On April 14, 2021 Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-March 2021 at 8:00 CET on April 22, 2021. All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST (Press release, Hansa Biopharma, APR 14, 2021, https://www.prnewswire.com/news-releases/hansa-biopharma-to-host-conference-call-to-provide-interim-results-from-q1-2021-and-business-update-301268463.html [SID1234578055]). The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

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Slides used in the presentation will be live on the company website during the call under "Events & Webcast," and will also be made available online after the call. Link to presentation

On April 14, 2021 Adlai Nortye, a global biopharmaceutical company focused on developing innovative oncology drugs, reported that the first patient has been dosed in the global phase III clinical trial (BURAN) at Shanghai Eastern Hospital Medical Center in China (Press release, Adlai Nortye Biopharma, APR 14, 2021, View Source [SID1234578053]). This clinical study evaluates Buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This represents the first global multicenter phase III trial for HNSCC in the class of PI3K inhibitors.

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This trial is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of Buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC. The primary endpoint of this study is overall survival (OS) for the entire population of patients. This study plans to recruit approximately 500 HNSCC patients from around 150 clinical centers across 15 major countries and regions in North America, Europe and Asia-Pacific. Enrollment includes patients who have disease progressed after prior anti–PD–1/anti–PD–L1 monotherapy, prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy, or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post, platinum-based therapy.

"Results from a previously completed phase II trial have demonstrated that Buparlisib (AN2025) is well tolerated and shows clear clinical benefits," said Professor Denis Soulières, the Primary Investigator of BURAN study." The objective with BURAN is to be able to offer patients with progression after platinum-based and immunotherapy a better option than taxol."

"Although progress has been made in the treatment of patients with HNSCC in recent years, for those with recurrent or metastatic HNSCC, there is still a high unmet medical need. This BURAN study is expected to change the paradigm of second-line treatment for HNSCC, which offers a new treatment option for patients in China and the rest of the world," said Professor Guo Ye, Director of Phase I Clinical Trail Center of Shanghai East Hospital Affiliated to Tongji University and Member of the Head and Neck Cancer Committee of the Chinese Society of Clinical Oncology (CSCO). "As a physician, I am pleased and welcome more and more clinical trials to be carried out in China. This trial will provide us firsthand data in terms of safety and efficacy in Chinese patients with HNSCC and we are looking forward to bringing the best treatment option for them."

"Cooperating with world-class researchers to conduct high-quality clinical trials is an essential part of Adlai Nortye’s global strategy," said Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye. "We hope to provide safer and more effective treatments to patients in a timely manner to ultimately save lives. With an impressive median overall survival of 10.4 months and the FDA granted Fast-Track designation, Buparlisib (AN2025) has the potential to become the first PI3K inhibitor on the market for patients with HNSCC."

About BURAN study

The BURAN study is a randomized, open-label, multicenter phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti–PD–1/anti–PD–L1 monotherapy; prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post, platinum-based therapy.

About Buparlisib (AN2025)

Buparlisib (AN2025) is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the global phase II clinical trial for the treatment of head and neck squamous cell carcinoma (HNSCC), the median overall survival was as high as 10.4 months. It has received Fast-Track designation and an approval for initiating the phase III clinical study from FDA. The BURAN study investigating Buparlisib is also the first global phase III clinical trial conducted by Adlai Nortye.

About HNSCC

HNSCC is the 8th leading cancer by incidence worldwide and constitutes 90% of all head and neck cancers. The overall annual incidence of HNSCC patients globally reached approximately 0.84 million in 2020, and is expected to increase to approximately 1 million in 2030. Most patients are suffering from locally advanced HNSCC present with a high risk of recurrence; approximately 50-60% of HNSCC patients are diagnosed with metastatic disease. Although immune checkpoint inhibitors have significantly benefited patients with HNSCC, the overall response rates are relatively low in general. Treatment option for patients that do not respond to immune checkpoint inhibitors is increasingly becoming a significant unmet medical need.

On April 14, 2021 StemSynergy Therapeutics reported that A major scientific breakthrough in the development of novel cancer therapeutics targeting the Notch pathway has been published online ahead of print in the journal Cancer Research (Press release, StemSynergy, APR 14, 2021, View Source [SID1234578051]). In this report scientists describe a small-molecule inhibitor of the Notch pathway that is selective against Notch1, which contributes to many stages of cancer including in the maintenance of cancer stem cells, a main cause of resistance to chemotherapy and metastatic disease. StemSynergy Therapeutics, Inc., who collaborated on this study holds worldwide exclusivity to develop these molecules for the clinic.

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"The Notch pathway is an extremely attractive target for cancer therapeutics, as it is a critical driver of many human cancers. However, several approaches have failed to inhibit Notch safely in clinical trials and progress has nearly stagnated over the last few decades," said Anthony J. Capobianco, Ph.D., corresponding author of the study. "To date, there are no inhibitors that directly target the intracellular Notch pathway with any significant specificity, which is central to safety in humans. Pharma has been trying to target this pathway for more than 20 years and this is the first example of a targeted therapeutic specific for Notch1 that has robust efficacy and minimal toxicity in human-derived malignant tumors models."

In this study, the team of scientists refined their previous proof-of-concept inhibitor using computer modeling and experimental validation to identify chemical compounds that are selective for the Notch1 transcriptional complex. The lead compound, NADI-351, potently disrupts the formation of the Notch1 transcriptional complex which prevents transcription of oncogenic target genes and inhibits the growth of Notch1-dependent cancer cells and tumors.

