On March 16, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the fourth quarter and full year ended December 31, 2022 (Press release, 2seventy bio, MAR 16, 2023, View Source [SID1234628885]).

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"In our first full year of operations, 2seventy made tremendous strides across all aspects of our business: from advancing early-stage research, building out manufacturing capabilities, initiating clinical studies, and delivering to patients in the commercial setting with Abecma," said Nick Leschly, chief kairos officer. "Bolstered by strong growth in the fourth quarter, we delivered Abecma to hundreds of patients with multiple myeloma in the U.S. and expect continued strong growth in 2023. With our partners at BMS, we continue to develop this product into earlier lines of multiple myeloma treatment on the back of positive data from the KarMMa-3 study and the planned KarMMa-9 study and continue to grow our manufacturing capabilities to support a potential peak sales opportunity of $2-3 billion in the U.S. With our recent financing and the growth of Abecma, we are in a strong position to continue to prudently advance our clinical and preclinical pipeline, driving towards delivering proof-of-concept data this year for our bbT369 and SC-DARIC33 programs and advancement of MUC and MAGE solid tumor programs to IND by the end of the year. I couldn’t be more optimistic for what lies ahead in 2023 and the position we are in today, and that is thanks to the hard work of our employees, the patients and physicians who participate in our studies, and our shareholders who share in our mission to deliver more time to patients with cancer."

Abecma Commercial Summary
Our partner, Bristol Myers Squibb (BMS), reported total U.S. Abecma (idecabtagene vicleucel; ide-cel) fourth quarter revenues of $94 million, which represents 25% growth over the prior quarter, and 40% growth over the fourth quarter of 2021, and full year revenues of $297 million, which is in line with our stated 2022 U.S. Abecma revenue guidance of $250-300 million, in each case such revenue is shared equally with BMS. Assuming continued strong demand for Abecma and achievement of planned increases in manufacturing capacity throughout the year, we anticipate topline 2023 U.S. revenues of $470-570 million.

Assuming continued increases in manufacturing capacity and growth in the addressable patient population based on an anticipated approval in 3L+ multiple myeloma, we expect Abecma to generate $200-300 million in operating income for 2seventy bio in the 2024-25 period.

We reported Abecma-related collaborative arrangement revenue of $8.7 million for the fourth quarter of 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the year.

Financial Guidance
At the end of February 2023, 2seventy bio raised approximately $117 million in net proceeds through a public equity offering. Based on our current operating plans, which includes these net proceeds and the ongoing commercialization of Abecma, we believe our current cash position will be sufficient to fund operations into 2026.

"The financial outlook for 2seventy continues to strengthen, and the recent equity financing puts us in a privileged position, with cash runway now into 2026," said Chip Baird, chief financial officer. "We expect the cash flow from the Abecma collaboration to grow significantly over the 2023-25 time period, which will continue to reduce our annual net cash spend and our need for future capital infusions. Our pipeline programs have the potential to deliver meaningful benefit for cancer patients and we will balance an entrepreneurial mindset with a disciplined approach to capital allocation."

RECENT HIGHLIGHTS
KARMMA-3 DATA IN NEJM – On February 10, 2023, 2seventy announced the publication of our KarMMa-3 data in the New England Journal of Medicine. The positive results of this pivotal Phase 3 showed at median follow up of 18.6 months, treatment with Abecma (n=254) demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; p<0.0001). This represents a 51% reduction in risk of disease progression or death with Abecma. Based on results from KarMMa-3, Abecma is the first and only chimeric antigen receptor (CAR) T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. 2seventy and BMS anticipate submitting an sBLA to the FDA in the first quarter of 2023 to seek approval in the third line setting.

