On November 26, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY; ISIN DE0007921835) reported its third quarter business update for the period ending September 30, 2020 (Press release, Vivoryon Therapeutics, NOV 26, 2020, View Source [SID1234571781]). The third quarter 2020 report is available for download on the Company website (View Source).

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KEY HIGHLIGHTS

Enrollment of first patient in VIVIAD, the Company’s European Phase 2b Alzheimer’s disease study evaluating varoglutamstat (PQ912)
Announcement of IND approval for varoglutamstat (PQ912)
Successful completion of the Ordinary General Meeting of Shareholders

CORPORATE REVIEW

Financial Review (According to IFRS)

In the third quarter of 2020, research and development expenses amounted to EUR 3,653k and increased compared to the third quarter of 2019 (EUR 1,196k). General and administrative expenses increased to EUR 1,051k (Q3 2019: EUR 768k). The Company did not generate any revenue in the reporting period, in line with corporate planning. Therefore, the net loss of the period was EUR 4,598k compared to EUR 1,935k in the third quarter of 2019.

Vivoryon Therapeutics held EUR 10.0 million in cash and cash equivalents as of September 30, 2020. In addition, the Company holds other securities in amount of EUR 19,967k which can be liquidated at any time.

All results are in line with management expectations.

OPERATIONAL REVIEW

Announcement of Enrollment of First Patient in VIVIAD, European Phase 2b Alzheimer’s Disease Study with Varoglutamstat (PQ912)

The Company announced that the first patient was enrolled in VIVIAD, a Phase 2b, randomized and multi-center clinical study in Europe. The study will evaluate the safety and efficacy of Vivoryon’s lead candidate, varoglutamstat (PQ912), in patients with Alzheimer’s disease .

IND Approval for Phase 2 Study of Varoglutamstat (PQ912) in Patients with Alzheimer’s Disease

The Company announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for varoglutamstat (PQ912). FDA clearance of the IND will enable Vivoryon to initiate its U.S. Phase 2 clinical trial program for varoglutamstat (PQ912) in Alzheimer’s disease as planned.

Ordinary General Meeting of Shareholders of Vivoryon Therapeutics AG

The Company announced that its shareholders approved all resolutions proposed by the Company’s management and Supervisory Board at the Company’s Annual General Meeting which took place on Wednesday, September 30, 2020. This included the transfer of the statutory seat to Amsterdam, the Netherlands, leading to a conversion into a public company under the laws of the Netherlands.

On November 25, 2020 Grand Pharmaceutical and Healthcare Holdings Limited reported the company submitted new drug application ("NDA") for the world’s innovative product SIR-Spheres Y-90 resin microspheres to the National Medical Products Administration of the PRC ("NMPA") and got formally accepted (Press release, Grand Pharmaceutical, NOV 25, 2020, View Source [SID1234653969]). SIR-Spheres Y-90 resin microspheres is one of the Group’s blockbuster products in precision interventional therapy and anti-tumor radioactive pharmaceuticals. Meanwhile, Telix Pharmaceuticals Limited (ASX: TLX) ("Telix"), the Group’s partner in the field of radionuclide-drug conjugates ("RDC"), has submitted the NDA for TLX591-CDx (68Ga-HBED-CCPSMA11) ("TLX591-CDx"), the world’s innovative RDC product for the imaging of prostate cancer. The NDA has been recently accepted for filling by the United States Food and Drug Administration ("FDA"), and it is expected to receive the outcome of the request for priority review on 10 December 2020, with the expectation of shortening the time for US approval for commercialization through priority review.

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The Group adopts the strategy of "global expansion and dual-cycle operation", and regards anti-tumor radiopharmaceuticals and precision interventional therapy as one of the focus areas in future strategic planning, gradually forming a new pattern of domestic and international cycles that synergize with each other. At present, the Group has obtained seven innovative first-in-class RDC including Y-90 resin microspheres and TLX591-CDx in the field of radioactive pharmaceuticals, for diagnostics and treatment of prostate cancer, clear cell renal cell carcinoma and glioblastoma. In the field of precision interventional therapy, TAVOTM, the core product of OncoSec Medical Incorporated (NASDAQ: ONCS) ("OncoSec", an associate of the Group), the Group’s research and development platform in tumor immunotherapy and DNA technology, are undergoing clinical trials in treating metastatic melanoma, triple-negative breast cancer and squamous cell tumors, having shown satisfactory effectiveness. The Group so far has owned 11 innovative products globally, covering 8 major solid tumors. The variety and quantity of the Group’s product pipeline are at the leading level in this industry.

