On March 28, 2023 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma" or "the Group", Stock Code: 600196.SH; 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China, announced its 2022 annual results today (the "Reporting Period") (Press release, Fosun Pharma, MAR 28, 2023, View Source [SID1234629470]).

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The revenue from new products and sub-new products including Han Li Kang, Han Qu You, Comirnaty, Jie Bei An, Su Ke Xin, Han Si Zhuang accounted for more than 30% of the revenue from the pharmaceutical manufacturing segment, and the revenue structure continued to be optimized;
The revenue from new products and sub-new products including Han Li Kang, Han Qu You, Comirnaty, Jie Bei An, Su Ke Xin, Han Si Zhuang accounted for more than 30% of the revenue from the pharmaceutical manufacturing segment, and the revenue structure continued to be optimized;
During the Reporting Period, Fosun Pharma achieved steady business growth, mainly driven by the revenue growth from new and sub-new products and the effective control of sales expenses. In 2022, Fosun Pharma achieved a revenue of RMB 43.952 billion, with a year-on-year growth of 12.66%; the net profit after deducting extraordinary gain or loss attributable to shareholders of the listed company was RMB 3.873 billion, with a year-on-year growth of 18.17%; the net cash flow from operating activities was RMB 4.218 billion, with a year-on-year growth of 7.1%. The Company has achieved remarkable results in R&D innovation and transformation, and the international operation capability was further improved to achieve long-term sustainable development.

Continuously Increased R&D Investment with Remarkable Results in Innovation and Transformation

Fosun Pharma is a patient-centered, clinical demand-oriented, and innovative R&D driven company. Through independent R&D, cooperative development, licensing introduction, and in-depth incubation, Fosun Pharma continued to enrich innovative product pipelines, improved the research and clinical development ability of FIC (First-in-class) and BIC (Best-in-class) drugs, and accelerated the research, development, and transformation of innovative technologies and products.

Focusing on core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease), Fosun Pharma continued to increase its investment in innovative R&D, with a total R&D expenditure of RMB 5.885 billion for the year, with a year-on-year growth of 18.22%, among which, the R&D expenses amounted to RMB 4.302 billion, with a year-on-year growth of RMB 0.465 billion or 12.12%. The R&D expenditures in the pharmaceutical manufacturing business amounted to RMB 5.097 billion, with a year-on-year growth of 13.62%, and the R&D expenditures in the pharmaceutical manufacturing business accounted for 16.54% of the revenue from the pharmaceutical manufacturing business, among which, the R&D expenses amounted to RMB 3.552 billion, accounting for 11.53% of the revenue from the pharmaceutical manufacturing business.

During the reporting period, 6 self-developed innovative drugs (indications), 4 license-in innovative drugs (indications), and 27 generic drugs (indications) of Fosun Pharma were approved for launch in Chinese Mainland/Hong Kong, China/United States; 7 innovative drugs (indications) and 30 generic drugs (indications) had applied for launch (NDA) in Chinese Mainland; and 22 innovative drugs (indications) were approved for clinical trials (IND) in Chinese Mainland.

In 2022, multiple innovative products and indications of Fosun Pharma were approved for launch, benefiting more patients worldwide. Among them, Fosun Pharma’s first self-developed biopharmaceutical innovative drug, Han Si Zhuang (Serplulimab Injection), has been successively approved for three indications, Microsatellite Instability-high (MSI-H) solid tumors, Squamous Non-small Cell Lung Cancer (sqNSCLC) and Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Chinese Mainland; the indication of Small Cell Lung Cancer (SCLC) was granted with Orphan Drug Designation by the U.S. FDA and the European Commission (EC). The innovative indication Rheumatoid Arthritis (RA) of Han Li Kang (Rituximab injection) has been approved for launch and included in the 2022 National Reimbursement Drug List.

Both the monovalent COVID-19 vaccine COMIRNATY (30 mg per dose) (also known as BNT162b2 or COMIRNATY Original) and COMIRNATY Original/Omicron BA.4/BA.5 bivalent COVID-19 vaccine (also known as COMIRNATY Bivalent COVID-19 Vaccine) were officially registered in Hong Kong SAR and approved as a regular imported vaccine by the Macao SAR. The related dosage forms for children and infants have also been granted the Emergency Use Authorization (EUA) in Hong Kong SAR and Macao SAR, respectively, and included in the local immunization programs; Azvudine Tablets jointly developed by Fosun Pharma and Genuine Biotech obtained the emergency use authorization from the National Medical Products Administration in July 2022 for use in the treatment of adult COVID-19 patients with moderate symptoms.