Further validation confirmed NADI-351 is selective against Notch1 and against cancer stem cells, which require Notch1 activity. This mechanism was observed in multiple in vitro cancer models and replicated in NADI-351-treated human tumors in mice. "Our analysis confirms NADI-351 selectively disrupts Notch1-dependent transcription and that this mechanism has powerful downstream effects on cancer," said Annamil Alvarez-Trotta, Ph.D., first author on the study. "Specifically, NADI-351 clears cancer stem cells by starving them of Notch signaling and causes cell death in tumors, including esophageal and triple-negative breast cancer. "

Most importantly, NADI-351 does not induce the gastrointestinal toxicity which has long hampered development of Notch pathway inhibitors. The key to this therapeutic window is in the selective inhibition of the Notch1 transcriptional complex, while sparing those of other Notch proteins. "It’s likely that this selectivity, along with the short ‘pulse’ of inhibition that small molecules achieve, allows us to preferentially inhibit tumors addicted to Notch1 signaling without causing toxicity in tissues dependent on Notch signaling more generally," noted William Guerrant, Ph.D., Senior Scientist at StemSynergy Therapeutics.

"We feel this new class of Notch1 inhibitors could be a game-changer for patients with Notch-dependent tumors and those that are highly resistant due to cancer stem cell activity," said Capobianco, who is also a co-founder and President of StemSynergy Therapeutics. At the same time this breakthrough science is being published, StemSynergy Therapeutics is developing this class of compound for clinical evaluation. "We plan on aggressively pushing this through preclinical development and into cancer patients as a high priority and hope to be in clinical trials in the near term."

On April 14, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the completion of patient recruitment in its Phase 1/2 brain cancer study with lead candidate, NOX-A12 plus radiotherapy (Press release, NOXXON, APR 14, 2021, View Source [SID1234578050]). All three patients participating in the third and final dose cohort have been successfully enrolled and received initial treatment. NOXXON’s Phase 1/2 clinical study is investigating three dose regimens of CXCL12 inhibitor, NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed brain cancer patients.

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Once the last patient in the third cohort completes four weeks of therapy with NOX-A12 combined with radiotherapy, the independent Data Safety Monitoring Board (DSMB) will convene to assess the safety and tolerability of 600 mg NOX-A12 per week, the highest dose planned in the study. As outlined in the approved study protocol, it is planned for each patient to be treated with NOX-A12 for up to six months. Top-line data from this arm is planned to be available in November 2021.

"The combination of NOX-A12 and radiotherapy has been well tolerated by the participating patients so far. In the upcoming and final planned DSMB meeting, the safety of the highest dose tested will be assessed. Once patients have received treatment over a longer time period, the clinical investigators will analyze all available trial data to define the recommended dose for a Phase 2 glioblastoma study," said Prof. Frank Giordano, Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn.

"Completing patient recruitment for this dose escalation study is an important step in the continued clinical assessment of our novel therapy for patients with difficult-to-treat and highly aggressive brain cancer. We are currently preparing the submission of a protocol amendment to allow the inclusion of additional patients with the goal of expanding the data base for the recommended Phase 2 dose. In addition, our expansion aims to create a basis for enrolling a broader group of patients in future studies, in particular brain cancer patients who would also receive chemotherapy in addition to NOX-A12. Notably, this would allow NOX-A12 to be tested in all first line glioblastoma patients," commented Aram Mangasarian, CEO of NOXXON.

On April 14, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported data from an independent, prospective study published in the American Journal of Surgery demonstrating DecisionDx-Melanoma’s utility for prediction of outcomes in patients with cutaneous melanoma (Press release, Castle Biosciences, APR 14, 2021, View Source [SID1234578049]). DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors.

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The publication, titled "Utility of a 31-gene expression profile for predicting outcomes in patients with primary cutaneous melanoma referred for sentinel node biopsy," describes a study comparing tumor features, sentinel node biopsy (SLNB) results, and patient outcomes from a prospective database of 383 patients with cutaneous melanoma who both underwent SLNB and had their primary tumor assayed with DecisionDx-Melanoma. Groups were compared by univariate and multivariate analyses, and relapse-free and distant metastasis-free survival (RFS, DMFS) were estimated by Kaplan-Meier method.

The study’s results demonstrated that a Class 2 (high-risk) DecisionDx-Melanoma result was significantly associated with higher rates of SLNB positivity compared to Class 1 (low risk). With respect to risk prognoses, patients who received a Class 2B DecisionDx-Melanoma result and were SLNB-positive experienced the highest recurrence rates (38%), compared to only a 2% recurrence rate for patients who were Class 1A and SLNB-negative. DecisionDx-Melanoma Class 2 results were significantly associated with poorer RFS and DMFS rates compared to Class 1 results, both in the entire cohort of 383 cases and in patients staged as "low risk" (IA-IIA) according to American Joint Committee on Cancer (AJCC) staging criteria.

"We sought to study the utility of this 31 gene expression profile (31-GEP) test in the largest, independent, prospective study to date," said corresponding author John T. Vetto, M.D., FACS, Professor of Surgery, Division of Surgical Oncology, Oregon Health & Science University, Portland. "Current staging parameters in melanoma are invaluable but also imperfect. We were encouraged to find that, like AJCC stage, the 31-GEP results were independently associated with patient outcomes, including recurrence and distant metastasis, and that the 31-GEP results added prognostic information when incorporated with existing features to evaluate patient risk."

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.