1stOncology™: Cancer Intelligence Service – Page 10528 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Anixa Biosciences and Cleveland Clinic Announce FDA Clearance to Initiate Clinical Trial of Breast Cancer Vaccine

On December 21, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its breast cancer vaccine (Press release, Anixa Biosciences, DEC 21, 2020, View Source [SID1234573162]).

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!

This breast cancer vaccine technology was invented and developed by Cleveland Clinic immunologist Dr. Vincent Tuohy, and his research team.
Oncologist, Dr. Thomas Budd, also of Cleveland Clinic, will lead the clinical trial.
Anixa Biosciences has an exclusive worldwide license to the technology.
The technology immunizes against a protein called alpha-lactalbumin that is expressed in the mammary glands of women, only during the latter part of gestation and during lactation. After lactation ceases, this protein is no longer expressed until a woman develops breast cancer. In a vaccinated woman, the researchers anticipate that these cancer cells will be destroyed by the immune system before they have the opportunity to grow into a mature cancer.
The initial focus is Triple Negative Beast Cancer, but this technology is expected to potentially prevent other types of breast cancer.
Animal studies showed notable ability to prevent breast cancer.
The preclinical studies and two trials of this vaccine are being funded by the U.S. Department of Defense.
Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer. This approval triggers a cascade of events and activities, that will eventually lead to recruitment of patients and initiation of the trial."

"This is a significant milestone for our program. Our vision has always been to prevent cancer before it arises," said Dr. Tuohy. "We are looking forward to beginning clinical trials in patients."

SELLAS Announces Promising Initial Clinical Data for Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors in Two Solid Tumor Indications

On December 21, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported initial data from two clinical studies of galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with checkpoint inhibitor therapies in patients with two different types of advanced solid cancers who had exhausted their standard therapy options (Press release, Sellas Life Sciences, DEC 21, 2020, View Source [SID1234573161]).

In the first study, a phase 1/2 ‘basket’ trial of GPS in combination with the checkpoint inhibitor pembrolizumab (Keytruda), which is conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), the first set of evaluable patients (n = 8) diagnosed with 2nd or 3rd line WT1(+) relapsed or refractory metastatic ovarian cancer demonstrated a disease control rate (the sum of overall response rate and rate of stable disease) of 87.5% with a median follow-up of 9.4 weeks. In this difficult to treat patient population, at the first assessment time-point of 6 weeks post-therapy initiation, 100% of the patients were free of disease progression. Using a validated immunohistochemistry (IHC) assay during the screening period, the rate of WT1 positivity in this ovarian cancer patient population was approximately 70%. Six of the eight evaluable patients are continuing to receive GPS plus pembrolizumab. Enrollment is continuing with a target of a total of 20 patients. More mature clinical and immunobiological data are expected to be announced by the end of the second quarter of 2021.

In the second study, a Phase 1 investigator-sponsored clinical trial (IST) of GPS in combination with the checkpoint inhibitor nivolumab (Opdivo) in patients with macroscopic measurable deposits of malignant pleural mesothelioma (MPM) who were either refractory to or relapsed after frontline tri-modality standard therapy, the first set of evaluable patients (n = 3) had a median progression free survival of at least 10 weeks since therapy initiation. In primary refractory MPM patients, any prolongation of progression-free interval greater than 8 weeks would be considered clinically meaningful, considering the current lack of effective therapies. All patients had the epithelioid variant of MPM, a tumor which is universally expressing WT1. Moreover, in this study, GPS was found to be appropriately immunogenic, leading to the emergence of antigen (WT1)-specific CD4+ T-memory cell responses at 3 months post-therapy initiation. Additional MPM patients are currently being enrolled; completion of study enrollment (target total n = 10) and more mature clinical and immunobiological data are expected by the end of the second quarter of 2021.

In both studies, the safety profile of the combination of GPS with the checkpoint inhibitor was similar to that seen with checkpoint inhibitors alone, with the addition of only low grade, transitory local reactions at the site of injection of GPS, consistent with previously performed clinical studies of GPS.

