Introduction
So far in the first half of Q1 2022 seven biopharma companies have IPO’d on the NASDAQ. They are focused on oncology, cardio-renal diseases, neurodegenerative diseases, and cell therapy. Figure 1 shows the global pharmaceutical market share of these indications as of 2020.
Figure 1: 2020 global market share vs. indication.
There is some overlap between cell therapy and oncology, for example two of the four oncology focused companies that IPO’d in 2022 are also cell therapy companies. Two companies specialize in neurodegenerative diseases, and one company treats both cardiovascular and renal disease, which may result secondarily.
Oncology IPOs
Hillstream BioPharma Inc.
Hillstream is at the cutting edge of oncology drug development, taking a new class of therapeutic candidates into the clinic targeting ferroptosis, an emerging mechanism resulting in iron mediated cell death (IMCD) of drug resistant cancers.
Hillstream’s Chief Executive Officer (CEO) is Randy Milby, who previously held a Board of Directors position at CorMedix, developing and commercializing drugs for inflammatory and infectious diseases. Inflammation is one of the hallmarks of cancer, putting Mr. Milby in a great position to direct Hillstream’s development.
The very experienced Robert Niecestro, PhD, heads Regulatory Affairs. Notably, he previously served as Senior Director, Clinical Development and Therapeutic Head for Gastrointestinal, Oncology and Stroke at Eisai Inc., amongst others. Dr. Niecestro has contributed to filing of over 60 INDs, and has gained drug marketing approval through 13 NDAs/ BLAs in the United States. His NDA/BLA to IND ratio (22%) is exceptional, considering that according to the trade association Biotechnology Innovation Organization (BIO) the overall likelihood of drug approval from IND to market between 2011 to 2020 was only 8%. The leadership also includes experienced translational/ manufacturing/ clinical/ regulatory personnel as well as a data science position.
Their most advanced product candidate is HSB-1216, a nanoparticle formulation of salinomycin derived from the company’s PLA/ PEG Quatramer technology, which has several benefits compared to free salinomycin. Salinomycin is a potent cancer stem cell inhibitor and IMCD inducer. It is also an antibiotic. In a clinical pilot study conducted in Germany by the University of Heidelberg, salinomycin was found to reduce tumor burden in treatment resistant cancers, including triple negative breast cancer and epithelial carcinomas.
The company has developed Trident Artificial Intelligence (TridentAI), a precision medicine platform, that is used to identify biomarkers in their clinical programs that represent specific patient subgroups. This ability may greatly improve their chances of navigating clinical trials to market approval.
Nuvectis Pharma, Inc.
Nuvectis are focused on developing targeted therapies for cancer. Their two lead candidates are tablet formulated inhibitors of the Heat Shock Factor 1 (HSF1) pathway and the SRC/YES1 kinase.
Ron Bentsur serves as Chairman, CEO and President, Enrique Poradosu, PhD is Executive Vice President, Chief Scientific and Business Officer, and Shay Shemesh is Executive Vice President & Chief Development Officer. The team has extensive experience in licensing promising product candidates.
The company is focused on a “tumor-agnostic” approach, that is they believe the mutational signature of a given cancer is more important than its anatomical location for selecting a treatment. They are developing their two lead candidates with this in mind and intend to use a biomarker-based patient selection approach for clinical trials and beyond.
NXP800 (HSF1 inhibitor) entered the clinic in December 2021. Once phase Ia is completed the phase Ib will further assess safety and begin evaluating the preliminary anti-tumor activity of NXP800 in biomarker-selected patients, initially in ovarian clear cell carcinoma and endometrioid carcinoma.
Cell Therapy
Arcellx, Inc.
Arcellx is a clinical-stage biotechnology company enginee...
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