REGENERON COLLABORATION AMENDMENT – In January, 2seventy bio announced an expanded translational collaboration with Regeneron to facilitate the acceleration of novel cell therapy-based combinations for solid tumors. The collaboration will leverage 2seventy bio’s unique cell therapy engineering and early-stage development capabilities, including the newly built in-house clinical cell therapy manufacturing facility, with Regeneron’s differentiated antibodies and bispecifics. To support this expanded clinical development plan Regeneron made an approximately $20 million equity investment in 2seventy bio at a 50% premium and has committed to another approximately $20 million in near-term pre-clinical and clinical milestones. The parties will continue sharing costs for these activities in a manner largely consistent with the existing agreement, with Regeneron covering 75% of certain preclinical costs necessary to study combinations and 100% of the costs for the arms of the clinical studies that include Regeneron agents through regulatory approval. For other programs, cost-sharing will follow the existing 50/50 cost sharing agreement.

BOARD APPOINTMENT – Earlier this month, 2seventy bio announced the appointment of Wei Lin, M.D. to the company’s Board of Directors.

UPCOMING ANTICIPATED MILESTONES
ABECMA

Initiation of KarMMa-9 study in patients with newly-diagnosed multiple myeloma by end of 2023
Potential FDA approval of sBLA in 3L+ multiple myeloma by the end of 2023
PIPELINE

Data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023
Data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia by the end of 2023
Submission of an IND for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron by end of 2023
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors by end of 2023
FINANCIAL GUIDANCE

Topline U.S. Abecma revenue of $470-570 million in 2023
Net cash spend of $180-220 million in 2023
Cash runway into 2026
SELECT FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Our partner, BMS, reported total U.S. revenues of $94 million and $297 million for Abecma for the three and twelve months ended December 31, 2022, respectively. 2seventy bio and BMS share equally in all profits and losses related to development, manufacture, and commercialization of Abecma in the U.S. We reported collaborative arrangement revenue of $8.7 million for the three months ended December 31, 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the twelve months ended December 31, 2022.
Total 2seventy bio revenues were $56.2 million for the three months ended December 31, 2022 compared to $16.0 million for the three months ended December 31, 2021. Total revenues were $91.5 million for the twelve months ended December 31, 2022 compared to $54.5 million for the twelve months ended December 31, 2021. The increase for both the three and twelve-month periods was primarily due to an increase in service revenue in the fourth quarter of 2022, driven by the release of deferred revenue relating to bb21217, the development of which was discontinued in 2022.
Research and development expenses were $60.1 million for the three months ended December 31, 2022 compared to $57.2 million for the three months ended December 31, 2021. This increase was primarily driven by increased costs for manufacturing activities of suspension lentiviral vector for ide-cel and MAGE-A4 development, partially offset by a decrease in costs related to our share of research and development expenses under our collaboration with BMS. Research and development expenses were $248.7 million for the twelve months ended December 31, 2022, compared to $252.6 million for the twelve months ended December 31, 2021. This decrease was primarily driven by a decrease in costs related to our share of research and development expenses under our collaboration with BMS, partially offset by increases in costs for manufacturing activities of suspension lentiviral vector.
Selling, general and administrative expenses were $18.7 million for the three months ended December 31, 2022, compared to $24.5 million for the three months ended December 31, 2021. Selling, general and administrative expenses were $79.5 million for the twelve months ended December 31, 2022, compared to $93.5 million for the twelve months ended December 31, 2021. The decrease for both the three and twelve-month periods was primarily driven by decreased employee compensation expenses, reflective of efforts to streamline 2seventy bio’s operating model and a decrease in IT and other facility-related costs due to a lower allocation of these costs to selling, general and administrative expense based on headcount and facility square footage.
Net loss was $23.1 million for the three months ended December 31, 2022, compared to $61.0 million for the three months December 31, 2021. Net loss was $254.2 million for the twelve months ended December 31, 2022, compared to $292.2 million for the twelve months ended December 31, 2021.
2seventy bio ended 2022 with cash, cash equivalents and marketable securities of $267.7 million.