"These early data confirm the tolerability profile seen in earlier studies of GPS, which is one of the primary endpoints in these solid cancer trials, in a variety of cancer indications, even in the most refractory patients who underwent numerous prior therapies," commented Jeffrey S. Weber, MD, PhD, Deputy Director of the Perlmutter Cancer Center at New York University (NYU)-Langone Health, co-Director of its Melanoma Research Program Center and Chair of SELLAS’ Scientific Advisory Board. "These safety findings are accompanied by promising early indications of an efficacy signal for patients with advanced metastatic disease, whose management is extremely challenging even with checkpoint inhibitor monotherapy."

"We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies," stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. "We now have early evidence that supports further expanding the field of potential GPS indications into solid cancers with high rates of WT1 positivity. GPS has previously been shown to invoke multi-epitope, broad cross-reactivity along the full-length of the WT1 protein, suggestive of epitope spreading, and immunologically mediated cancer cell destruction, which are hallmarks of an effective cancer vaccine. The scientific rationale in combining GPS with checkpoint inhibitors is the immunbiologic and pharmacodynamic synergy between the two agents, whereby the negative influence of the tumor microenvironment is mitigated by checkpoint inhibitors and thus allowing the patients’ own immune cells specifically sensitized against WT1, by GPS, to invade and destroy cancerous cells."

About the Phase 1/2 Basket Study of GPS in Combination with Pembrolizumab (Keytruda) in Patients with Selected WT1-Positive Advanced Cancers, Including Ovarian Cancer

This is a Phase 1/2 open-label, multicenter, multi-arm study conducted under a Clinical Trial Collaboration and Supply Agreement (CTSA) with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada) to assess the efficacy and safety of the combination of GPS and pembrolizumab (Keytruda) (ClinicalTrials.gov identifier: NCT03761914). The primary endpoints of the study include safety and overall response rate, while secondary endpoints include progression-free survival, overall survival and immune response correlates. The study will enroll approximately 90 patients at up to 20 centers in the United States. The trial is currently evaluating patients with ovarian cancer (second or third line).

About the Phase 1 Trial of GPS in Combination with Nivolumab (Opdivo) in Patients with Malignant Pleural Mesothelioma (MPM)

This is a Phase 1 open-label clinical study conducted by Memorial Sloan Kettering Cancer Center (MSK) and is enrolling patients with MPM who harbor relapsed or refractory disease after having received frontline, standard-of-care multimodality therapy (target total n = 10; ClinicalTrials.gov identifier: NCT04040231). The principal investigator for the study is Marjorie G. Zauderer, MD, Co-Director, Mesothelioma Program and Associate Attending Physician in the Thoracic Oncology Service, Department of Medicine at MSK. The trial is investigating the potential of GPS in combination with nivolumab (Opdivo) to demonstrate anti-tumor immune responses and meaningful clinical activity in the presence of macroscopic advanced disease in MPM patients and gauging the degree of clinical benefit by assessment of the overall response rate with the combination in comparison with that reported with nivolumab alone in historical comparable patient populations.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products. Opdivo is a registered trademark of Bristol Myers Squibb, and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

Propanc Biopharma Receives First Granted Patent for Method to Treat Cancer Stem Cells from Australian Patent Office

On December 21, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the first granted patent for an important patent family (i.e., a set of patents filed in various countries to protect an invention) was received by the Company from the Australian Patent Office (Press release, Propanc, DEC 21, 2020, View Source [SID1234573160]). The granted patent protects proprietary claims, capturing methods and uses for pancreatic proenzymes to treat cancer, specifically, by targeting and eradicating cancer stem cells ("CSCs"). CSCs represent only a small fraction of the cancer cells within a tumor and can remain dormant for extended periods of time, thereby evading standard treatments like chemotherapy and radiotherapy that target dividing cells. Consequently, a priority for improving cancer treatment and reducing risk of cancer relapse is to develop new strategies that selectively target CSC eradication whilst sparing normal stem cells. This continues to be the focus of ongoing research, as the Company’s lead product candidate, PRP, advances towards clinical trials for the treatment of patients with advanced solid tumors.

The granted patent, citing the novel CSC treatment method, is one of our four patent families, consisting of 65 patents either in force, or pending, and is the first to be granted covering a method of minimizing the progression of cancer in a patient by administering a therapeutically effective amount of the two proenzymes, trypsinogen and chymotrypsinogen, thereby preventing metastatic, or spreading cancer in the patient. As a result, examination of patent applications in a number of other jurisdictions can be expedited where the Australian claims will be utilized for supplementary examination.