Y-90 resin microspheres is the only radioactive microspheres around the world approved by the FDA, which are used in selective internal radiation therapy for malignant liver tumors, and has the dual advantages of radiopharmaceuticals and precision interventional therapy. A number of high-quality and large-sample clinical studies on Y-90 resin microspheres have been carried out in Europe, US, Hong Kong and Taiwan, and the results prove that Y-90 resin microspheres can significantly increase response rate, reduce tumor burden and achieve tumor downstaging, so that patients can gain the chances to undergo surgical resection. It can also significantly prolong the progression-free survival, control tumor progression and increase the waiting time for liver transplantation. In the meantime, Y-90 resin microspheres bring less side effects and higher quality of life for patients.

Y-90 resin microspheres has been given to over 100,000 people in 50 countries and regions around the world. With its remarkable clinical efficacy, it has been covered by medical insurance in places such as the United States and Europe. It is also recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network ("NCCN") and European Society for Medical Oncology ("ESMO"). In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition) with clear clinical demands delineated. Y-90 resin microspheres will provide new treatment option to hundreds of thousands of cancer patients in China after being launched to the market.

TLX591-CDx is a world’s innovative radionuclide-antibody conjugated diagnostic radiopharmaceutical product targeting prostate-specific membrane antigen ("PSMA"), for diagnostics of metastatic prostate cancer. It is currently the fastest RDC project under development using Positron Emission Tomography ("PET") for the imaging of prostate cancer, expected to be the first approved radiopharmaceutical product by the FDA. PSMA imaging is already included in the leading clinical practice guidelines in the United States and Europe, based on evidence that definitively demonstrates superiority over conventional imaging. This is highly supportive of rapid promotion of TLX591-CDx upon approval for commercialization.

The 2020 edition of NCCN guidelines for prostate cancer recommends TLX591-CDx as a new type of positron-emitting radiopharmaceutical ("PET Tracer"), which may provide better detection of recurrences at lower prostate-specific antigen ("PSA") levels than approved imaging agents.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "The FDA has accepted NDA for TLX591-CDx and is likely to be granted priority review next month, together with NDA for the world’s innovative product SIR-Spheres Y-90 resin microspheres being formally accepted by the NMPA, which further demonstrates the Group’s capabilities of selecting world-class innovative products, precise and powerful business development capabilities at home and abroad as well as ability to introduce and fully implement international advanced technologies."

"Looking ahead, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including US based OncoSec, Australia based Sirtex and Telix, the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and precision interventional platform integrating diagnostics and treatment. Meanwhile, the Group makes full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide Chinese cancer patients with more advanced and diverse treatment options."

On November 25, 2022 Hengrui Pharmaceuticals reported that Carrelizumab + Famitinib Malate Was Included in the Public Announcement of the Proposed Breakthrough Treatment (Press release, Hengrui Pharmaceuticals, NOV 25, 2020, View Source [SID1234633521]).

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Cervical cancer is one of the common malignant tumors in women. Its incidence ranks first among female reproductive system tumors in my country, and its mortality ranks seventh among malignant tumors. According to the epidemiological survey results of cervical cancer reported in my country in 2014 reported in 2018, it is estimated that the number of new cervical cancer cases nationwide is 102,000, with an incidence rate of 15.30 per 100,000; the number of deaths is about 30,400, and deaths The rate is 4.57 per 100,000.

Early cervical cancer can be treated by means of surgery, radiotherapy and chemotherapy, but under comprehensive treatment, about 15-20% of patients still relapse; in addition, 70% of locally advanced cervical cancer will relapse after concurrent radiotherapy and chemotherapy ; For metastatic (FIGO stage IVB) or recurrent cervical cancer, systemic chemotherapy is the main treatment, and the 5-year survival rate is poor, with only about 17% reported in the literature.

The current recommended first-line treatment for patients with recurrent and metastatic cervical cancer is a combination of platinum (cisplatin or carboplatin) combined with paclitaxel. For patients with contraindications to taxanes, cisplatin combined with topotecan can be considered. The objective response rate of the first-line combination chemotherapy is about 30%, the median PFS is about 6 months, and the median OS is about 12 months. For recurrent or metastatic cervical cancer that has failed first-line treatment, there is currently no standard treatment plan. The guidelines recommended options include bevacizumab single-agent, albumin paclitaxel, docetaxel, pemetrexed, gemcitabine, and vinorelbine However, the remission rate of these drugs in the treatment of recurrent and metastatic cervical cancer is less than 15%, the median PFS is about 3 months, and the median OS is about 7 months. It can be seen that for recurrent and metastatic cervical cancer, treatment options are limited, and those who have failed first-line systemic treatment face the dilemma of no drugs to choose from, and it is urgent to develop effective treatment drugs.

