On May 24, 2022 Shasqi, a clinical-stage biotechnology company developing click chemistry-activated oncology therapeutics, reported the additions of Steve Abella, M.D., as Chief Medical Officer and Scott Wieland, Ph.D., MBA, as Senior Vice President of Clinical Development (Press release, Shasqi, MAY 24, 2022, View Source [SID1234615000]).

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"To maximize the potential of our novel, click chemistry-based platform and continue expanding our portfolio of programs, clinical experience and leadership are critical," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "As we reach the end of dose escalation of SQ3370, we will initiate Phase 2 studies in advanced sarcomas and other solid tumors. In addition, we are rapidly advancing our second program toward the clinic, which activates high doses of monomethyl auristatin E, a commonly used antibody-drug conjugate payload, at the tumor. Now is the perfect time to add the deep expertise in clinical strategy and execution that both Steve and Scott bring to the team. We look forward to their contributions and working with them."

"Shasqi has made tremendous progress advancing SQ3370 into and through the clinic and building a robust pipeline of click chemistry-activated therapeutics to harness potent payloads and target them precisely to the tumor," said Dr. Abella. "I’m excited to join the company’s mission and help expand the reach of their platform."

"A click chemistry-based approach has enormous potential to dramatically improve the efficacy of powerful therapies that can be localized at the tumor site using a variety of delivery methods such as direct injection or biomarker targeting," said Dr. Wieland. "I look forward to seeing where we can take this technology and what the next iterations of Shasqi’s approach can achieve in improving the cancer therapeutic landscape and the lives of patients."

Dr. Steve Abella

Dr. Abella has been working in oncology clinical research for nearly 35 years, including more than 12 years in the pharmaceutical industry. Before joining Shasqi, he served as Chief Medical Officer at Vida Development Sciences. Prior to Vida, Steve served as Chief Medical Officer at BioClin Therapeutics. Prior to that, he served as Senior Director at Gilead Sciences where he led the non-Hodgkin’s lymphoma and leukemia drug development efforts and served as a core member of the oncology senior leadership team. Prior to Gilead, he served as Executive Director at Amgen, predominately responsible for the white cell franchise (Neulasta/Nepogen) and led global development efforts across clinical research and medical affairs. Before he joined the biopharmaceutical industry, he spent 15 years in academic oncology, serving as a Professor of Pediatric, Oncology, and Medicine at the Barbara Ann Karmanos Cancer Institute where he focused on stem cell transplantation and oncology clinical trials. Steve completed his fellowship and residency training at Wayne State University School of Medicine after graduating with a degree in medicine from the Universidad Central del Este. He attended the University of Pennsylvania for undergraduate studies.

Dr. Scott Wieland

Dr. Wieland is a biopharmaceutical veteran with over 30 years of experience in the biopharmaceutical industry. Over the course of his career, Scott has served in a variety of roles and responsibilities, most recently as Executive Vice President of Development at Nanobiotix, a nanomedicine company based in Paris, France. Scott started his career leading the Behavioral Pharmacology lab at CoCensys, then moved into a variety of positions across several small biopharmaceutical companies. Scott has been responsible for drug discovery, safety pharmacology, toxicology, bioanalytical development, manufacturing, formulation, clinical supply and distribution, regulatory affairs, and all aspects of clinical trials and development during his career. Scott received a bachelor’s degree in Physiological Psychology from UC Santa Barbara, CA. He received his master’s and Ph.D. in Psychology/Biopsychology with a minor in Neuropharmacology from the University of Arizona, Tucson, AZ, and an MBA in Management from Webster University, St. Louis, MO.

About CAPACTM and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the tumor site. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing therapeutics across various modalities with a limited therapeutic window.

On May 24, 2022 PeLeMed reported that it will present the preclinical study results of the FLT3/RET dual inhibitor candidate ‘PLM-102’ at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 (ASCO 2022) (Press release, PeLeMed, MAY 24, 2022, View Source [SID1234615603]).

