On February 15, 2023 Alercell reported the opening of Alercell UK LTD. with principal office in central London (UK) (Press release, Alercell, FEB 15, 2023, View Source [SID1234627273]).

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Alercell will develop in London its R&D facility centered on neuroscience research. Alercell intends to invest into a new R&D center to be created and operational by Summer 2023. Several locations have been already scouted in central London.

Alercell, Inc., is a molecular diagnostics company pioneering novel therapeutics to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in Oncology in-vitro Diagnostic Testing and Neuroscience. Alercell is located in Bozeman Montana (USA).

"In London we intend to develop a new approach to neurodegenerative diseases, and we do have a plan already in place. Along our innovative work in preventative cancer medicine, we believe that patients suffering from neurodegenerative diseases need help and we believe that we have a solution. We will develop it in a state-of-the-art R&D center that will be operational by Summer 2023." Said Frederic Scheer Alercell CEO.

The company is on an aggressive growth pattern as it is in the process of finalizing the incorporation of Alercell France SAS, an Alercell wholly owned subsidiary in Paris where it intends to expand and develop additional research and offer its cancer and leukemia diagnostic tests.

Alercell recently introduced Lena Q51 a Leukemia diagnostic test that was developed to detect up to 51 genes mutations associated with Leukemia. (www.Lenadx.com).

On February 15, 2023 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Henlius’ HLX02 (trastuzumab for injection, trade name in Europe: Zercepac, trade name in China: HANQUYOU; trade names in Australia: Tuzucip and Trastucip) submitted by the company’s business partner Accord BioPharma Inc. (Accord US) (Press release, Henlius Biopharmaceuticals, FEB 15, 2023, View Source [SID1234627272]). The BLA seeks approval of HLX02 for the adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In 2021, the company granted Accord US the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

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Mr. Jason Zhu, President of Henlius, said, "Henlius independently developed HLX02 in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines. It is now approved in more than 30 countries and benefitted more than 100,000 Chinese patients. The U.S. FDA’s acceptance of the BLA filing not only expands the Henlius’ international footprint. More importantly, we prioritize the needs of patients. As breast cancer has become the most prevalent cancer in the world, trastuzumab has been the cornerstone of treating HER2-positive cases. In collaboration with Accord, we look forward to bringing HLX02 to more patients around the world."

HLX02 is the first China-developed mAb approved both in China and Europe. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively. HLX02 is now indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. The BLA submission is based on robust structural and functional analytical comparison data using multiple orthogonal techniques and head to head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab. The clinical results proved that HLX02 and reference trastuzumab are highly similar in terms of quality, safety, and efficacy.

Henlius has established a quality management system in line with international quality standards, which covers the entire product life cycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post-marketing surveillance, laying the foundation for globalisation. The company has built 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 litres, and the total production capacity in 2026 is expected to reach 144,000 litres. In 2022, Songjiang First Plant was approved for the commercial production of HLX02 and has been officially put into operation, which effectively ensures market penetration and forms synergy with the Xuhui Facility with a commercial production capacity of 24,000 litres. The company’s commercial production facility and supporting quality management system have been certificated by China and the EU GMP. They have also passed on-site inspections and audits conducted by the NMPA, the EMA, the EU Qualified Person, and multiple international business partners. At the present, a stable supply has been achieved in the Chinese and the EU markets, strongly supporting the continuous expansion of the products globally.

Henlius has aggressively pursued international commercialization of HLX02, actively collaborating with global partners such as Accord Healthcare, Abbott, Cipla, Eurofarma, Mabxience and the Jacobson Group to bring its therapeutics to patients in the United States, Canada, Europe, and other emerging markets, covering about 100 countries and regions. Up to now, HLX02 (trade name in China: HANQUYOU, trade name in Europe: Zercepac, trade names in Australia: Tuzucip and Trastucip) has launched in over 30 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, and Saudi Arabia. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.

About Accord BioPharma

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients’ perspective and develop high-quality therapies that impact patients’ lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies. For more information, Visit AccordBioPharma.com.

On February 15, 2023 Genome Medical and xCures reported to have joined forces to provide patients with a new level of personalized care. Through this collaboration, Genome Medical’s genetic counselors will have access to xCures’ comprehensive care summaries for patients based on electronic medical records from across the healthcare ecosystem (Press release, xCures, FEB 15, 2023, View Source [SID1234627271]). This information will be used to better inform the treatment of Genome Medical patients.

