On March 26, 2024 Keymed Biosciences Inc. (HKEX: 02162) reported its 2023 annual results, along with recent pipeline highlights and corporate updates (Press release, Keymed Biosciences, MAR 26, 2024, View Source [SID1234641461]).

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"We made solid advances across our business in 2023 toward our goal to become a fully-integrated innovative biopharmaceutical company," said Dr. Bo Chen, Chairman, Executive Director, and Chief Executive Officer of Keymed Biosciences. "We successfully filed for NDA for Stapokibart (CM310), gaining priority review status, and have reported positive results from multiple clinical studies. We continued to develop our innovative and differentiated pipelines, actively explored value-accretive strategic partnerships, further expanded our cGMP-compliant manufacturing capacity and efficiently prepared for the company to become a commercial organization. The year 2024 is set to be an exciting one for Keymed, as the commercialization of our first product will propel us from being a clinical-stage biotech to a commercial-stage biopharmaceutical company. We will build on our plans to enable the successful launch of our product, as we continually strive to develop, manufacture and commercialize innovative biological therapies for patients worldwide."

Pipeline Highlights

The progress of core pipeline products:

Stapokibart (CM310) (IL-4Rα antibody)

Submitted a New Drug Application (NDA) of Stapokibart (CM310) for the treatment of moderate-to-severe AD in adults. The NDA was accepted by the China’s NMPA and granted priority review.
Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart in adolescent subjects with moderate-to-severe AD in February 2024, and the patient enrollment is currently in progress.
Advanced a Phase III clinical study of Stapokibart for the treatment of CRSwNP and completed the unblinding of data from the double-blind treatment period and the preliminary statistical analysis in December. The results of the Phase III clinical trial are positive with co-primary endpoints both achieved. We expect to file an NDA for CRSwNP indication in 2024.
Launched and advanced a Phase III clinical study to evaluate the efficacy and safety of Stapokibart in patients with seasonal allergic rhinitis under background therapy in 2023, and a multi-center, single-arm Phase II clinical study to evaluate the safety of Stapokibart in patients with seasonal allergic rhinitis.
Our partner, CSPC, has initiated the critical Phase II/III clinical study for the treatment of moderate-to-severe asthma, and the patient enrollment is currently in progress.
CMG901/AZD0901 (Claudin 18.2 antibody conjugated)

Entered into a global exclusive license agreement with AstraZeneca for the research, development, registration, manufacturing and commercialization of CMG901 and received an upfront payment of US$63 million in 2023.
As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901/AZD0901 for the treatment of advanced solid tumors.
In November 2023, the latest data from Phase I clinical study of CMG901 in the treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer has been presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series. Among 89 evaluable patients with claudin 18.2-positive G/GEJ cancer confirmed objective response rate (ORR) and confirmed disease control rate (DCR) were 33% and 70%, respectively. Among others,CMG901 showed a 42% confirmed ORR in 2.2 mg/kg dose cohort, with median progression free survival (mPFS) of 4.8 months.
CM313 (CD38 antibody)

Continuously proceeded with a Phase I clinical trial of CM313 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of CM313 monotherapy in hematological malignancies including relapsed/refractory multiple myeloma (RRMM) and lymphoma.
In June 2023, we presented, in the form of a poster, the latest data from the Phase I clinical study of CM313 for the treatment of RRMM and relapsed/refractory lymphoma at the 28th European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2023. CM313 exhibited a good safety profile in general in this study for it at dose levels of ≥2.0 mg/kg and yielded preliminary efficacy in patients with RRMM.
Continuously proceeded with a Phase Ib/IIa clinical study in 2023 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with systemic lupus erythematosus (SLE).
In December 2023, the latest data from the investigator-initiated single-arm, open-label, exploratory clinical study to evaluate CM313, which aimed to evaluate the safety and preliminary efficacy of CM313 for the treatment of primary immune thrombocytopenia in adults, were presented in a poster form at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. As of June 30, 2023, a total of 21 patients were enrolled in the study. 7 subjects completed 8 treatments with follow-up period of more than 8 weeks. Among the 7 patients, 100.0% (7/7) achieved a platelet count ≥50 × 109/L within 8 weeks after administration with the first dose, with a median time to response of 1 week (range from 1 to 3).
CM326 (TSLP antibody)

