On April 9, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported the publication of preclinical data on the potent anti-tumor activity of FS120, a first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 and OX40, in leading peer-reviewed journal Cancer Immunology Research (Press release, F-star, APR 9, 2020, View Source [SID1234556236]).

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Preclinical data from the article show that FS120 delays tumor growth by improving the activation and proliferation of peripheral T cells. These data also reinforce the superiority of dual agonist targeting over alternative TNFR-targeting agonists and support the clinical development of FS120 to treat patients with cancer.

FS120 is a first-in-class dual agonist bispecific antibody that has the potential to address ‘cold’ tumors and overcome cancer resistance by simultaneously targeting CD137 (4-1BB) and OX40 (CD134, TNFRSF4), two receptors which are part of the Tumor Necrosis Factor Receptor family (TNFRSF) of receptors and broadly expressed on activated T-cells and NK cells. Most (TNFRSF) -targeting antibodies require cross-linking via Fcγ receptors (FcγRs), which can limit their clinical activity and lead to undesirable toxicity effects. Preclinical data from this study show that FS120 can activate both CD4+ and CD8+ T-cells in an FcγR-independent mechanism, therefore promoting focused immune stimulation. FS120 is currently a clinical stage program, with the investigational new drug application being accepted by the Food and Drug Administration (FDA) earlier this year.

In this study, FS120 showed greater anti-tumor activity than a combination of CD137 and OX40 agonists, which was associated with activation and proliferation of CD4+ and CD8+ T-cells independently of FcγR interaction. Furthermore, FS120 induced lower levels of liver T-cell infiltration when compared to a crosslink-independent CD137 agonist monoclonal antibody.

A link to the full study can be found here.

Neil Brewis, CSO of F-star, said: "Driven by the open IND filed earlier this year, these data are a great validation of F-star’s tetravalent bispecific technology and a further endorsement for the clinical development of FS120. FS120 exhibits disruptive activity in cold tumors and has been shown to successfully induce T-cell activation in an FcγR‑independent manner, which can potentially display broader clinical activity, likely to be used in a combination drug therapy, compared to already existing compounds. This is an exciting time for us as we continue to develop our pipeline and progress our research towards improving treatment outcomes for patients with difficult-to-treat cancers."

On April 9, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the United States Patent Office (USPTO) issued U.S. Patent No. 10,597,443 with an expiry of May 2034 (Press release, Scholar Rock, APR 9, 2020, View Source [SID1234556237]). This patent broadly covers methods for making activation modulators of TGFβ that utilize Scholar Rock’s proprietary platform approach of targeting the precursor form of growth factors.

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"We are pleased with this important addition to our patent portfolio as it further differentiates our leadership position in the development of antibodies that modulate signaling of TGFβ isoforms," said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. "TGFβ is a key driver of a number of disease-relevant processes, including fibrosis and immune system evasion by cancer cells, for which we have discovered highly potent and selective inhibitors of TGFβ1 activation. Notably, this patent covers SRK-181, our product candidate being developed for the treatment of cancers resistant to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies."

The issued claims are directed to manufacture methods that include selection of modulators that specifically bind a large latent complex antigen of TGFβ isoforms. This broadly relates to TGFβ activation inhibitors that are specific to the context of presenting molecules, such as GARP and LTBP, as well as activation inhibitors that are not dependent on a specific presenting molecule. The latter class of antibodies includes our cancer immunotherapy clinical product candidate, SRK-181, being developed to expand the number of patients who could benefit from checkpoint inhibitor therapies.

On April 9, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported the details of its cervical cancer awareness activities to increase the screening rate (Press release, Chugai, APR 9, 2020, View Source [SID1234556223]). The activities target the age group most at risk for developing cervical cancer and parents of adolescents.

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The number of younger patients with cervical cancer has been increasing in recent years, particularly among those in their 20s to 40s.1) The cervical cancer screening is the only cancer screening program that is currently recommended by the Ministry of Health, Labour and Welfare (MHLW) for women aged 20 or above since this type of cancer should be detected at early curable stage.2) In Japan, however, the cervical cancer screening rate still remains at 42.1%,3) the lowest level in 30 member countries of the Organisation for Economic Co-operation and Development (OECD).

In order to eradicate cervical cancer, Chugai started disease awareness activities last year to improve the screening rate in Japan in collaboration with Osaka, Yokohama and other local governments. This year, Chugai rolls out further activities in partnership with Roche Diagnostics K.K. (Head Office, Tokyo; President and CEO, Makoto Ogasawara; hereinafter "RDKK"), the Japanese subsidiary of the Diagnostics Division of Roche Group, by leveraging the strengths of both companies. Specifically, the activities will include the shared use of disease awareness videos, brochures, and posters, as well as disease awareness initiatives through a tie-up with local governments with which we have concluded the comprehensive partnership agreements. RDKK has been actively focusing on the importance of early detection of cervical cancer with HPV testing and engaging in various awareness activities to prevent cervical cancer since 2009.

Main Activities
(1) Call for the importance of cervical cancer screening through commonly used media among young generation (e.g., Facebook, YouTube, and News app.).

Distribute educational articles to encourage the screening via Facebook(Chugai’s Official Facebook) and News App. (grape) at the occasion of Uterus Day (April 9).
Further provide young people with an opportunity to consider their health through Chugai’s educational video ("You…the one most responsible for you"; play time, 6 min. and 30 sec.) released last year on YouTube (View Source).
(2) Roll out activities in collaboration with local governments with which Chugai concluded the comprehensive partnership agreements and RDKK to increase the screening rate.

Conduct collaborative activities with RDKK by mutually utilizing each party’s expertise and materials to increase the screening rate particularly among women in their 20s with low screening rate, involving each local government.
Use an educational flyer for cervical cancer screening with Q&A to relieve uneasiness, clearly explaining the flow of the screening with illustrations. Distribute the flyer at coming-of-age ceremonies and universities in collaboration with each local government.
(3) Awareness activities to increase the screening rate among Chugai Group employees

Achieved improvement in the screening rate in some Chugai offices by establishing a system that allows employees to simultaneously undergo regular checkup and gynecological cancer screening in corporation with the health insurance association (the overall screening rate of cervical cancer screening which had been 60.4% in the previous year, increased to 62.9% across the company in 2019).
Conducted an in-house workshop presenting the current situation around cervical cancer in Japan at the occasion of World Cancer Day.
As a leading company in the oncology area, Chugai will continue to engage in disease awareness activities in oncology including gynecological cancer, which will lead to trust and appreciation from all stakeholders including patients, their families, and healthcare professionals.

On April 9, 2020 -X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases resulting from dysfunction of the CXCR4 pathway, reported that management will present and conduct one-on-one meetings during the virtual 19th Annual Needham Healthcare Conference on Wednesday, April 15th, 2020 at 8:40 am EDT (Press release, X4 Pharmaceuticals, APR 9, 2020, View Source [SID1234556238]).

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A live webcast of the presentation will be available on the investor section of the X4 Pharmaceuticals website at www.x4pharma.com. After the live webcasts, the events will remain archived on the X4 Pharmaceuticals’ website for 90 days.

On April 9, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release first-quarter 2020 financial results before the market opens on Thursday, April 23, 2020, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, APR 9, 2020, View Source [SID1234556224]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 1865786.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the site three hours after the live call and will be available through Thursday, April 30, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 1865786.