On June 19, 2019 Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to create breakthrough medicines for patients, reported that it will present new preclinical data demonstrating its first-in-class oral IRAK4 protein degraders cause tumor regression in MYD88-mutant B cell lymphoma (Press release, Kymera Therapeutics, JUN 19, 2019, View Source [SID1234537183]). Data will be shared during an oral presentation at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Thursday, June 20 at 5:45 PM CEST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are highly encouraged by the data, which strongly supports clinical advancement of our orally active IRAK4 protein degraders in MYD88-driven B cell malignancies, both as monotherapy and in combination with drugs targeting complementary pathways," said Jared Gollob, MD, CMO, Kymera Therapeutics. "We look forward to sharing our findings and engaging with an international group of lymphoma experts at this year’s ICML meeting to define the path forward into the clinic in 2020."

Activating mutations in MYD88 are frequent across multiple subsets of aggressive B cell lymphomas, including activated B cell-like diffuse large B cell lymphoma (ABC-DLBCL, 30-40%), primary central nervous system lymphoma (30-70%), and primary extranodal lymphoma (45-75%), as well as Waldenström Macroglobulinemia (>90%). Myddosome signaling triggered by MYD88 is dependent on both the kinase activity and scaffolding function of IRAK4. Kymera is using a chemical knockdown strategy to develop heterobifunctional small molecule IRAK4 protein degraders such as KYM-001 for the treatment of B cell malignancies driven by MYD88 mutations.

ICML Study Highlights
ABSTRACT #083: "KYM-001, a first-in-class oral IRAK4 protein degrader, induces tumor regression in xenograft models of MYD88-mutant ABC-DLBCL alone and in combination with BTK inhibition"

Presented by Duncan Walker, PhD, VP of Oncology, Kymera Therapeutics

Kymera’s IRAK4 degrader achieved potent and selective E3 ligase-dependent degradation of IRAK4 in both MYD88 mutant and MYD88 wild-type (WT) ABC-DLBCL cell lines.
Cell viability was impacted in MYD88 mutant but not WT ABC-DLBCL cell lines, whereas an IRAK4 kinase inhibitor had no effect.
Orally dosed KYM-001 caused in vivo tumor regression in a dual MYD88/CD79 mutant OCI-LY10 mouse xenograft model of ABC-DLBCL associated with ≥75% IRAK4 knockdown in tumors.
Subtherapeutic doses of KYM-001 in combination with the BTK inhibitor ibrutinib increased OCI-LY10 apoptosis in vitro and drove tumor regression in vivo in the OCI-LY10 mouse xenograft model.

On June 19, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported that it has received formal scientific advice from the European Medicines Agency (EMA) regarding a proposed design of a Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer (Press release, Sophiris Bio, JUN 19, 2019, View Source [SID1234537182]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Based on the safety profile of topsalysin in 451 patients in our clinical development program along with the efficacy seen in our Phase 2 studies in localized prostate cancer, we approached the EMA with our proposed study design for a single Phase 3 trial to support registration in Europe, and we are pleased to have now obtained formal feedback from the Agency," said Randall Woods, president and CEO of Sophiris. "We believe that data from a single Phase 3 trial, if successful, will be sufficient to support market approval in Europe."

The Phase 3 study design, agreed upon by the EMA, will enroll patients with a confirmed diagnosis of intermediate risk disease. Approximately 700 men who meet the eligibility criteria will be equally randomized to receive a single administration of either topsalysin or placebo. The primary endpoint for the study will be the proportion of patients at 12 months who have failed treatment, defined as histological progression of disease resulting in the need for alternative intervention, per an independent central adjudication panel.

Webcast scheduled for today at 9:30 a.m. Eastern Time

The Sophiris management team will host a conference call and webcast today, June 19, at 9:30 a.m. Eastern Time to review the key details of the proposed Phase 3 clinical trial design and to address the potential commercial opportunity for topsalysin, along with Professor Hashim Ahmed, Faculty of Medicine Department of Surgery & Cancer, Chair in Urology, Imperial College of London & Imperial College Healthcare NHS Trust and a member of the Scientific Advisory Board at Sophiris.

A live audio webcast will be accessible on the "Investor Relations" page of the Sophiris corporate website at www.sophirisbio.com. A replay will be available at the same location.

About Localized Prostate Cancer

Prostate cancer is the second most common form of cancer in men in the United States with an estimated 175,000 new cases in 2019. Approximately 77 percent of patients in the United States are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically-significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence and rectal toxicity.

