On August 23, 2022 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported its liver drug candidate Namodenoson has been approved for compassionate use for the treatment of patients with advanced liver cancer in Romania (Press release, Can-Fite BioPharma, AUG 23, 2022, View Source [SID1234618573]). Namodenoson was previously approved for compassionate use in Israel, where advanced liver cancer patients have been treated for several years.

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In parallel, Can-Fite’s pivotal Phase III study in patients with advanced liver cancer (hepatocellular carcinoma), is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe. This pivotal study received a ‘green light’ to proceed from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and if successfully concluded, the Company will be in a position to submit the drug for approval with each of the regulatory authorities. Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.

"We are committed to providing Namodenoson, with an excellent safety profile and strong efficacy in this patient population in clinical trials to date, to fulfill an urgent unmet medical need. The anti-cancer effect of Namodenoson together with its liver protective properties make it unique among anti-cancer drugs for this devastating disease," stated Can-Fite CEO Dr. Pnina Fishman.

The hepatocellular carcinoma (HCC) drug market is expected to reach $3.8 billion in 2027 in the G8 countries according to DelveInsight. The American Cancer Society estimates that in the U.S., liver cancer incidence has tripled since 1980, with an estimated 41,000 cases diagnosed and 31,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for advanced hepatocellular carcinoma in a pivotal Phase III trial. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On August 23, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported positive results from a pivotal study of Abivertinib on 209 response evaluable, heavily pretreated NSCLC patients by an IRC assessment with matured long-term follow up data (Press release, Sorrento Therapeutics, AUG 23, 2022, View Source [SID1234618572]).

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Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold greater potency as compared with wild-type EGFR. Previously, a positive interim result assessed by investigators was published in the peer-reviewed Clinical Cancer Research journal with interim data (View Source). In these IRC-assessed preliminary topline results with more matured long-term follow up data (previously 16.8 months, now 38.8 months), Abivertinib showed significant treatment benefits in 209 response evaluable, heavily treated NSCLC patients with ORR of 56.5%, and notably a significant CR rate was seen with Abivertinib (5.3%) in comparison with that of osimertinib (Tagrisso) (0.5%)*, while the ORR rate is comparable between the two drugs. This combined data, the ORR of 56.5%, the CR rate of 5.3%, and median OS of 28.2 months (versus Tagrisso’s median OS of 26.8 months)**, is potentially superior to that of the approved third generation EGFR inhibitor (osimertinib). Abivertinib demonstrated significantly efficacious effects in overcoming the resistant mutation in NSCLC. Based on these results, Sorrento is closing the study and preparing the pre-NDA materials and NDA package. Sorrento will request a pre-NDA meeting with the FDA and other regulatory agencies around the world with potential NDA filings pending agreements with the regulatory agencies in different countries.

"We are very encouraged by the significant positive results of Abivertinib assessed by the IRC with long-term follow up data and look forward to meeting with the FDA and other regulatory authorities for the possibility of bringing Abivertinib to the U.S. and global markets," said Dr. Henry Ji, Chairman and CEO of Sorrento. Abivertinib is one of the multiple clinical and pre-clinical stage assets obtained by Sorrento in the previously completed acquisition of ACEA Therapeutics, Inc. in June of 2021.

On August 23, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer, reported that Company management will participate in the following investor conferences in September 2022 (Press release, Sensei Biotherapeutics, AUG 23, 2022, View Source [SID1234618571]):

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Citi’s 17th Annual Biopharma Conference
September 7th-8th
Boston, MA

Wells Fargo’s 2022 Healthcare Conference
September 7th-9th
Boston, MA

Portfolio managers and analysts who would like to request a meeting with management should contact their representative at the respective hosting firms.

On August 23, 2022 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company’s Pediatric Investigation Plan (PIP) (Press release, Northwest Biotherapeutics, AUG 23, 2022, View Source [SID1234618570]). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax-L.

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The Company’s approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG. In each of the 2 pediatric trials, 24 patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.

The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.

Under applicable UK law, when a new medicine is developed for adult patients, that medicine must also be tested for potential application to pediatric patients. The sponsor must develop an overall Plan to select the specific form or stage of the disease to be treated, to adapt the dosing and administration of the medicine for pediatric physiology, and to evaluate the safety and efficacy of the medicine in pediatric patients. Further, the Plan must include not just general focus areas, aims and approaches — it must include the full design of the specific clinical trials to be carried out, including all aspects required for clinical trial approvals, such as the patient population, eligibility criteria, stage of disease, treatment regimen, trial design and endpoints.

The Plan developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators. This process can typically take more than a year.

The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check.

Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG. The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. On August 17, the Company received final approval of the PIP from the MHRA.

The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.

On August 23, 2022 NETRIS Pharma, a clinical-stage immuno-oncology pharmaceutical company pioneering dependence receptors-based drug discovery and development, reported that CEO and Founder Patrick Mehlen, and CFO Christophe Guichard, will be attending the ESMO (Free ESMO Whitepaper) Congress taking place JuSeptember 9-13, 2022, in Paris (Press release, Netris Pharma, AUG 23, 2022, View Source [SID1234618569]).

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