On March 15, 2023 Protai, a proteomics and AI-powered drug discovery startup revolutionizing the way new drugs are discovered, reported that it has added $12 million to its seed round, bringing the total amount to $20M (Press release, Protai Bio, MAR 15, 2023, View Source;bringing-the-total-to-20-million—to-build-an-oncology-drug-discovery-pipeline-301772904.html [SID1234647410]). The round includes existing investors Grove Ventures and Pitango HealthTech and was joined by Copenhagen-based Maj Invest Equity Fund. The additional funding will be used to build Protai’s oncology drug discovery pipeline, expand data acquisition as well as increase its discovery activities via pharma partnerships.

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Genomic biomarkers are only relevant for approximately 15% of tumors, thus limited in use. Protein-level biomarkers can predict patient populations not seen by genomic means, by directly measuring proteins, their interactions, and their functions. To tap into the potential of protein-level data, Protai has built a proteomics AI-based platform that comprehensively maps the course of a disease on the protein level. Its technology allows it to better predict which patients will respond to a given drug, as well as discover novel drug targets that were missed by genomic approaches. These discoveries may be the key to significantly accelerating drug discovery and clinical development, lowering the time and costs of R&D.

Since its initial funding last year, Protai has opened laboratories at its Israel R&D center for data acquisition, biological validation and drug discovery activities and recruited an experienced drug discovery team with significant experience in successfully bringing drugs to the clinic. Additionally, Protai established collaborations with several leading hospitals, and now has access to over 100k well-defined banked samples for its comprehensive tumor mapping process, focused on gyno-oncology and lung cancer indications.

With the additional funding, Protai will expand its activities to include an oncology drug discovery pipeline, initially focusing on targets with a clearly-defined novel patient population biomarker, derived from its AI proteomics platform. To help navigate these efforts, the company has added Dr. Sharon Shacham, a serial biotech entrepreneur and Founder of Karyopharm Therapeutics, to Protai’s Board of Directors. In addition, Protai is supported by leading oncology experts, including Prof. Giulio Draetta, Chief Scientific Officer at MD Anderson and former Pharma executive; Prof. Bradley J. Monk, Director of Gynecologic Oncology at the University of Arizona College of Medicine; Prof. Funda Meric-Bernstam, Chair of the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center, and Dr. Jurgen Moll, former Head Molecular Oncology, Sanofi Vitry. In addition,

"We are excited to announce this funding that supports our mission to enhance the drug development pathway from discovery through commercialization," said Eran Seger, CEO and co-founder of Protai. "I am extremely proud of our talented team and the achievements we have made to date. We look forward to scaling our organization and its important work towards revolutionizing the drug development landscape."

"Our investment in Protai highlights Maj Invest’s increasing investment in the Israeli tech ecosystem," said Jeppe Christian, CEO of Maj Invest Equity Fund. "We are excited to partner with this exceptional team, and we are positive that Protai will make a huge leap forward in how patients are treated and cured."

On March 15, 2023 Aptamer Science reported the company that it will participate in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and present research results on ‘CD25-ApDC immunotherapy’ (Press release, Aptamer Sciences, MAR 15, 2023, View Source;idx=234 [SID1234641617]). The presentation abstracts selected this time will be released on the AACR (Free AACR Whitepaper) official website on the 31st.

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AACR is the world’s largest international cancer society where more than 20,000 researchers from over 120 countries gather every year to share cancer-related knowledge and clinical research.

This year, it will be held in Orlando, Florida, USA from April 14th to 19th (local time).

Aptamer Science plans to present research results on the topic of ‘Removal and inhibition of regulatory T cells by aptamer-drug transporter targeting human CD25’.

‘CD25-ApDC immune anti-cancer drug’ specifically binds to CD25 on regulatory T cells within tumors to prevent cancer cells from evading the body’s immune system.

In particular, CD25-ApDC not only selectively suppresses the function of Treg cells, but also promotes immune function by inducing the activation of cytotoxic T cells and antigen-labeling cells that prevent tumor growth.

The study on ‘CD25-ApDC immune anti-cancer drug’ presented at this conference has been selected for the National New Drug Development Industry hosted by the Korea New Drug Development Foundation (KDDF), and mechanism research and animal model evaluation are currently in progress at the lead material stage.