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PLM-102, a target anticancer drug candidate of Pelemed, targets even FLT3-resistant mutations (D835Y, F691L) that develop resistance after treatment with existing drugs such as ‘Xospata, gilteritinib’, an FLT3 inhibitor for the treatment of acute myeloid leukemia (AML). do. Pelemed is aiming to submit an IND to the Korean and US Food and Drug Administration (FDA) next year.

At this ASCO (Free ASCO Whitepaper), Pelemed will present △in vitro biochemical, cellular △ in vitro efficacy, △mode of action, etc. of PLM-102 along with the existing drug Zosphata. .

Specifically, PLM-102 showed an excellent Kd value for binding even at a lower dose compared to the FLT3/AXL inhibitor Zosphata in the binding affinity test. The Kd value of PLM-102 was 0.019 nM (vs 1.4 nM) for normal FLT3 and 0.01 to 1.1 nM (vs 0.16 to 19 nM) for TKD mutant, which showed a lower Kd value than that of Zosphata.

Pelemed’s PLM-102 resulted in effective cell growth inhibition at a lower dose than Zosphata in acute myeloid leukemia cell lines (MV4-11, MOLM-13, MOLM-14) and Ba/F3 cell lines with FLT3 mutations. showed

A tumor mouse model administered with a dose of 5 mg/kg or more of PLM-102 showed complete remission with tumor growth inhibition when administered orally once a day. In addition, Pelemed explained that the anticancer effect was also confirmed in drug-resistant double mutation models (ITD/F691L, ITD/D835Y) administered with PLM-102.

Pelemed confirmed the RET inhibitory effect of PLM-102 and the decomposition effect of RET and FLT3 proteins. This proteolysis phenomenon did not appear in Zosphata and another approved RET inhibitor, Roche’s ‘Gavreto, pralsetinib’, indicating a differentiated mechanism of RLM-102, the company explained.

Acute myeloid leukemia (AML) is a type of blood cancer in which tumor cells appear in the blood or bone marrow. FLT3 mutations are observed in about 30% of acute myeloid leukemia patients. It is known that 50% of patients with acute myeloid leukemia who have achieved complete remission with high-intensity chemotherapy experience recurrence, and patients with FLT3 mutations are known to have a higher risk of recurrence and a lower survival rate than those who do not.

An official from Pelemed said, "PLM-102, which has a differentiated mechanism, is under non-clinical research this year.

On May 23, 2022 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 the following (Press release, Greenwich LifeSciences, MAY 23, 2022, View Source [SID1234614943]):

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We have completed the manufacturing of GP2, released 3 clinical lots, and started the stability testing program for these lots. Previously, the FDA informally asked us to allow them to review an updated chemistry and manufacturing section on drug product before initiating the Phase III trial as our manufacturing information for the final drug product was incomplete and the lots were being tested for the first time. Subsequently, we received a formal clinical hold letter. Greenwich has provided a response and is working with the FDA to resolve all outstanding issues. All hold issues are associated with manufacturing and pharmacy procedures.

We continue to work toward study initiation. We are scheduling site initiation visits to train clinicians, nurses, coordinators, and pharmacists to activate and open clinical sites. We, along with our CRO, continue to actively recruit and prepare sites for site initiation.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "We continue to make progress towards opening up our first sites. We just completed our first Data Safety Management Board (DSMB) meeting and are currently scheduling our initial Steering Committee Meeting with the lead clinicians of FLAMINGO-01. Our electronic data capture and inventory management systems are anticipated to go live in June. We are working to address all FDA issues rapidly so that the study can be initiated shortly."

