On June 11, 2021 Shanghai Yingli Pharmaceuticals Ltd (Yingli Pharma), a clinical stage pharmaceutical company providing new therapies for cancer and metabolic diseases, reported the topline data from a clinical trial sponsored by the company at the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 9-17, 2021 (Press release, Yingli Pharmaceutical, JUN 11, 2021, View Source [SID1234583915]).

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The study entitled ‘A Phase 2 study of an oral PI3Kδ inhibitor YY-20394 in patients with relapsed or refractory follicular lymphoma’ will be presented at EHA (Free EHA Whitepaper) by Dr. Lugui Qiu, a lead investigator from Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China. This is a registration study that enrolled 93 relapsed or refractory Follicular Lymphoma (FL) patients having received 2 or more prior systemic therapies and was conducted at 32 clinical sites in China. Linperlisib was evaluated as a monotherapy for safety, tolerability and efficacy at recommended phase 2 dose of 80 mg once daily. Following a data cutoff on March 15, 2021, the fully enrolled study was analyzed for 89 evaluable patients. The Overall Response Rate (ORR) was 79.5%, with 12.4% Complete Response, 67.4% Partial Response, and 16.1% Stable Disease, combining to achieve a Disease Control Rate of 96.6%. Previously, the Phase 1 study of linperlisib had shown similar preliminary efficacy of 90% ORR in 10 patients with r/r FL. As of the data cutoff for the Phase 2, the median Progression Free Survival was 11.8 months, and the Duration of Response was 12.3 months. Forty seven patients were continuing to receive linperlisib treatment.

Follicular Lymphoma is increasingly harder to treat if patients progress on previous therapies, usually immuno-chemotherapy is a mainstay as a prior treatment. On this study, 65% of the patients had received 3 or more prior systemic treatments, and all patients had previously received rituximab-based therapies.

The safety data from the FL Phase 2 study indicated that linperlisib was generally safe and tolerable with manageable adverse events. Most of the adverse events were Grade 1 and Grade 2. The most common (>5%) treatment related hematologic adverse events of ≥ Grade 3 were neutropenia (15.1%), leukocytopenia (5.4%), lymphocytopenia (5.4%). The most common (>5%) treatment related non-hematologic adverse events of ≥ Grade 3 were pneumonia (15.1%).

Dr. Lugui Qiu, a prinicipal investigator on the study, stated "FL is complicated as the relapsed and refractory patients tend to progress rapidly, requiring aggressive therapies. From the clinical findings with linperlisib treatment of FL patients, we are seeing durable responses for most patients. Patients are in desperate need of effective therapies that target these lymphoma key signaling pathways and therapies that are oral medications, easy for patients to use outside of a clinic."

Dr. Zusheng Xu, General Manager of Yingli Pharma commented "We are excited to be developing Linperlisib for the treatment of lymphomas and solid tumors. Linperlisib is a next-generation PI3Kδ-selective inhibitor. The clinical data suggest that Linperlisib might be a potentially advantageous treatment option for patients. We have applied a linperlisib marketing approval in China in relapsed or refractory FL, based on the data from this phase II registration study. We hope to broaden the use of linperlisib and are exploring its anti-tumor activities in different indications in additional clinical trials."

Dr. Qiu also indicated "It is a major step that Linperlisib has been accepted by the NMPA for the NDA application, and we are very optimistic about the outcome."

About Linperlisib

Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, exciting anti-tumor activities, and good PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to the current trial. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL, and T cell lymphoma. A clinical trial in r/r FL is launching in the US. Multiple linperlisib clinical trials being conducted in other lymphomas, solid tumors, and in combination with gemcitabine/oxaliplatin in r/r DLBCL. Preliminary results from a PTCL Phase1b study were reported at ASCO (Free ASCO Whitepaper) 2021, indicating an overall response rate of 70% with 33% CRs in 30 evaluable patients with r/r PTCL, a difficult to treat and aggressive form of lymphoma.

On June 11, 2021 ImmVira reported that in the Phase II Clinical Trials of its leading oncolytic virus product, MVR-T3011* as intratumoral administration (MVR-T3011 IT), ImmVira has completed the first dosing in both China and the U.S. on May 28 2021 and June 11 2021, respectively (Press release, Immvira, JUN 11, 2021, View Source [SID1234583938]).

