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.

On August 25, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its annual report and financial results for the year ended 30 June 2022 (Press release, Starpharma, AUG 25, 2022, View Source;mc_eid=bf52dd3418 [SID1234618667]).

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Download Annual Report 2022.

Financial Results

Strong cash position with a balance of $49.9M as at 30 June 2022
Revenue up 128% to $4.9M (FY21: $2.2M) on the rollout of VIRALEZE
Reported loss down 18% to $16.2M (FY21: $19.7M)
Receipt of $7.7M R&D tax incentive
Highlights

Two new DEP partnerships with leading, global pharmaceutical companies, Genentech and Merck & Co., Inc.
Sales of VIRALEZE have significantly increased in FY22, following new product launches in Vietnam and Italy and relaunch in the UK by LloydsPharmacy
Positive interim efficacy findings reported in the prostate cancer cohort of the Phase 2 DEP cabazitaxel trial showing efficacy signals in 100% of evaluable patients
Three clinical-stage internal DEP oncology assets advancing well, with encouraging efficacy signals observed
AstraZeneca’s partnered DEP product, AZD0466: additional indication (non-Hodgkin’s lymphoma) added and recruitment initiated in a global Phase 1/2 clinical trial; additional trial sites opened for the initial Phase 1/2 leukemia trial
VIRALEZE demonstrated high levels of protection against Omicron in an in vivo challenge model as well as impressive antiviral effects against influenza in laboratory studies and outperformed other antiviral agents used in marketed nasal sprays
Starpharma CEO, Dr Jackie Fairley, commented on the full year results:

"Starpharma has achieved many significant milestones across our business during FY22, including significant increases in revenue and the execution of new and valuable corporate partnerships, despite the ongoing challenges presented by the global pandemic.

"Starpharma was very pleased to sign two new DEP partnerships with leading, global companies – Genentech and Merck & Co., Inc – while our most advanced partner, AstraZeneca, further expanded the global clinical program for their DEP product, AZD0466, adding a new cancer type (non-Hodgkin’s lymphoma) and significantly increasing the number of trial sites worldwide. These new AZD0466 developments are particularly exciting for Starpharma, given the expanded market potential, and together with our new DEP partnerships, signify the growing momentum and value in our DEP platform.

"During the year, Starpharma’s internal DEP products continued to yield impressive responses in our Phase 2 oncology trials, including significant tumour shrinkage and stable disease in some of the most common and deadly cancers. We were pleased to report the positive interim findings from the prostate cancer cohort of Starpharma’s DEP cabazitaxel trial in which efficacy signals were observed in all evaluable patients treated with our DEP version of the leading prostate cancer drug cabazitaxel.

"Starpharma’s marketed products have reached more people this year than ever before, with sales of VIRALEZE significantly increasing following successful product launches in Vietnam and Italy, and relaunch in the UK through LloydsPharmacy. In parallel with commercial activities for VIRALEZE, we have continued to test the efficacy of SPL7013, the antiviral agent in VIRALEZE, against important respiratory viruses, including multiple variants of SARS-CoV-2 and influenza. SPL7013 has demonstrated consistent potent activity against a broad spectrum of respiratory viruses and has outperformed other marketed products when tested head-to-head.

"Looking ahead, Starpharma is well positioned for growth, with a strong balance sheet, growing sales revenue, an expanding portfolio of DEP products and valuable corporate DEP partnerships. Starpharma continues to champion its Environment, Social and Governance (ESG) pillars by creating important products that have the potential to make a significant contribution to the health and wellbeing of patients around the world."

Key activities

Partnered DEP Programs

Signed and commenced a second DEP Research Agreement with MSD (Merck & Co., Inc.), building on our DEP partnership in the innovative and valuable research area of antibody drug conjugates (ADCs).

Signed and commenced an exploratory DEP Research Agreement with Genentech, which was expanded within six months of the initial agreement to include an additional DEP program.

Under Starpharma’s DEP licence with AstraZeneca, the global clinical program for AZD0466 continued to advance with multiple new sites opening and commencement of a new clinical trial in an additional cancer type – non-Hodgkin’s lymphoma (NHL).

Starpharma also continued to progress its DEP program with Chase Sun, which involves the development of a DEP anti-infective product for Chase Sun.

