On August 25, 2022 Kriya Therapeutics, Inc., a fully integrated gene therapy company advancing a broad portfolio of innovative therapeutics, reported that it has appointed Curt Herberts, M.B.S., as President and Chief Operating Officer (Press release, Kriya Therapeutics, AUG 25, 2022, View Source [SID1234618674]). Herberts will oversee all general and administrative functions at Kriya .

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"Curt’s extensive experience building successful biotech companies will be a great asset for Kriya, as we expand our operations and capabilities for developing gene therapies to treat patients in need," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya. "Curt and I will be working in close partnership to build value for patients, investors, and employees."

Herberts joins Kriya from Senti Biosciences, Inc., where he was Chief Financial Officer and Chief Business Officer from 2018 to 2021, and Chief Operating Officer from 2021 to 2022. Prior to joining Senti, Herberts held various positions at Sangamo Therapeutics including as the company’s Chief Business Officer, as well as at Campbell Alliance Group, a leading management consulting firm specializing in the life science industry. Herberts earned his B.A. from Stanford University in human biology, and his Master of Business and Science from the Keck Graduate Institute of Applied Life Sciences.

"I am excited to join a company with a fully-integrated gene therapy engine that has the potential to develop a robust pipeline of therapies to treat a wide range of diseases," Herberts said. "I’m looking forward to helping the company lead the industry in ushering in a new era of innovative gene therapies for a broad range of therapeutic areas."

On August 25, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conference in September (Press release, Horizon Therapeutics, AUG 25, 2022, View Source [SID1234618673]):

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Morgan Stanley 20th Annual Global Healthcare Conference

Date: Tuesday, Sept. 13, 2022
Presentation Time: 2:05 p.m. ET
Location: New York, NY
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for one year following the event.

On August 25, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended June 30, 2022 (Press release, Can-Fite BioPharma, AUG 25, 2022, View Source [SID1234618671]).

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Corporate and Clinical Development Highlights Include:

Strong Balance Sheet – On June 30, 2022, Can-Fite had approximately $12.72 million in cash, cash equivalents, and short-term deposits.

Namodenoson Approved for Compassionate Use in Romania, Pivotal Phase III Liver Cancer Study Open for Enrollment – In August, Can-Fite announced Romania became the second country, following Israel, to approve Namodenoson for compassionate use in patients with advanced liver cancer. Namodenoson induced a complete response with disappearance of all metastases in a Romanian patient who was enrolled in Can-Fite’s prior Phase IIb liver cancer study, and the patient will now continue treatment under the compassionate use program.Can-Fite’s pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies.

Phase III COMFORT Trial for Psoriasis Meets Primary Endpoint – Topline results were announced during the second quarter, and further data are expected in the coming weeks. Piclidenoson, Can-Fite’s lead drug candidate, successfully met its primary endpoint in the Phase III COMFORT trial in more than 400 adults with moderate to severe plaque psoriasis. At week 16, patients receiving Piclidenoson 3mg demonstrated statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response (representing a 75% reduction in psoriasis severity): Piclidenoson 3mg: 9.7% vs. placebo: 2.6% (P< 0.04). A linear increase in the response of patients to Piclidenoson was achieved along the study period, on week 48 reaching a PASI 50 response (50% reduction in psoriasis severity) in 90% of patients, a PASI 90 response (90% reduction in psoriasis severity) in 10% of patients, and Psoriasis Disability Index (PDI) improvement in 60% of patients.

Company to Submit FDA & EMA Registration Plans for Piclidenoson for the Treatment Psoriasis – Following the successful COMFORT study, Can-Fite is planning to submit its marketing registration plans to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis. The pivotal Phase III study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data will be submitted to the FDA and EMA along with the pivotal Phase III protocol and other supporting clinical pharmacology plans.

Data show Piclidenoson’s Superior Safety Profile and Higher Patient Compliance Compared to Otezla – In July, Can-Fite announced that further analysis of the Phase III COMFORT data point toward a better safety profile for Piclidenoson as compared to Otezla, which induced gastrointestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. Discontinuation of treatment amongst patients treated with Otezla was significantly higher compared to that of the Piclidenoson treated patients.

Piclidenoson Demonstrates Higher Efficacy in Patients with More Severe Disease – Also announced in July a sub-analysis of the efficacy data that divided patients into those who had PASI>25 (more severe psoriasis) and PASI<25 (less severe) at baseline revealed that patients who started with higher PASI values at entry benefitted more from treatment with Piclidenoson as compared to placebo.

NASH Patent Granted in Israel, Phase IIb Study is Ongoing – Patient enrollment is ongoing in Can-Fite’s Phase IIb study evaluating Namodenoson in 140 subjects with biopsy-confirmed NASH. Can-Fite was granted a patent for NASH titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" in Israel, adding to the approximately 40 other countries in which the same patent has been issued.

Piclidenoson to Enter Clinical Trial for Osteoarthritis in Dogs – Through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company in June of 2021, Piclidenoson is set to enter a clinical trial for the treatment of osteoarthritis in dogs. This follows a successfully completed safety study in dogs exploring dose-range safety and pharmacokinetics. Piclidenoson was well tolerated, with the pharmacokinetic data proportional to dose. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028.

"Positive data from our Phase III COMFORT study further supports our belief that Piclidenoson’s excellent safety profile, combined with its efficacy as compared to placebo, position it very favorably in the market for psoriasis patients who seek an oral drug that can be used long-term," stated Can-Fite CEO Dr. Pnina Fishman. "As we prepare for a Phase III registration trial for Piclidenoson in psoriasis, we are concurrently advancing our portfolio in several other indications with an aim toward monetizing our significant progress through distribution and collaboration agreements."

