On April 23, 2024 Curium, a world leader in nuclear medicine, reported that it has successfully enrolled and scanned patients in its SOLAR clinical trials (Press release, Curium, APR 23, 2024, View Source [SID1234642246]):

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The first trial is SOLAR-STAGE: a Phase 3, multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in staging of men with newly diagnosed unfavorable intermediate-risk, high-risk or very-high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection.
The second study, SOLAR-RECUR: a Phase 3, multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer after radical prostatectomy or radiation therapy.
These clinical trials are currently enrolling patients at sites across the U.S. and will be opening clinical trial sites in Europe later this year.

Sakir Mutevelic, MD, Curium’s Chief Medical Officer said: "The successful start of patient enrollment is a significant step forward for Curium’s Phase 3 SOLAR-STAGE and SOLAR-RECUR clinical trials. As we continue Curium’s journey to redefine the experience of cancer through our trusted legacy in nuclear medicine, we look forward to building on our well-established and successful 64-Cu diagnostic imaging platform."

Amy Bartalotta, Vice President of Clinical Operations added: "To ensure that the SOLAR clinical trials recruit a diverse set of patients – including minority groups that are often more affected by and less likely to be screened for prostate cancer – we have 50 sites in the U.S. and over 30 sites in Europe participating in these trials. We are pleased to announce the first patients enrolled and scanned were at XCancer under the direction of Dr. Luke Nordquist. We look forward to additional trial sites scanning patients across the U.S. and Europe in the coming months."

For more information about the SOLAR-STAGE (NCT06235151) and SOLAR-RECUR (NCT06235099) studies visit www.solarclinicaltrials.com or contact Curium’s Clinical Trial team directly at [email protected] with questions or to locate a clinical trial site near you.

On April 23, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use (Press release, BeiGene, APR 23, 2024, View Source [SID1234642245]).

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"Tislelizumab is foundational for BeiGene’s solid tumor portfolio and has demonstrated its potential across multiple tumor types, including NSCLC, in which there remains a significant unmet need at all stages of the disease," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union. Second-line use in ESCC was also approved just weeks ago by the U.S. Food and Drug Administration, putting us well on our way to fulfilling our commitment to bring this innovative therapy to many more patients around the world."

The approved indications for tislelizumab are:

In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
"Non-small cell lung cancer remains one of the most common and deadly cancers in Europe, with 50% of patients diagnosed already progressed to advanced stages, making it difficult to treat," said Luis Paz-Ares, M.D., Ph.D., Head of the Medical Oncology Service at the Hospital Universitario 12 de Octubre, Madrid. "Across three Phase 3 studies, tislelizumab has been shown to improve outcomes for patients with certain types of NSCLC, providing a new option for those facing the disease."

Tislelizumab was approved for these NSCLC indications under the brand name TIZVENI. BeiGene plans to combine the NSCLC indications with the second-line ESCC indication under the brand name TEVIMBRA, which will launch in the first EU countries later in 2024. TEVIMBRA is approved in the U.S. and EU for advanced or metastatic ESCC after prior chemotherapy and is under review by the European Medicines Agency and the U.S. Food and Drug Administration as a first-line treatment for patients with unresectable, recurrent, locally advanced or metastatic ESCC and for first-line gastric or gastroesophageal junction cancers.

The EC approval is based on the results from three Phase 3 studies in the RATIONALE program that enrolled 1,499 patients:

