On November 11, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that two abstracts and posters have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) (Press release, Greenwich LifeSciences, NOV 11, 2021, View Source [SID1234595250]).

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!

SABCS 2021 will be held in a hybrid in-person and virtual format from December 7-10, 2021. SABCS anticipates publishing the two posters on the evening of December 8, 2021.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are thrilled to be presenting our 4th poster of our 5 year Phase IIb data at SABCS, completing a full year of publications. This data is a result of our ongoing data analysis and will speak to the mechanism of GP2 and the potential to use immune response data in novel ways. As a result of our previously published immune response data and this upcoming data, we plan to substantially improve the immune response technology and to increase the frequency of testing and sample collection in our Phase III trial. This data will be published on the 1 year anniversary of our initial poster at SABCS showing the 100% disease free survival or 0% metastatic breast cancer recurrence rate over 5 years of follow-up."

The second abstract and poster will present additional features of the Phase III clinical trial providing information to breast cancer clinicians who will be attending the in-person conference, visiting our poster session, and participating in our first Phase III trial investigator meeting where the global primary investigator and the Company will present the trial to participating clinicians.

About SABCS

The 44th annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. For more information, please visit the conference website at: View Source

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 11, 2021 Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, reported that preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Prokarium, NOV 11, 2021, View Source [SID1234595249]). The data presented in a scientific poster session establish the preclinical efficacy of their live-attenuated Salmonellaenterica Typhi strain ZH9 as a novel microbial immunotherapy in bladder cancer. Prokarium is advancing the program towards the initiation of a clinical trial based on these promising results.

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!

"Microbial immunotherapy, in the form of intravesical Bacillus Calmette-Guérin (BCG), has been the standard-of-care for non-muscle invasive bladder cancer for 30 years. With BCG therapy suffering product supply shortages and being associated with significant side-effects and high disease recurrence and progression rates, there is huge opportunity for innovation and for a new approach to treating this disease," said Livija Deban, PhD, Chief Scientific Officer of Prokarium. "Our data presented at SITC (Free SITC Whitepaper) demonstrates that our therapy has the potential to offer a significant benefit over the current standard-of care."

Therapeutic efficacy of intravesical Salmonella ZH9 was demonstrated in a stringent orthotopic bladder cancer model. Mice treated with a single intravesical dose of ZH9 four days after tumor challenge demonstrated significant survival benefit compared to both the control group and BCG-treated animals (median survival 30 vs. 20.5 (p=0.003) and 23.5 (p=0.025) days, respectively). Surviving ZH9-treated animals demonstrated 100% protection in a tumor rechallenge model, suggesting lasting anti-tumor immunity resulting from ZH9 treatment. Importantly, a single treatment with intravesical ZH9 resulted in a strong local immune response characterized by recruitment of NK cells, CD4+ and CD8+ T cells, and dendritic cells with an activated, cross-presenting (Ly6C+, CD103+) phenotype. In addition, the efficacy of intravesical ZH9 is further increased by a systemic priming dose of Salmonella, which recruits immune cells within the bladder prior to the intravesical dose, enhancing subsequent anti-tumor responses.

Presentation Details:

Title: Novel microbial immunotherapy approach for the treatment of bladder cancer

Poster Number: 878

Presenter: Livija Deban, PhD, Chief Scientific Officer, Prokarium

Date/Time: Saturday, November 13, 2021

Full text of the abstracts was released on the SITC (Free SITC Whitepaper) website at 7:00 a.m. ET on November 9, 2021.

About NMIBC

Bladder cancer represents 5% of all new cancer cases in the US and accounts for 550,000 new cases yearly worldwide. The clinical staging is determined by the depth of invasion into the bladder wall and more than 70% of cases are diagnosed at an early stage, also known as Non-Muscle Invasive Bladder Cancer (NMIBC). Despite the early diagnosis, the only approved therapies are Bacillus Calmette–Guérin (BCG) and chemotherapy. Bladder cancer has the highest recurrence rate of any known cancers (up to 80%), which makes it one of the most expensive cancers to treat, and patients ultimately require surgical bladder removal (cystectomy), associated with increased morbidity/reduced quality of life.

On November 11, 2021 Oasmia Pharmaceutical reported that it will publish its Q3 2021 report on November 18, 2021, at 08.00 am CET (Press release, Oasmia, NOV 11, 2021, View Source [SID1234595248]).

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 company will hold a conference call and an online presentation on the same day at 10.00 am CET. The call will be hosted by CEO Francois Martelet and CFO Fredrik Järrsten. The presentation will be in English.
The conference call will be broadcast live on the web via the link:
View Source

On November 11, 2021 Notable Labs, Inc. (Notable), a pioneer and developer of predictive precision medicines, reported that it has obtained worldwide rights to volasertib from Oncoheroes Biosciences Inc., a Boston-based biotechnology company focused on advancing new therapies for childhood cancer (Press release, Notable Labs, NOV 11, 2021, View Source [SID1234595246]). Volasertib is a Polo-like kinase 1 (PLK-1) inhibitor with demonstrated activity in acute myeloid leukemia (AML) and other tumor types with significant unmet medical need.