"The advancement of this patent to grant status in Australia is a significant step forward for our intellectual property portfolio and represents a novel therapeutic approach for the treatment and prevention of metastatic cancer by targeting and eradicating cancer stem cells, which is the main cause of death for sufferers," said James Nathanielsz, Propanc’s Chief Executive Officer. "It is especially important to continue to expand and grow our intellectual property portfolio as we advance PRP to clinical trials."

"Our main point of difference from other CSC therapies is the ability of our technology to differentiate cancer stem cells back towards normal cell behavior, so they die naturally, rather than directly killing CSCs. This way, we selectively target CSCs, leaving healthy stem cells alone, which means PRP is less toxic compared to standard treatment approaches," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "Expanding our intellectual property portfolio by patenting new inventions using a world first, novel proenzyme treatment approach to target CSCs builds confidence that we are on track with our research."

Onconova Therapeutics Announces FDA Permission for Study to Proceed Under its Investigational New Drug Application for Multi-kinase CDK4/6 Inhibitor ON 123300

On December 21, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported receipt of U.S. Food and Drug Administration (FDA) permission for a Phase 1 study to proceed under the Company’s Investigational New Drug application (IND) for ON 123300, a proprietary, differentiated, first-in-class multi-kinase inhibitor (Press release, Onconova, DEC 21, 2020, View Source [SID1234573159]).

"We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We are advancing the process to secure Institutional Review Board approval, and affirm our expectation that the first patient will be enrolled during the first half of 2021."

The Phase 1 trial will be conducted in the U.S. and will assess the safety, tolerability and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily or higher for consecutive 28-day cycles. The trial will enroll patients with relapsed/refractory advanced cancer, including but not limited to patients with HR+ HER2- metastatic breast cancer with clinical resistance to approved second-generation CDK4/6 inhibitors. Once the dose escalation phase of the trial is completed and the recommended Phase 2 dose is established, additional HR+ HER2- postmenopausal metastatic breast cancer patients resistant to approved second-generation CDK4/6 inhibitors will be enrolled. Additional patient cohorts are under consideration, including but not limited to patients diagnosed with advanced colorectal cancer, and non-Hodgkin’s lymphoma, in particular mantle cell lymphoma.

The design of this U.S. Phase 1 trial differs from the ongoing study with ON 123300 in China conducted by the Company’s partner HanX Biopharmaceuticals, Inc., which is dosing patients daily for 21 days. The HanX trial has enrolled four patients to date, has opened the second dosing cohort and is expected to continue enrolling patients with advanced cancer at two sites until the recommended Phase 2 dose is identified. Notably, of the three currently approved CDK4/6 inhibitors, two are approved for dosing in 21-day cycles and one is approved for dosing in a 28-day cycle. All three are blockbuster drugs marketed in HR+ HER2– metastatic breast cancer by well-known pharmaceutical companies, and all of these approved therapies require concomitant treatment with an aromatase inhibitor.

"Based on its differentiated mechanism of action, we believe that ON 123300 presents an innovative approach to study advanced cancers including in HR+ HER2- metastatic breast cancer that is or has become resistant to commercial CDK4/6 inhibitors. Beyond metastatic breast cancer, we believe that ON 123300 may present a novel approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer and hepatocellular carcinoma, as well as inoperable glioblastoma based on preclinical studies suggesting ON 123300 crosses the blood-brain barrier," added Richard Woodman, M.D, Chief Medical Officer.

About ON 123300

Onconova’s lead pipeline compound is the novel small molecule ON 123300, a proprietary, first-in-class multi-kinase inhibitor targeting tumor-driving kinases including CDK4/6 and ARK5. ON 123300 is reported to simultaneously inhibit both cell cycle and cellular energy metabolism through CDK4/6 and ARK5, respectively, and in vitro has been shown to be cytotoxic to cancer cells (killing the cancer cells). The current commercial CDK inhibitors are reported to be cytostatic (inhibiting the growth of cancer cells). With its differentiated mechanism of action, ON 123300 may present an innovative approach for treating solid tumors and hematologic malignancies that are refractory to or have become resistant to other CDK4/6 inhibitors. Based on experiments in preclinical models, ON 123300 exhibits single-agent cytotoxicity, and may have utility for certain types of cancers including breast cancer, non-Hodgkin’s lymphoma including mantle cell lymphoma, multiple myeloma, colorectal cancer, hepatocellular carcinoma, and inoperable glioblastoma.

