On February 4, 2021 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), reported the start of an expansion of the ongoing Phase 1 study with its lead RNA-based cancer drug candidate, CV8102 (Press release, CureVac, FEB 4, 2021, View Source [SID1234574608]). Initial results from the dose-escalation part in four solid cancer types were presented at the SITC (Free SITC Whitepaper) conference in 2020. CV8102 had shown promising evidence of efficacy after intratumoral application as a single agent, and in combination with systemic anti-PD-1 antibody treatment. Translation of a locally induced immune response into a systemic immune response was observed in several patients, showing the ability of CV8102 to impact injected as well as distant lesions. The objective of the expansion is to confirm safety, tolerability, and efficacy of CV8102 in patients with advanced melanoma at 600µg, the selected dose to be advanced in a Phase 2 clinical trial. Furthermore, the trial expansion will evaluate the effects of CV8102 on systemic and intratumoral immune markers, which will provide additional clinical insights on CV8102’s mode of action.

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"Initial clinical data in cancer has demonstrated the ability of our RNA immunomodulator to trigger a systemic immune response attacking cancer not only at the site of injection but also in other areas of the body," said Ulrike Gnad-Vogt, Senior Vice President Area Head Oncology at CureVac. "The CV8102 trial expansion is expected to provide further insights into clinical efficacy and mechanism of action in patients with advanced PD-1 refractory melanoma, an indication with a high unmet medical need. We are very pleased to see CV8102 progress to the next stage, an important step to further leverage the potential of immunostimulating RNA therapeutics in oncology."

The expansion part of the trial will enrol 30 patients with PD-1 refractory melanoma, who will receive intratumoral injections of CV8102 in combination with PD-1 antibodies, as well as 10 patients who will be treated with CV8102 only. Initially, CV8102, with or without co-administration of anti-PD-1 treatment, will be injected weekly for five weeks, followed by three injections at two- or three-week intervals depending on the anti-PD-1 antibody schedule. Patients showing evidence of clinical benefit are eligible for further injections for up to 12 months.

About CV8102

CV8102 is a noncoding single stranded RNA complexed with a cationic peptide and functions as a strong immunomodulator based on TLR (toll-like receptor) 7/8 and RIG-1 (retinoic-acid-inducible protein 1) activation. It is designed to modulate the tumor microenvironment following intratumoral injection and to translate a local immune response towards released tumor antigens into a systemic immune response to control both injected as well as distant lesions. The currently ongoing Phase 1 dose escalation study is assessing tolerability as well as activity of CV8102 in the dose range of 25 to 900 µg. It is administered as both a single agent and in combination with systemic anti-PD-1 antibodies for the intratumoral treatment of four types of solid tumors: cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of the skin, and squamous cell carcinoma of the head and neck. Initial results from the dose-escalation study presented at the SITC (Free SITC Whitepaper) conference in November 2020 showed that the 600µg dose was tolerated without dose limiting toxicities as a single agent and in combination with anti-PD-1 antibodies. Preliminary evidence of efficacy was observed in the single agent and combination group, with several patients showing responses of distant noninjected lesions.

On February 4, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) reported that Steve Hoerter, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Idea Forum Oncology Day on February 11, 2021 at 11:00 AM ET (Press release, Deciphera Pharmaceuticals, FEB 4, 2021, View Source [SID1234574607]). The conference will be held in a virtual meeting format.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On February 4, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the fiscal year ended December 31, 2020 and forecasts for the fiscal year ending December 31, 2021 (Press release, Chugai, FEB 4, 2021, View Source [SID1234574606]).

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"The COVID-19 pandemic had a dramatic impact on the world in 2020, but Chugai was able to achieve record high revenues and profits for the fourth consecutive year, mainly driven by the expansion of overseas revenues related to in-house products Actemra and Hemlibra. Among many achievements in the year, we successfully completed the domestic and overseas launch of Enspryng, a treatment for neuromyelitis optica spectrum disorder and the fourth global product under the strategic alliance with Roche. Our foundation for future growth has also been strengthened with progress in multiple in-house projects in both early and late development stages, including the start of clinical development for the novel antibody engineering technology Switch AntibodyTM. Based on our unique scientific and technological capabilities, including a mid-size molecule drug that is expected to start clinical development this year, we will continue to make strong progress in 2021 under our new growth strategy, TOP I 2030, aiming to achieve innovation that addresses unmet medical need with world-class drug discovery capabilities," said Tatsuro Kosaka, Chugai’s Chairman and CEO.

Chugai reported financial results in 2020 (Core-basis) with revenues of ¥786.9 billion (+¥100.7 billion, +14.7%) and the overseas revenues ratio of 46.8% given significant increases in overseas sales and royalties and other operating income, despite a decrease in domestic sales by approximately 7% year on year mainly due to the impact of the NHI drug price revisions in April 2020. Overseas sales increased by approximately 50% due to an increase in export of Actemra, including those for clinical trials for COVID-19, the start of export at a regular shipping price and the market penetration of hemophilia A treatment Hemlibra, and the start of export of Enspryng, the first drug using recycling antibody technology. Royalties and other operating income increased by approximately 60%, primarily due to a significant increase in royalty and profit-sharing income for Hemlibra.

