On May 16, 2023 Astrazeneca reported Positive high-level results from the FLAURA2 Phase III trial showed Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to Tagrisso alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, MAY 17, 2023, View Source [SID1234631785]).

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Safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine. At the time of this analysis, the overall survival (OS) data were immature and will be formally assessed at a subsequent analysis.

Each year, there are an estimated 2.2 million people diagnosed with lung cancer globally with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.1-3 Approximately 70% of people are diagnosed with advanced NSCLC. Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4-6

Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: "As the global standard of care for EGFR-mutated non-small cell lung cancer, osimertinib monotherapy has transformed the treatment landscape allowing many patients the opportunity to achieve improved survival. FLAURA2 provides compelling evidence that the addition of chemotherapy to osimertinib can provide a new option for patients and clinicians that further improves outcomes compared to osimertinib alone and as such, can further delay treatment resistance and disease progression."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing. This meaningfully builds on successive trials which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer."​

The data will be presented at a forthcoming medical meeting and shared with global health authorities.

These results add to the extensive body of evidence for Tagrisso in EGFRm NSCLC, which has improved patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial. Tagrisso has also shown proven clinical activity in treating central nervous system (CNS) metastases across settings.

As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in unresectable NSCLC in the pivotal LAURA Phase III trial, with results expected later this year.

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.1 Lung cancer is broadly split into NSCLC and small cell lung cancer.2 The majority of all NSCLC patients are diagnosed with advanced disease.7

Patients with EGFRm NSCLC 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.8

FLAURA2
FLAURA2 is a randomised, open-label, multi-centre, global Phase III trial in the 1st-line treatment of 586 patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with Tagrisso 80mg once daily oral tablets in combination with chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5)) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.

The trial was enrolled in more than 150 centres across more than 20 countries, including in the US, Europe, South America and Asia. This is the final analysis of the primary endpoint of PFS. 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 CNS metastases. AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. These include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC, where Tagrisso recently demonstrated a statistically significant and clinically meaningful OS benefit.

In addition to investigating Tagrisso and chemotherapy in late-stage disease (FLAURA2), AstraZeneca has several ongoing Phase III trials focused on earlier stages of lung cancer. Tagrisso is being tested in the neoadjuvant resectable setting (NeoADAURA), in the Stage IA2-IA3 adjuvant resectable setting (ADAURA2), and in the Stage III locally advanced unresectable setting (LAURA).

The Company 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.

On May 16, 2023 Tyligand Bioscience, a clinical stage biotech company focused on the development of innovative drugs to treat drug resistant tumors, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TSN084, the company’s multi-kinase inhibitor for the treatment of Acute Myeloid Lymphoma (AML) (Press release, Tyligand Bioscience, MAY 16, 2023, View Source [SID1234644986]).

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The orphan drug designation process ("ODD") begins with an application to the US Food and Drug Administration ("FDA") Orphan Drug Designation office, and is accompanied by a comprehensive package that includes the basic science, analysis of addressable number of individuals with Acute Myeloid Lymphoma (AML) and description of the patients projected to be helped by a therapy.

Dr. Tony Zhang, cofounder and CEO of Tyligand Bioscience stated, "Orphan drug designation represents a major milestone for Tyligand in pursuit of accelerated marketing approval for TSN084, our front runner of innovative molecules designed to treat drug resistant malignancies."

The company developed TSN084 leveraging a novel Type II kinase binding mode that targets CDK8/19, FLT3, AXL & cMet etc., for the treatment of both solid tumors and hematological malignancies. Drugs intended to treat orphan diseases (rare diseases that affect less than 200,000 people in the US) are eligible to apply for ODD, which provides multiple benefits to the sponsor during development and after approval.

About Acute myeloid Leukemia :
Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults. The average age at diagnosis is around 68 years—though it can also occur in adolescents and children. According to the National Cancer Institute, AML accounts for 1% of all cancer cases in the U.S., and an estimated 20,050 people in the U.S. were newly diagnosed with it in 2022. Despite currently available treatments for AML, the five-year overall survival rate for patients remains less than 30%. Novel therapies are needed to improve patient survival and quality of life.

On May 16, 2023 iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, reported the peer-reviewed publication of comprehensive translational research on the novel autotaxin (ATX) inhibitor IOA-289 in the ESMO (Free ESMO Whitepaper) journal Immuno-Oncology and Technology (IOTECH) (Press release, iOnctura, MAY 16, 2023, View Source [SID1234640232]).