Financial Results

Revenues for the six months ended June 30, 2022 were $0.40 million, an increase of $0.01 million, or 2.7%, compared to $0.39 million for the six months ended June 30, 2021. The increase considered to be not material.

Research and development expenses for the six months ended June 30, 2022 were $3.27 million, a decrease of $0.54 million, or 14.2%, compared to $3.81 million for the six months ended June 30, 2021. Research and development expenses for the six months ended June 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to lower costs incurred in 2022 associated with the two studies for Namodenoson and due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.

General and administrative expenses for the six months ended June 30, 2022 were $1.57 million a decrease of $0.32 million, or 16.9%, compared to $1.89 million for the six months ended June 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the six months ended June 30, 2022 were $0.18 million compared to finance income, net of $0.20 million for the six months ended June 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.

Net loss for the six months ended June 30, 2022 was $4.62 million compared with a net loss of $5.09 million for the six months ended June 30, 2021. The decrease in net loss for the six months ended June 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.

As of June 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $12.72 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the six months ended June 30, 2022 is due to the ongoing operations of the Company.

The Company’s consolidated financial results for the six months ended June 30, 2022 are presented in accordance with US GAAP Reporting Standards.

On August 25, 2022 AstraZeneca reported that it’s Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery (Press release, AstraZeneca, AUG 25, 2022, View Source [SID1234618670]). This approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the global ADAURA Phase III trial.

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While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease.1,2 Historically, over half of patients diagnosed in Stage II, and approximately three quarters of patients diagnosed in Stage III, have experienced recurrence within five years of resection.3,4 In Japan, lung cancer is the leading cause of cancer death and among patients with NSCLC, more than 35% have tumours with an EGFR mutation.5,6

Masahiro Tsuboi, MD, PhD, Chief and Director, Department of Thoracic Surgery & Oncology, National Cancer Center Hospital East, Japan, and principal investigator in the ADAURA trial, said: "Osimertinib was first approved in Japan over six years ago and it has since played a critical role in our treatment of patients with lung cancer, particularly given the high prevalence of EGFR mutations among Japanese patients. This approval of osimertinib for early-stage lung cancer means these patients will now have, for the first time, a targeted therapy option available earlier in their treatment journey, after surgery and chemotherapy as indicated."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Patients diagnosed with lung cancer in Japan are more likely than patients anywhere else in the world to be alive five years after their diagnosis. Yet lung cancer remains the country’s leading cause of cancer death. With this approval of Tagrisso, early-stage lung cancer patients in Japan now have a targeted treatment option available after surgery that can dramatically change the course of their disease, potentially helping them live cancer-free even longer."

In the ADAURA trial, Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC. The trial also showed a statistically significant and clinically meaningful improvement in DFS in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint. These results were published in The New England Journal of Medicine in October 2020.

The ADAURA trial is ongoing to assess overall survival (OS). Final DFS results will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.

Tagrisso is approved to treat early-stage lung cancer in more than 85 countries, including in the US, EU and China, and additional global regulatory reviews are ongoing. In Japan, this is the third approved indication for Tagrisso following previous approvals for 2nd-line T790M and 1st-line EGFRm NSCLC in March 2016 and August 2018, respectively.

Notes

Lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.7 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.8,9 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.1,2

Among patients with resectable tumours (Stage IB-IIIA), the majority of patients eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.3 In the absence of organised screening efforts, early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.10,11

Approximately 30-40% of patients in Asia, and 10-15% of NSCLC patients in the US and Europe, have EGFRm NSCLC.12-14 These patients are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signaling pathways that drive the growth of tumour cells.15

ADAURA
ADAURA is a randomised, double-blind, placebo-controlled, global Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and, at physicians’ and patients’ discretion, adjuvant chemotherapy. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.

The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint was DFS in Stage II and IIIA patients and a key secondary endpoint was DFS in Stage IB, II and IIIA patients.

Though the primary data readout was originally anticipated in 2022, data from the trial were reported early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy. The trial is ongoing and will continue to assess the secondary endpoint of OS.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat more than 600,000 patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

In Phase III trials, Tagrisso is being tested in the neoadjuvant resectable setting (NeoADAURA), in the Stage IA2-IA3 adjuvant resectable setting (ADAURA2), in the Stage III locally advanced unresectable setting (LAURA), and in combination with chemotherapy (FLAURA2). AstraZeneca is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso given concomitantly with savolitinib, an oral, potent and highly selective MET TKI, as well as other potential new medicines.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and tremelimumab; Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in onclogy
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On August 25, 2022 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of cancers, reported that the first colorectal cancer patient in the RAD-18-002 phase 2A clinical trial has been treated with its drug candidate, Radspherin (Press release, Oncoinvent, AUG 25, 2022, https://www.oncoinvent.com/press-release/oncoinvent-initiates-radspherin-phase-2a-trial/?utm_source=mailpoet&utm_medium=email&utm_campaign=oncoinvent-initiates-radspherin-phase-2a-trial [SID1234618669]). The study is conducted at two sites, the Radium Hospital in Oslo Norway and at the Uppsala University Hospital in Uppsala Sweden and will include a total of thirty patients.

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"The start of the RAD-18-002 phase 2A study marks an entry into the next stage of development for both our product candidate Radspherin as well as for Oncoinvent" said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "This new study takes us a step closer to achieving our primary goal of developing an effective therapy for cancer patients suffering from peritoneal carcinomatosis."

About the RAD-18-002 Study

The phase 2A open-label expansion cohort of the RAD-18-002 clinical trial is designed to assess the safety, tolerability, and anti-tumor activity of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal carcinoma following complete cytoreductive surgery and HIPEC. Key objectives in the study include survival benefit as well as acute and long-term safety of the drug product candidate.