Continuously proceeded with a Phase II clinical study to evaluate the efficacy and safety of CM326 in adult patients with moderate-to-severe AD.
Continuously proceeded with a Phase Ib/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, immunogenicity, and preliminary efficacy of CM326 in subjects with CRSwNP.
Our partner, CSPC, has initiated the Phase II clinical study for the treatment of moderate-to-severe asthma.
Progress of other pipeline products:

CM355/ICP-B02 (CD20xCD3 bispecific antibody)

Continuously proceeded with a Phase I/II clinical trial to assess the safety, tolerability, PK, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin’s lymphoma (r/r NHL). As of the date of this announcement, all the 13 patients who were treated CM355 at dose ≥6mg achieved response with the ORR of 100%.
CM336 (BCMAxCD3 bispecific antibody)

Continuously proceeded with a Phase I/II clinical study in 2023 to assess the safety, tolerability, pharmacokinetics, and the anti-tumor activity of CM336 in RRMM.
CM350 (GPC3xCD3 bispecific antibody)

Continuously proceeded with a Phase I/II clinical study in 2023 to assess the safety, tolerability, pharmacokinetics, and the preliminary efficacy of CM350 in patients with advanced solid tumors.
CM338 (MASP-2 antibody)

Continuously proceeded with a Phase II clinical study in 2023 to evaluate the efficacy and safety of CM338 injection in subjects with immunoglobulin A nephropathy (IgAN).
CM369/ICP-B05 (CCR8 antibody)

Continuously proceeded with a Phase I trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL. We will explore the combination of CM369 with other immunotherapies in various cancer indications after collecting the safety data of monotherapy.
CM383 (Aβ protofibrils antibody)

Submitted an IND application for CM383 in February 2024, and we are about to conduct a Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single dose-escalation administration in healthy subjects.
Financial and Business Highlights

Revenue amounted to RMB354 million for the year ended December 31, 2023, mainly representing collaboration income from AstraZeneca in respect of granting the relevant license; R&D expenses increased by RMB89 million to RMB596 million; As at December 31, 2023, our time deposits, cash and cash equivalents and bank wealth management products amounted to RMB2,719 million.
The production capacity of the production base in Chengdu has reached 18,600 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA.
Continue to recruit talents to meet the growing needs of commercialized sales of products, research and development, clinical, production and operation of the Company.

On March 26, 2024 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis, and inflammation, reported a research collaboration with Dr. Raul Torres’s Lab at the University of Colorado School of Medicine (Press release, BridgeBio, MAR 26, 2024, View Source [SID1234641460]). The collaboration will focus on exploring the potential of BBT-877, a novel autotaxin (ATX) inhibitor, as an immuno-oncology treatment for cancer.

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Throughout his previous and ongoing research, Dr. Raul Torres, Professor of Immunology and Microbiology at the University of Colorado School of Medicine, has shown that lysophosphatidic acid (LPA) plays a role in modulating CD8 T cell immunosurveillance and metabolism, ultimately disrupting the body’s anti-tumor immunity.[i] LPA, a lipid that increases in its concentration across various cancer types, interacts with six different G protein-coupled receptors (LPA receptor 1-6, LPAR 1-6) to activate pathways and downstream signaling molecules leading to inflammation and fibrosis. According to recent research by Dr. Torres, the engagement of LPAR5 to LPA leads to the inhibition of cytotoxic function of CD8 T cells, thereby allowing cancer cells to evade immune surveillance. Silencing the inhibitory signaling of the LPA-LPAR5 pathway by reducing LPA levels is expected to enhance CD8 T cell immunity and improve effectiveness in killing cancer.[ii]

The joint research effort is focused on BBT-877, a novel ATX inhibitor that has been found to reduce LPA production by as much as 90% in human studies. The goal is to assess BBT-877’s potential as an immuno-oncology treatment. Early findings suggest that it may boost the immune system’s ability to attack cancer cells by enhancing antigen-specific target cell killing, reducing LPA-mediated activation of LPAR5, and suppressing T cell dysfunction, leading to stronger anti-tumor immunity.

