology field, providing new hope for patients with limited treatment options.
The entry of DAY301 into the clinical stage establishes Day One Biopharmaceuticals as a significant player in the oncology market. The focus on PTK7, a target expressed in diverse and challenging cancer types, positions the company well within a high-demand therapeutic area. If successful, DAY301 could address substantial unmet needs in both adult and pediatric oncology markets, potentially capturing a significant market share.
The unique positioning of DAY301 as a potential first-in-class ADC creates an opportunity for Day One to differentiate itself from competitors. The decision to pursue an exclusive license also reflects strategic foresight by Day One, aiming to leverage its existing expertise and accelerate the development process. The anticipated commencement of Phase I trials by late 2024 or early 2025 suggests that investors should closely monitor clinical updates, as positive results could significantly impact the company's valuation and market perception.
However, the licensing agreement's scope excludes Greater China, which could limit global market penetration. Despite this, securing the worldwide rights outside this region allows Day One to maintain a strong position in key healthcare markets such as the U.S. and Europe.
Day One receives exclusive license for development and commercialization of MTX-13 (DAY301), which received IND clearance by the FDA in April 2024
Targets PTK7, highly expressed in broad range of adult and pediatric solid tumors
BRISBANE, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it has entered into an exclusive licensing agreement (the Agreement) with MabCare Therapeutics (MabCare) for MTX-13, a novel ADC targeting protein-tyrosine kinase 7 (PTK7). Pursuant to the terms of the Agreement, Day One has exclusive rights to develop, manufacture, and commercialize MTX-13 worldwide, excluding Greater China.
In April 2024, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for MTX-13, which going forward will be identified as DAY301. In pre-clinical studies, DAY301 showed antitumor activity in a wide range of solid tumors.
“Our priorities for 2024 are to successfully launch OJEMDA™ (tovorafenib), to advance our existing programs and to expand our pipeline by in-licensing clinical-stage assets that have the potential to transform outcomes for patients of all ages living with cancers,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “We are excited by the opportunity presented by DAY301, and we believe we have the right team in place to develop the program to its full potential.”
DAY301 targets PTK7, a highly-conserved, catalytically inactive transmembrane protein that is overexpressed in multiple adult cancers, including esophageal, ovarian, lung, and endometrial cancer, as well as pediatric cancers such as neuroblastoma, rhabdomyosarcoma and osteosarcoma. PTK7 has limited expression in normal tissues or organs, making it an attractive target for therapeutic development.
“The addition of DAY301 to our pipeline strategically fits our mission of advancing both pediatric and adult medicines in areas of unmet need with equal urgency,” said Dr. Samuel Blackman, co-founder and head of research and development at Day One. “We believe the linker-payload technology embodied in DAY301 will overcome the limitations of earlier PTK7-targeted ADCs, giving us a potential first-in-class drug against a clinically-validated target. We are excited to add this program to Day One and will look to enter the clinic in the coming months.”
Under the terms of the licensing agreement, MabCare will receive
About Day One Biopharmaceuticals
Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.
Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™) and pimasertib.
Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop cancer therapies, including DAY301, expectations regarding planned and current clinical trials and the ability of tovorafenib to treat pLGG or related indications.
Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
FAQ
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