Keverprazan Hydrochloride Tablets (trade name: Bei Wen), the first potassium ion competitive acid blocker (P-CAB) independently developed in China, jointly developed by the Group and Carephar and exclusively commercialized by the Group, was approved for launch in Chinese Mainland in February 2023 for the treatment of duodenal ulcer (DU) and reflux esophagitis (RE); Han Qu You (Trastuzumab for Injection), independently developed by Fosun Pharma and licensed to Cipla, has been approved for launch in Australia, and its approved indications cover all approved indications of the branded drug in the local market.

As the first CAR-T cell therapy product approved for domestic launch, Yi Kai Da (ejilunsai injection) from Fosun Kite, the cell therapy platform of Fosun Pharma, was further improved in drug accessibility. As of the end of 2022, Yi Kai Da has been included in the urban customized commercial health insurance of 70 provinces and municipalities and over 60 commercial insurances, while the number of treatment centers on record ~exceeded 130. As of the end of January 2023, nearly 300 patients with relapsed or refractory large B-cell lymphoma lymphoma had been treated with Yi Kai Da.

As of the end of the Reporting Period, the revenue from new and sub-new products accounted for more than 30% of the revenue from the pharmaceutical manufacturing business, which is mainly due to the revenue contribution of newly launched products, namely Han Si Zhuang and Jie Bei An, as well as the growth contribution of sub-new products, namely Han Qu You and Su Ke Xin, promoting the sustained and steady growth of business.

Adhered to Globalization with Continuously Improvement in Global Operation Capability

Relying on years of industrial experience, investment in innovative R&D and expanding of global channel network, Fosun Pharma has the industry-leading global two-way licensing capability to maximize the value of self-developed products and cooperative innovative products. During the Reporting Period, Fosun Pharma’s revenue outside the Chinese Mainland and other countries amounted to RMB 13.938 billion, accounting for 31.71%.

In 2022, Fosun Pharma and Amgen’s subsidiary formed collaboration on the exclusive licensing to commercialize two innovative drugs, namely Otezla (Apremilast Tablets) and Parsabiv (Etelcalcetide) in Chinese Mainland (excluding Hong Kong SAR, Macao SAR, and Taiwan region), further enriching Fosun Pharma’s innovative product layout in the non-tumor field; Shanghai Henlius, a subsidiary, successively granted a number of product licenses to Getz Pharma, Eurofarma, Abbott, Organon, and other companies in order to cover the incremental markets with the help of international leading partners. In addition, Gland Pharma, a subsidiary, proposed to acquire Cenexi, a European CDMO company, with a maximum total amount payable of up to EUR210 million, so as to strategically lay out its CDMO business in the European market and construct localized manufacturing capacity in Europe.

Fosun Pharma has taken the United States as a breakthrough in overseas markets, actively promoted the launch of generic drugs and Han Si Zhuang (Serplulimab Injection), and continuously improved the commercialization capacity in the U.S. market. At the same time, Tridem Pharma and Gland Pharma have established their own sales teams in Africa and India respectively, and will further improve the promotion and sales of products in other emerging markets in the future.

Continuous R&D Innovation for the Benefit of the Public and Active Practice of Social Responsibility

R&D innovation is the most important responsibility for Fosun Pharma’s sustainable development. Over the years, Fosun Pharma has adhered to R&D innovation, with a number of innovative achievements continuously implemented and a number of innovative drugs and new indications included in the latest version of the National Medical Insurance Drug Catalogue, further improving the accessibility and affordability of innovative drugs and benefiting more patients in China.

At the same time, Fosun Pharma has also given full play to its own advantages and vigorously promoted the construction of basic medical and health systems in developing countries and underdeveloped areas to help solve the problem of drug accessibility. In 2022, a subsidiary of Fosun Pharma was licensed under MPP to produce and supply two high-quality and affordable oral COVID-19 drugs to low- and middle-income countries in the globally agreed regions; as of the end of 2022, Fosun Pharma’s Artesun (Artesunate for Injection), a self-developed antimalarial innovative drug, was adopted to treat more than 56 million severe cases of malaria worldwide.