Lee Dae-gyeon, head of Aptamer Science Research and Development Division, said, "I believe that the presentation at this global conference will be an opportunity to verify the feasibility and competitiveness of aptamer-based immunotherapy research."

"Based on this, we plan to secure momentum for developing treatments and speed up development to conclude early partnerships in the future."

Go to article: Aptamer Science announces immunotherapy research results at AACR (Free AACR Whitepaper) in the U.S.

On March 15, 2023 Neowise Biotechnology, a world-leading company specializing in TCR-T cell therapy for solid tumors, reported the company has completed an A+ round of financing of nearly 200 million yuan (Press release, Neowise Biotechnology, MAR 15, 2023, View Source [SID1234638952]). Investors in this round of financing include well-known medical and health professional funds such as Yuanhe Origin, Yuanyi Capital, GEM Co., Ltd., Tonggao Capital, Zhongxin Capital, and Leading Venture Capital. Old shareholders Taifu Capital continue to invest, and Haoyue Capital Acted as the exclusive financial advisor for this round of financing.

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Founded in 2020 and headquartered in Suzhou, Xinjing Zhiyuan is a global leader committed to discovering natural tumor antigen-specific TCRs and developing TCR-T cell therapy drugs for solid tumors. The founder, Dr. Peng Songming, is a top scientist in the field of cell therapy. As a co-founder, he co-founded PACT Pharma in the United States with Nobel Prize winners and many founders in the field of cell therapy. He has long been active at the forefront of the cell therapy industry and has developed forward-looking scientific insights into T cell biology, immunology, genomics, etc. The core senior management team of Xinjing Zhiyuan have all worked in well-known pharmaceutical companies at home and abroad for many years. They are engaged in bioinformatics predictive analysis, new antigen target discovery, TCR sequence discovery and verification, TCR-T production technology and CMC development, translational medicine and We have rich management and operational experience in the entire chain including clinical development.

Xinjing Zhiyuan innovatively built an industry-leading TCR discovery platform through mutual feedback and iteration of bioinformatics prediction and experimental verification, which can quickly and efficiently discover and accumulate new antigen targets and natural high-affinity TCR pairing data. At present, Xinjing Zhiyuan has established the world’s leading target antigen-natural TCR library, and has successfully transformed its first-mover advantage into patent barriers. The TCR sequences discovered by this platform are significantly better than similar products from the world’s top pharmaceutical companies in multiple dimensions such as affinity, killing activity, and safety. This round of financing will accelerate its further expansion of its existing product pipeline and rapid transformation to the clinical stage.

Globally, adoptive cell therapy has demonstrated excellent disease remission rates and survival advantages compared to chemotherapy and traditional immunotherapy, and has become a hot spot for biomedical innovation. In recent years, cell therapy based on TCR (T cell receptor) has gradually begun to show its unique charm after years of technological accumulation, especially in the treatment of advanced malignant solid tumors. TCR recognition signal is the first signal of T cell activation in immune surveillance. TCR can recognize a wider range of intracellular antigens than CAR, and the resulting activation of tumor-specific T cells is targeted at tumors (especially solid tumors). The most critical step in the cellular immune response. Currently, TCR-T therapies targeting tumor-related antigens such as MAGE-A4 and NY-ESO-1 have achieved considerable efficacy in clinical trials. However, the expandable indications of TCR-T drugs targeting these targets are relatively limited. How to target neoantigens (neoantigens) produced by tumor driver gene mutations that cover a wider range of population indications and discover extremely low-frequency natural TCR sequences with high affinity and guaranteed safety is the bottleneck of the current TCR-T cell therapy industry. question.

Because of this, biotechnology companies focusing on "new antigen target discovery" and "natural TCR" in the past two years are setting off an increasing wave in the international capital market. In March 2022, Affini-T completed a US$175 million Series A financing, expanding the potential application areas of cell therapy to lung cancer, colorectal cancer and pancreatic cancer; in January 2023, AstraZeneca announced that it would acquire clinical trials for US$320 million. Neogene, a TCR-T R&D company in the previous stage, uses this to enter the TCR-T cell therapy track.

