On February 2, 2022 Scandion Oncology reported that The CORIST phase II-trial studying Scandion Oncology’s lead compound SCO-101 as combination therapy in patients with metastatic colorectal cancer is now approved to recruit patients in Germany and Spain in addition to Denmark (Press release, Scandion Oncology, FEB 2, 2022, View Source,c3496820 [SID1234607601]).

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!

Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, now further upscales its efforts in clinical development by expanding the ongoing CORIST phase II-trial with its lead compound SCO-101 to also include patients in Germany and Spain.

The Federal Institute for Drugs and Medical Devices (BfArM) and The Spanish Agency of Medicines and Medical Devices (AEMPS) as well as the local German and Spanish ethical committees have now given the approval for the trial to be conducted, and Scandion will activate clinical sites in these countries shortly.

The approvals mark the beginning of the planned internationalization of the CORIST-trial, which has so far recruited patients in Denmark, and is now expanded to other countries. This is expected to support recruitment of patients to the trial, which is scheduled to conclude in the second or third quarter of 2022.

The expansion of the CORIST-trial, which studies SCO-101 as combination therapy in patients with metastatic colorectal cancer, follows the earlier internationalization of the PANTAX phase Ib-trial, which studies SCO-101 in patients with unresectable or metastatic pancreatic cancer.

Both expansions show how Scandion is scaling up its efforts in clinical development as the company is building capabilities to conduct clinical trials in all relevant countries, including the US, as well as conducting randomized pivotal trials going forward. This will enable Scandion to carry through full clinical development of its potential new first in class medicines. Further, the internationalization of the CORIST-trial will help increase the awareness of SCO-101 with authorities and leading international investigators.

"We are pleased to expand the CORIST-trial and further enhance our capabilities to conduct clinical trials internationally. It is a corner stone of our strategy to build the capacity to carry through full clinical development. This will allow us to pursue co-development partnerships or independently develop our molecules depending on how we can best create maximum value for patients, caregivers, the company and its owners", says Bo Rode Hansen, President & CEO of Scandion.

About the CORIST phase II-trial

The trial investigates SCO-101 as combination therapy in patients with metastatic colorectal cancer. On June 24, 2021, Scandion reported positive results from the dose-finding part 1 of the trial. A well tolerated dose of SCO-101 in combination with the chemotherapy regimen FOLFIRI was determined and the treatment resulted in notable potentiation of FOLFIRI. Scandion Oncology also identified the oncogene RAS as a predictive biomarker, which led the company to making an amendment to the clinical protocol, optimizing the inclusion of patients and de-risking the study.

The design for the ongoing part 2 of the trial (the proof-of-concept arm) is a standard single arm phase II-trial with the aim of assessing preliminary effect and further evaluating safety and tolerability of SCO-101 in combination with FOLFIRI. The primary efficacy objective is assessment of response (tumor reduction) and secondary objectives include assessment of Clinical benefit (the duration of Stable Disease, Progression Free Survival (PFS), Overall Survival (OS)) as well as biomarker assessment and correlation to treatment tolerability and outcome. Part 2 of the CORIST phase II-trial is planned to include 25 patients.

On February 2, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, President and CEO of Aclaris, will participate in a fireside chat at the SVB Leerink Virtual 11th Annual Global Healthcare Conference on Wednesday, February 16, 2022 at 9:20 a.m. ET (Press release, Aclaris Therapeutics, FEB 2, 2022, View Source [SID1234607600]). Management will be available February 16th throughout the day for virtual 1×1 meetings.

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!

A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On February 2, 2022 miReven scientists reported that it awarded an Australian competitive NHMRC Development grant for 2022-23 (Press release, MiReven, FEB 2, 2022, View Source [SID1234607598]). Prof Leedman and the team were successful in being awarded a Development Grant for two years to help drive the further development of mRx-7 into a therapy for liver cancer.

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!

On February 2, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that at the meeting of the Board of Directors held today, a resolution was adopted to acquire its own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act (Press release, Astellas, FEB 2, 2022, View Source [SID1234607595]). The Company also announced that it decided to cancel its treasury stock pursuant to the provisions of Article 178 of the Companies Act. The details are as follows.

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. Reasons for the acquisition of own shares
To improve capital efficiency and shareholder return.

2. Details of the acquisition of own shares
(1) Class of shares to be acquired: Common stock of the Company
(2) Total number of shares to be acquired: Up to 29 million shares
　(Ratio to the total number of shares outstanding [excluding treasury stock]: 1.57%)
(3) Total amount of acquisition cost: Up to 50 billion yen
(4) Period of acquisition: From February 3, 2022 to March 24 ,2022

3. Details of the cancellation of treasury stock
(1) Class of shares to be cancelled: Common stock of the Company
(2) Number of shares to be cancelled: All of the shares acquired as stated in 2 above
(3) Cancellation date: March 29, 2022 (planned)

* The actual number of shares to be cancelled will be announced after
completing the acquisition of own shares stated in 2 above.

(Reference) Status of treasury stock as of December 31, 2021:
Total number of shares outstanding (excluding treasury stock): 1,852,927,335 shares
Total number of treasury stocks: 8,859,740 shares

On February 2, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first nine months (April 1, 2021 – December 31, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, FEB 2, 2022, View Source [SID1234607594]).

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!

Consolidated financial results for the first nine months of FY2021 (core basis)
1. Qualitative information on consolidated financial results for the first nine months of FY2021
(1) Business performance

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia, Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and EVENITY for the treatment of osteoporosis contributed to revenue growth as well.
-Moreover, another factor for the increase in sales in the first nine months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to prepandemic level which decreased mainly in the first three months of the previous fiscal year by the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales agreements for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first nine months of FY2021 increased by 5.5% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥992.3 billion.

Core operating profit / Core profit
-Gross profit increased by 6.0% year-on-year to ¥798.2 billion. The cost-to-revenue ratio fell by 0.4 percentage points year-on-year to 19.6%, mainly due to changes in product mix.
-Selling, general and administrative expenses increased by 11.9% year-on-year to ¥406.4 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥18.5 billion year-on-year), impact of the foreign exchange rates (increase of ¥16.5 billion year-on-year), investment in Digital Transformation (increase of approximately ¥6.0 billion year-on-year), and the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥2.5 billion year-on-year), despite a decrease in expenses due to the global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥5.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 9.1% year-on-year to ¥297.7 billion.
-Research and development (R&D) expenses increased by 5.2% year-on-year to ¥177.6 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota). 3
-Amortisation of intangible assets increased by 17.1% year-on-year to ¥20.2 billion.
-Gain on divestiture of intangible assets was ¥24.1 billion. Including such as transfer of five products to Cheplapharm which were sold in Europe and other regions (¥12.3 billion), transfer of a pipeline asset (¥9.2 billion) and transfer of Bendamustine (¥2.0 billion).

As a result of the above, core operating profit increased by 8.0% year-on-year to ¥220.0 billion, and core profit increased by 1.8% year-on-year to ¥169.7 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first nine months of FY2021 are shown in the table below. The resulting impacts were a ¥42.8 billion increase in revenue and a ¥15.4 billion increase in core operating profit compared with if the exchange rates of the first nine months of FY2020 were applied.