On July 4, 2022 Chiome Bioscience Inc. reported that the first patient has been dosed CBA-1535 in a Phase I clinical trial (Press release, Chiome Bioscience, JUL 4, 2022, View Source [SID1234625709]).

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!

The first part of the trial will evaluate the safety, tolerability, pharmacokinetics, and identification of biomarker for the solid tumor patients. In the expansion part, exploratory efficacy will be evaluated in combination with cancer immunotherapy agent Pembrolizumab. This first-in-human study is conducted at National Cancer Center Hospital and Shizuoka Cancer Center. We will continue to update the future process in a timely manner.

There is no impact on the financial performance in the fiscal period ending December 31, 2022.

＜About CBA-1535＞

CBA-1535 is cancer therapeutic antibody with three antigen binding sites; two of them are used for the binding with 5T4 protein that expresses multiple type of solid tumor, and one is for the binding with CD3 protein on the surface of immune T cells. CBA-1535 is anticipated to have strong cytotoxicity arisen from T cell proliferation and activation. CBA-1535 is targeted for refractory cancer such as malignant mesothelioma, small cell lung cancer, and non-small cell lung cancer and for solid tumor such as kidney, ovarian, and breast cancer.

On July 4, 2022 Sanofi Global Health reported the launch of Impact, a new brand of standard of care medicines produced by Sanofi dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries (Press release, Sanofi, JUL 4, 2022, View Source [SID1234616562]).

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!

The Impact brand, which includes insulin, glibenclamide and oxaliplatin amonst others, will enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. Considered essential by the World Health Organization, the medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer.

The launch of the Impact brand is among the steps taken since the formation last year of Sanofi Global Health, a nonprofit unit within the company aiming to increase access to healthcare through the distribution of medicines, and the building and bolstering of local healthcare systems in countries with among the lowest per capita GDP. Sanofi Global Health is the first and only global initiative to provide access to such a broad portfolio of medicines in so many countries and across multiple therapeutic areas while funding local support programs and strengthening local inclusive businesses.

Paul Hudson

Chief Executive Officer, Sanofi

"At Sanofi, we believe we have a responsibility to make a difference for the health of those most in need, and we know we have the ability and the ambition to bring about lasting change. With critical medicines, relentless drive and impactful partnerships, we can take our innovation beyond the lab and use it to strengthen health systems and access to medicines for those most vulnerable communities of patients. Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need. Sanofi’s renewed purpose is to chase the miracles of science to improve people’s lives. And our quest to make life better for all people must include helping to provide better access to care and quality medicines for underserved populations."

The company also announces the establishment of an Impact fund that will support startup companies and other innovators that can deliver scalable solutions for sustainable healthcare in underserved regions. By providing inclusive businesses financing and technical assistance, the fund will complement the GHU mission of leveraging global, regional and local investment to support the training of healthcare professionals and aiding communities in running sustainable care systems. The announcements come as Sanofi gathers key global health stakeholders to discuss how to build effective end-to-end health programs that are embedded in the communities in which they serve, to best reach, treat and manage patients’ health effectively and sustainably.

Jon Fairest

Head, Global Health Unit, Sanofi

"The launch of the Impact brand and our Impact Fund are our latest steps to make our medicines available and to help bring quality, sustainable healthcare to people in the world’s poorest countries. But we know that we cannot do this alone, and so we are building partnerships at global, regional and local levels that will help to improve and establish health systems to reach our goal of a healthier, more resilient world."

On July 4, 2022 EXACT Therapeutics AS (‘EXACT-Tx’ or the ‘Company’) reported regarding the issuance of 5,052 new shares in the Company, for the purpose of issuing shares under the Company’s restricted stock unit (RSU) program to its Board members (Press release, Exact Therapeutics, JUL 4, 2022, View Source [SID1234616459]).

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!

The share capital increase pertaining to the issuance of the new shares has now been registered with the Norwegian Register of Business Enterprises. The Company’s new registered share capital is NOK 119,988.876 divided into 29,997,219 shares, each with a nominal value of NOK 0.004.

DISCLOSURE REGULATION This information is subject to the disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act.

On July 4, 2022 Abbisko Therapeutics Co., Ltd. (HKEX Stock Code: 2256.HK, referred to "Abbisko Therapeutics" hereafter) reported completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally (Press release, Abbisko Therapeutics, JUL 4, 2022, View Source [SID1234616458]).

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!

The clinical trial (ABSK061-101, NCT05244551) is a First-in-Human Phase 1 study of ABSK061 to assess the safety, tolerability, pharmacokinetics in patients with advanced solid tumors, and to determine the Recommended Phase 2 Dose (RP2D) and evaluate preliminary anti-tumor activities. The trial is currently being conducted in both China and US.

ABSK061 is a next-generation, orally available, highly potent and selective small molecule FGFR2/3 inhibitor independently discovered and developed by Abbisko Therapeutics with global intellectual property rights. Several first-generation pan-FGFR inhibitors have demonstrated clinical efficacy in multiple types of tumor carrying FGFR2/3 alterations and have been approved globally, including China and US. Their therapeutic window and efficacy, however, are limited by the side effects associated with FGFR1 inhibition. With reduced FGFR1 activity while maintaining strong potency against FGFR2/3, ABSK061 is expected to achieve improved therapeutic window and clinical efficacy as a second-generation FGFR inhibitor. In addition to oncology indications, ABSK061 also has great potential to expand its use in non-oncology indications, such as achondroplasia.

On July 4, 2022 Scandion Oncology ("Scandion" or the "Company"), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported the final outcome of its rights issue of shares of up to SEK 93.7 million (the "Rights Issue"), for which the subscription period ended July 1, 2022 (Press release, Scandion Oncology, JUL 4, 2022, View Source,c3596448 [SID1234616457]). Shares corresponding to approximately 80% of the Rights Issue were subscribed for, including subscriptions by guarantors. Through the Rights Issue, Scandion raises approximately SEK 75 million before deduction of issue related costs.

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!

Final outcome

The Rights Issue comprised a maximum of 10,711,848 ordinary shares. The final outcome of Scandion’s Rights Issue of shares shows that 1,396,886 shares, corresponding to approx. 13% of the Rights Issue, has been subscribed for by exercise of subscription rights (incl. subscription undertakings). Additionally, 55,750 shares, corresponding to approx. 0,5% of the Rights Issue, were subscribed for without preferential rights. 7,118,792 shares, corresponding to approx. 66.5% of the Rights Issue, were subscribed for by guarantors. Through the Rights Issue, Scandion raises approx. SEK 75 million before deduction of issue related costs.

Notification regarding allocation

Allocation of shares has been made according to the principles described in the prospectus which was published in conjunction with the Rights Issue. Subscribers who are allocated shares subscribed for without preferential rights will receive an allocation notice in the form of a settlement note. Payment for such shares is to be made according to the instructions on the settlement note.

Number of shares and share capital

When the Rights Issue has been registered with the Danish Business Authority, the total number of shares in Scandion will amount to 40,706,972 shares and the share capital amount to DKK 2,991,962.4420.

Trading in BTA

Trading in BTA (paid subscribed shares) is currently conducted on Nasdaq First North Growth Market Stockholm, which will cease once the issue has been registered with the Danish Business Authority. BTA’s will subsequently be converted into ordinary shares.

Advisers

Redeye AB acts as financial adviser and Horten Advokatpartnerselskab (as to Danish law) and Advokatfirman Schjødt (as to Swedish law) act as legal advisers in connection with the Rights Issue. Hagberg & Aneborn Fondkommission AB acts as the issuing agent in the Rights Issue.