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MVR-T3011, ImmVira’s proprietary next-generation, genetically modified oncolytic herpes simplex virus ("oHSV"), is developed on a novel virus backbone design driven by ImmVira’s innovative insights in oncolytic viruses and superior gene recombinant technology. The incorporation of two exogenous genes, PD-1 antibody and IL-12, further enhances immune responses. MVR-T3011 is ImmVira’s first pipeline undergoing clinical trial and includes intratumoral administration of MVR-T3011. Phase I clinical trials commenced in China in April 2020 and commenced in the United States and Australia in September 2020. Data collected from these preliminary Phase I clinical studies have demonstrated a favorable safety profile and promising efficacy profile. No dose-limiting toxicities have been observed in participants.

The U.S. Phase IIa portion of the study consists of two parts: (i) MVR-T3011 as a single agent for melanoma and metastatic solid tumors; (ii) MVR-T3011 in combination with pembrolizumab for non-small-cell lung carcinoma. The China Phase IIa (MVR-T3011 as a single agent) study targets head and neck cancer, sarcoma and breast cancer. These multi-center studies cover various indications providing highly efficient and cost-effective clinical development strategy to rapidly advance clinical development for MVR-T3011 across regions.

"Leveraging the OvPENS new drug R&D platform, ImmVira is a pioneer in the field," said Dr. Grace Zhou, Chairwoman of the Board of ImmVira. "ImmVira will make best use of its long-term experience and creative insights in oncolytic virus to construct broader product pipelines and provide effective, innovative and safe single-agent as well as combined oncolytic virotherapies for the anti-tumor market." Professor Bernard Roizman has resigned from as Chairman of the Board in February 2020 due to personal health reason and he has not held any positions in ImmVira and its subsidiaries since then. Dr. Grace Zhou has been appointed as Chairwoman of the Board since February 2020.

* Note: MVR-T3011 is the pipeline designation representing T3011, the product code registered in the US and China for clinical trials.

On June 11, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting highlighting transfusion independence with momelotinib is associated with improved overall survival, including in patients with anemia at baseline (Press release, Sierra Oncology, JUN 11, 2021, View Source [SID1234583900]). In addition, transfusion independence is seen irrespective of baseline degree of anemia, platelet count or transfusion status.

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"Momelotinib has previously been shown to provide an anemia benefit for myelofibrosis patients, resulting in higher rates of transfusion independence. The data presented at EHA (Free EHA Whitepaper) are particularly exciting because they suggest myelofibrosis patients randomized to momelotinib who achieve or maintain transfusion independence at Week 24 achieve a clinically relevant improvement in overall survival, the gold standard measurement of oncology treatment.," said Barbara Klencke, MD, Chief Medical Officer at Sierra Oncology. "The correlation between Week 24 transfusion independence response and overall survival observed with momelotinib is unique among JAK inhibitors. This suggests that the likelihood of achieving or maintaining transfusion independence may become an important consideration for physicians when recommending myelofibrosis treatment options. With this in mind, we wanted to understand which patients were most likely to maintain or achieve transfusion independence by Week 24. In other data presented at EHA (Free EHA Whitepaper), we report observing higher rates of transfusion independence with momelotinib relative to ruxolitinib, regardless of a patient’s baseline degree of anemia, platelet count or transfusion status."

Transfusion Independence is Associated with Improved Overall Survival in Myelofibrosis Patients Receiving Momelotinib

Efficacy data examining the association between transfusion independence and overall survival for momelotinib patients from SIMPLIFY-1 (JAKi-naïve) and SIMPLIFY-2 (JAKi-exposed) were presented in an oral presentation by Ruben Mesa, MD, Director of the Mays Cancer Center, UT Health San Antonio, MD Anderson Cancer Center. Previously published data demonstrated higher transfusion independence response rates in the momelotinib arms of SIMPLIFY-1 (67% vs. 49%) and SIMPLIFY-2 (43% vs. 21%) compared with ruxolitinib or best available therapy, respectively. Additionally, robust overall survival was observed with extended momelotinib treatment in both JAKi-naïve and JAKi-exposed patients (median not yet reached in SIMPLIFY-1 and 34.3 months in SIMPLIFY-2) as reported at ASH (Free ASH Whitepaper) 2020. These new analyses being presented at EHA (Free EHA Whitepaper) 2021 suggest JAKi-naïve patients receiving momelotinib achieve or maintain transfusion independence (TI) at Week 24 have favorable overall survival compared to non-responders, with a similar trend observed in SIMPLIFY-2.