Fosun Pharma received many awards for its outstanding performance in ESG management, social responsibility, and other sustainable development fields. In 2022, Fosun Pharma was upgraded to A level in the ESG rating published by MSCI, an international index authority. Fosun Pharma has released CSR reports for 15 consecutive years to show stakeholders its practices and achievements in the field of social responsibility. Experts of the rating team of the China CSR Report Rating Expert Committee are of the view that Fosun Pharma’s CSR report is excellent and has awarded the Company with a five-star rating.

On March 28, 2023 Freenome, a privately held biotech company reported that Renown Health has joined as a partner for the Sanderson Study, Freenome’s study of its multiomics platform, in combination with real-world data to detect multiple cancers (Press release, Freenome, MAR 28, 2023, View Source [SID1234629469]).

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The study encompasses both traditional and real-world data to generate evidence of clinical validation for certain high- and elevated-risk populations while also refining the platform’s cancer classification and risk prediction models. In addition, the Sanderson Study will build the necessary infrastructure to bridge the gap between clinical research and day-to-day clinical impact.

Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to detect cancer in its earliest stages using a standard blood draw.

"We are delighted to partner with Freenome to launch this far-reaching trial which has transformative potential," said Lee Schwartzberg, M.D., medical oncology section chief and the principal investigator for the Sanderson Study at Renown. "Studying the impact of merging real-world information from patients with multiomics technology holds the promise of a truly personalized approach to early detection of cancer."

Renown Health has multiple clinical trials currently available to patients in northern Nevada across a variety of specialties, including oncology, cardiology, neurology, pediatrics, and pulmonology.

Cancer is the second-leading cause of death in the Silver State, claiming the lives of more than 5,400 Nevadans each year. This number has increased since the last five-year plan estimate of 4,400 deaths per year.[1]

Promoting research to improve cancer prevention, detection, diagnosis and treatment is a key goal outlined in the Nevada Cancer Plan, 2021-2025, a framework developed by the Nevada Cancer Coalition in partnership with the Nevada Department of Health and Human Services.

Access and participation in clinical trials is a key component of the plan, which, Renown says, makes participation in the Sanderson Study even more significant.

"At the inception of the William N. Pennington Cancer Institute, we committed to not only provide the very best care possible to our community, but to also help improve outcomes through participation in research," said Max Coppes, M.D., PhD, MBA, cancer center director of the William N. Pennington Cancer Institute. "The research collaboration with Freenome has the potential to make a dream come true: Finding cancer early when it’s most treatable."

The Sanderson Study will enroll approximately 8,000 patients through Freenome’s clinical study partner network and numerous regional health systems across the United States.

"Renown is committed to making a difference in the health and well-being of patients in communities across the state of Nevada, and that includes access to innovative research," said Lance Baldo, M.D., chief medical officer at Freenome. "The combination of real-world data and multiomics is poised to transform the landscape of early cancer detection."

Freenome’s clinical studies are named for employees’ loved ones who fought cancer. This study honors Tim Sanderson, the loving father of a Freenome engineer.

For residents of Nevada interested in participating in the Sanderson Study, contact the William N. Pennington Cancer Institute clinical research coordinators at [email protected]. For more information on the Sanderson Study, visit the study webpage.

On March 28, 2023 Sirnaomics Ltd. (the "Company"; together with its subsidiaries, "Sirnaomics" or the "Group"; stock code: 2257), a leading biopharmaceutical company engaged in the discovery and development of advanced RNAi therapeutics, reported its audited annual results for the year ended 31 December 2022 (the "Year") (Press release, Sirnaomics, MAR 28, 2023, View Source [SID1234629468]).

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The Group’s loss for the year narrowed significantly from US$215.9 million in 2021 to US$97.4 million in 2022. The decrease in loss was primarily attributable to the decrease in loss on changes in fair value of financial liabilities at fair value through profit or loss (FVTPL) and listing expenses, though partly offset by the increase in research and development expenses and administrative expenses, which is in line with the Group’s continuous research and development efforts to support its steadily advancing and expanding pipeline of drug candidates.

Breakthroughs in Clinical-Stage Research and Development of Core Product Candidates

The Group has consistently strived to push the boundaries of innovation and continuously improved its technology platform. Two drug product formulations formulated with our PNP delivery platform have been evaluated for local therapeutic treatment (STP705) and systemic therapeutic treatment (STP707), both of which are currently undergoing late-stage clinical trials.

STP705

The interim results of the part-one Phase IIb clinical trial have demonstrated the efficacy of STP705 treatment, with the majority (78%) of the 32 patients evaluated achieving histological clearance. Impressively, the lowest dosage achieved 89% histological clearance. In the first quarter of 2023, the Group has commenced communication with the U.S. Food and Drug Administration (FDA) regarding its Phase III clinical study proposal for the treatment of isSCC.

