On September 6, 2022 Sysmex Corporation (HQ: Kobe, Chairman and CEO: Hisashi Ietsugu) reported that applied on September 2, 2022 for a partial change of the manufacturing and marketing approval for the OncoGuide NCC Oncopanel System, a gene mutation analysis set (the "System") to include its use as a companion diagnostic for patients with advanced biliary tract cancer harboring FGFR2 gene1 rearrangements, including gene fusions (Press release, Sysmex, SEP 6, 2022, View Source [SID1234619009]).

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Biliary tract cancer2 is known to develop in approximately 26,000 patients annually in Japan,3 with a 5-year relative survival rate4 of less than 30%,5 and has the second poorest prognosis of any cancer after pancreatic cancer. At present, this disease has few treatment options, and no standard treatment has been sufficiently established for locally advanced or metastatic biliary tract cancer which progresses after first-line treatment. Development is actively underway in pursuit of molecular-targeted therapeutic agents that target specific genetic abnormalities such as FGFR2 gene rearrangements, which are believed to be closely related to cancer cell survival and proliferation.

In 2018, Sysmex became the first company in Japan to receive manufacturing and marketing approval for such a system for use in cancer genome profiling.6 The company has since contributed to the promotion of cancer genomic medicine by promptly delivering the System to various medical institutions. Sysmex has also been working on the development of a companion diagnostic device aimed at commercialization, jointly with Taiho Pharmaceutical Co., Ltd. (HQ: Chiyoda-ku, Tokyo; President and Representative Director: Masayuki Kobayashi), which is developing futibatinib7 (generic name), an FGFR inhibitor for the treatment of locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions, in Japan.

Sysmex has recently applied for a partial change of the System’s approval in Japan to include its use as a companion diagnostic for patients with biliary tract cancer, to determine indications of futibatinib. Taiho Pharmaceutical applied on July 28, 2022, for manufacturing and marketing approval for futibatinib for the treatment of previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions. If, through these initiatives, the System can be used to determine indications for the use of futibatinib in the future, it will provide another treatment option to patients with locally advanced or metastatic biliary tract cancer.

Sysmex will continue to work on the early commercialization of high-value testing and diagnostic technologies that will lead to offering optimal treatment for each patient, while also contributing to the development and evolution of personalized medicine.

FGFR2 gene:
Four types of fibroblast growth factor receptors (FGFRs), FGFR1-4, have been identified. These are proteins involved in cell growth and proliferation. When FGFR genes with abnormalities including fusion, mutation, and amplification are activated, they are thought to lead to cancer cell proliferation, survival, migration, tumor angiogenesis, drug resistance, etc.
In a study in Japan of patients with unresectable bile duct cancer, the positivity rate of FGFR2 gene rearrangement was reported to be 7.4% for intrahepatic cholangiocarcinoma and 3.6% for extrahepatic cholangiocarcinoma (hilar region). (Source: Maruki Y, et al., "Molecular detection and clinicopathological characteristics of advanced/recurrent biliary tract carcinomas harboring the FGFR2 rearrangements: a prospective observational study" (PRELUDE Study), J Gastorenterol. 2021 Mar; 56 (3): 250-260)

Biliary tract cancer:
A generic term for cancers that develop in the biliary tract, which are classified into bile duct cancer (including intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver), gallbladder cancer, or papillary carcinoma, depending on their primary sites.

Calculated based on the Cancer Information Service, National Cancer Center, Japan, Cancer Statistics (National Cancer Registry), National Cancer Incidence Data (2016-2018), and the Annual Report of Hospital-Based Cancer Registries, 2020 Nation-wide Aggregate Results (Tumor information).

5-year relative survival rate:
An index that indicates how much lower the percentage of individuals diagnosed with a certain type of cancer who are alive after five years is than the percentage of the entire Japanese population who are alive after five years.

Five-year relative survival rates in the 2013-2014 diagnosis are 20.6% for intrahepatic cholangiocarcinoma and 29.4% for gallbladder cancer, according to the Cancer Information Service, National Cancer Center, Japan, "Annual Survival Report of Hospital-Based Cancer Registries".

Cancer genome profiling:
A test designed to obtain a comprehensive cancer genome profile in tumor tissues for analysis of solid tumors, including advanced biliary tract cancer. Analyzing abnormalities in cancer-specific genes provides useful information for determining treatment methods, including diagnosis and selection of potentially effective anti-cancer drugs.

