PAT-DX1 Engineering Run Successfully Completed

On July 4, 2022 Patrys has reported a positive update on the second engineering run for its lead asset PAT-DX1, a critical step for ensuring we can manufacture at commercial scale (Press release, Patrys, JUL 4, 2022, View Source [SID1234616450]).

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This follows an earlier set-back when the first engineering run for PAT-DX1 was unsuccessful due to low recoveries of drug product during the purification phase.

Patrys CEO and MD, Dr James Campbell, was delighted to share the news today:

"This is an outstanding result, and a tribute to the close working relationship between Patrys and our CDMO. The commercial‑scale manufacture of antibodies is a complex, multi‑dimensional process. The efforts made to understand and remediate the issues with the first engineering run have been both extensive and exhaustive. We are delighted that this has delivered such a successful outcome."

First patient in of cancer therapeutic antibody CBA-1535 in a Phase 1 clinical trial

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]).

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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.

Transactions in connection with share buy-back program

On July 4, 2022 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUL 4, 2022, View Source [SID1234616453]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from June 27, 2022 to July 1, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 362,885 shares as treasury shares, corresponding to 0.55% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

Sareum notes GSK’s completed acquisition of Sierra

On June 4, 2022 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that GSK has completed its acquisition of Sierra Oncology, Inc ("Sierra"), the licence holder for SRA737 (a novel Chk1 inhibitor), for US$1.9 billion in cash (Press release, Sareum, JUL 4, 2022, View Source [SID1234616454]). The acquisition was approved by Sierra’s shareholders on 29 June 2022.

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GSK has noted that the key driver of the acquisition was momelotinib, a drug Sierra is developing for the treatment of myelofibrosis. Sierra reported positive topline results from a Phase III study investigating momelotinib in this indication in January 2022 and submitted a New Drug Application ("NDA") to the US Food and Drug Administration ("FDA") in June 2022 for marketing approval.

Following the acquisition, GSK also now owns the licence rights to SRA737, a clinical-stage oral, selective Checkpoint kinase 1 inhibitor that targets cancer cell replication and DNA damage repair mechanisms. SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed to Sierra in September 2016 and has progressed through multiple preclinical and early-stage clinical trials demonstrating potential for further investigation in combination with other agents in haematologic and solid tumour indications.

Under an amended US$299m licensing deal on SRA737 between Sierra and CRT Pioneer Fund LP (announced 12 November 2020), Sareum is eligible to receive a 27.5% share of any future milestone payments as well as royalties on any future sales. The dosing of the first patient with SRA737 in any new clinical trial would result in a US$2.0m payment from Sierra (now GSK), with 27.5% of this due to Sareum.

Sanofi Global Health launches nonprofit Impact® brand for 30 medicines in low-income countries

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]).

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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."