Equillium Appoints Industry Veteran, Dolca Thomas, M.D. as Executive Vice President of
Research & Development and Chief Medical Officer

On December 21, 2020 Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported the appointment of Dolca Thomas, M.D., as its executive vice president of research and development and chief medical officer (Press release, Equillium, DEC 21, 2020, View Source [SID1234573158]). Dr. Thomas joins Equillium from Principia Biopharma (recently acquired by Sanofi) where she was chief medical officer focused on developing treatments for immune-mediated diseases.

"Equillium has made tremendous progress in 2020 and is now at a critical juncture as we begin to strategically outline more advanced development of itolizumab," said Bruce Steel, chief executive officer at Equillium. "Dolca’s significant track record of success and broad experience in executing late-stage programs, specifically in immunology, comes to Equillium at an important time. With several key readouts expected over the next twelve months, as well as interactions with the U.S. Food and Drug Administration that will help guide the future of our lead program in acute graft versus host disease, her expertise will come to bear immediately. I’d also like to take this opportunity to thank Dr. Krishna Polu, our departing chief medical officer, who contributed significantly to advancing our clinical programs and building our experienced research and development team; we wish Krishna well as he transitions to a new role in venture capital."

"I’m thrilled to join Equillium at such an exciting time and to advance the development of itolizumab, a highly novel drug targeting the CD6-ALCAM co-stimulatory signaling pathway. Modulating this biology may potentially have therapeutic effect in a number of immuno-inflammatory diseases beyond the current pipeline," said Dr. Thomas. "I look forward to guiding itolizumab’s path to registration in acute graft versus host disease, leading our clinical research efforts in lupus/lupus nephritis and uncontrolled asthma, and building a pipeline where we can have the most profound effect on the lives of patients."

Dr. Thomas brings almost two decades of industry and medical experience with strategic and operational responsibility for clinical development, pharmacovigilance, safety and medical affairs of approximately two dozen pharmaceutical product candidates. Prior to her position as chief medical officer at Principia, Dr. Thomas was vice president and global head of translational medicine for immunology, inflammation, and infectious disease at Roche, where she was responsible for advancing multiple product candidates through clinical development. Prior to Roche, Dr. Thomas held roles of increasing responsibility at Pfizer, including vice president of clinical development and clinical immunophenotyping, and vice president and chief development officer of the biosimilars research and development unit where she was responsible for all stages of development of multiple assets. Dr. Thomas began her industry career at Bristol-Myers Squibb as director of global clinical development in immunology, where she was involved in the development and approval of belatacept, a novel therapeutic targeting the co-stimulatory pathway CD28.

Dr. Thomas received her medical degree from Cornell University and completed her residency in internal medicine, in addition to her post-doctoral training in nephrology and transplantation, at New York-Presbyterian Hospital, Weill Cornell Medical Center.

"Supporting the momentum we have achieved, we are continuing to build the company," continued Mr. Steel. "I am pleased to announce that we have recently added Michael Son, Ph.D., as vice president of regulatory affairs, Nelson Lugo as vice president of manufacturing, and Michael Moore as vice president of investor relations and corporate communications. Their leadership has already begun to pay dividends and we look forward to their continued support as we rapidly transition to later-stage clinical development."

Dr. Son joins Equillium from Allergan where he served as global regulatory affairs lead. At Equillium, Dr. Son will be responsible for a global regulatory strategy and execution across Equillium’s development programs to support regulatory approvals.

Mr. Lugo previously directed technical services and commercial contract manufacturing operations for U.S. and international drug substance and drug product process operations at AstraZeneca, and was vice president of manufacturing at Nielsen Biosciences. At Equillium, Mr. Lugo will oversee the CMC (chemistry manufacturing and controls), clinical production and commercial manufacturing operations.

Mr. Moore comes to Equillium with over 20 years of experience in investor relations and corporate communications, representing all niches of life sciences, at every stage of development. At Equillium, Mr. Moore will be responsible for leading the company’s communications strategy, corporate messaging and ongoing external communications with the financial community and other stakeholders.