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Genome Medical’s national reach and industry-leading genetic counseling services deliver critical insights and care to patients as they understand the risk factors and genetic implications of their conditions.

"Together, we are delivering the knowledge and data that is vital for precision medicine," said Mika Newton, CEO of xCures. "Our real-time clinical data offers unique insights for patients and providers in their fight against cancer."

"We look forward to collaborating with xCures to deliver an enhanced level of care to our patients and with an even more complete view of the patient’s health background," said Jill Davies, CEO of Genome Medical. "This collaboration will have a great impact on the patients we serve, with the potential for an even greater impact on population health through enhanced research for oncology and other inherited diseases."

Incorporating xCures’ real-world clinical data into the comprehensive Genome Medical genetic counseling sessions is another example of both companies’ mission to help integrate powerful genetic insights into a patient’s health journey. It brings to life the promise of genomic medicine, making genetic information clinically actionable for patients and their providers while supporting providers in their efforts to deliver genetic services at-scale.

The companies will also collaborate with researchers to use the aggregated knowledge gathered from this initiative to further research and treatment that has the potential to improve care and outcomes across care settings. With this exciting new collaboration, Genome Medical and xCures are revolutionizing patient care and shaping the future of connected health.

On February 15, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that data published in the International Journal of Radiation Oncology, Biology, Physics (aka, "The Red Journal") demonstrate that the company’s Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer (Press release, Veracyte, FEB 15, 2023, View Source [SID1234627270]). The data, from a pre-specified analysis of three phase 3 trials, represent the first validation of any gene-expression biomarker on pre-treatment biopsy samples from prospective randomized trials, and suggest the Decipher test provides clinically useful prognostic information to help personalize shared treatment decision-making.

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Approximately 30% of men with newly diagnosed localized prostate cancer present with high-risk disease, meaning they have an increased risk of disease recurrence, metastasis and death compared to men with lower-risk disease. However, previous studies have shown that more than 70% of men with high-risk prostate cancer who receive standard-of-care definitive radiotherapy and long-term androgen deprivation therapy (ADT) will never develop metastatic disease.

"High-risk prostate cancer is heterogenous and standard prognostic tools do a poor job of discriminating which men are likely to develop distant metastases and may benefit from more aggressive therapy, and who will do well when treated with standard radiotherapy and ADT," said Paul L. Nguyen, M.D., vice-chair for Clinical Research in the Department of Radiation Oncology at The Dana Farber/Brigham Cancer Center and professor at Harvard Medical School, and lead author of the published manuscript. "Because of this, clinicians are forced to use a one-size-fits-all approach that inherently leads to under- and over-treatment of many men. The data published today validate the role of the Decipher Prostate test in more accurately prognosticating patient outcomes, even within a high-risk group, to better personalize care. This utility is being further examined prospectively in ‘PREDICT-RT’, two parallel, randomized phase 3 clinical trials conducted by NRG Oncology and sponsored by the National Cancer Institute."

The Decipher Prostate Genomic Classifier is a 22-gene prognostic biomarker that provides a low, intermediate or high score indicating the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.

For the current analysis, Dr. Nguyen and colleagues obtained Decipher test scores on 265 biopsy samples from men with prostate cancer that was designated "high-risk" by National Comprehensive Cancer Network (NCCN) classification and who participated in one of three NRG Oncology randomized Phase 3, definitive radiotherapy trials (RTOG 9202, RTOG 9413 and RTOG 9902). With a median follow-up of 11 years, the researchers evaluated the association between Decipher scores and participants’ time to distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS).

Results demonstrate the Decipher Prostate test was independently prognostic for DM, PCSM and OS, with Decipher high-risk patients experiencing worse outcomes than Decipher low-risk patients on all three endpoints. After adjusting for age, PSA, Gleason score, cT-stage, trial, and randomized treatment arm, the analysis found that the Decipher test scores were independently associated with DM (HR 1.22, 95%CI 1.09-1.36), PCSM (sHR 1.23, 95%CI 1.09-1.39), and OS (HR 1.12, 95%CI 1.05-1.20). Notably, the Decipher test had similar prognostic ability in patients receiving short-term (4 months) or long-term (>24 months) ADT, though the absolute improvement in outcomes varied by Decipher risk. For example, at 10 years, the DM estimates were 31% for short-term vs 20% for long-term ADT in those with higher Decipher Prostate risk scores (an absolute benefit of 11%) but were 7% vs 4% in those with lower Decipher Prostate risk scores (an absolute benefit of 3%).

