On June 22, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology drug-development company, reported that affirmed that the independent Data Monitoring Committee (iDMC) is scheduled to meet during the first half of July to conduct the second pre-planned interim safety and efficacy analysis of the Phase III OPTIMA Study with ThermoDox plus RFA (radiofrequency ablation) in patients with hepatocellular carcinoma (HCC), or primary liver cancer (Press release, Celsion, JUN 22, 2020, View Source [SID1234561482]). Members of the iDMC represent the global market for HCC and are based in the U.S., Canada and Europe, and Celsion believes that any logistical challenges to the Committee’s performing its work presented by the global COVID-19 pandemic have been addressed. Celsion expects to announce the iDMC’s recommendations and Company next steps soon after the meeting concludes.

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 lock for the second pre-specified interim analysis occurred during April 2020 after the prescribed minimum number of events of 158 patient deaths was reached.

As previously announced, the hazard ratio for success at 158 deaths is 0.70, which represents a 30% reduction in the risk of death compared with RFA alone. The p-Value required is 0.022. Both compare favorably with the hazard ratio of 0.65 and p-Value = 0.02 observed in the prospective HEAT Study subgroup upon which the OPTIMA Study is based.

Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, said, "The iDMC meeting is expected to take place as planned and we look forward to receiving their recommendation. While we are hopeful for a positive outcome, it is not a binary event for the OPTIMA Study. Should the data not reach the threshold for success, we believe the OPTIMA Study is ultimately well-positioned for success at the final analysis, if necessary. The final analysis would be based on 197 patient deaths where the hazard ratio for success is 0.75 or a 25% reduction in the risk of death, with a p-Value = 0.042. We believe that a successful study has blockbuster revenue potential and, more importantly, will be globally transformational for patients with HCC, the largest unmet need in oncology with more than 750,000 cases annually."

About the OPTIMA Study

The Phase III OPTIMA Study enrolled 556 patients at 65 clinical sites in North America, Europe, China and Asia Pacific. The Study is evaluating ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3-7 cm in size, versus optimized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analyses of data from the Company’s 701-patient HEAT Study, where optimized RFA demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

About ThermoDox

Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD) whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox is positioned for use with multiple heating technologies and has the potential to treat of a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream.

In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.

On June 22, 2020 Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, reported the appointment of Allen Melemed, M.D., M.B.A., as Chief Medical Officer (Press release, Chimerix, JUN 22, 2020, View Source [SID1234561433]).

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 delighted to welcome Dr. Melemed as a key member of our management team. We look forward to leveraging his considerable clinical and regulatory experience as a distinguished pharmaceutical executive. His vast experience bringing oncology therapeutics through development and approval across multiple modalities will be invaluable as we initiate our dociparstat sodium (DSTAT) Phase 3 trial in first line acute myeloid leukemia (AML), our ongoing Phase 2/3 trial to combat acute lung injury (ALI) in COVID-19 patients, and finalize our rolling New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox," said Mike Sherman, Chief Executive Officer of Chimerix.

"I am particularly pleased to be joining Chimerix at such an important juncture in its growth trajectory. DSTAT’s potential to improve survival in newly-diagnosed AML patients is critically important in a disease where five-year survival rates remain far too low, particularly in older populations. Furthermore, DSTAT’s broad mechanism to manage inflammation and hematologic disorders offers promise to treat ALI in COVID-19 patients and underpins its mechanism of action in ALI beyond the current pandemic. I look forward to working with the team to advance our pipeline of important therapies and to bringing these life-saving treatments to patients in need," said Dr. Melemed.

Dr. Melemed joins Chimerix from Eli Lilly and Company, where he spent more than 20 years dedicated to the clinical development and approval of oncology medicines across a broad range of tumor types including VERZENIO, CYRAMZA, LARTRUVO , ALIMTA and RETEVMO among others. Most recently, he served as a Distinguished Medical Fellow and Senior Director of Regulatory Affairs Oncology, North America. In addition to his role at Eli Lilly, Dr. Melemed was an attending physician in pediatric oncology at Indiana University (IU) School of Medicine, Riley Children’s Hospital from 1996 to 2012.

Dr. Melemed holds a B.S. in Genetics and Cell Biology from the University of Minnesota and a M.D. from the University of Minnesota School of Medicine. In addition, he completed his residency in pediatrics at the University of Wisconsin, Madison and fellowship in pediatric hematology/oncology at IU School of Medicine. He earned an M.B.A. from the University of Chicago Booth School of Business. Dr. Melemed has authored dozens of scientific and clinical publications.

On June 22, 2020 Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) reported that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) (Press release, Pfizer, JUN 22, 2020, View Source [SID1234561428]). With this validation, the application is complete, and the EMA will now begin the review procedure.

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!

The application is based on results from the Phase III JAVELIN Bladder 100 study which showed a statistically significant improvement in overall survival (OS) for BAVENCIO plus best supportive care (BSC) as first-line maintenance treatment following induction chemotherapy versus BSC alone in patients with locally advanced or metastatic UC. The data were presented at the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Meeting.

In the European Union alone, nearly 200,000 people are diagnosed each year with bladder cancer.1 Urothelial carcinoma accounts for approximately 90 percent of bladder cancers.2 Urothelial carcinoma becomes harder to treat as it advances, spreading through the layers of the bladder wall.3 Despite available therapies, more than 60,000 Europeans die from bladder cancer each year.1

Earlier this year, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for first-line maintenance treatment of patients with locally advanced or metastatic UC for Priority Review under the agency’s Real-Time Oncology Review (RTOR) pilot program. The FDA also granted Breakthrough Therapy Designation to BAVENCIO for this indication.

In addition, a supplemental new drug application has also been accepted by Japan’s Ministry of Health, Labour and Welfare for BAVENCIO as a first-line maintenance therapy for locally advanced or metastatic UC.