STP705 for the treatment of BCC has demonstrated an improved cosmetic result with no significant cutaneous skin reaction and achieved an excellent safety profile with a 100% complete response using a 180 ug dosage. The Group has now completed the 240 ug dosage cohort and expects to have the final data readout in the second quarter of 2023. The latest results demonstrated very favourable efficacy without any drug related AEs and SAEs, further validating the broad potential of this drug candidate for the treatment of non-melanoma skin cancers and beyond.

Sirnaomics’ Phase I proof of concept clinical trial of STP705 for medical aesthetics treatment in adults undergoing abdominoplasty represents its first activity to apply an RNAi therapeutic candidate for localized fat remodeling. The Group expects interim data to be available in the second quarter of 2023 and the study should be completed in the second half of 2023.

Regulatory clearance for the Group’s IND application to participate in the global Phase I trial of STP705 for the treatment of patients with advanced liver tumors was granted by the Taiwan Ministry of Health and Welfare (TMHW) in July 2022 and the first patient will be initiated into the study during second half of 2023.

STP707

In February 2022, the Phase I clinical trial of STP707 for treating various solid tumor types was launched in the U.S. The interim data for the first three dosing cohorts was announced by the Group in December 2022. To date STP707 has demonstrated an excellent safety profile with the first three dosing cohorts and has exhibited a positive efficacy signal with many participants exhibiting the best response of stable disease with a meaningful number of participants remaining on study past the 100-day mark. In addition, this study has also been approved in the second half of 2022 to expand to Taiwan as part of the global multicenter clinical trial. The Group plans to expand oncology clinical studies in the Asia-Pacific, a region with a high unmet demand for innovative therapies.

Exciting Progress in IND Enabling Studies and Anticipated Clinical Studies

STP122G, the Group’s leading GalNAc-based therapeutic candidate targeting Factor XI, showed long-lasting target silencing activity, up to 28-week after one dose and in toxicology studies in mics and non-human primates. A U.S. IND was submitted in March 2023, and the Group is on track to start filing the clinical study application in the second quarter of 2023, if greenlight is given by the FDA.

RIM730, developed by RNAimmune Inc., a non-wholly owned subsidiary of the Group, comprises mRNA coding for a modified full length spike protein from the variant, and is formulated with LNP delivery technology for intramuscular administration. The Group expects to submit a U.S. IND in the first quarter of 2023.

Successful Commissioning of Guangzhou Facility Enables Flexibility and Capacity for Clinical Trials and Production Needs

Sirnaomics’ Guangzhou Facility successfully completed the full commissioning tasks with media fill simulation and trial run of STP705 in a lyophilized solid dose. During the Year, the Guangzhou Facility has supported the production of lyophilized toxicity lots for STP707, STP908, STP355 and STP369. With the recent full GMP batch of STP707 for human injection produced in the first quarter of 2023, the Guangzhou Facility is expected to be in full GMP-compliant manufacturing of pipeline products. In early 2023, the Guangzhou Facility initiated filling line capacity expansion to include liquid dose fill in 2R vial to support the Group’s GalAheadTM platform. An anticipated annual capacity of around 50,000 vials of lyophilized solid dose and 150,000 to 200,000 vials of liquid dose for human injectables dose capacity is sufficient to support all clinical trials the Group has currently planned.

Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics said, "Over the years, we have been dedicated to enriching our innovative RNA drug product pipeline and taking it to the next level, as part of our commitment to improving the wellbeing of patients worldwide. 2022 was a remarkable year for us. We made significant strides in advancing the research and development of our core products, which help us solidify a leadership position in RNA medicine for cancer treatment on the global stage, and was recognized by the capital market through our selection as a constituent stock of the Hang Seng Composite Index. Looking ahead, we will focus on expanding our competitive advantages by advancing the development of our lead product candidates STP705 and STP707 through clinical trials and capitalizing on our dual proprietary delivery platforms furthering more innovative first-in-class preclinical assets into the clinical stage, and selectively pursuing synergistic partnership opportunities to maximize the potential of our clinical product candidates. We will also strive to secure sustainable value growth for our shareholders."

On March 28, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, reported a corporate update and announced financial results for the fourth quarter and full-year 2022 (Press release, Aadi Bioscience, MAR 28, 2023, View Source [SID1234629467]).