Carrelizumab is a humanized PD-1 monoclonal antibody independently developed by Hengrui Medicine with intellectual property rights. It can bind to human PD-1 receptors and block the PD-1/PD-L1 pathway to restore the body Anti-tumor immunity, which forms the basis of cancer immunotherapy. Since its listing in May 2019, four indications have been approved for Hodgkin’s lymphoma, advanced hepatocellular carcinoma, advanced esophageal squamous cell carcinoma and non-squamous non-small cell lung cancer. In April 2019, the first-line phase III clinical study of carrelizumab for injection combined with apatinib for the treatment of advanced hepatocellular carcinoma has been conducted in the United States, Russia, Belgium, Germany, France, Spain, Italy, Poland, South Korea and China, etc. 123 centers in 14 countries and regions were launched simultaneously.

Famitinib Malate Capsules is a small molecule multi-target tyrosine kinase inhibitor independently developed by Hengrui Pharmaceuticals. It is effective against multiple receptor tyrosine kinases such as c-Kit, KDR, PDGFR, VEGFR3, Flt1, Ret, Flt3, c-Src, FGFR2, FGFR3 and PDGFRα have good inhibitory activity. Currently, clinical studies at different stages for multiple indications such as advanced solid tumors, nasopharyngeal carcinoma, non-small cell lung cancer, gastrointestinal stromal tumors, neuroendocrine tumors, renal clear cell carcinoma, and colorectal cancer are being carried out.

Preliminary research data shows that carrelizumab combined with famitinib malate has shown outstanding efficacy and controllable safety for patients with recurrent and metastatic cervical cancer who have failed first-line treatment.

Hengrui Medicine submitted an application for a breakthrough treatment drug for carrelizumab combined with famitinib malate for the treatment of recurrent and metastatic cervical cancer on October 21, 2020, and was approved by the National Medical Products Administration on November 23. The review center included the list of proposed breakthrough treatments for publicity. This is a major milestone for Hengrui Pharmaceuticals to develop carrelizumab combined with famitinib malate treatment plan, which means that the combination drug is expected to be approved quickly and bring new treatment options to patients as soon as possible. At the same time, Hengrui Medicine is carrying out clinical research on the combination of carrelizumab and famitinib malate in various fields such as metastatic non-squamous non-small cell lung cancer and advanced renal cell carcinoma.

On November 25, 2020 SBI Pharmaceuticals and TAGCyx biotechnologies reported entering into a research and develop collaboration to develop innovative products in the field of cancer treatment (Press release, TAGCyx Biotechnologies, NOV 25, 2020, View Source [SID1234625951]).

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SBI Pharmaceuticals is specialized in the application of 5-ALA (5-aminolevulinic acid) and is dedicated to provide innovation for a wide range of health applications in the healthcare and health food field in order to help improve the health and quality of human life all over the world.

TAGCyx has invented artificial nucleic acid base-pair technology that enables to produce high affinity and selective DNA aptamers "Xenoligo".

By combining SBI Pharmaceuticals’ technology and TAGCyx’s Xenoligo, both companies intend to develop novel technologies in oncology arena.

As part of the joint research and development, TAGCyx will receive research and development funds, multiple milestones at certain steps during the development as well as sales related royalties accordingly.

(*1) 5-aminolevulinic acid (5-ALA): An amino acid produced in mitochondria. It is an important substance that serves as a functional molecule related to energy production in the form of heme and cytochromes, and its productivity is known to decrease with age. 5-ALA is contained in food such as shochu lees, red wine and Asian ginseng. It is also known as a material forming chloroplasts in plants.

On November 25, 2020 Hamlet Pharma AB reported its successfully secured patent protection in Europe for its lead clinical candidate, Alpha1H (Press release, HAMLET Pharma, NOV 25, 2020, View Source;utm_medium=rss&utm_campaign=alpha1h-patent-granted-in-europe [SID1234574599]). This protection is granted as European patent number EP 3618848 B1, which will remain valid until May 14, 2038.

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Alpha1H is currently used in clinical trials in patients with bladder cancer. With this patent, Hamlet Pharma AB continues to expand it’s intellectual property portfolio in areas where its key products show benefit. Following this success at the European Patent Office, where the claims of EP 3618848 B1 were readily accepted for grant, Hamlet Pharma AB plans to seek equivalent protection in further key countries around the world.

"This demonstrates the uniqueness of the innovation and the opportunities Alpha1H may offer cancer patients" says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.

"Alpha1H is our lead drug candidate and this is an important milestone to secure long-term protection in Europe" says Mats Persson, CEO of Hamlet Pharma Ltd.