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!

Notable will leverage its high-fidelity Predictive Precision Medicines Platform to identify and select volasertib-responsive patients prior to their treatment and fast-track volasertib’s clinical development in this patient population.

Notable’s proprietary platform was built upon deep expertise across therapeutics, diagnostics, software, engineering, machine learning and automation. It quickly determines the response profile of individual patients prior to their cancer treatment, allowing for selective enrollment of predicted clinical responders into clinical trials.

"Volasertib represents an exciting milestone towards fulfilling Notable’s mission to deliver life-changing therapies precisely to those who will benefit, and leads the way in a new era of predictive precision medicine," said Thomas Bock, M.D., Chief Executive Officer of Notable. "We targeted and licensed volasertib because of its compelling performance on our Predictive Precision Medicine Platform and as an important addition to our growing clinical pipeline. We plan to fast-track volasertib’s development with phase 2/3 clinical trials in AML and other cancers, selectively enrolling patients who are predicted to respond."

Dr. Bock added, "With the power of our high-fidelity prediction platform, volasertib represents just one of many compelling opportunities to match highly promising clinical candidates with the optimal patient population. We established our platform across a broad spectrum of drug classes and cancers, and are continuing to expand its capabilities across hematology and oncology. We are actively seeking in-licensing and partnership opportunities for those clinical-stage therapies that pass our platform’s rigorous demands. We are thrilled to be at the forefront in the field of predictive precision medicines and advance with the sense of urgency that patients with life-threatening conditions deserve."

License Agreement
Under terms of the agreement, Notable will have exclusive rights to develop and commercialize volasertib in leukemias, lymphomas and other adult cancer indications. Oncoheroes will retain the license for development and commercialization of volasertib in pediatric indications. Financial terms of this deal are not disclosed.

About Volasertib
Volasertib is an inhibitor of Polo-like-kinase 1 (PLK-1), an enzyme known to be involved in disease progression in a number of cancers. The compound was originally discovered and developed by Boehringer Ingelheim for the treatment of acute myeloid leukemia. Oncoheroes in-licensed volasertib from Boehringer Ingelheim and is developing volasertib for the treatment of rhabdomyosarcoma (RMS), the most common soft tissue sarcoma in children and young adults. Volasertib was previously granted Orphan Drug Designation (ODD) for its use in treating pediatric rhabdomyosarcoma and other rare soft tissue sarcomas and received Rare Pediatric Disease Designation in 2020, by the U.S. Food and Drug Administration (FDA).

On November 11, 2021 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) has granted rivoceranib with orphan drug designation for the treatment of hepatocellular carcinoma (HCC) (Press release, Elevar Therapeutics, NOV 11, 2021, View Source [SID1234595245]). HCC is the most common primary liver malignancy and is a leading cause of cancer-related death worldwide.

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 orphan drug designation granted by the FDA recognizes the potential of rivoceranib to address the urgent unmet need for new therapies that can improve patient outcomes for people with HCC," said Kate McKinley, Chief Executive Officer of Elevar Therapeutics. "The medical community is eager to see the results of clinical trials exploring new combination regimens in HCC and we look forward to rapidly advancing our clinical trial of rivoceranib and camrelizumab, an investigational PD-L1 inhibitor. This Phase 3 trial is being conducted in collaboration with Jiangsu Hengrui Medicine Company, Ltd., in patients with advanced HCC who have not received prior systemic therapy. In addition to our HCC program, we are committed to accelerating the clinical development for rivoceranib as a potential therapy for the treatment of gastric cancer, adenoid cystic carcinoma, and colorectal cancer."

HCC is a highly lethal form of liver cancer with limited treatment options, which is primarily caused by chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), nonalcoholic steatohepatitis (NASH), and excessive alcohol consumption.

"Unfortunately, HCC is often diagnosed at later stages of disease and there are limited treatment options currently available," said Maureen G. Conlan, M.D., F.A.C.P., Chief Medical Officer of Elevar Therapeutics. "We are encouraged by the progress that we are making in our Phase 3 clinical trial and believe that the combination of rivoceranib and camrelizumab, if approved, will offer an important new therapeutic option for clinicians and patients."

The FDA’s Office of Orphan Drug Products grants orphan status to medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user filing fees and potential eligibility for seven years of marketing exclusivity post-approval.

About Rivoceranib (apatinib)
Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer, under the name apatinib, in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Apatinib has been studied in over 1,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy.

Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma, and colorectal cancer (combination with Lonsurf). Orphan Drug designations have been granted in gastric cancer (U.S., EU, and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar Therapeutics holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd under the brand name Aitan.