ABOUT JAVELIN BLADDER 100
JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. A total of 700 patients whose disease had not progressed after platinum-based induction chemotherapy as per RECIST v1.1 were randomly assigned to receive either BAVENCIO plus BSC or BSC alone. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay.

ABOUT BAVENCIO (AVELUMAB)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.4-6 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications in the US

BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.
BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.
Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade ≥3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.
BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACE occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, ≥ 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, ≥20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, ≥20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

On June 22, 2020 Shasqi, a leader in chemistry based locally-activated cancer drugs, reported data showing that the company’s lead candidate SQ3370 produced robust anti-tumor responses both at the target site and at distal lesions in a preclinical cancer model (Press release, Shasqi, JUN 22, 2020, View Source [SID1234561411]). The study, titled "SQ3370, a Local Activation Therapy of Cytotoxic Agents, Produces Sustained Responses in Target and Distal Lesions via Immune Activation," was presented in a poster with audio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II.

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!

Shasqi’s SQ3370 is a novel investigational drug product that uses bioorthogonal "click" chemistry reactions to capture and activate an attenuated anthracycline prodrug at the target tumor site enabling higher doses of the cancer drug while reducing side effects commonly experienced with conventional chemotherapy. Unlike other therapeutic approaches, Shasqi’s technology is solely based on chemistry and is independent of tumor biology such as biomarker expression and enzymatic activity.

This new therapeutic modality can precisely control the duration of exposure and magnitude of activated drugs at a specific area in the body. This allows the exploration of therapeutic benefits of a drug that had been previously limited by existing routes of administration in the clinic (oral, intravenous, direct injection or controlled release).

"SQ3370 is powered by an innovative chemistry based approach to precisely deliver high doses of a cancer drug locally and potentially activate the immune system against human tumors, independent of biological markers," said Carolyn R. Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University.

SQ3370 consists of two components – SQL70, a hyaluronic acid-based biomaterial and SQP33, a prodrug of Doxorubicin, a commonly used chemotherapy. During treatment, SQL70 biomaterial is first injected at the target tumor site. SQP33 prodrug is then given systemically through daily IV infusions for 5 days. SQP33 prodrug remains in attenuated form in the body until it reaches the target tumor site and is captured by SQL70. Once captured, SQP33 is converted and released as active Doxorubicin at the target tumor.

In the study, Shasqi’s scientists evaluated SQ3370 in a preclinical cancer model in mice bearing two tumors, where the target lesion was injected with the SQL70 biomaterial and the distal lesion was not.

Treatment with SQ3370 significantly prolonged overall survival by reducing target lesions compared to controls. Interestingly, SQ3370 also reduced tumor growth at the distal lesion, which was not injected with the SQL70 biomaterial. Together, this suggests SQ3370 can induce both local and systemic anti-tumor responses.

"Our data demonstrate that SQ3370 can significantly reduce tumor size in both, tumors injected with the biomaterial, and at distal lesions. The preclinical data suggests that our approach can be relevant against the critical challenges facing clinicians today: undetectable lesions or widely disseminated solid tumors," said Nathan Yee, Ph.D., Senior Scientist at Shasqi and an author of the study.

Immune biomarker analysis indicates that SQ3370 triggers an immune response as shown by an increase in cytotoxic and helper T cells, and a decrease in regulatory T cells in both target and distal lesions. To further validate the immune activating properties, combination treatment with SQ3370 and an immune-activating agent led to more robust and sustained anti-cancer responses than controls with conventional Doxorubicin.

Additionally, in a separate study in rats, SQ3370 reduced adverse exposure to heart, kidney and liver tissue compared to conventional Doxorubicin treatment, indicating lower off-target toxic effects.

"Because of its highly modular nature, we can use our platform on numerous cancer drugs with doses traditionally limited due to toxicity and uncover new pharmacological benefits," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "To evaluate the translation of our findings to humans, we are initiating our first clinical trial of SQ3370 as a monotherapy in advanced solid tumors, and expect to dose our first patient shortly."

The entire AACR (Free AACR Whitepaper) poster presentation plus an audio description of the data by Dr. Yee, can be found here. In addition, the abstract for the poster can be found here.

On June 22, 2020 Saniona (OMX: SANION), a clinical-stage biotech company focused on rare diseases, reported that it has raised SEK 22 million (USD 2.3 million) through the sale of shares in Scandion Oncology A/S (Spotlight Stock Market: SCOL) (Press release, Saniona, JUN 22, 2020, View Source(OMX%3A%20SANION)%2C,Spotlight%20Stock%20Market%3A%20SCOL).&text=The%20sale%20of%20shares%20brings,in%20Scandion%20Oncology%20below%2015%25. [SID1234561406]).

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!

Saniona sold 754,577 shares of Scandion Oncology. The sale of shares brings Saniona’s ownership stake in Scandion Oncology below 15%. Proceeds will be used to continue Saniona’s advancement of mid/late-stage clinical trials with Tesomet in two rare eating disorders: hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based leadership team in support of these programs.

"Saniona continues to tighten our focus on building a global, commercial-stage rare disease company, which will require significant capital investment over the next few years" said Rami Levin, CEO of Saniona. "The 2017 spin-out of our oncology assets into Scandion Oncology has resulted in a win-win situation, creating a highly successful cancer start-up in Scandion Oncology, while allowing Saniona to remain strategically focused on rare diseases, and providing funding for our rare disease programs."

Saniona is preparing to initiate two pivotal clinical trials over the next 12 months, one in hypothalamic obesity and the other in Prader Willi Syndrome. This follows the recent release of the positive top line data from its phase 2 trial in Hypothalamic obesity and the positive FDA interactions on Tesomet in Prader Willi Syndrome.