Futibatinib (development code: TAS-120):
A novel oral anticancer drug currently under development by Taiho Pharmaceutical for the treatment of patients with advanced solid tumors with FGFR1-4 genetic aberrations, including biliary tract cancer, who were previously treated with chemotherapy or other therapies. In May 2018, futibatinib was granted orphan drug status for the treatment of cholangiocarcinoma, and also received Breakthrough Designation for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions in April 2021 from the US FDA. In March 2022, the FDA accepted the New Drug Application (NDA) for futibatinib for priority review.

On September 6, 2022 Selvita S.A. [WSE: SLV], one of the largest contract research organizations (CRO) in Europe, reported its preliminary financial results for Q2 and H1 2022 (Press release, Selvita, SEP 6, 2022, View Source [SID1234619026]). According to the preliminary estimates published, the Group continues its dynamic growth, already exceeding the assumptions of the development strategy for 2022-2025 presented in March.

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In Q2 2022, Selvita Group generated EUR 22.4 million in revenues, indicating 46% increase y/y. EBITDA profit amounted to EUR 6.1 million and was 64% higher compared to same period in 2021. The net profit reached EUR 3.4 million – i.e. 50% more than in the previous year. This means an increase in both profitability at the EBITDA level from 24.5% to 27.5%, and the net profit from 14.9% to 15.3% y/y.
In the whole H1 2022, the Group achieved EUR 42.9 million in revenues, which indicates an increase of 40% y/y. The EBITDA profit in this period achieved EUR 12.1 million and was 60% higher than in the previous year. The net profit reached EUR 7.1 million (an increase of 79% compared to H1 2021). Thus, the EBITDA profitability increased in the referenced period from 24.8% to 28.2%, and the net profit increased from 12.9% to 16.5% y/y.
The Group’s backlog for the entire year 2022 exceeds EUR 77.3 million (as on 2nd September 2022) and is 32% higher than the value reported a year earlier (as on 16th September 2021).
– Since the beginning of 2022, we have been working very intensively to accelerate the development of Selvita. In Q1 2022, we presented the updated development strategy for 2022-2025, and implemented changes in the company’s structure. After a few months, we can already see the first effects of the actions taken. The second quarter of this year was even better than the first one, with our revenues increasing by 46% year on year in this period. In the entire first half of the year, our revenues reached EUR 43 million. The level of the backlog for this year indicates that we can grow significantly above our assumptions. At the same time, we are maintaining high profitability. We also do not observe the geopolitical situation or turbulences in the global economy and supply chains to have any negative effect on the implementation of our plans – comments Bogusław Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

In both Q2 and H1 2022, the research services executed in Poland and Croatia accounted for 88% of the Group’s revenues. In the April-June period, aforementioned activities generated EUR 19.3 million in revenues, which indicates an increase of 43% y/y. From the beginning of the year until June, the value of revenues had amounted to EUR 37.0 million, i.e. 38% more than in the corresponding period previous year. In the first six months of 2022, EBITDA profit of research services executed in Poland and Croatia reached EUR 11.3 million, which shows an increase of 61% y/y.

The bioinformatics segment i.e. Ardigen, generated almost EUR 4.6 million in external revenues in H1 2022, which indicates a 62% increase y/y (over EUR 2.3 million in Q2 alone, i.e. 63% higher y/y). At the end of H1, EBITDA in this part of the business amounted to EUR 0.8 million – 39% increase y/y. The bioinformatics backlog currently amounts to EUR 9.4 million, which means an increase of 56% compared to the same period a year earlier.

Such a significant increase in Selvita’s financial results is, among others, a result of the internal integration of the drug discovery area executed as part of the organizational structure changes and putting more focus on the high-margin services.

– We are already seeing the first effects of the consolidation of both companies under the Selvita brand. We are maximizing synergies, developing high-value services and entering new research areas. At the same time, we are looking for niches in which we could stand out from our competition. All this has a positive effect on the effectiveness of our business. We are convinced that it will also be visible in our future results – explains Dr. Adrijana Vinter, Global Head of Drug Discovery and Board Member at Selvita.

Further organizational structure changes were aimed at preparing the Group for further dynamic growth and involved integration of the business development teams.