The cost to sales ratio continued to improve mainly due to a larger proportion of in-house products including Hemlibra in the total product mix. The increase in operating expenses was limited to approximately 5% as marketing and distribution expenses decreased chiefly by restrained sales activities in Japan owing to the spread of COVID-19. As a result, Core operating profit was ¥307.9 billion (+¥83.0 billion, +36.9%).

Reflecting the favorable results and based on our dividend policy, we plan to pay year-end dividends of ¥30 per share. As a result, the annual dividend will be ¥55 per share*, and the Core dividend payout ratio is 44.9% on a five-year average basis (41.2% on a single fiscal year basis).

* Based on the assumption that the stock split was implemented at the beginning of the fiscal year.

The Company also made good progress in research and development. Achievements in in-house projects include the start of Phase III global clinical trials of anti-C5 recycling antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria, and a regulatory application was filed in Japan for nemolizumab, an anti-IL-31 receptor A antibody created by Chugai, for the treatment of atopic dermatitis by Maruho Co., Ltd., the licensee in Japan. In addition, AMY109, STA551, and SPYK04 have entered Phase I clinical trials for solid tumors. Line extensions were approved for some core products including anti-PD-L1 antibody Tecentriq, which received approval for the treatment of hepatocellular carcinoma in combination with Avastin, and the HER2-positive breast cancer treatment Kadcyla, which received approval for HER2-positive postoperative breast cancer. Mid-size molecule drugs technologies, which are expected to become the third drug discovery technology platform following small molecules and antibodies, also made steady progress toward commencing clinical development in 2021.

Regarding the impact of COVID-19 on performance during the fiscal year under review, there were no major negative impacts on revenues and profits. However, the pandemic has affected the progress of certain business activities as described below.

Product supply system maintained stable by taking measures to prevent infection of employees and business partners. No impacts on the product supply have been seen both in Japan and overseas up to now.
Delay of the introduction of new products and those with additional indications, such as Tecentriq and Hemlibra, in the domestic market due to various reasons including restrained sales activities and decrease in the number of hospitalizations and outpatients.
Increase in export of Actemra to Roche, including those for clinical trials for COVID-19 pneumonia.
Steady increase in export of Hemlibra to Roche, however royalties were affected due to the overseas market penetration of Hemlibra taking longer than initially expected.
Some expenses were curbed mainly due to cancellation of overseas travels and restrained sales activities in Japan.
No major impacts on the timing of regulatory filing or approval.
Some delays in the initiation and progress of clinical trials for projects under development. These delays are expected to be resolved in time.
No delays in drug discovery activities for high-priority projects.
Construction for Chugai Life Science Park Yokohama temporarily suspended. All construction resumed with limited impacts on the overall construction schedule.

In 2021, the Company expects revenues and profits to mark a record high for the fifth consecutive year. Revenues, Core operating profit, and Core net income are expected to be ¥800.0 billion (+¥13.1 billion, +1.7%), ¥320.0 billion (+¥12.1 billion, +3.9%), and ¥232.0 billion (+¥12.6 billion, +5.7%), respectively. Sales are expected to decrease slightly to ¥631.0 billion (-¥2.3 billion, -0.4%) as the negative impact on domestic sales mainly due to intensifying competition associated primarily with launches of biosimilars and generics as well as NHI drug price revisions, will exceed the expected increase in overseas sales assuming a steady growth of the export of Hemlibra to Roche. Overseas sales of Actemra are expected to decrease, for which a large amount of additional exports was made in the previous fiscal year. Royalties and other operating income are expected to increase by a double-digit percentage driven by Hemlibra-related income from Roche.

Chugai expects the annual dividends per share of ¥60 with the Core dividend payout ratio of 43.8% on a five-year average basis (42.6% in a single fiscal year basis).

Substantially exceeding the performance targets for three years in only two years, Chugai has decided to conclude the mid-term business plan IBI 21 one year ahead of the initial schedule of 2021. The Group has formulated a new growth strategy TOP I 2030 to become "the top innovator" in 2030 with a view toward realizing the Envisioned Future set out in its Mission Statement.

On February 4, 2021 Chugai Pharmaceutical Co., Ltd. reported that there is a difference regarding the individual financial results (Japanese standard) for the year ended December 2020 (Jan. 1, 2020– Dec. 31, 2020) as compared to the actual results for the previous year (Jan. 1, 2019 – Dec. 31, 2019) (Press release, Chugai, FEB 4, 2021, View Source [SID1234574604]).

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1. Difference between the actual results for the year ended December 2020 and the actual results for the previous year

*Effective July 1, 2020, Chugai has implemented a three-for-one stock split of its common stock. "Earnings per share" are calculated based on the assumption that the stock split was implemented at the beginning of the previous year.

2. Reasons for the difference occurring
The difference occurred mainly due to increase in exports to Roche, increase in royalties and other operating income, and improvement in cost to sales ratio due to changes in product mix, etc.

On February 4, 2021 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its financial results for fiscal 2020 (January 1 – December 31, 2020) (Press release, Chugai, FEB 4, 2021, View Source [SID1234574602]).

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Roche owns 59.89% of Chugai’s outstanding shares (61.17% of the total number of shares issued excluding treasury stock) as of the end of December 2020.