Starpharma continues to pursue further partnering opportunities for its DEP drug delivery platform and active commercial discussions are underway in a number of research areas including DEP radiotheranostics.

Internal DEP Programs

Starpharma’s Phase 2 clinical trial of DEP cabazitaxel continues to recruit well with 70 patients enrolled to date. During the year, Starpharma reported positive interim findings from the prostate cancer cohort of this trial, where 100% of evaluable patients treated with DEP cabazitaxel demonstrated one or more efficacy signals. This trial continues recruitment of patients with ovarian and gastroesophageal cancers, following observation of encouraging efficacy signals in these tumour types, thereby expanding the market potential for DEP cabazitaxel.

The DEP irinotecan Phase 2 clinical trial continues to progress well, with 83 patients now enrolled. Efficacy signals including prolonged tumour shrinkage and reductions in tumour markers have been observed in multiple tumour types, including colorectal, breast, ovarian, pancreatic, lung, and oesophageal cancers. Enrolment of patients in the combination arm for DEP irinotecan in combination with 5-FU + leucovorin (a commonly used combination treatment regimen in colorectal cancer) has now commenced.

The clinical program for DEP docetaxel has enrolled 72 patients to date across the monotherapy and combination arms. Encouraging efficacy signals such as prolonged stable disease and significant tumour shrinkage have been observed in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.

Manufacture of DEP gemcitabine is now complete in readiness for Starpharma to commence a Phase 1/2 clinical trial, with planned clinical trial sites in the UK and Australia. Preparations for trial commencement are well advanced, with the clinical research organisation and site selection processes, regulatory and ethics preparations nearing completion.

Starpharma also continues to deepen its pipeline of DEP assets by actively progressing a number of its own internal programs in areas including DEP radiotheranostics and DEP ADCs.

Marketed Products

Starpharma signed sales and distribution arrangements for VIRALEZE broad-spectrum antiviral nasal spray with commercial partners in Italy (ADMENTA Italia Group) and Vietnam (Health Co), and an agreement with Etqan & Nazahah for nine countries in the Middle East.

VIRALEZE was launched in Vietnam and Italy and relaunched in the UK through LloydsPharmacy.

Starpharma continued its scientific collaboration with The Scripps Research Institute to test VIRALEZE and SPL7013 against a range of respiratory viruses, including multiple variants of SARS-CoV-2[1] (Omicron and Delta) and influenza.

VIRALEZE demonstrated excellent protection against infection with the highly transmissible SARS-CoV-2 Omicron variant in a stringent in vivo viral challenge model[2]. These in vivo findings build on the in vitro findings reported by Starpharma earlier in the financial year, which showed that VIRALEZE achieved the maximal possible reduction of virus infectivity against the Omicron variant of SARS-CoV-2 in laboratory-based antiviral and virucidal assays.

The broad-spectrum activity of VIRALEZE was further demonstrated with impressive results for SPL7013, in VIRALEZE, against influenza A and B. SPL7013 achieved more than 90% reduction in viral infectivity of both influenza A and B viruses within one minute. SPL7013 also demonstrated irreversible virucidal properties against both types of influenza virus and outperformed other antiviral agents used in marketed nasal sprays.

VIRALEZE is registered in more than 30 countries and is available in pharmacies, retail outlets and online in a number of countries. Sales of VIRALEZE have significantly increased in FY22.

Starpharma continued to pursue registration and commercialisation for VIRALEZE in multiple other countries, with regulatory submissions in progress and active commercial discussions underway. In Australia, the review by the TGA for the nasal spray application as a medical device is ongoing.

Regulatory approvals for VivaGel BV were achieved in the Middle Eastern countries, Bahrain and Qatar, and pre-launch marketing activities have commenced. Starpharma’s marketing partner, Mundipharma, is also progressing further launches of VivaGel BV in Asia and registrations in other countries across Asia and the Middle East.

An important publication for VivaGel BV was achieved in the highly regarded peer-reviewed European journal, Archives of Gynecology & Obstetrics. This publication will support marketing activities and importantly, the inclusion of the product in clinical management guidelines for BV.