About Topsalysin

Topsalysin (PRX302), an innovative, "First-in-Class" transmembrane pore-forming protein, was genetically modified to be activated only by enzymatically-active PSA, which is produced in large quantities within the prostate of men with prostate cancer. The targeted focal treatment of prostate cancer is in line with current treatment trends for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ and organ function as possible.

Topsalysin has the potential to provide a targeted focal therapy for the ablation of localized prostate cancer lesions while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in software to co-register previously obtained mpMRI images with real-time three-dimensional ultrasound images enables urologists to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.

On June 19, 2019 Bayer reported that the Stivarga (regorafenib) arm of the platform trial GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) has opened enrollment for patients with newly diagnosed and recurrent glioblastoma, the most aggressive and common form of primary brain cancer (Press release, Bayer, JUN 19, 2019, https://www.prnewswire.com/news-releases/bayers-stivarga-regorafenib-becomes-first-compound-used-in-clinical-trial-platform-to-investigate-new-therapies-for-brain-cancer-300871305.html [SID1234537181]).1 The opening of the first clinical trial site, at Henry Ford Cancer Insititute in Detroit, marks the start of the international clinical trial program sponsored by the Global Coalition for Adaptive Research (GCAR). Bayer’s Stivarga will be the first drug to be evaluated in this trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Glioblastoma treatment options and patient outcomes have remained largely unchanged over several decades.1 Ninety-five percent of patients die within five years of diagnosis and more than half die within the first 15 months after diagnosis.1

"GBM is an aggressive brain tumor with few effective therapies. We are excited to open GBM AGILE and test new treatment options for our patients, who so desperately need them," said Tom Mikkelsen, M.D. of the Henry Ford Cancer Institute and medical director of Precision Medicine and Clinical Trials at Henry Ford Health System.

Bayer will provide drug supply and support the clinical trial at sites enrolling patients in the Stivarga arm. By the end of 2019, GBM AGILE will open in over 40 academic medical centers and community-based institutions across the United States, with plans to expand across Europe, China, Canada, and Australia through 2020.

"We are excited that the regorafenib arm of the GBM AGILE trial is the first to enroll patients and are looking forward to seeing how regorafenib can potentially help these patients in need of treatment options," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceuticals Division. "Bayer actively supports the clinical research of regorafenib in a range of different tumor types to explore the potential of this drug to help even more patients in need."

About Stivarga (regorafenib)2
In April 2017, Stivarga was approved for use in patients with hepatocellular carcinoma who have been previously treated with Nexavar (sorafenib). In the United States, Stivarga is also indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

Stivarga is approved in more than 90 countries.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

Important Safety Information for Stivarga2

WARNING: HEPATOTOXICITY

– Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.

– Monitor hepatic function prior to and during treatment.

– Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as
manifested by elevated liver function tests or hepatocellular necrosis, depending
upon severity and persistence.

Hepatotoxicity: Severe drug-induced liver injury with fatal outcome occurred in STIVARGA-treated patients across all clinical trials. In most cases, liver dysfunction occurred within the first 2 months of therapy and was characterized by a hepatocellular pattern of injury. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm. In hepatocellular carcinoma (HCC), there was no increase in the incidence of fatal hepatic failure as compared to placebo.

Liver Function Monitoring: Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue STIVARGA, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

Infections: STIVARGA caused an increased risk of infections. The overall incidence of infection (Grades 1-5) was higher (32% vs 17%) in 1142 STIVARGA-treated patients as compared to the control arm in randomized placebo-controlled trials. The incidence of grade 3 or greater infections in STIVARGA treated patients was 9%. The most common infections were urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) and pneumonia (2.6%). Fatal outcomes caused by infection occurred more often in patients treated with STIVARGA (1.0%) as compared to patients receiving placebo (0.3%); the most common fatal infections were respiratory (0.6% vs 0.2%). Withhold STIVARGA for Grade 3 or 4 infections, or worsening infection of any grade. Resume STIVARGA at the same dose following resolution of infection.

Hemorrhage: STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 18.2% in 1142 patients treated with STIVARGA vs 9.5% with placebo in randomized, placebo-controlled trials. The incidence of grade 3 or greater hemorrhage in patients treated with STIVARGA was 3.0%. The incidence of fatal hemorrhagic events was 0.7%, involving the central nervous system or the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.

Gastrointestinal Perforation or Fistula: Gastrointestinal perforation occurred in 0.6% of 4518 patients treated with STIVARGA across all clinical trials of STIVARGA administered as a single agent; this included eight fatal events. Gastrointestinal fistula occurred in 0.8% of patients treated with STIVARGA and in 0.2% of patients in the placebo arm across randomized, placebo-controlled trials. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula.

