Purple Biotech Ltd. (NASDAQ/TASE: PPBT), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, rang the opening bell in a virtual ceremony on Tuesday, January 5, 2021 at 9:30 EST to start the trading on the Nasdaq Stock Market to celebrate its recent name change from Kitov Pharma. The name change to Purple Biotech reflects its evolution to a focus on advancing first-in-class oncology therapies.
“We are thrilled to celebrate with the NASDAQ team this important moment in our corporate history,” said Isaac Israel, the Company’s Chief Executive Officer. “Our transformation to a focus on advancing first-in-class oncology therapies reflects Purple Biotech’s commitment to enhancing the length and quality of lives of cancer patients. To this end, we are excited about the potential of our lead clinical-stage assets, NT219 and CM24, to be effective, safe and long-lasting cancer treatments. With a great team and the necessary funding in place, we look forward to further advancing these promising product candidates in 2021 and beyond.”
In November 2020, Purple Biotech and Bristol Myers Squibb amended their Clinical Trial Collaboration and Supply Agreement to reflect the expansion of the planned Phase 1/2 clinical trial evaluating CM24 in advanced non-small cell lung cancer (NSCLC) with a new cohort to also evaluate CM24 in patients with pancreatic cancer.
The Phase 1/2 clinical trial will evaluate CM24, a monoclonal antibody targeting CEACAM1, in combination with nivolumab (Opdivo®) in patients with advanced non-small cell lung cancer. With this expansion, the trial is now also planned to evaluate CM24 in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE®) in patients with pancreatic cancer.
In an initial Phase 1 study consisting of a monotherapy dose escalating IV administration of CM24 administered every two weeks, in 27 patients with advanced malignancies, CM24 was found to be safe and well-tolerated in all patients, with no discontinuations of study drug or dose limiting toxicities (up to 10mg/kg). In the efficacy evaluable patients (n=24), subjects were highly refractory to therapy, having received between two and eight prior therapies (with a median of four). Eight of the evaluable patients (33%) achieved stable disease, with most of these patients responding at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested that a higher dose level is required to achieve full saturation of CEACAM1 receptors.
Purple Biotech launched in the US its ConsensiTM, a fixed-dose combination of celecoxib, and amlodipine besylate, designed for the simultaneous treatment of osteoarthritis pain and hypertension, that was approved for marketing by the U.S. Food & Drug Administration. Purple Biotech’s manufacturing partner, Coeptis Pharmaceuticals, completed the packaging, release and shipment of Consensi TM for Purple Biotech’s marketing partners, that started selling ConsensiTM in the U.S. during 2020.
According to the U.S. marketing and distribution agreements, Purple Biotech is eligible to receive up to $99.5 million in milestone, reimbursement payments, and royalties. The Company expects to receive aggregate milestone and royalty revenues of between $28 million and $36 million from 2020 through 2022. The projected revenues will provide an important source of financial support for Purple Biotech as the Company continues to advance its emerging oncology pipeline, including bringing both CM-24 and NT-219 into the clinic this year.
About Purple Biotech
Purple Biotech (NASDAQ/TASE: PPBT) is a clinical-stage company focusing on advancing first-in-class therapies to overcome tumor immune evasion and drug resistance in order to create successful long-lasting treatments for people with cancer. The Company’s oncology pipeline includes NT219 and CM24. NT219 is a small molecule targeting the novel cancer drug resistance pathways IRS1/2 and STAT3. The Company is currently advancing NT219 as a monotherapy treatment of advanced solid tumors and in combination with cetuximab for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck cancer (SCCHN) in a phase 1/2 study.
CM24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. The Company plans to advance CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in selected cancer indications in a phase 1 study. This is to be followed by a phase 2 for the treatment of non-small cell lung cancer and pancreatic cancer. The Company has entered into a clinical collaboration agreement, as amended, with Bristol Myers Squibb for the planned phase 1/2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo®) in patients with non-small cell lung cancer and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE®) in patients with pancreatic cancer.
The Company is also the owner of Consensi®, a fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the U.S. Consensi® is being sold in the U.S. by Burke Therapeutics, the marketing partner of the Company’s U.S. distributor, Coeptis Pharmaceuticals. The Company has also partnered to commercialize Consensi in China and South Korea.
For more information, visit http://www.kitovpharma.com.
Contact: Gil Efron – Deputy CEO & Chief Financial Officer
IR at purple-biotech.com +972-3-933-3121 ext. #105
https://kitovpharma.com/
Source: Globes Newswire Jan 4, 2021
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