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Inhibition of ATX is a novel treatment strategy for cancer that offers a three-pronged attack on the tumor through cancer cell inhibition, immune system stimulation and inhibition of fibrotic processes. ATX-mediated lysophosphatidic acid (LPA) signalling directly encourages tumor cell proliferation and inhibits anti-tumor immune responses via a direct effect on T cells. Further, it has a predominant role in fibrotic processes, including those important in cancer propagation, metastasis and resistance to therapy. Cancers surrounded by scar tissue (fibrotic tissue) and without markers visible to the immune system are tough to treat with existing therapies.

IOA-289 is a novel ATX inhibitor with a unique chemical structure, excellent potency and an attractive non-clinical safety profile. It has a unique binding mode that places it in an inhibitor class of its own. Avoidance of interaction with the catalytic site likely contributes to the improved safety profile of IOA-289 compared to other ATX inhibitors, avoiding toxicities seen with first-generation entities.

Michael Lahn, Chief Medical Officer of iOnctura, commented: "Despite the advances in the treatment of cancer in the last few decades, a large proportion of tumors are resistant to current treatments such as chemotherapy, immunotherapy and radiotherapy. Based on this translational research, we are excited to be investigating the safety and mode of action of IOA-289 in pancreatic cancer patients, where ATX signalling plays a central role."

In this translational research, IOA-289 demonstrates positive effects in highly fibrotic cancer models, preventing metastasis and tumor outgrowth. In iOnctura´s Phase Ib clinical study, IOA-289 is being combined with standard of care nab-paclitaxel and gemcitabine. While assessing the safety of an ATX inhibitor in cancer patients for the first time, a broad biomarker program will investigate the translation of the non-clinical observations to clinical application. As demonstrated in healthy volunteers in this research, single ascending doses of IOA-289 were safe, tolerable and blood exposure showed a reduction of the pharmacologic marker circulating LPA. Disclosure of results of the ongoing Phase 1b study will be released at a future medical meeting.

On May 16, 2023, Coherus BioSciences, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC and Citigroup Global Markets Inc. as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell an aggregate of 11,764,706 shares (the "Firm Shares") of its common stock, par value $0.0001 per share ("Common Stock") to the Underwriters (the "Offering") (Filing, 8-K, Coherus Biosciences, May 16, 2023, View Source [SID1234631841]). Additionally, under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, for 30 days from the date of the Underwriting Agreement, to purchase up to an additional 1,764,705 shares of Common Stock (the "Optional Shares," and together with the Firm Shares, the "Shares"), which the Underwriters have elected to exercise in full. The price to the public in the Offering was $4.25 per share. The Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $3.995 per share.

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The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-268252).

On May 18, 2023, the Company completed the sale and issuance of an aggregate of 13,529,411 shares of Common Stock, including the exercise in full of the Underwriters’ option to purchase additional shares. The Company received net proceeds of approximately $53.5 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by the Company.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The Company and the Company’s directors, executive officers and certain stockholders that are affiliated with the Company’s directors also agreed not to sell or transfer any Common Stock for 45 days after May 16, 2023, with respect to the Company, and 60 days after May 16, 2023, with respect to the other parties, without first obtaining the written consent of J.P. Morgan Securities LLC, on behalf of the Underwriters, subject to certain exceptions as described in the prospectus supplement.

A copy of the Underwriting Agreement, including the form of lock-up agreement, is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing descriptions of the Underwriting Agreement and lock-up agreements are not a complete description thereof, and are qualified in their entirety by reference to such exhibit.

A copy of the opinion of Latham & Watkins LLP relating to the validity of the securities issued in the Offering is filed herewith as Exhibit 5.1.

On May 17, 2023 Clinical stage oncology company Prescient Therapeutics (ASX: PTX) reported that it will present two of its abstracts at an annual conference of the International Society of Cell & Gene Therapy (ISCT) in France later this month (Press release, Prescient Therapeutics, MAY 16, 2023, View Source [SID1234631811]).

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Prescient researchers will showcase new preclinical data on the company’s next-generation immune receptor platform OmniCAR and its cell therapy enhancement platform CellPryme.

Both abstracts will also be published in the next issue of the ISCT’s official journal Cytotherapy.

The ISCT is focused on pre-clinical and translational aspects of cell and gene-based therapeutic developments and aims to advance scientific research into innovative treatments for patients.

The annual conference brings together clinicians, regulators, researchers and industry partners with a shared vision to translate cell and gene technologies into safe and effective therapies.

It attracts more than 2700 experts from 60 countries each year.