On June 23, 2022 Berry Oncology, a global leading company specialized in genomic testing and early cancer screening, reported the launch of its innovative one-time precision product HIFI Pan-Cancer Screening, which is an early multi-cancer screening product developed based on the company’s proprietary HIFI technology platform (Press release, Berry Oncology, JUN 23, 2022, View Source [SID1234616218]). With one single testing, the product can accurately detect 6 high-risk and high-incident cancers in China that include lung cancer, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, and colorectal cancer, with a global leading performance of 87.58% sensitivity, 99.09% specificity and 82% traceability accuracy.

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Cancer has become a global public health challenge. According to the 2020 global cancer burden data released by the International Agency for Research on Cancer (IARC), there were 19.29 million new cancer cases and 9.96 million cancer deaths worldwide in 2020, while the numbers in China were 4.57 million and 3 million respectively in the same year, ranking the first in the world which has imposed a heavy disease burden on individuals and society.

The Healthy China 2030 Plan, issued by the Central Committee of the Communist Party of China and the State Council, clearly states that early diagnosis and treatment of major high-risk cancers is highly encouraged, opportunistic cancer screening should be promoted, and the 5-year overall cancer survival rate in China is expected to be increased by 15% by 2030. In the recently released 14th Five-Year Plan for Bioeconomic Development, it also stated that it is necessary to incorporate advanced technologies such as genetic testing into disease prevention, and to carry out early screening for major diseases such as cancers, so as to provide precision solutions and decision support for individualized treatment.

NGS-based liquid biopsy technology has greatly improved the possibility of early cancer screening. On top of significant improvement in the overall testing performance, innovative liquid biopsy products for early cancer screening, taking HIFI Pan-Cancer Screening as an example, have accessible benefits of minimal invasiveness and user friendliness, which help increase the compliance of high-risk groups and create bigger clinical intervention window for patients with early-stage cancer to improve their survival rate, compared with traditional cancer screening methods such as tumor markers and imaging.

HIFI Pan-Cancer Screening is the first early screening product for multiple cancer types using whole genome sequencing (WGS) of cell-free DNA (cfDNA) worldwide. Compared with other technologies, this technology can capture early cancer signals in a wider range and reduce missed detection caused by individual differences and differences in molecular biological characteristics across various tumor types.

In addition, HIFI Pan-Cancer Screening is developed based on Berry Oncology’s proprietary HIFI technology platform. The self-iterative HIFI technology platform can reduce the costs of product development and testing services, and thus making early screening for multiple cancers more affordable.

Since its establishment, Berry Oncology has been committed to the development of innovative liquid biopsy products for cancer based on the NGS platform. Today, the company has carried out product development covering the full disease course, from early screening and early diagnosis, companion diagnosis, minimal residual disease, to recurrence monitoring.

Zhang Kai, deputy director of the National Cancer Center and the Cancer Prevention Department of the Cancer Hospital of the Chinese Academy of Medical Sciences, said, "With the innovative liquid biopsy technology, we can detect a variety of cancers at one time, making early diagnosis and early treatment more possible for patients, while providing new solutions for China to achieve the goals of cancer prevention and control. However, in addition to technology, the general public still needs to improve their awareness in self screening so that this new technology can be more widely used to truly increase early diagnosis rate and reduce mortality rate."

Oscar Zhang, Principal of Qiming Venture Partners, said, "Qiming has been keeping close company to Berry Oncology since day 1, and has witnessed the upgrades of its HIFI technology platform and its determination in building the cancer prevention and treatment ecosystem. Early cancer screening is a high barrier industry, which examines both technical and execution capabilities of a team from the selection of technical route, the translation of theory to practice, the overall layout of the experiment and so on. The launch of the multi-cancer early screening product will further reinforce Berry Oncology’s leadership in the early screening sector."

Zhou Jun, CEO of Berry Oncology, said, "Since its establishment, Berry Oncology has been dedicated to developing technologies and delivering products for early cancer screening based on the spectrum of malignant tumors, to help more high-risk people identify hidden risks and help more patients prolong survival time and improve quality of life. Moving forward, Berry Oncology will continue to optimize its technology system and iterate early screening products to deliver more advanced early cancer screening solutions in accordance with the actual market demand and environment. In the meanwhile, we will further our partnerships with industry players, universities and research organizations to co-build an ecosystem for cancer prevention and treatment that enables innovations more accessible."

