On October 12, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that BRUKINSA (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator (Press release, BeiGene, OCT 12, 2022, View Source [SID1234621933]). BRUKINSA was generally well tolerated; safety findings at the final PFS analysis were consistent with prior reports.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This positive result adds to the growing body of evidence underpinning our belief in the potential for BRUKINSA to provide new hope for CLL patients facing this intractable disease. With this final PFS analysis, BRUKINSA has achieved superior progression free survival, as well as superiority in overall response rate versus ibrutinib," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "We look forward to sharing the full results with the medical and patient communities and will submit for presentation at a medical congress and for publication."

BeiGene’s supplemental New Drug Application for BRUKINSA for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) is currently under review with the FDA, with a target action date of January 20, 2023.

About ALPINE

ALPINE is a randomized, global Phase 3 trial (NCT03734016) comparing BRUKINSA against ibrutinib in previously treated patients with relapsed or refractory CLL or SLL. In the trial, a total of 652 patients across Europe (60%), the United States (17%), China (14%), New Zealand and Australia (9%) were randomized into two arms, with the first receiving BRUKINSA (160 mg orally twice daily) and the second receiving ibrutinib (420 mg orally once daily) until disease progression or unacceptable toxicity.

The primary endpoint of overall response rate (ORR), defined by pre-specified non-inferiority of BRUKINSA versus ibrutinib, was assessed by investigator and IRC using the modified 2008 iwCLL guidelines, with modification for treatment-related lymphocytosis for patients with CLL, and per Lugano Classification for non-Hodgkin’s lymphoma for patients with SLL. There was pre-specified hierarchical testing of non-inferiority followed by superiority in ORR as assessed by investigator and IRC. Key secondary endpoints include PFS and event rate of atrial fibrillation or flutter; other secondary endpoints include duration of response, overall survival, and incidence of adverse events. In April 2022, BeiGene announced results from the final response analysis showing BRUKINSA demonstrated superiority versus ibrutinib in ORR as assessed by an IRC.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program, which includes more than 4,500 subjects in 35 trials across 28 markets. To date, BRUKINSA has received approvals covering more than 55 countries and regions, including the United States, China, the EU, Great Britain, Switzerland, Canada, Australia, and additional international markets.

On October 12, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported the approval, as of October 7, 2022, of an application for a partial change to the manufacturing and marketing approval in Japan of its gene amplification reagent LYNOAMP CK19 marketed as a lymph node metastasis test reagent for breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, expanding its amplification to cervical cancer and endometrial cancer (Press release, Sysmex, OCT 12, 2022, View Source [SID1234621932]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Whether lymph node metastasis has occurred is an indicator of cancer progression during treatment for cervical cancer and endometrial cancer. Lymph node metastasis testing plays an important role in forming a medical treatment plan such as operating procedures and post-operative adjuvant therapy.

This testing is typically performed during or after surgery when a pathologist prepares samples from surgically removed lymph nodes, and then views the samples under a microscope to determine whether the cancer cells have metastasized. However, the test places a heavy workload on pathologists. Combined with a shortage of pathologists, this type of testing presents problems in medical settings.

Sysmex has employed its proprietary technology, the OSNA method,1 in rapidly detecting cancer lymph node metastasis, using its a gene amplification detector RD-100i and the reagent LYNOAMP BC, and has marketed them in in Japan since 2008. After gaining manufacturing and marketing approval for breast cancer in the same year, Sysmex strove to expand the system to further cancer types. In 2018, Sysmex launched the gene amplification detector RD-200 and the reagent LYNOAMP CK19, which shortens the testing process while increasing the number of samples that can be tested simultaneously. This has been approved by the national health insurance in Japan as the only lymph node metastasis testing system that adopts a molecular biological technique.

The system automates and simplifies cancer lymph node metastasis testing, and provides objective test results without relying on the examiner’s proficiency. This reduces the workload on pathologists and contributes to the equalization of medical care2 and the formulation of medical treatment plans, taking into account the burden on patients and their QOL.

Sysmex has now gained approval for a partial change to expand the application of LYNOAMP CK19, currently used as a lymph node metastasis test reagent for breast cancer, colorectal cancer, gastric cancer and non-small cell lung cancer, to cervical cancer and endometrial cancer. Through the provision of rapid and accurate results in lymph node metastasis testing, the system is expected to contribute to the formulation of appropriate medical treatment plans for patients with cervical or endometrial cancer.

Sysmex will continue working toward the further rollout of testing of lymph node metastasis using the OSNA method, contributing to the standardization of healthcare and improvement of patients’ QOL.

On October 12, 2022 NEC Corporation ("NEC") reported the status of a repurchase of shares of its own common stock, pursuant to Article 459, Paragraph 1 of the Companies Act of Japan and NEC’s Articles of Incorporation, which was approved at the Board of Directors meeting held on August 29, 2022, as follows (Press release, NEC, OCT 12, 2022, View Source [SID1234621931]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(1)Type of shares repurchased:
Common stock
(2)Total number of shares repurchased:
1,505,800 shares
(3)Aggregate value of shares repurchased:
7,455,282,000 yen
(4)Repurchase period:
September 1, 2022 – September 30, 2022
(5)Method of repurchase:
Open market purchase through the Tokyo Stock Exchange based on a discretionary trading contract
(For Reference)
1. Details of Matters Relating to the Repurchase (as announced on August 29, 2022)

(1)Type of shares to be repurchased:
Common stock
(2)Total number of shares to be repurchased:
Up to 6.7 million shares
(2.46% of total shares outstanding excluding treasury stock)
(3)Aggregate repurchase price:
30 billion yen (maximum limit)
(4)Repurchase period:
August 30, 2022 – March 31, 2023
(5)Method of repurchase:
Open market purchase through the Tokyo Stock Exchange based on a discretionary trading contract
Depending on market trends and other factors, all or part of the planned repurchase may not be completed.