"We are excited to collaborate with Dr. Torres’s Lab to investigate the potential of BBT-877 as a novel immuno-oncology treatment," said James Lee, CEO of Bridge Biotherapeutics. "Dr. Torres’s groundbreaking research on the role of the LPA-LPAR axis and T cell antigen receptor signaling in anti-tumor immunity has suggested the potential of autotaxin inhibitors to expand its indication into immuno-oncology," he added.

Dr. Raul Torres, Professor at the University of Colorado School of Medicine, stated, "By collaborating with Bridge Biotherapeutics, we aim to deepen our understanding of the intricate mechanisms underlying anti-tumor immunity with regards to the LPA-LPAR axis and to translate scientific findings into novel therapeutic strategies that can enhance immune responses against cancer."

Under the terms of the collaboration, Bridge Biotherapeutics will provide financial support and access to BBT-877, while Dr. Raul Torres’s Lab will contribute its expertise in immunology and cancer biology. Together, the two entities will conduct preclinical studies to evaluate the therapeutic potential of BBT-877 in enhancing anti-tumor immunity.

On March 26, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy (Press release, Innovent Biologics, MAR 26, 2024, View Source [SID1234641459]).

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Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS).

Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant therapy in patients with resectable MSI-H/dMMR colon cancer, the pCR rate in the IBI310+sintilimab group was significantly higher as compared with the sintilimab monotherapy group. No subjects in the IBI310+sintilimab group were inoperable due to adverse reactions, and there was no additional safety risk. Data from this Phase 1b trial will be published at an upcoming medical conference or in an academic journal in future.

The Principal Investigator of the Neoshot study, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated, "At present, R0 resection for T4 and/or N+ stage colon cancer patients remain a significant challenge, along with risks of extensive trauma and poor prognosis. The results of the FOxTROT study suggested that neoadjuvant chemotherapy is not effective in MSI-H/dMMR colon cancer, and the pCR rate is only about 5%[2]. Therefore, effective neoadjuvant treatment scheme is urgently needed to reduce preoperative staging, decrease tumor burden, narrow the scope of radical resection, and increase R0 resection rate, so as to improve long-term prognosis. IBI310 combined with sintilimab is expected to be the first neoadjuvant immunotherapy in China for resectable MSI-H/dMMR colon cancer, which has demonstrated encouraging efficacy and a good tolerance profile in a Phase 1b study. I look forward to working together with other investigators in Neoshot to obtain high-quality clinical data, in support of potentially providing a more effective treatment option for patients with MSI-H/dMMR colon cancer in China."

Dr. Zhou Hui, Senior Vice President of Innovent, stated, "There is a huge unmet clinical need for neoadjuvant therapy of resectable MSI-H/dMMR colon cancer in China. The results of NICHE study showed that postoperative pCR rate after neoadjuvant treatment for locally advanced colon cancer can be well translated into survival benefits[3]. In the Phase 1b study, IBI310 combined with sintilimab achieved excellent efficacy and safety results. We are pleased that the Phase 3 clinical study of Neoshot has completed the first patient dosing, and we are looking forward to the positive results generating from this study to provide a more ideal treatment option for MSI-H/dMMR colon cancer patients in China."