On June 23, 2022 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that Daniel Lang, M.D., President, Athenex Cell Therapy, will participate in The Next Cells & Mechanisms to Watch in Oncology panel at the Truist Securities Cell Therapy Symposium on Tuesday, June 28, 2022 at 11:30 am Eastern Time in New York, NY (Press release, Athenex, JUN 23, 2022, View Source [SID1234616203]). Company management will also participate in one-on-one investor meetings during the event.

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Registration is available on the Truist symposia-cel website. An audio archive of the webcast will be available in the "Events and Presentations" section of the Athenex website for the following 90 days.

On June 23, 2022 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported that new data on the mechanism of action of its lead clinical candidate BTM-3566 will be presented at the Third AACR (Free AACR Whitepaper) International Meeting – Advances in Malignant Lymphoma taking place on the 23-26 June in Boston (Press release, Bantam Pharmaceutical, JUN 23, 2022, View Source;advances-in-malignant-lymphoma-301573728.html [SID1234616219]).

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The studies evaluated the activity of BTM-3566 in tumor lines in vitro and in vivo while further elucidating the mechanism of action.

A PDF of the poster will be available on the Bantam website following the conference.

Michael Stocum, CEO of Bantam Pharmaceutical, commented: "Our data demonstrate exceptional single-agent activity in patient derived xenograft models of difficult-to-treat lymphomas. We are excited to bring this novel mechanism of action to the clinic in the coming months and explore its value as a treatment for relapsed and refractory DLBCL."

Title: Pharmacological activation of the mitochondrial protease OMA1 reveals a therapeutic liability in Diffuse Large B-Cell Lymphoma

About BTM-3566
BTM-3566 is an orally-available novel small molecule compound with broad anti-cancer activity in hematologic and solid tumors, initially focused on Diffuse Large B-cell Lymphomas (DLBCL). BTM-3566’s anti-cancer mechanism of action is unique and differentiated from other therapeutics, disrupting mitochondrial function in tumor cells to induce apoptosis (cell death). An IND application for BTM-3566 in B-cell malignancies is being completed with plans to initiate First in Human trials in lymphoma patients in the fall of 2022.

On June 23, 2022 Immunicum, a biopharmaceutical company focused on improving survival outcomes for cancer patients with tumor recurrence through cell-based immunotherapies, reported that it has changed its corporate name from Immunicum AB to Mendus AB (Press release, Immunicum, JUN 23, 2022, View Source [SID1234623752]). The name change is effective as of today and is approved by the Swedish Companies Registration Office. The rebranding to "Mendus" reflects the Company’s maturing clinical pipeline and its broader positioning in cancer recurrence immunotherapy. In addition, this marks an important operational transition as the Company continues to mature with a longer-term focus on a global reach. The Company will continue trading under the ticker symbol "IMMU.ST" and the new website for Mendus AB is www.mendus.com.

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"Today’s news marks an exciting step in a transformative period for the Company. Initiated with the merger and integration of Immunicum and DCprime and accelerated by subsequent directional pipeline decisions and promising novel R&D initiatives, these developments have resulted in a multi-faceted and broader long-term vision for the Company. The name Mendus captures our continued commitment to develop therapies that delay or reduce cases of cancer recurrence, while preserving the quality of life of people living with cancer," commented Erik Manting, PhD, Chief Executive Officer of Mendus. "As we move forward in this new phase of important growth, we look forward to continuing our dedicated work in the development of safe and effective cell-based therapies that we believe can significantly decrease the chance of cancer relapse and improve overall survival."

The Company received approval from its shareholders for the name change at the Annual General Meeting on May 10, 2022 and has since implemented the required legal and organizational changes. Mendus will continue to operate from its headquarters in Stockholm, Sweden, with an office in Gothenburg, Sweden and its main R&D center in Leiden, The Netherlands, which will be operating as a fully owned subsidiary Mendus BV. The Company’s stock ticker symbol will stay unchanged and Mendus AB will continue trading under the ticker symbol IMMU.ST at the Nasdaq Stockholm Main Market section.