2. Total number and aggregate value of shares repurchased pursuant to the resolution approved at the above-mentioned Board of Directors meeting (as of September 30, 2022)

Total number of shares repurchased:
1,786,100 shares
Aggregate value of shares repurchased:
8,879,015,000 yen

On October 12, 2022 Australian diagnostics company Minomic International Ltd (Minomic) reported that their lead product, MiCheck Prostate,1 has recorded its initial commercial sales in the US, the world’s largest healthcare market (Press release, Minomic, OCT 12, 2022, View Source [SID1234621930]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Each year, two million American men2 undergo highly invasive prostate biopsies to diagnose prostate cancer after an elevated Prostate-Specific Antigen (PSA) test result. Prostate biopsies can result in side effects such as bleeding, infections and difficulty urinating.3 A significant proportion of these biopsies are unnecessary,4 as the patient does not have cancer or has a low-grade cancer that requires monitoring rather than intervention.

MiCheck Prostate is a blood test that can be quickly measured and reported providing an easy-to-understand graphical result. Urologists who have patients with elevated PSA can order the test and receive a report with the percentage risk of aggressive prostate cancer, helping avoid unnecessary biopsies.

The MiCheck Prostate test is run at Minomic Inc’s CLIA Certified "High Complexity" Laboratory located in Gaithersburg, Maryland. The test has become available following CLIA Laboratory registration and internal validation of MiCheck Prostate in 2022. The first tests have already been ordered by Las Vegas Urology, a large urology practice based in Nevada.

Each year, there are 1.2 million American men returning an elevated PSA result and a further 3 million under active surveillance due to an already elevated PSA, who would benefit from the use of MiCheck Prostate.

Importantly, MiCheck Prostate will be reimbursed through Medicare increasing access for a significant number of men. The most affected cohort are men over the age 65 with the majority (65%) covered by Medicare. Reimbursement also provides a direct pathway to commercial revenues for Minomic.

Dr Brad Walsh, Minomic CEO, said: "We are very excited to have completed the journey, bringing MiCheck Prostate to commercial reality in the key US market. The high negative predictive value of the test and its superior specificity can better inform urologists and uro-oncologists about the patient’s risk of aggressive prostate cancer."

Dr Vijay Goli, Urologist at Las Vegas Urology, said: "I really like the test, I can make a decision whether to biopsy in seconds using the graph in the MiCheck Prostate report. The report is much easier than other tests which take more time to work out the pathway and are very complicated."

Prostate cancer is the most commonly diagnosed cancer in Australia,5 with one in seven men affected. In the US, one in eight men will face this disease in their lifetime.6

Minomic is currently expanding their sales and marketing teams to reach more urology practices across the US, so that more men can benefit from this revolutionary test.

MiCheck Prostate is available through Minomic’s US laboratory and will soon be available for patients at selected Sonic pathology laboratories in Australia.

On October 12, 2022 Tavros Therapeutics, Inc., a precision oncology platform company leading the new frontier of targeted therapies exploiting tumors’ genetic vulnerabilities, and Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Bayer AG, reported the companies have entered into a collaboration agreement to discover or target four oncology targets across an initial five-year term (Press release, Tavros Therapeutics, OCT 12, 2022, View Source [SID1234621928]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tavros leverages its functional and computational genomics technologies to uncover unique vulnerabilities within tumors to discover novel targets and biomarkers in areas of high unmet clinical need and identify novel clinical positioning strategies for existing molecules.

Under the terms of the agreement, Tavros will receive $17.5 million in a cash upfront payment from Vividion, and is eligible to receive up to $430.5 million in potential future payments based on the achievement of prespecified preclinical, clinical development, and commercial milestones, as well as low-single-digit royalties on sales of certain potential programs. Vividion has options to pursue up to five additional targets with up to $482 million in potential additional future payments.

"The future of cancer treatment lies in the precision targeting of therapies in the optimal clinical settings. This partnership allows Tavros to expand the actionability of our platform into a new target space by pairing our precision oncology platform with Vividion’s unmatched ability to drug the traditionally undruggable," said Tavros CEO and co-founder Eoin McDonnell, Ph.D. "We’re thrilled to launch our work with Vividion and harness our combined expertise to reach patients with difficult-totreat cancers by uncovering and drugging the next generation of high-value targets and augmenting the efficacy of emerging compounds." RESTRICTED

"Despite decades of effort, many targets remain inaccessible to traditional small molecule drugs, and many others have uncertain relevance to disease," said Vividion Therapeutics CEO Jeffrey Hatfield. "This collaboration brings together two orthogonal, highly innovative and synergistic approaches to drug discovery that will address both of these challenges. Vividion has the ability to find and drug previously unknown, or cryptic, functional binding pockets on oncology and immunology targets of high interest, while Tavros has the potential to uncover previously unknown synthetic vulnerabilities or dependencies in deadly tumor cells. We believe this powerful combination of leading-edge technologies has the potential to deliver multiple breakthrough discoveries for cancer patients in need."