– After the merger with Fidelta, we worked on creating the most clear and consistent offer. Along with the integration of the Croatian company under the Selvita brand, we have introduced numerous changes and improvements in our business development structures. The recorded growth dynamics are the result of, among others, these activities. We are maximizing our potential and strengthening our position on the market – says Dr. Miłosz Gruca, Chief Commercial Officer and Vice President of the Management Board at Selvita.

In order to provide the infrastructure resources necessary for further organic growth, Selvita is building its own laboratories in Krakow, creating workplaces for 250 scientists.

– We are undertaking numerous activities to secure ourselves a place for further organic growth. The key project implemented in this area is the construction of our own research building, which completion is planned for the first quarter of 2023. At the beginning of the year, Selvita also purchased a second, adjacent construction plot. As a result, depending on our needs, four research facilities can be built, creating over 1000 workplaces. At the same time, we are continuously looking to expand our infrastructure in Poznan and Zagreb – explains Dr. Mirosława Zydroń, Chief Operating Officer and Member of the Management Board of Selvita.

Implementation of the development strategy 2022-2025

At the end of Q1 2022, Selvita, having achieved the strategic goals set for the end of 2023 one year ahead, announced an updated development strategy for 2022-2025. During this period, the company plans to triple its sales revenues (up to EUR 200 million), while maintaining high profitability. The company will implement its strategy through organic growth and acquisitions. The implementation of the planned investments intends to allow Selvita to become the leading global preclinical CRO.

The Selvita Group Development Strategy for 2022-2025 is based on three key pillars:

Comprehensive drug discovery and development offer – supplementing the drug discovery offer and building the drug development segment
Focus on high-value services for the client – specialization in selected therapeutic areas and development of unique competences
Development of the Group’s operations in the largest markets in the United States and Great Britain – increasing teams and potentially new locations for laboratories
In the area of acquisitions, in 2022-2025, Selvita intends to acquire at least two preclinical CROs in Europe or North America, providing services complementary to the Company’s offer or enabling the expansion of the scale of its operations, allocating a total of EUR 110 million for this purpose.

– The results we achieved in the first half of 2022 mean that at this stage organic growth is ahead of our assumptions. At the same time, we have prepared our structure for further acquisitions and we are in continuous discussions with potential acquisition targets. I am convinced that also in this area we will be able to implement our development plans – adds Bogusław Sieczkowski.

On September 6, 2022 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported members of its management team will participate at the following investor conferences in September 2022 (Press release, Alpine Immune Sciences, SEP 6, 2022, View Source [SID1234619046]).

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H.C. Wainwright 24th Annual Global Investment Conference
Date: Monday, September 12, 2022
Time: 7:00 a.m. PT/10:00 a.m. ET
Event: Corporate Presentation & One-on-One Investor Meetings
Presenter: Remy Durand, PhD, Chief Business Officer, Alpine Immune Sciences, Inc.

Morgan Stanley 20th Annual Global Healthcare Conference
Date: Wednesday, September 14, 2022
Event: One-on-One Investor Meetings

A link to the H.C. Wainwright corporate presentation will be available online in the investor relations section of the Company’s website at View Source and will be available on the Company website for 90 days following the webcast. Investors interested in participating in One-on-One meetings at these conferences should reach out to their sales representatives at H.C. Wainwright and Morgan Stanley for more information.

On September 6, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported that a pre-recorded corporate presentation by Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will become available for on-demand viewing at the H.C. Wainwright 24th Annual Global Investment Conference, on Monday, September 12, 2022, at 7:00 a.m. ET (Press release, Aileron Therapeutics, SEP 6, 2022, View Source [SID1234619064]).

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The presentation will be available under the Investors & Media section of the company’s website at aileronrx.com. A replay of the webcast will be archived on the Aileron website for approximately 30 days following the presentation.

On September 6, 2022 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported that Mina Sooch, MBA, Founder and CEO will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference being held September 12-14, 2022 (Press release, Ocuphire Pharma, SEP 6, 2022, View Source [SID1234619082]).

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H.C. Wainwright 24th Annual Global Investment Conference – September 12-14, 2022

If you are interested in arranging a 1×1 meeting request, please contact your bank/conference representative or [email protected]. For more details, please see the Investors and Events section of Ocuphire’s corporate website.