In May 2022, the Company presented positive interim results from its ongoing ADVANCE II clinical study evaluating its most advanced proprietary development program, the cancer relapse vaccine DCP-001, as a maintenance therapy option in acute myeloid leukemia (AML). The trial is continuing follow-up of patients and Mendus expects to report on the status of key survival endpoints and immunomonitoring data in the fourth quarter of 2022. Mendus is preparing to advance the development of DCP-001 into a subsequent clinical study in AML maintenance and working to establish a scalable manufacturing infrastructure for the continued development of the program. The company also explores cancer relapse vaccination in ovarian cancer in an ongoing Phase I trial and is preparing for a signal-confirmatory trial in gastro-intestinal stromal tumors with its intratumoral immune primer ilixadencel. Mendus has established a broad collaboration network to further leverage its expertise in allogeneic dendritic cell biology to design novel immunotherapeutic approaches.

On June 23, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech’s fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors (Press release, BioNTech, JUN 23, 2022, View Source [SID1234616204]). BNT211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the Company’s proprietary drug products, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate is currently being investigated in an ongoing Phase 1/2 study (NCT04503278; 2019-004323-20) that aims to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors.

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"Patients with relapsed or treatment refractory testicular cancers have a poor prognosis with limited remaining treatment options. The PRIME designation underlines the potential of our approach in this high medical need setting. Our approach brings together several new elements: Firstly, targeting CLDN6, a pan-cancer cell surface marker, secondly, our CAR design, and thirdly, "remote control" of CAR T cells by our uridine RNA-lipoplex based vaccine. We believe that a combination of engineered T cells and mRNA vaccines in one treatment regimen can stimulate and expand T cells. This could enable us to develop truly powerful precision immunotherapies," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "With the PRIME status and support by the EMA, we aim to expedite the further development of the BNT211 program to bring a novel therapeutic option for patients with life-threatening testicular cancer, and thus to extend the successes of CAR-T therapy also to hard-to-treat solid tumors."

The designation is based on positive preliminary Phase 1/2 data from the ongoing study that was presented at the AACR (Free AACR Whitepaper) Annual Meeting in April 2022. The results demonstrated that treatment with CLDN6 CAR-T alone or in combination with CARVac was well tolerated and showed encouraging signs of anti-tumor activity in testicular cancer patients at the first evaluated dose levels. In the study all six patients with heavily pretreated testicular cancer eligible for efficacy analysis showed clinical benefits highlighting the potential of this novel approach. One patient achieved a complete response 18 weeks after infusion. Three patients achieved a partial response and showed deepening and durability of responses (one of them in the lowest CAR-T dose level cohort in combination with CARVac). One patient had stable disease with shrinkage of target lesions.

The PRIME scheme is a regulatory mechanism introduced by the EMA that provides early and proactive support to developers of promising medicines, to optimize development plans and speed up evaluations so these medicines can reach patients faster. The goal is to help patients benefit as early as possible from innovative new therapies that have demonstrated the potential to significantly address an unmet medical need.

About BNT211
Aiming to harness the power of cell therapies for solid cancers and to overcoming hurdles to date, BioNTech has combined their CAR-T and FixVac platform technologies to develop a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that is based on BioNTech`s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen. The CARVac is based on BioNTech’s backbone-optimized uridine mRNA (uRNA)-lipoplex technology which through its inherent adjuvant function enables a potent T cell stimulation to improve persistence and functionality of the adoptively transferred CAR-T cells, thus enabling and maintaining a therapeutic effect even at low CAR-T doses. BNT211 is an investigational CAR-T cell therapy directed against the novel oncofetal antigen Claudin-6 (CLDN6), a target discovered by BioNTech founders and expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in a first-in-human Phase 1/2 trial as a monotherapy and in combination with a CLDN6-encoding CARVac, aiming to boost persistence and functionality of the CLDN6-CAR-T cells, in patients with CLDN6-positive relapsed or refractory advanced solid tumors.