About Colorectal Cancer

Colorectal cancer is the second most common malignant tumor and the fourth leading cause of cancer death in China. It is estimated that in 2022, there are more than 510,000 new cases and approximately 240,000 fatal cases[4]. In addition, the incidence of colorectal cancer has continued to rise over the past 15 years[5]. MSI-H/dMMR is more common in localized colorectal cancer (10-15%) compared to metastatic colorectal cancer (5%)[6]. T4 and N2 are important prognostic indicators for MSI-H/dMMR colon cancer. Studies have shown that the 3-year disease-free survival rate of MSI-H/dMMR stage III colon cancer patients (T4 and/or N2) is about 60-65%[7],[8]. Therefore, the perioperative treatment for stage II-III MSI-H/dMMR colon cancer patients needs to be continually improved.

About IBI310

IBI310 is a fully human monoclonal antibody injection independently developed by Innovent. IBI310 can specifically bind cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4 mediated T cell inhibition, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[9].

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope of TYVYT (sintilimab injection) includes:

For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
In addition, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
Disclaimer: The above two indications are still under clinical study, which have not been approved in China. Innovent does not recommend any off-label usage.

On March 26, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that the University of Texas Southwestern Medical Center (UT Southwestern) will lead a clinical trial studying Actinium’s Iomab-ACT, a targeted radiotherapy conditioning agent prior to patients receiving an FDA approved commercial CAR T-cell therapy (Press release, Actinium Pharmaceuticals, MAR 26, 2024, View Source [SID1234641458]). UT Southwestern will start recruiting patients following FDA’s review and clearance of the study. CAR T-cell therapy utilizes patients’ own immune cells called T-cells, which are engineered to include a chimeric antigen receptor and then reinfused into the patient to recognize and destroy cancer cells. Currently, there are six CAR-T therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that collectively reached sales in 2023 exceeding $3.5 billion.

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Actinium developed Iomab-ACT with the goal of replacing the chemotherapy conditioning regimens currently used prior to cell and gene therapies. Early clinical data with Iomab-ACT conditioning prior to CAR-T demonstrates its ability to produce targeted lymphodepletion along with negligible incidences of immune effector cell-associated neurotoxicity syndrome (ICANS) or cytokine release syndrome (CRS), which are the major toxicities observed with the current chemotherapy based conditioning regimens, which are suboptimal and can limit patients from CAR-T access and may result in poor outcomes.

Sandesh Seth, Actinium’s Chairman and CEO, stated, "This is a pivotal moment for our Iomab-ACT program that presents the opportunity to produce potential practice changing clinical data. Cellular therapies such as CAR-T and gene therapies represent a multi-billion market opportunity with an expectation of nearly doubling to reach approximately 93,000 patients annually in the U.S. alone by 2030. We believe Iomab-ACT can be a universal conditioning regimen based on its potential to reduce CAR-T related toxicities such as ICANS and CRS, as evidenced by our early clinical work with a novel CD19 CAR T-cell therapy and may improve patient access and outcomes by eliminating the need for the non-targeted chemotherapy-based conditioning that are currently required prior to CAR-T therapies. This trial is a clear demonstration of Actinium’s commitment to being at the forefront of applying targeted radiotherapy to innovative applications and novel indications."

Dr. Avinash Desai, Actinium’s Chief Medical Officer, added, "Cellular therapies like CAR-T have transformed outcomes for tens of thousands of patients but clinicians continue to be frustrated with the need to use chemotherapy for conditioning. We are excited to be collaborating with the team at UT Southwestern on this first ever trial to study Iomab-ACT with a commercial CAR-T. Given the extensive data with CAR-T therapies, ­results from this study can allow us to show the impact of Iomab-ACT on reducing CAR-T related toxicities such as ICANS and CRS and improving efficacy including persistence of CAR-T cells, rates of response, and other efficacy outcomes. Based on the initial results from our clinical trial with Memorial Sloan Kettering’s CD19 CAR-T therapy, we are looking forward to initiating this study and delivering clinical proof of concept data with a commercial CAR-T."

Ongoing Iomab-ACT Phase 1 CAR-T Conditioning Results

Actinium presented results from its ongoing phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) at the Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in February 2024. Importantly, no patients (0/4) developed immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, a major safety measure of the study, as ICANS is observed in 25% or more of pts w/ R/R B-ALL and DLBCL treated with various CAR T-cell products and minimal CRS. Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes and monocytes. Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been observed to date.

