biotickrPurple Biotech Ltd., a clinical-stage company, is developing treatments for cancers to overcome drug resistance. The lead oncology asset CM24 is a monoclonal antibody that is intended to block the cancer-associated antigen (carcinoembryonic antigen). CM24 is being investigated as a combined therapy with anti-PD-1 checkpoint inhibitors. The pipeline is in Phase Ib/II clinical trials for the treatment of pancreatic cancer and non-small cell lung cancer. The next important asset – NT219 is an insulin receptor substrate 1 and 2 being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.
The mechanism of action of CM24 involves immunostimulation, eliciting antibody-dependent cell-mediated cytotoxicity and inhibition of CD66 antigen, which are collectively important to achieve anti-cancer activity. So far, the reported pharmacokinetics and side effect profile of CM24 appears to be promising. No scientific red flags can be observed.
Similarly, the interim safety studies readout of NT219 appears to be encouraging without serious side effects in advanced cancer patients. Durable efficacy was observed in gastroesophageal junction cancer and colorectal carcinoma patients. Studies are underway to demonstrate the efficacy in squamous cell carcinoma of the head and neck (SCCHN) and recurrent/metastatic SCCHN patients.
Taken together, so far so good in the clinical trials and the possibilities of clinical trial success appear to be high, if no safety signals are detected.
Recent events
January 3rd, 2023 Purple Biotech and Mor Research Applications announced research collaboration to identify promising investigational oncology treatments
November 15th, 2022 – Purple Biotech presented new data on mechanism of action for CM24 at the AACR Special Conference: cancer metastasis
November 8th, 2022 – Purple Biotech reported third quarter 2022 financial results
November 2nd, 2022 – Purple Biotech appointed Lior Fhima as chief financial officer
Addressable market
Solid tumor:
The global solid tumor treatment market is valued at USD 185.97 billion in 2022 and expected to reach around USD 532.42 billion by 2032, at a CAGR of 11.09% during 2023 to 2032.
Pancreatic cancer:
The global pancreatic market was valued at USD 3.43 billion in 2021 and likely to hit 6.93 billion by 2030 at a CAGR of 8.13% during 2022 – 2030.
Head and neck cancer:
In 2021, the global head and neck cancer treatment market was USD 1.51 billion and expected to reach USD 2.99 billion by 2030 at a CAGR of 7.9%.
Current finances
Cash position:
Over the last 5 years, the earnings have declined by around 18% per year and generated less than USD 1 million in revenue. The share price has been highly volatile in the last few months and shareholders could get diluted in the upcoming months.
Insider activity
Over the last 6 months, no shares were transacted (sold or purchased) by the insiders, which is a huge red flag.
Competitors
One of the important competitors of PPBT is Immunocore, a biotechnology company developing treatments for various cancers, infectious diseases and autoimmune disorders. The lead asset is ImmTAX™ (Immune Mobilizing Monoclonal TCRs against X disease), a bispecific molecule with TCR and effector function against cancer, infections and autoimmunity.
The lead candidate KIMMTRAK that targets gp100 for treatment of uveal melanoma has received USFDA approval and other pipelines such as Tebentafusp is in phase II clinical trial for treatment of advanced melanoma, IMC-F106C and IMC-C103C are intended for treatment of multiple solid tumors. Other candidates are in early stages of clinical trials.
Immunovant is a clinical-stage biopharmaceutical company developing therapies for various autoimmune disorders. The important pipeline Batoclimab (IMVT-1401 is a human monoclonal antibodies to reduce circulatory levels IgG antibody in autoimmune disorders. The next asset IMVT-1402 is a humanized FcRn-targeting antibody,
Some of the medical conditions that can be treated by IMVT-1401 and IMVT-1402 are myasthenia gravis, thyroid eye disorder (TED), chronic inflammatory demyelinated polyneuropathy (CIDP), Graves’ disease, and warm autoimmune hemolytic anemia (WAIHA).
Summary
Based on the available data, it appears that the science behind PPBT’s NT219 drug has the potential for success in clinical trials. The company is currently conducting a phase I/II study evaluating NT219 as both a monotherapy and a combination therapy with cetuximab for the treatment of advanced solid tumors and head and neck cancer. The results of this study are expected to be released in Q2 2023, which will be a crucial determining factor in the drug’s development.
The oncology industry is a highly competitive field, but Purple Biotech appears to have a strong chance of success with its pipeline of drugs in development, despite being in early stages. The company’s NT219 drug is considered as one of the shots on goal by the company to make an impact in the field of oncology.