On December 7, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the first patient was enrolled in an expansion arm of the GLORIA clinical trial of NOX-A12 in MGMT unmethylated brain cancer (glioblastoma, GBM) (Press release, NOXXON, DEC 7, 2021, View Source [SID1234596561]). The patient has received their first week of treatment of NOX-A12 (600 mg/week) and the VEGF inhibitor bevacizumab combined with radiotherapy.

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The GLORIA Phase 1/2 clinical trial evaluates the safety and efficacy of NOX-A12 combined with radiotherapy. In three expansion arms, the synergistic benefit of NOX-A12 with other therapeutic settings will be evaluated:

Arm A: NOX-A12 with radiotherapy in patients with complete tumor resection
Arm B: NOX-A12 with radiotherapy and bevacizumab in patients with incomplete tumor resection
Arm C: NOX-A12 with radiotherapy and anti-PD-1 in patients with incomplete tumor resection.

Each expansion arm plans to evaluate 6 patients.

Aram Mangasarian, CEO of NOXXON, commented: "After the compelling results seen with NOX-A12 in glioblastoma patients in the GLORIA trial when combined only with radiotherapy, we are excited to move forward and explore additional treatment combinations that will potentially bring further benefits to these very difficult to treat patients. At this point, we are planning to prioritize recruitment to the bevacizumab and pembrolizumab arms and look forward to seeing the results."

Expansion arms A and B have already been approved by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte), while the third arm is still under review. The expansion arms aim at providing additional clinical data to support the design of the planned pivotal trial and discussions with the regulatory agencies.

On December 7, 2021 Privo Technologies, Inc. ("Privo"), a clinical-stage biopharmaceutical company focused on optimizing state-of-the-art chemotherapies to be "Tough on cancer, Easy on patients", reported that senior management will be virtually attending BIO Partnering at JPM from January 10 to January 14, 2022 (Press release, Privo Technologies, DEC 7, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-to-attend-2022-bio-partnering-at-jpm [SID1234596546]). Those looking to meet with Privo can schedule a 1×1 meeting through the BIO One-on-One Partnering portal.

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On December 7, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the expansion of Dr. F. Joseph Daugherty’s role to include the critical responsibility of Medical Monitor of the Phase III clinical trial and a long-term agreement to serve as Chief Medical Officer (Press release, Greenwich LifeSciences, DEC 7, 2021, View Source [SID1234596563]).

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Dr. Daugherty commented, "I look forward to supporting the GLSI-100 clinical trials as Medical Monitor. While GP2 has been shown to be both effective and safe in the Phase IIb trial, we will maintain our vigilance in the larger Phase III trial. The mild local and systemic reactions observed in the Phase IIb trial have served to further validate the immune response and mechanism of action of GP2, thus requiring the balancing of dosing to ensure that local and systemic reactions are tolerable and safe, yet still sufficiently robust enough to lead to the prevention of metastatic breast cancer recurrence."

CEO Snehal Patel added, "We are very excited that Dr. Daugherty is expanding his role with a very significant commitment to serve as medical monitor of our upcoming and future clinical trials as we seek to expand GP2’s potential to all HER2 positive breast cancer patients and to explore HER2 low breast cancer and other HER2 expressing cancers. While we have not seen any serious adverse events in the 138 patients we have treated to date across four clinical trials attributable to GP2 immunotherapy, Dr. Daugherty’s responsibility to oversee the safety of our Phase III trial will be a key component of our regulatory strategy in this potential single registration trial."

Dr. Daugherty has over 40 years of experience in managing and overseeing biotechnology and biomedical projects. He served first as President and recently as Chief Executive Officer, Chief Medical Officer, and the Chairman of the board of directors of Eleos, Inc., a clinical-stage, private biotech company focused on anti-sense technology in hematologic cancers. In addition to being an officer and director, Dr. Daugherty has served in various other capacities, including as a management consultant to over 20 public and private biomedical companies including Dupont, Inc, and as President of ConAgra’s biotech division. He received a BA in Biology from Washington University, a MD from the University of Nebraska, and a MS in Industrial Administration from Carnegie Mellon University.

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 December 6, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered eribulin mesylate (product name: Halaven, halichondrin class microtubule dynamics inhibitor, "eribulin"), MORAb-202, an antibody drug conjugate (ADC), and H3B-6545 (selective estrogen alpha receptor covalent antagonist), discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be given at the 44th San Antonio Breast Cancer Symposium (SABCS2021) to be held, partly virtual, from December 7 to 10, 2021, in San Antonio, Texas in the United States (Press release, Eisai, DEC 6, 2021, View Source [SID1234596453]).