Targeted Radiotherapy Conditioning Opportunity

The opportunity exists for better conditioning in other areas of cellular therapy, such as CAR-T as well as gene therapies. The pipeline of CAR-T and gene therapies has rapidly expanded, with the addressable patient population expected to nearly double and reach approximately 93,000 patients in the U.S. by 2030 based on the current pipeline of cellular therapies. The CAR-T market size in terms of revenue is estimated to grow at a CAGR of approximately 11% over the next 5 plus years. Currently, there are six CAR T-cell therapies approved by the FDA that are used to treat patients with lymphomas, leukemia, and multiple myeloma, which collectively had total sales of over $3.5 billion in 2023. The addressable market for Iomab-ACT is in line with the patient population for cell and gene therapies as all patients receive conditioning of some type prior to these treatments. We will continue to develop Iomab-ACT, our next-generation conditioning program for rapidly growing cell and gene therapies based on early promising results, ultimately with the value proposition of improving overall access and outcomes for patients who need cellular or gene therapies. A potential blockbuster revenue opportunity exists for Iomab-ACT assuming it can provide one or more clinical benefits related to lower CRS, less ICANS, longer duration of response or a higher overall success rate of cellular therapy due to benefits of targeted conditioning.

On March 26, 2024 Volastra Therapeutics, a clinical-stage biotechnology company, reported partnerships with Microsoft, Function Oncology and Tailor Bio with the goal of broadening the potential of its evolving therapeutics pipeline across a large number of tumor types through identification of predictive biomarkers (Press release, Volastra Therapeutics, MAR 26, 2024, View Source [SID1234641454]).

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Volastra leads the field in development of therapeutics that target chromosomal instability (CIN), a key characteristic of cancer associated with accelerated disease progression, increased resistance to therapies, and shortened patient survival. While CIN is a hallmark of cancer, levels of CIN vary widely across tumor types from being nearly ubiquitous in some to only partially present in others.

Volastra’s two KIF18A inhibitors are in parallel Phase 1 clinical trials treating tumor types with near-universally high levels of CIN. Significant potential remains in many other tumor types, for which a biomarker-defined approach may be able to identify subsets of patients most likely to benefit from treatment.

"Predictive biomarkers can help us expand the reach of our therapies to as many patients as possible," said Charles Hugh-Jones, M.D., FRCP, CEO at Volastra. "By leveraging the diverse expertise of our partners, we believe we can achieve this even in cancers with heterogenous levels of CIN."

Volastra has collaborated with Microsoft Research since 2020 to develop image-based artificial intelligence (AI) models that quantify CIN in patient samples.

"Our collaboration has shown extraordinary progress in creating AI techniques to identify visual hallmarks of CIN with high levels of accuracy, a process that is incredibly difficult and expensive for humans to do alone," commented Jonathan Carlson, Ph.D., Managing Director, Microsoft Research Heath Futures. "We are thrilled to continue to combine our research expertise with Volastra’s so they may amplify their impact and reach more patients."

This novel visual approach will now be complemented by the unique and distinct expertise of Function Oncology and Tailor Bio, both recognized leaders in precision medicine.

"Function’s collaboration with Volastra integrates our unique CRISPR platform to decipher patient-specific drug target vulnerabilities," said Srinath Sampath, M.D., Ph.D., M.Phil., co-founder and CEO of Function Oncology. "Our platform allows us to reach ground-state genetic truth about target dependence in cancer and beyond, and we look forward to applying this technology to Volastra’s clinical programs."

Jason Yip, MBA, co-founder and CEO of Tailor Bio commented, "Our latest Nature publication demonstrated the remarkable potential for genomic CIN signatures to quantify unique aspects of chromosomal instability. We are excited to apply our proprietary precision medicine platform to clinical trials in the rapidly advancing field of KIF18A inhibition."