RATIONALE 307 (NCT03594747) is an open-label, randomized Phase 3 trial that enrolled 360 patients with advanced squamous NSCLC. The study met its primary endpoint, with first-line tislelizumab in combination with chemotherapy resulting in statistically significant improvement in progression free survival (PFS), as well as higher objective response rates and a manageable safety/tolerability profile, regardless of PD-L1 expression. The most common grade ≥3 treatment emergent adverse events (TEAEs) were decreased neutrophil levels, neutropenia and leukopenia. See full study results published in JAMA Oncology.
RATIONALE 304 (NCT03663205) is an open-label, randomized Phase 3 trial that enrolled 334 patients with locally advanced or metastatic non-squamous NSCLC. The study met its primary endpoint, with first-line tislelizumab in combination with chemotherapy resulting in statistically significant improvement in PFS compared to chemotherapy (HR: 0.65 [95% CI: 0.47-0.91]; P=0.0054) along with higher response rates and longer response duration. The most common grade ≥3 TEAEs were associated with chemotherapy and included neutropenia and leukopenia. See full study results published in the Journal of Thoracic Oncology.
RATIONALE 303 (NCT03358875) is an open-label, randomized Phase 3 trial with tislelizumab versus docetaxel that enrolled 805 patients with advanced NSCLC who progressed on prior platinum-based chemotherapy. The study met its primary endpoint, with second- or third-line tislelizumab resulting in statistically significant and clinically meaningful improvement in overall survival compared with docetaxel in the intent-to-treat population (HR: 0.66 [95% CI: 0.56-0.79]; P<0.0001), regardless of PD-L1 expression. The most commonly reported grade ≥3 TEAEs were pneumonia, anemia and dyspnea. See full study results published in the Journal of Thoracic Oncology.
BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts. Through these trials, tislelizumab has demonstrated its potential to deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types – in many cases, regardless of PD-(L)1 status – both as monotherapy and in combination with other regimens. More than 900,000 patients have been prescribed tislelizumab globally to date.

About NSCLC

Lung cancer is the second most common type of cancer and the leading cause of cancer-related death worldwide.1 Lung cancer is the third most common cancer in Europe; NSCLC represents 85–90% of all lung cancers.2 In 2020, the number of new cases of lung cancer diagnosed in Europe was estimated at 477,534.3

About Tislelizumab

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Important Safety Information

The full European Summary of Product Characteristics (SmPC) for the NSCLC indications for tislelizumab, which includes safety data for NSCLC and ESCC, is available from the European Medicines Agency.

On April 23, 2024 Be Biopharma, Inc. ("Be Bio"), a company pioneering the development of engineered B Cell Medicines (BCMs), reported that it will present at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting being held May 7-11, 2024, in Baltimore, MD (Press release, Be Biopharma, APR 23, 2024, View Source [SID1234642243]).

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Details regarding the Be Biopharma presentation at the conference are as follows:

Title: CRISPR/Cas9-based precision B cell gene engineering coupled with artificial intelligence-guided protein design produces active and sustained levels of tissue nonspecific alkaline phosphatase for the treatment of Hypophosphatasia

Presenter: Monika Musial-Siwek, Ph.D., Director, Protein Sciences, Be Biopharma

Date: May 10, 2024

Time: 12:00 PM ET

Session Title: Friday Posters: Musculo-Skeletal Diseases
Session Room: Exhibit Hall
Final Abstract Number: 1649

The abstract highlights Be Bio’s novel approach using engineered B-cell Medicines (BCMs) as a potential new treatment for Hypophosphatasia (HPP), a genetic disorder characterized by loss-of-function mutations in the ALPL gene which impairs the mineralization of bones. Researchers used CRISPR/Cas9 precision gene engineering and artificial intelligence-guided protein design to modify primary human B cells to produce tissue nonspecific alkaline phosphatase (ALP), an enzyme deficient in people living with HPP. The nonclinical data demonstrates the engineered BCM successfully produces active ALP , highlighting the therapeutic potential of the BCM platform as a novel treatment modality for HPP. BCMs have key attributes of plasma cells, including natural longevity, high levels of protein secretion, the ability to engraft without host preconditioning, and the ability to be re-dosed, making them an attractive platform for sustained supply of biologics.

For more information, please visit the conference website View Source

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

On April 23, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported the European Commission (EC) has approved a label extension for XTANDI (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (Press release, Astellas, APR 23, 2024, View Source [SID1234642242]).