Dermatological Toxicity: In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients with STIVARGA arm and 25.5% of patients in the placebo arm including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome (PPES) and severe rash, requiring dose modification. In the randomized, placebo-controlled trials, the overall incidence of HFSR was higher in 1142 STIVARGA-treated patients (53% vs 8%) than in the placebo-treated patients. Most cases of HFSR in STIVARGA-treated patients appeared during the first cycle of treatment. The incidences of Grade 3 HFSR (16% vs <1%), Grade 3 rash (3% vs <1%), serious adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson syndrome (<0.1% vs 0%) were higher in STIVARGA-treated patients. Across all trials, a higher incidence of HFSR was observed in Asian patients treated with STIVARGA (all grades: 72%; Grade 3:18%). Toxic epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients across all clinical trials of STIVARGA administered as a single agent. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.

Hypertension: Hypertensive crisis occurred in 0.2% in STIVARGA-treated patients and in none of the patients in placebo arm across all randomized, placebo-controlled trials. STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC, 59% vs 27% in GIST, and 31% vs 6% in HCC). The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (67% in randomized, placebo-controlled trials). Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension.

Cardiac Ischemia and Infarction: STIVARGA increased the incidence of myocardial ischemia and infarction (0.9% with STIVARGA vs 0.2% with placebo) in randomized placebo-controlled trials. Withhold STIVARGA in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome of subcortial vasogenic edema diagnosed by characteristic finding on MRI occurred in one of 4800 STIVARGA-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, severe headache, visual disturbances, confusion, or altered mental function. Discontinue STIVARGA in patients who develop RPLS.

Wound Healing Complications: Treatment with STIVARGA should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. STIVARGA should be discontinued in patients with wound dehiscence.

Embryo-Fetal Toxicity: STIVARGA can cause fetal harm when administered to a pregnant woman. There are no available data on STIVARGA use in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with STIVARGA and for 2 months after the final dose.

Nursing Mothers: Because of the potential for serious adverse reactions in breastfed infants from STIVARGA, do not breastfeed during treatment with STIVARGA and for 2 weeks after the final dose.

Most Frequently Observed Adverse Drug Reactions in mCRC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), pain (59% vs 48%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).

Most Frequently Observed Adverse Drug Reactions in GIST (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 12%), pain (60% vs 55%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

Most Frequently Observed Adverse Drug Reactions in HCC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in HCC, respectively, were: pain (55% vs 44%), HFSR/PPE (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31% vs 18%), decreased appetite and food intake (31% vs 15%).

Please see full Prescribing Information, including Boxed Warning for Stivarga (regorafenib).

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes five marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On June 19, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported new interim results from the Company’s ongoing Phase 2a study of cerdulatinib, an investigational, oral SYK/JAK inhibitor, in patients with relapsed/refractory follicular lymphoma (FL) receiving cerdulatinib alone or in combination with rituximab (Press release, Portola Pharmaceuticals, JUN 19, 2019, Portola Presents New Interim Data on its Oral SYK/JAK Inhibitor Cerdulatinib in Heavily Pre-Treated Patients with Relapsed/Refractory Follicular Lymphoma
[SID1234537180]). Data were presented this month in a poster session at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam (June 13-16) and during an oral session today at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (June 18-22).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data included safety and efficacy findings for 40 patients who received single agent cerdulatinib at 30 mg twice daily (with the exception of two patients who initiated treatment at 35 mg) and 17 patients who received cerdulatinib at 30 mg twice daily in combination with a standard dosing regimen of rituximab. The number of prior treatment regimens including anti-CD20 antibody, bendamustine and anthracyclines ranged from one to nine, with a median of three.

Among the 40 patients in the cerdulatinib-only cohort, the objective response rate (ORR) was 45%; five patients (13%) achieved a complete response (CR), 13 patients (33%) achieved a partial response (PR) and 10 patients (25%) achieved stable disease (SD). Of the 27 patients with a PR or SD at first evaluation in the single agent cerdulatinib cohort, 17 (63%) had a further reduction in tumor volume at a subsequent efficacy evaluation. To date, 15 of the 40 patients (38%) in the cerdulatinib-only cohort have been on study drug for at least 10 months.

Among the 13 patients evaluated for efficacy in the cerdulatinib and rituximab combination cohort, the ORR was 62%; one patient (8%) achieved a CR, seven patients (54%) achieved a PR and five patients (39%) achieved SD. To date, 10 of the 13 patients have been on study drug from three to 10 months.