Xinjing Zhiyuan complies with the general trend of industry development and is at the forefront of the industry in the discovery of neoantigens and natural TCRs. Its powerful discovery platform has accumulated thousands of neoantigen target-natural TCR data, which has not only lifted the last hurdle in the TCR-T field. A shackle enables cell therapy to bring better therapeutic effects to a wider population. It is also expected to empower more drug forms with high-quality paired data and bring good news to cancer patients.

Dr. Peng Songming, the founder of the company , expressed his gratitude to new and old shareholders for their trust and support, as well as the team’s efforts and dedication. In the past year, Xinjing Zhiyuan has solved the biggest barrier in the TCR-T industry – quickly obtaining safe and effective natural TCR sequences, and built the world’s leading target antigen-natural TCR library, filling the gap at home and abroad. There is a gap in this field. We look forward to helping more patients with advanced solid tumors in subsequent clinical trials and striving for more possibilities for every life.

Mr. Zhao Qun, a partner of Yuanhe Origin , said that Yuanhe Origin is very optimistic about the potential of TCR-T treatment modality to be applied in broader and more severe clinical needs of solid tumors. Since its establishment in 2020, Xinjingzhi has been highly focused on the core pain points in the TCR-T industry, and has successfully broken through the bottleneck of high-throughput and high-sensitivity discovery of targets and high-affinity natural TCRs. Based on founder Dr. Peng Songming’s deep insights gained from years of deep experience in the cutting-edge field of TCR discovery and the strong cohesion and high execution within the team, Xinjing Zhiyuan quickly established highly competitive industry barriers, and through rich TCR- T full-process experience, efficiently pushing the pipeline into the clinical stage. We continue to be optimistic about the company’s explosive power and prospects in the field of solid tumor treatment. We hope that Yuanhe Origin can provide assistance for the future development of Xinjing Zhiyuan and achieve win-win cooperation.

Ms. Tang Yinan, Managing Director of Yuanyi Capital, said that Xinjing Zhiyuan, with its unique BT+IT platform, has unleashed the unlimited potential between computing and biology, improved the quality and efficiency of TCR discovery by orders of magnitude, and broken through key bottlenecks in the industry. Yuanyi is optimistic about the world’s leading target-TCR database established by the company, and its platform value and data assets are of great value. The company’s core team has scarce experience in TCR-T product development and clinical operations in China and the United States, and has the ability to lead the company to develop rapidly in this early stage of long and snowy terrain, bringing life possibilities to more patients with solid tumors.

Professor Xu Kaihua, Chairman of GEM Group, said that Xinjing Zhiyuan has an innovative team with the mission of serving the life and health of all mankind. In just over a year, with its tenacious and innovative spirit, Xinjing Zhiyuan has broken through the key technologies of the industry and built a global The unique target antigen-natural TCR library has achieved world-class innovative results and will bring the gospel of life to more patients with solid tumors! We are very optimistic about the future development prospects and value of Xinjing Zhiyuan, and we will firmly support the continuous innovation of the Xinjing Zhiyuan team and the clinical application of innovative results.

Mr. Song Jie, a partner at Tonggao Capital, said, "We are very pleased to have the opportunity to cooperate with Xinjing Zhiyuan and participate in the field of immune cell therapy for solid tumors." Through its independently developed antigen-antigen receptor discovery platform, the company has established a large-scale target antigen-TCR pairing database covering multiple targets, breaking through the bottleneck of industry development. With high execution efficiency and solid research work, we believe that Xinjing Zhiyuan will continue to make breakthroughs under the leadership of Dr. Peng and the joint efforts of the team.

