At PLUS THERAPEUTICS, we fully understand that establishing successful relationships with global business partners and suppliers are essential to fulfilling our company mission in discovering, developing, and delivering complex and innovative treatments for patients battling rare cancers.
We aim to collaborate with parties that share similar priorities and values and can benefit from PLUS THERAPEUTICS’ strengths — proprietary technology, deep product and clinical development expertise, in-house manufacturing and analytical testing capabilities, and close proximity to and relationships with world-renowned cancer institutions and researchers in the state of Texas. We are also seeking collaborations with parties that can help PLUS THERAPEUTICS continue to innovate, advance and expand our pipeline, and deliver new treatments to patients in need around the globe.
We believe that we can create more value for and establish a higher bar in the healthcare industry by working together.
PRODUCT & TECHNOLOGY LICENSING OPPORTUNITIES
186RNL (BMEDA-Chelated Rhenium-186 NanoLiposome)
PLUS THERAPEUTICS’ 186RNL is a patented, targeted radiotherapeutic consisting of a BMEDA-chelated Rhenium-186 beta/gamma radiation particle encapsulated within a 100 nanometer diamter NanoLiposome. 186RNL is currently being evaluated in the ReSPECT™ U.S. NIH-supported Phase 1 clinical trial for recurrent glioblastoma and developed for additional indications including leptomeningeal metastases, pediatric brain cancer, peritoneal carcinomatosis, and head/neck cancer.
According to an Analyst Briefing by GlobalData in April 2021, the total market value of radiopharmaceuticals in oncology is projected to increase from $738M in 2020 to $3.6B by 2026. The radiopharmaceutical market in oncology has witnessed a significant amount of deal activity and R&D investment:
- In 2021, Aktis Oncology raised $72M in Series A funding
- In 2021, POINT Biopharma IPO resulted in $287M gross proceeds
- In 2020 and 2021, RayzeBio raised $258M in Series A, B, and C funding
- In 2020, Fusion Pharma IPO resulted in ~$213M gross proceeds
- In 2019, Fusion Pharma raises $105M to support development of targeted alpha-particle radiotherapeutics for cancer
- In 2018, Novartis acquires Endocyte for $2.1B, gaining drug conjugation technology to develop targeted therapies with companion imaging agents including 177Lu-PSMA-617 for prostate cancer
- In 2018, Novartis acquires Advanced Accelerator Applications for $3.9B, gaining access to LUTATHERA® (lutetium Lu 177 dotatate) for neuroendocrine tumors; LUTATHERA® achieved global sales of $445M in 2020
- In 2013, Bayer acquires Algeta for $2.9B, gaining access to XOFIGO® (radium Ra 223 dichloride) for prostate cancer; XOFIGO® achieved global sales of $339M in 2018
PLUS believes 186RNL holds significant promise for patients and welcomes the opportunity to discuss various partnering approaches and pathways. If interested, please contact us at email@example.com.
LUTATHERA is a registered trademark of Advanced Accelerator Applications SA
XOFIGO is a registered trademark of Bayer
DocePLUS™ (Albumin-stabilized PEGylated Liposomal Docetaxel)
DocePLUS™ is being developed as a new therapy for small cell lung cancer and potential replacement for HYCAMTIN® (topotecan), the only U.S. FDA-approved second-line therapy. According to Decision Resources, topotecan generated $190M USD in sales in 2018 across the U.S., EU5, and Japan.
The World Health Organization has reported that 1.1 billion people smoke tobacco around the world. Given that tobacco smoking is by far the leading cause of small cell lung cancer and that treatment regimens have changed little since HYCAMTIN® was approved 20 years ago, we believe there is potentially a significant global market opportunity for DocePLUS™. We are actively seeking development and commercial partners for this Phase 2-ready asset for all markets, with a priority on the United States, Europe, and China.
Further, based on results from 1) comprehensive, independent, primary market research performed with U.S. medical oncologists and payers and 2) the completed U.S. Phase 1 clinical trial, we believe there is also a compelling market opportunity for DocePLUS® as a therapy for other solid tumors, including pancreatic cancer, breast cancer, esophageal cancer, and cholangiocarcinoma. The combined annual revenue potential for DocePLUS™ for these clinical indications is estimated at over $600M.