Key Data Presented

In SIMPLIFY-1 (JAKi-naïve patients)
Patients randomized to momelotinib who were TI responders show a three-year overall survival of 80% compared to 50% for non-responders (HR=0.30; p<0.0001)
Patients with anemia at baseline (RBC transfusion <12 weeks before baseline, or baseline Hgb <10 g/dL) show a similar survival advantage for momelotinib patients who achieve a TI response at Week 24 compared to TI non-responders (HR=0.32; p=0.0006)
In SIMPLIFY-2 (JAKi-exposed patients)
Patients randomized to momelotinib who were TI responders at Week 24 show a trend toward better OS compared to TI non-responders (HR=0.52; p=0.0652)
Improved Transfusion Independence Rates for Momelotinib vs. Ruxolitinib in Anemic JAKi Naïve Myelofibrosis Patients Independent of Baseline Platelet or Transfusion Status

Progressive anemia is a common occurrence in myelofibrosis, with nearly all patients requiring transfusions as their disease advances. As noted in the EHA (Free EHA Whitepaper) oral presentation, JAKi-naïve patients receiving momelotinib who maintain or achieve transfusion independence at Week 24 have favorable overall survival compared to non-responders, with a similar trend observed in SIMPLIFY-2.

Data presented in a poster presentation by Jean-Jacques Kiladjian, MD, PhD, Professor of Clinical Pharmacology, Paris Diderot University and Consultant Hematologist and Head of the Clinical Investigation Center, Saint Louis Hospital, show that the prognostically important Week 24 TI rates in JAKi-naïve myelofibrosis patients were consistently higher in anemic patients receiving momelotinib compared to ruxolitinib in all patient subsets with baseline hemoglobin <14 g/dL and all subsets defined by baseline platelet count and baseline transfusion status. Combined with data from the oral presentation, these data suggest the goal of achieving TI should become an important driver of treatment decisions in myelofibrosis.

On June 11, 2021 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 45 cents per share (Press release, Abbott, JUN 11, 2021, View Source [SID1234583886]).

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This marks the 390th consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Aug. 16, 2021, to shareholders of record at the close of business on July 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have increased dividends annually for at least 25 consecutive years.

On June 11, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported a research collaboration agreement with Mayo Clinic to conduct human clinical proof of concept studies using the Sofusa Lymphatic Drug Delivery System (S-LDDS) technology across multiple products and indications (Press release, Sorrento Therapeutics, JUN 11, 2021, View Source [SID1234583902]). Sofusa is a drug delivery platform which delivers biologic therapies through the skin and directly into the lymphatic system with potential to improve the efficacy and safety of immuno-oncology therapies. Targeting delivery to the lymphatics should also enable reduced dosing as compared to traditional systemic infusions or subcutaneous injections.

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The first study resulting in this agreement is MC20711, a Phase 1b study of the administration of Ipilimumab Intra-Lymphatically using the Sofusa DoseConnect in Patients with Metastatic Melanoma. This is an investigator-initiated study developed by Svetomir Markovic, MD, PhD, and his team. "Checkpoint therapies have shown good results in some patients; however, response rates are still low, and this may be due to poor exposure to drug targets which reside in lymph nodes. By delivering checkpoint therapies directly to the lymphatics, we expect to see an increase in clinical response and potentially a decrease in systemic side effects" – Mike Royal, MD, CMO for Sorrento Therapeutics.

This agreement builds upon the previously announced exclusive licensing agreement where Sorrento licensed Mayo Clinic’s proprietary Antibody-Drug-Nanoparticle albumin-bound Immune Complex platform technology. "Both of these agreements are part of our strategic focus to combine potent antibodies from our G-MAB library with next-generation therapeutic platform technologies to deliver unparalleled safety and efficacy" – Henry Ji, President and CEO, Sorrento Therapeutics.

Mayo Clinic, Dr. Svetomir Markovic and Dr. James Jakub have financial interests in the technology referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.