Mr. Dai Jinsong, a partner at Zhongxin Capital, said that immune cell therapy technology has developed rapidly in recent years. CAR-T therapy has shown amazing efficacy in hematomas, while TCR-T therapy, which can specifically recognize tumor intracellular antigens, It is even more promising to break through the bottleneck of hematological tumors and shine in solid tumors. How to provide patients with cell therapy drugs quickly, accurately and effectively has always been a major pain point that has plagued the development of the TCR-T industry. The Xinjing Zhiyuan team has been working in representative companies in this field for many years, and has an international vision and practical experience. Also very rich. The company has independently developed high-throughput target antigen-TCR screening technology, analyzed a large number of patient samples, discovered thousands of TCRs that can specifically recognize neoantigens, and established the world’s leading tumor target – Natural TCR pairing relationship database. Based on this database, the Xinjing team can quickly select TCRs for patients that specifically recognize their tumor targets, edit, amplify and functionally identify the patient’s own T cells, and finally reinfuse highly specific T cells. achieve treatment goals. We highly recognize the breakthrough contributions made by the Xinjing Zhiyuan team in this field, and hope to work with the Xinjing Zhiyuan team to witness the successful application of TCR-T therapy in the field of solid tumors.

Ms. Tao Shanshan, head of the Investment Department of Leading Venture Capital , said that Xinjing Zhiyuan benefited from its independently developed high-throughput antigen-TCR screening platform, which can quickly find targets suitable for solid tumor treatment and provide precise cell therapy. Compared with other Products in the same field have the advantages of large number of targets, wide range of indications and few side effects. Leading Venture Capital greatly appreciates the innovative spirit of the project founder and team and is optimistic about the prospects of the project platform. At the same time, the cooperation with Xinjing Zhiyuan has also better improved the biomedical industry ecosystem of Suzhou Industrial Park and enhanced regional innovation capabilities. In the future, leading venture capital will continue to integrate resources from all parties and work together to support the rapid development of Xinjing Zhiyuan.

Mr. Li Yishi, senior partner of Haoyue Capital , said that we are honored to assist Xinjing Zhiyuan in completing this round of financing. In recent years, TCR-based specific recognition technology is bringing vitality to tumor immunotherapy. TCR can recognize a variety of membrane and intracellular proteins, including tumor-specific targets, thereby unlocking targets that other cell therapies cannot reach. Through its unique high-throughput target antigen-TCR screening and discovery platform, Xinjing Zhiyuan has successfully established matched data covering a broad population and with high clinical value, empowering cell therapy to achieve greater success in a broader population of solid tumor patients. value. We believe that with the help of capital, Xinjing Zhiyuan will continue to lead the research and development of the new generation of TCR-T drugs and continue to achieve innovative breakthroughs. We are confident that we will continue to support Xinjing Zhiyuan’s subsequent financing and accompany our customers’ rapid growth.

On March 15, 2023 Cortalix BV reported that the company acquires patents and know-how from BiOrion on its single domain antibody platform and fibrogenesis biomarker radiopharmaceuticals (Press release, Cortalix, MAR 15, 2023, View Source [SID1234638786]).

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With these patents and know-how, Cortalix can continue to work on 2 active clinical programs around PET imaging of fibrogenesis, the active stage of organ fibrosis. The company recently completed a first clinical PET imaging study in humans following a basket design clinical trial in patients suffering from organ fibrosis. It was found that especially patients with a history of conditions associated with cardiac fibrosis showed a clear uptake of 68-Gallium-BOT5035 in typical heart regions within 60 minutes after administration, while this was not the case in patients without a history of heart disease. A follow-up phase 2 study will soon start in heart failure patients with conserved ejection fraction (HFpEF). A third phase 2 PET-imaging study is expected to start in Q1 2024 in patients suffering from idiopathic pulmonary fibrosis (IPF) in collaboration with a consortium of US major pharmaceutical companies.
In addition, Cortalix will soon start testing a 2nd generation fibrogenesis PET imaging diagnostic in patients with early-stage NASH/liver fibrosis, in collaboration with a consortium of US pharmaceutical companies and an imaging CRO.