Cerdulatinib was generally well-tolerated and the safety profile appeared similar in both cohorts. The most common adverse events (AEs) occurring in ≥10% of patients were lipase increase (25%), neutropenia (15%), amylase increase (13%) and diarrhea (10%). The most common AEs in the combination cohort included lipase increase (35%), neutropenia (23%) and diarrhea (12%). The lipase and amylase increases were generally asymptomatic and not associated with pancreatitis. Additionally, there was no emergence of late-stage colitis, cardiac or liver abnormalities, or other evidence of cumulative toxicity among patients in the single-agent cerdulatinib arm.

"Despite recent advances, relapsed or refractory follicular lymphoma remains a challenging and heterogeneous disease. Oral therapies that can address multiple signaling pathways and overcome chemoresistance without cumulative side effects are urgently needed," said Paul Hamlin, M.D., medical director for the David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center. "Cerdulatinib continues to show promise across a range of B- and T-cell malignancies, and I am encouraged by these interim results, indicating sustained clinical activity and good tolerability of cerdulatinib in these follicular lymphoma patients."

"We are very encouraged by these early findings and look forward to continuing to gather additional data that will further characterize the safety and efficacy profile of cerdulatinib in patients with relapsed/refractory follicular lymphoma," said Jeff Myers, Portola’s interim chief medical officer. "Simultaneously, we are continuing to move forward with the development of cerdulatinib in relapsed/refractory peripheral T-cell lymphoma and plans to initiate a registrational trial by the end of the year."

ICML Oral Presentation Details
Wednesday, June 19, 2019 from 17:15 p.m. CEST/ 8:15 a.m. PDT

Rapid and Durable Responses with the SYK/JAK Inhibitor Cerdulatinib in a Phase 2 Study in Relapsed/Refractory Follicular Lymphoma—Alone or in Combination With Rituximab (Abstract #30)

Presenter: Stephen Smith, M.D., of the University of Washington/Fred Hutchinson Cancer Research Center.
Cerdulatinib has demonstrated broad clinical activity in both B- and T-cell malignancies. At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, the Company presented an update on cerdulatinib’s activity in relapsed/refractory peripheral T-cell lymphoma (PTCL); angioimmunoblastic T-cell lymphoma (AITL), a subset of PTCL; and cutaneous T-cell lymphoma (CTCL). As of the November 1, 2018 cut-off date, the ORR in the PTCL cohort was 34% with 27% achieving a CR. Among the subset of patients in the PTCL cohort with AITL, the ORR was 57% with a CR of 50%. The ORR in the CTCL cohort was 26% with 7% of patients achieving a CR. Importantly, rapid improvements in pruritus, or severe itching – a common and often serious condition associated with CTCL – were observed. Follow-up analysis of these cohorts is ongoing with plans to start a registrational study in PTCL by the end of the year.

About the Phase 2a Study
The Phase 2a, open-label study was designed to assess the safety and efficacy of cerdulatinib in patients with relapsed/refractory FL (alone or in combination with rituximab), small lymphocytic lymphoma (SLL) and specific subtypes of T-cell Non-Hodgkin Lymphoma, including PTCL, AITL and CTCL.

Tumor response in the two cohorts evaluating patients with relapsed/refractory FL was assessed by Lugano classification, with treatment continued until disease progression or unacceptable toxicity. Tumor response assessments were performed at the end of cycle two and every three cycles thereafter.

About Cerdulatinib
Cerdulatinib is an investigational oral, dual spleen tyrosine kinase (SYK) and janus kinase (JAK) inhibitor that uniquely inhibits two key cell signaling pathways implicated in certain hematologic malignancies and autoimmune diseases. There is a strong rationale for inhibiting both SYK (B-cell receptor pathway) and JAK (cytokine receptors) in B-cell malignancies where both targets have been shown to promote cancer cell growth and survival.

The U.S. Food and Drug Administration granted cerdulatinib Orphan Drug Designation for the treatment of PTCL in September 2018.

On June 19, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health, reported that it will issue financial results for fiscal year 2019, ended March 31, 2019, at 4:15pm Eastern time on Monday, July 1, 2019 (Press release, Aethlon Medical, JUN 19, 2019, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-fiscal-year-end-financial-results-and-host-conference-call-on-july-1-2019-300871472.html [SID1234537179]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Management will host a conference call on Monday, July 1, 2019 at 4:30pm eastern time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. All callers should ask for the Aethlon Medical, Inc., conference call.

A replay of the call will be available approximately one hour after the end of the call through July 8, 2019. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10132719.