On July 5, 2022 AstraZeneca reported an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma1 (Press release, AstraZeneca, JUL 5, 2022, View Source [SID1234616462]).

The acquisition of TNB-486 aims to accelerate the development of this potential new medicine for B-cell haematologic malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. Building on the success of Calquence (acalabrutinib), TNB-486 further diversifies AstraZeneca’s haematology pipeline that spans multiple therapeutic modalities and mechanisms to address a broad spectrum of blood cancers.

TNB-486 belongs to a class of therapeutic antibodies known as T-cell engagers, which are emerging as a promising therapeutic approach in haematologic malignancies and solid tumours. T-cell engagers are bispecific molecules that are engineered to redirect the immune system’s T-cells to recognise and kill cancer cells. By binding to both CD19, an antigen expressed on B-cells, and to the CD3 receptor on T-cells, TNB-486 activates and recruits T-cells to CD19-expressing tumours where they can elicit an immune response.

Anas Younes, Senior Vice President Haematology R&D, AstraZeneca said: "By redirecting the body’s natural immune response to target B-cell malignancies, TNB-486 alone or in combination with CD20-targeted therapy could potentially deepen clinical responses and improve patient outcomes. We believe this innovative molecule, which was designed to optimise the therapeutic window of T-cell activation, will enable us to explore novel combinations that have the potential to become new standards of care in this setting."

Financial considerations
AstraZeneca will acquire all outstanding equity of TeneoTwo in exchange for an upfront payment of $100m on deal closing.

Under the terms of the agreement, AstraZeneca will make additional contingent R&D-related milestone payments of up to $805m and additional contingent commercial-related milestone payments of up to $360m to TeneoTwo’s equity holders.

Overall, the transaction will be accounted for as an intangible asset acquisition, recognised initially at the present value of non-contingent consideration, with future milestones capitalised into the intangible asset as they are recognised.

The transaction is expected to close in the third quarter of 2022, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2022.

iTeneoTwo, Inc., is a majority owned subsidiary company of TBio, LLC, a limited liability company formed in Delaware, US

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide transformative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.

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 July 5, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the strategic transaction to acquire Rigenerand Srl, signed in May 2022, has been completed (Press release, Evotec, JUL 5, 2022, View Source [SID1234616461]). Based out of Medolla, Italy, the cell technology company with leading edge in the field of cGMP manufacturing of cell therapies will operate as Evotec (Modena) Srl going forward.

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!

Cell therapy is a fast-growing and highly promising field of biomedical research with the potential to achieve substantial disease-modifying or even curative effects within a single treatment. Deriving cell therapy products from induced pluripotent stem cells ("iPSCs") has opened up an almost unlimited source of consistent-quality material for large patient numbers. However, the scalability of the approach from bench to bedside is central for moving cell therapy approaches into clinical phases and thus, essential for the approval of any such therapy.

Evotec’s cell therapy platform EVOcells integrates the full end-to-end spectrum from the discovery and development to the manufacturing of off-the-shelf iPSC-based cell therapy products. With a leading team of cell therapy experts, Evotec (Modena) adds a high-quality cGMP manufacturing site to the EVOcells platform therefore adding capacity, critical expertise and capabilities to the critical scale-up of complex cell-based therapies.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "The Evotec Cell Accelerator gives us the opportunity to take our cell therapy business to the next level. We are extremely confident that this important addition to our EVOcells platform will enable us to progress our internal portfolio of early innovative projects. Further, the addition will allow us to enter new partnerships and support many projects towards clinical applications and onto the market in a very efficient way. This will have a significant impact to a great number of patients who are significantly under-served with the currently available treatment regimens."

Prof. Massimo Dominici, Scientific Director, Evotec (Modena) and Professor of Oncology at the University of Modena and Reggio Emilia, said: "We are very pleased that the acquisition of Rigenerand has been finalised and the teams have started working together as one. The concept of the Evotec Cell Accelerator is already coming to life and matches what is happening in Modena: enriching the pre-existing know-how through the experienced Evotec team. I am therefore convinced that the field has a new player capable of addressing the challenges of next generation cell therapy products, accelerating their development and manufacturing towards the clinic."

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.