Starpharma’s partner, Okamoto, launched a new VivaGel condom range in Japan, under the brand name Pure Marguerite. The range is being distributed through major retail chains in Japan. Okamoto has also commenced regulatory processes for the VivaGel condom in additional countries in Asia.

Corporate

Ms Lynda Cheng was appointed as an independent non-executive director on 1 August 2021. Ms Cheng has more than 25 years of experience as a finance executive including more than 15 years at Visy Industries/Pratt Holdings and 10 years in investment banking.

Dr Jeff Davies, former CSL executive, was appointed as an independent non-executive director on 1 April 2022, bringing over 35 years of biopharmaceutical industry experience to Starpharma’s Board.

Financials

Starpharma concluded FY22 in a strong financial position with a cash balance $49.9 million. Net operating cash outflows for the year were $13.2 million (FY21: $14.8 million). Receipts from customers and grants totalled $13.0 million, including receipts from customers of $4.8 million (FY21: $2.4 million) and R&D tax incentive of $7.7 million.

Revenue was up 128% to $4.9 million for the year, with $4.7 million for VIRALEZE and VivaGel product sales, royalty, and research revenue from commercial partners. Interest income was $0.2 million for the year. Other income of $0.3 million, consisted of grant funding awarded by the Australian Government’s Medical Research Future Fund to expedite development and commercialisation of VIRALEZE (FY21: $0.9 million).

The loss after tax of $16.2 million (FY21: $19.7 million) includes expensing of all research and development expenditure and IP costs across the portfolio. The decreased loss compared to the prior year reflects the combination of higher sales and partner revenue and lower R&D expenditure due to the completion of VIRALEZE development and the stage and progression of DEP internal clinical programs. The reduced loss reflects a favourable foreign exchange movement of $0.9 million over the prior year, primarily on foreign currency held.

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 8MB)

[1] SARS-CoV-2 is the virus that causes COVID-19

[2] The study used the K18-hACE2 mouse model, which is an in vivo humanised mouse model that expresses the human angiotensin converting enzyme (hACE2) receptor, the receptor used by SARS-CoV-2 to infect cells in the human nasal cavity and respiratory tract.

On August 25, 2022 xCures, Inc., a clinical study platform provider, and Oblato, Inc., a biotechnology company, reported the availability of OKN-007 through an intermediate size expanded access program (iEAP) for eligible patients with pediatric diffuse midline glioma (DMG), inclusive of diffuse intrinsic pontine glioma (DIPG) (Press release, xCures, AUG 25, 2022, View Source [SID1234618665]). Oblato is currently developing OKN-007 as a treatment for glioblastoma multiforme (GBM).

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Pediatric diffuse gliomas are rare but have a very poor prognosis, and current treatment options show little benefit. Because pre-clinical research and emerging clinical data support the potential for OKN-007 in this population and the life-threatening nature of malignant gliomas including DIPG, Oblato is making OKN-007 available to qualified physicians through the iEAP.

"xCures is pleased to continue our efforts to bring pre-approval access to investigational medications for pediatric cancer patients. We are excited about the underlying science behind OKN-007 and the opportunity to use our platform to generate evidence and accelerate OKN-007 development. Our platform offers an efficient solution for physicians and patients seeking access to promising therapies when clinical trials are not an option," says Mika Newton, CEO of xCures. "xCures’ has a track record of delivering high-value real-world evidence from expanded access programs."

Ki -Hong Ahn, CEO of Oblato comments, "We are pleased that xCures will serve as the partner for the iEAP. With the new protocol now in place, we look forward to initiating this important program for pediatric cancer patients. We will expand the investigation into OKN-007 for DMG and DIPG patients as well as GBM patients."

Interested patients or physicians can learn more at xcures.com/details/okn007/.

About Expanded Access:
Expanded access, which is often called "compassionate use," is the use of an unapproved drug for treatment of patients with serious or life-threatening illnesses outside of a clinical trial. Expanded access is subject to oversight from the US FDA in accordance with the regulations outlined in 21 CFR 312.305.

On August 25, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, AUG 25, 2022, View Source [SID1234618663]):

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2022 Wells Fargo Healthcare Conference at 11:00 a.m. ET on Thursday, September 8, 2022
Morgan Stanley 20th Annual Global Healthcare Conference at 11:05 a.m. ET on Monday, September 12, 2022
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.