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The extended approval for XTANDI is based on results from the Phase 3 EMBARK trial in 1,068 men with high-risk BCR nmHSPC, in whom levels of prostate-specific antigen (PSA), the biomarker which can be indicative of prostate cancer activity, doubled in nine months or less. The study showed patients treated with XTANDI in combination with leuprolide had a 57.6% lower chance of their cancer spreading or dying compared to those treated with leuprolide alone. Participants who were treated with XTANDI alone had a 36.9% reduction in risk.1

The European Association of Urology (EAU) revised their treatment guidelines in April 2024, recommending enzalutamide for men with high-risk BCR nmHSPC with or without ADT, after radiation therapy or surgery. Up until now, there has been no consensus on the standard of care for men in this setting.2

Dr. Antonio Alcaraz, Chairman of the Department of Urology at the University Hospital Clinic of Barcelona:
"When non-metastatic hormone-sensitive prostate cancer recurs and is allowed to evolve, it could potentially lead to metastasis. Facing a particularly high risk and poorer outcomes in this stage of prostate cancer are men with a rapidly rising PSA, where PSA levels double within 9 months. It is critical to manage the cancer carefully then, and I urge clinicians not to delay treatment in this setting. With this expanded approval for enzalutamide, clinicians now have an important new option to treat men with non-metastatic hormone-sensitive prostate cancer at high risk of metastasizing, which could become a new standard of care."

Ernst-Günther Carl, Chairman, Europa Uomo:
"There is a desperate need for additional effective treatment options for those living with advanced prostate cancer. Many men with hormone-sensitive prostate cancer undergo arduous surgery and rounds of radiotherapy, which can be a successful way to keep their cancer at bay. It is devastating then, when up to four in ten of those will go on to develop a recurrence that puts them at significantly greater risk of their cancer spreading and early death. The patient community welcomes any ongoing therapeutic research advances that may benefit those living with prostate cancer in progress."

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas:
"This expanded approval for XTANDI is a vitally important advance for patients with nmHSPC with high-risk BCR and is a testament to our long and ongoing collaboration with a global network of dedicated clinical trial investigators, patient groups, clinical trial participants and their families. Efficacy and safety results from the EMBARK study demonstrate the potential for XTANDI as a new option for treatment in the early, recurrent hormone-sensitive prostate cancer setting. Astellas is in active discussions with regulatory authorities around the world to bring XTANDI to those who may benefit."

The EC approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024, recommending approval of XTANDI in the high risk BCR nmHSPC setting.3

XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as nmHSPC) with BCR at high risk for metastasis in November 2023.

Astellas will reflect the impact from this matter in its financial forecast of the fiscal year ending March 31, 2025 that is scheduled to be disclosed on April 25, 2024.

For more information, please see the press releases "Astellas Receives Positive CHMP Opinion for XTANDI in Additional Recurrent Early Prostate Cancer Treatment Setting" issued on March 25, 2024, and "European Medicines Agency Validates Type II Variation for Astellas’ XTANDI (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence" issued on September 12, 2023.

About EMBARK
The Astellas- and Pfizer-led Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with nonmetastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk BCR at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered to experience high-risk BCR had a prostate-specific antigen doubling time (PSA-DT) ≤ 9 months; serum testosterone ≥ 150 ng/dL (5.2 nmol/L); and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer, or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide (n=355), enzalutamide 160 mg as a single agent (n=355), or placebo plus leuprolide (n=358). Leuprolide 22.5 mg was administered every 12 weeks.

EMBARK met its primary endpoint of metastasis-free survival (MFS) for the XTANDI plus leuprolide arm, demonstrating a statistically significant reduction in the risk of metastasis or death over placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death due to any cause, whichever occurred first.

The study also met a key secondary endpoint, by demonstrating that patients treated with XTANDI (single agent) had a statistically significant reduction in the risk of metastasis or death versus placebo plus leuprolide, meeting its MFS endpoint.