"This comprehensive analysis of three high-quality, randomized Phase 3 studies demonstrates that the Decipher Prostate Genomic Classifier provides information that can meaningfully impact clinical care for men with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Rigorous analyses and data like these are why we believe the Decipher Prostate test was given ‘Level 1’ evidence status in the NCCN’s most recent prostate cancer guidelines – the only gene-expression test to receive such designation. We believe the new data generated by Dr. Nguyen and colleagues could help physicians considering various treatment options for men with high-risk disease and who desire to tailor the duration and intensity of hormonal therapy for their patients on an individual basis."

On February 15, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, FEB 15, 2023, View Source [SID1234627269]). In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.

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"Many bladder cancer patients are elderly and suffer from comorbidities that make frequent office visits for treatment a real burden," said study investigator David Morris, M.D., F.A.C.S., Urologist at Urology Associates PC, Nashville, TN. "Moving healthcare out of the clinical setting and into a patient’s home would represent a new treatment paradigm for bladder cancer, which may reduce clinic and hospital costs while increasing patient comfort and convenience."

Eight patients were enrolled and treated with UGN-102 by 4 investigators. Median age was 75 years (range 55-84). Six patients completed treatment (6 doses), and 2 patients discontinued the study (5 doses and 4 doses, respectively) due to adverse events (AEs) unrelated to treatment. All 8 patients were evaluable for treatment response, and 6 of 8 (75%) achieved a complete response 3 months after starting treatment. The 2 patients who discontinued were assessed as non-responders. Treatment-related AEs were mild to moderate in severity (most common: dysuria and fatigue in 2 patients), and 3 patients with significant comorbidities had a serious AE, all of which were unrelated to treatment with UGN-102.

Patients, nurses and investigators completed home instillation feasibility questionnaires. These standardized feasibility questionnaires highlighted that all 8 patients preferred at-home to in-office treatment, and 5 of 6 patients recommended UGN-102 home instillation instead of transurethral resection of bladder tumors (TURBT). Home instillation was reported as feasible for visiting nurses, and 3 of 4 investigators considered at-home treatment "not different" than in-office treatment.

"As a urologic oncologist, I feel confident that the home instillation study results, appearing on the heels of our Phase 2 program and following the complete enrollment of our pivotal Phase 3 ENVISION study for UGN-102, provide us with even more reasons to believe that our novel approach to treating LG-IR-NMIBC has the potential to address genuine unmet needs of patients with bladder cancer," said Arie Belldegrun, M.D., Board Chair of UroGen.

The study enrolled patients with recurrent LG-IR-NMIBC who agreed to receive UGN‑102 at home. Six weekly doses of UGN-102 were administered. The first dose was administered on-site by a physician and the five remaining doses were administered at home by a visiting nurse. Patients were followed for AEs and treatment response was evaluated by visual observation, for cause biopsy, and urine cytology 3 months after treatment initiation. Complete response was defined as the absence of disease by white light cystoscopy, cytology, and histopathology.

"This study is another example of how UroGen continues to advance its mission to pioneer the way urothelial cancers are treated," says Liz Barrett, President and Chief Executive Officer, UroGen. "2023 will be a pivotal year for UroGen as we report on the ATLAS study of UGN-102 and start combinatorial treatments in the Phase 1 study of UGN-301. UroGen is in a strong position to achieve leadership in uro-oncology."

About LG-IR-NMIBC

Approximately 800,000 people are living with bladder cancer in the U.S., of that 80,000 suffer from LG-IR-NMIBC. Patients with LG-IR-NMIBC face a future of recurrence and additional surgeries. Currently, the only primary treatment available is a surgical procedure known as TURBT, which requires anesthesia. Every time TURBT is performed it may impose more burden and serious risks on patients, including pain, bleeding, infection and injury (including perforation).

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.