Please contact us at firstname.lastname@example.org if interested in DocePLUS™ for small cell lung cancer or other clinical applications.
HYCAMTIN is a registered trademark of Novartis Pharmaceuticals Corporation.
DoxoPLUS™ (PEGylated Liposomal Doxorubicin)
DoxoPLUS™ represents an opportunity to offer healthcare providers and their patients a complex generic of CAELYX® or DOXIL® for the treatment of breast cancer, ovarian cancer, multiple myeloma, and/or Kaposi’s sarcoma.
The European market for PEGylated liposomal doxorubicin is stable, estimated at $130M+ annually, and held entirely today by the originator-reference drug, CAELYX®. No generic versions of CAELYX® are currently approved in Europe. There is an opportunity for a generic, such as DoxoPLUS™, to take significant market share away from CAELYX®.
The Chinese market for PEGylated liposomal doxorubicin is growing rapidly, estimated at $250M+ annually. While CAELYX® was withdrawn from the market many years ago, generic versions from CSPC Pharma, Jemincare, and Fudan-Zhangjiang have filled the void. The U.S. market for PEGylated liposomal doxorubicin is stable, estimated at $180M+ annually, and held among the originator drug, DOXIL®, along with generic versions from Sun Pharma and Dr. Reddy’s. Because of their large patient populations, we believe there remains room in China and the U.S. to capture an attractive market share with DoxoPLUS™.
We have completed a substantial amount of nonclinical and clinical development work to support regulatory approvals in Europe, China, and the U.S. PLUS THERAPEUTICS’ completed bioequivalence clinical study of DoxoPLUS™ versus CAELYX® can be leveraged in Europe and China. However, in the U.S. where Sun Pharma’s Lipodox® is the reference drug, an additional bioequivalence clinical study comparing Lipodox® to DoxoPLUS™ will be required for FDA approval.
Please contact us at email@example.com if interested in DoxoPLUS™ for Europe or other major markets.
CAELYX and DOXIL are registered trademarks of Janssen Products, LP.
Lipodox is a registered trademark of Sun Pharmaceutical Industries Ltd.
Albumin-Stablized PEGylated Liposomal Docetaxel
|+ Solid Tumor|
+ Small Cell Lung Cancer
|Intravenous||FDA Orphan Drug||Published U.S. Phase 1 Clinical Trial|
PEGylated Liposomal Doxorubicin
|+ Breast Cancer|
+ Ovarian Cancer
+ Multiple Myeloma
+ Kaposi's Sarcoma
|Intravenous||Completed Clinical Bioequivalence Versus CAELYX®|
PLUS THERAPEUTICS has an open FDA-approved IND for patented DocePLUS™. We have completed and published results from a 29 patient U.S. Phase 1 clinical trial in solid tumors. We are preparing to initiate a Phase 2 clinical trial with patented DocePLUS™ as a second-line therapy for relapsed small cell lung cancer. To learn more about patented DocePLUS™, click here.
PLUS THERAPEUTICS is seeking divestiture opportunities for its complex generic DoxoPLUS™ asset. PLUS THERAPEUTICS has completed a substantial amount of nonclinical and clinical development, including a bioequivalence clinical study of DoxoPLUS™ versus CAELYX®. Much of the data generated can be used to support regulatory filings and approvals in Europe, China, the United States, and other countries/regions. To learn more about complex generic DoxoPLUS™, click here.
PLUS THERAPEUTICS is continually evaluating the most efficient and effective way to get things done. In many cases, we have the right people, materials, equipment, and facilities in-house to complete a particular task, project, or process. In other cases, outsourcing and partnering is a preferred alternative. Current principal contract development and manufacturing organizations for our business include ABX Advanced Biochemical Compounds GmbH, Eurofins BioPharma Product Testing, Invicro LLC (a Konica Minolta company), Piramal Pharma Solutions, and RadioMedix, Inc.
We are looking for new suppliers and vendors to help us in the areas of raw materials, product and clinical development, analytical chemistry, manufacturing, quality, regulatory affairs, and industry partnerships. If interested, please contact us at firstname.lastname@example.org.