In EMBARK, Grade 3 or higher adverse events (AEs) were reported in 46% of XTANDI plus leuprolide patients, 50% of patients treated with XTANDI (single agent), and 43% of patients receiving placebo plus leuprolide. Permanent discontinuation due to AEs as the primary reason was reported in 21% of XTANDI plus leuprolide patients, 18% in XTANDI (single agent) patients, and 10% in placebo plus leuprolide patients.

For more information on the EMBARK trial (NCT02319837) go to www.clinicaltrials.gov.

About High Risk Biochemical Recurrent Non-Metastatic Hormone Sensitive Prostate Cancer
In non-metastatic hormone (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC), no evidence of the cancer spreading to distant parts of the body (metastases) is detectable with conventional radiological methods (CT/MRI), and the cancer still responds to medical or surgical treatment designed to lower testosterone levels.4 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a BCR within 10 years.5 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of their metastatic prostate cancer.6 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC and high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA-DT ≤ 9 months. High-risk BCR patients with a PSA-DT of ≤ 9 months have a higher risk of metastases and death.7

About XTANDI (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. Enzalutamide is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Enzalutamide is currently approved for one or more of these indications in more than 90 countries, including in the United States, European Union and Japan. Over one million patients have been treated with enzalutamide globally.8

About XTANDI (enzalutamide) in the E.U.9
Enzalutamide is an androgen receptor signaling inhibitor indicated in the E.U.:

as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).
for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Important Safety Information
For Important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: View Source

On April 23, 2024 Apmonia Therapeutics, a biopharmaceutical company developing innovative cancer therapies, reported that it has secured additional non-dilutive financing for a total of €2.7M (Press release, Apmonia Therapeutics, APR 23, 2024, View Source [SID1234642241]). This new financing is part of France 2030 investment plan. Apmonia Therapeutics is one of the winners of the 11th edition of the i-Nov Innovation Contest (operated by Bpifrance), and will receive the largest amount of funding (€2.2M) among the 42 prizewinners. Additional funding (€0.5M) will be
granted as part of the regionalized Plan d’Investissement d’Avenir (PIA4), co-financed by the Grand-Est Region and the French Ministry of the Economy, Finance and Sovereignty.

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Including previous fundraisings and financing already obtained, a total of €11M has been leveraged for the development of Apmonia Therapeutics’ technological platform.

A first clinical trial in patients with solid tumors, and a pioneering position in a new therapeutic class in oncology

Awarded a prize in the i-Nov competition, Apmonia Therapeutics’ INOTAX project aims to bring new therapeutic solutions to the medical need for solid tumor cancers. The company has identified and developed the first-in-class drug candidate TAX2, a peptide that acts as a modulator of the tumor
microenvironment by targeting the TSP-1/CD47 interaction.

At the same time, Apmonia Therapeutics’ scientific teams are working to develop new peptide-based therapies targeting the tumor microenvironment. Using advanced in silico technologies, the company
aims to identify new therapeutic targets and optimize the design of antagonistic peptides. This new financing will enable Apmonia Therapeutics to industrialize its drug discovery capabilities to accelerate
the development of new drug candidates.

"We are delighted to have won the i-Nov innovation contest, which testifies to the strong potential of our technological platform and our original approach", says Dr. Albin Jeanne, President of Apmonia Therapeutics, adding "This funding is a new milestone and a strong signal as Apmonia Therapeutics prepares to start its first clinical trial. It will also enable us to strengthen the development of our product pipeline, with potential applications in various pathologies".

"Bpifrance is proud to once again support one of France’s DeepTech nuggets, which has already been recognized on numerous occasions. Apmonia Therapeutics has an original technology and a management team whose expertise is widely recognized, and the funding granted today under both
the i-Nov innovation competition and the 4th Plan d’Investissement d’Avenir aims to foster the emergence of Apmonia Therapeutics as a leading company in its field, by supporting two strategic axes: clinical development prior to industrial and commercial launch, and portfolio diversification", explains
Lucie Jolibois, in charge of innovation at Bpifrance’s Champagne-Ardenne Regional Office.