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At this symposium, regarding eribulin, the result of non-clinical studies on its effects to subsequent chemotherapy through the induction of epithelial-mesenchymal transition (Abstract No: P3-06-01) is scheduled to be presented.

MORAb-202 is Eisai’s first ADC and combines Eisai’s in-house developed anti-folate receptor alpha (FR) antibody, to Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. At this symposium, regarding MORAb-202, the experimental results of antitumor efficacy in Patient-Derived Xenograft models of triple-negative breast cancer (Abstract No: P5-08-02) is scheduled to be presented. In June 2021, Eisai and Bristol-Myers Squibb Company (Headquarters: the United States) entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202.

In addition, regarding H3B-6545, the results of Phase II clinical study evaluating monotherapy (Abstract No: P1-17-10) and Phase 1b study evaluating the combination therapy with palbociclib (Abstract No: P1-17-03) in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer will be presented.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is aspiring to making further contribution to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers through creating innovative new drugs based on cutting-edge cancer research.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval. No.21-96 December 6, 2021 Eisai Co., Ltd.

Major poster presentations at SABCS2021:

Product / Compound Abstract No. Title / Scheduled Date and Time (local time: Central Standard Time) Eribulin P3-06-01 Eribulin alters the chromatin landscape to induce MET, attenuating metastatic progression and sensitizing breast tumors to subsequent chemotherapy December 9 (Thu), 7:00AM-8:30AM MORAb-202 P5-08-02 MORAb-202, an Antibody-drug-conjugate (ADC) targeting Folate Receptor Alpha (FRα), exhibits durable anti-tumor efficacy in PDx models of TNBC December 10 (Fri), 7:00AM-8:30AM H3B-6545 P1-17-10 H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer – A Phase II study December 8 (Wed), 7:00AM-8:30AM H3B-6545 P1-17-03 H3B-6545 in combination with palbociclib in women with metastatic estrogen receptor–positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer, Phase 1b study December 8 (Wed), 7:00AM-8:30AM Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors]

1. Eisai’s Focus on Cancer Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

On December 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that it will host an investor event on updated data from the ongoing MARIO-3 clinical study during the San Antonio Breast Cancer Symposium (SABCS 2021) on Friday, December 10th at 9:30 am ET (Press release, Infinity Pharmaceuticals, DEC 6, 2021, View Source [SID1234596477]).

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The webinar will feature a presentation from Key Opinion Leader (KOL) Hatem Soliman, MD, MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center.

Dr Soliman will discuss the evolving treatment landscape in TNBC and the significant unmet medical need that remains for patients with frontline, metastatic TNBC.
Importantly, Dr Soliman will review the MARIO-3 study design and summarize patient demographics and baseline characteristics as well as the updated safety and efficacy data from the MARIO-3 study.
Infinity’s Chief Medical Officer, Dr. Robert Ilaria, will review of eganelisib’s mechanism of action and translational data from the MARIO-3 study.

A Q&A session will follow the formal presentations. To register for the webinar please click here.

Hatem Soliman, MD is one of the leading breast cancer physicians in the country and an investigator on the MARIO-3 study. Dr. Soliman serves as the Medical Director of the Clinical Trials Office at the Moffitt Cancer Center, with extensive experience as a clinical investigator conducting both translational research in breast cancer immunotherapy and leading numerous clinical trials as principal investigator since joining the faculty at Moffitt in 2008. He also serves as the Course Director for the fellowship clinical research rotation, medical director of the phase 1 program, chair of Moffitt’s clinical research leadership council, chair of clinical research feasibility committee, and principal investigator for Moffitt’s CPDM CCSG application, which was recently rated as outstanding and awarded funding for an additional five years.

Dr. Soliman received his BS in Genetics from the University of Georgia Athens in 1996 and then went on to receive his medical degree from the Medical College of Georgia in 2002. His residency and fellowship training in oncology/hematology was completed through the University of South Florida/Moffitt Cancer Center program in 2008. During fellowship, he authored investigator initiated early phase trials with mentorship from Dr. Daniel Sullivan, former ACD and EVP of Moffitt, in collaboration with the NCI CTEP RAID program investigators Drs. Jaime Zwiebel and Howard Streicher. Upon graduation, Dr. Soliman was offered an assistant member position at Moffitt as a clinical investigator to continue early drug development and translational research activities.