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"2022 was a year marked by successive milestones with the launch of FYARRO, the start of the PRECISION 1 trial, strengthening our balance sheet with a $72.5 million financing, taking our cash runway into 2025, and collaborating on a new combination of nab-sirolimus with Mirati’s adagrasib," said Scott Giacobello, CFO and interim President and CEO of Aadi Bioscience. "We look forward to another year of advancements as we enter 2023 including the progression in our first collaboration, which is expected to initiate in the second quarter. As planned, we will provide preliminary data on patients in the PRECISION 1 trial in the second quarter of 2023."

Fourth Quarter 2022 Updates and Recent Operational Highlights

FYARRO net product sales were $5.2 million in the fourth quarter, or 23% sequential growth quarter-over-quarter, and were $15.2 million for full-year 2022, representing 10 months of sales.

Continued advancement of the PRECISION 1 registrational-directed trial in patients with tumor agnostic TSC1 and TSC2 inactivating alterations is advancing with continued enrollment and the Company plans to provide preliminary data on a meaningful number of patients in the second quarter of 2023.

Announced the appointment of Mohammad Hirmand, M.D., to Board of Directors. Dr. Hirmand is the co-founder of Avenzo Therapeutics, Inc., and serves as executive vice president and chief medical officer of this privately held biotechnology company focused on oncology therapeutics. Previously, Dr. Hirmand served as executive vice president and chief medical officer of Turning Point Therapeutics, a publicly traded precision oncology company, where he was responsible for clinical development, clinical operations and regulatory affairs, from December 2019 until its acquisition by Bristol Myers Squibb in August 2022.

Closed on a $72.5M financing during the fourth quarter, extending the Company’s cash runway into 2025.

Signed a clinical collaboration agreement during the fourth quarter with Mirati Therapeutics on combination of adagrasib with nab-sirolimus. The Phase 1/2 trial is expected to begin in the second quarter of 2023.
Fourth Quarter and Full-year 2022 Financial Results

Cash, cash equivalents and short-term investments as of December 31, 2022 were $172.6 million as compared to $148.9 million as of December 31, 2021, which is expected to fund operations into 2025 based on current plans.

Total revenue for the quarter ended December 31, 2022 was $5.2 million, and $15.2 million for the full-year ended December 31, 2022, resulting from sales of FYARRO.

Net loss for the three months ended December 31, 2022 was $13.9 million as compared to $16.0 million for the three months ended December 31, 2021. Net loss for the full-year 2022 ended December 31, 2022 was $60.5 million, as compared to $110.1 million for the period in 2021 (The prior year included the non-cash impairment charge of $74.2 million related to the acquired contract intangible asset incurred in conjunction with the Aerpio merger).
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the fourth quarter and full-year 2022.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Biosciences website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About FYARRO
FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About the PRECISION 1 Trial
The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient in the PRECISION 1 trial was dosed in March 2022.

On March 28, 2023 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company that employs a suite of innovative technologies to develop best-in-class radiopharmaceuticals for the monitoring and treatment of cancers, reported the licensing of a Granzyme B-targeted agent for PET imaging applications from Merck, known as MSD outside the United States and Canada (Press release, Ratio Therapeutics, MAR 28, 2023, View Source [SID1234629466]).

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Under the terms of the agreement, Merck will provide Ratio with several candidates and supporting preclinical and CMC data of its Granzyme B-targeted agent for PET imaging applications. Ratio will also be responsible for clinical development and will build a GMP production network for the PET imaging agent across North America, Western Europe, Japan, Australia, and beyond.

"We are thrilled to contribute our knowledge in nuclear medicine to advance the development of a novel imaging diagnostic in immunology and work alongside Merck, a global biopharmaceutical leader that has demonstrated a strong commitment to innovation and excellence for more than a century," said Dr. Jack Hoppin, Ratio’s Chairman and Chief Executive Officer. "The development of a Granzyme B-targeted agent for PET imaging has the potential to monitor responses to therapeutic interventions in clinical research."

Granzyme B is an enzyme released by activated immune cells, such as natural killer and cytotoxic T cells, with the primary function of killing tumor cells and normal cells infected with viruses. As such, Granzyme B holds potential to serve as a PET imaging biomarker to monitor immune cell activation in a variety of inflammatory diseases, autoimmune diseases, cancer and infection. The ability to visualize and quantify localized immune response empowers physicians to measure the early efficacy of therapies and modify treatment accordingly.