Three abstracts and two posters were accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2022. The titles of the abstracts are as follows:

Abstract Number: LBA550; Poster Number: 322; Abstract Title: Evaluation of booster injections in maintaining peak immunity in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus GM-CSF alone after adjuvant trastuzumab in HER2 positive women with breast cancer.
Abstract Number: e12519; Abstract Title: Baseline GP2 immune response as an independent prognostic factor in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus. GM-CSF alone after adjuvant trastuzumab in HER2-positive women with breast cancer.
Abstract Number: TPS1110; Poster Number: 485b; Abstract Title: A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 (Co-authored with Baylor College of Medicine)
CEO Snehal Patel commented, "These abstracts and posters highlight the first steps to optimizing the use of GLSI-100. We are planning to study the peak immunity of GP2 and how to assess when to administer booster injections. The current methodology is to deliver 6 primary injections over the first 6 months and 5 booster injections 6 months apart, thus totaling 11 injections over 3 years. However, in the future, we envision using immune response and T-cell profiles to determine when boosters may be needed. This may allow GLSI-100 to protect breast cancer survivors over longer periods of time against recurring metastatic breast cancer. In addition, approximately 20% of patients in the Phase IIb trial had a GP2 immune response before being treated with GP2, possibly due to a potential impending recurrence. We found that some patients with baseline immune response to GP2 tended to recur at faster rates. We are planning to study this observation in the Phase III trial, which could lead us to being able to use GP2 immune response as an independent prognosticator for impending recurrence. This would allow doctors to detect recurrences sooner than current standard of care and to thus start aggressive treatments sooner with potentially better outcomes."

Mr. Patel further added, "This will be the first ASCO (Free ASCO Whitepaper) meeting in person since 2019, attended by oncologists from around the world. Greenwich is in discussions with 2 of the largest oncology networks in Europe for participation in FLAMINGO-01, and we look forward to expanding our outreach to potential international sites at ASCO (Free ASCO Whitepaper). In the US, we anticipate that the largest oncology network will provide one of the first sites to treat patients and that a second oncology network in the US may participate along side. We believe that the participation of clinical trial networks focused on cancer treatment will help to increase the enrollment rate in FLAMINGO-01 and expand the geographic footprint to allow more patients to participate."

About the ASCO (Free ASCO Whitepaper) Annual Meeting

Founded in 1964, ASCO (Free ASCO Whitepaper) is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO (Free ASCO Whitepaper) offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO (Free ASCO Whitepaper) Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: View Source

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, 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 registered on clinicaltrials.gov and can be seen here. 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 May 23, 2022 Genuv Inc., a clinical-stage biotechnology company focused on innovative drug discovery for degenerative central nervous system diseases and advanced immuno-oncology therapeutics, reported it will release new preclinical data at two major medical conferences in June (Press release, Genuv, MAY 23, 2022, View Source [SID1234614962]).

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"We are excited to share new preclinical data for our two drug candidates, SNR1611 and GNUV201," said Heung-rok Park, Ph.D., chief technology officer of Genuv.

Details of the presentations are shown below.

Keystone Symposium: Neurodegeneration: The Biological Pathways Driving the Future of Therapeutic Development, June 5-9, Keystone, CO

Poster number: 1023
Title: Trametinib rescues neurodegeneration by TFEB-mediated activation of autophagic lysosomal function in Alzheimer’s Disease model mice
Session: Poster session 1 on June 6, 2022
Presenter: Jenny Choih, K.M.D., Ph.D.

Poster number: 2022
Title: Trametinib activates endogenous neurogenesis and recovers Alzheimer’s disease phenotype of 5XFAD
Session: Poster session 2 on June 7, 2022
Presenter: Jenny Choih, K.M.D., Ph.D.

Keystone Symposia abstracts are available at View Source

ASCO 2022 Annual Meeting, June 3-7, McCormick Place, Chicago, IL

Abstract number: e14509
Title: GNUV201, a novel human and mouse cross-reactive PD-1 monoclonal antibody for cancer immunotherapy
Session: Online publication

The abstract will be released by ASCO (Free ASCO Whitepaper) on May 26, 2022, at 5:00 p.m. EDT on ASCO (Free ASCO Whitepaper).org/abstracts.

On May 23, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, reported it would resume its existing Stock Repurchase Program (Press release, Greenwich LifeSciences, MAY 23, 2022, View Source [SID1234614944]).

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Under the repurchase program previously authorized by the board of directors, Greenwich LifeSciences may repurchase its outstanding shares of common stock from time to time in open market or privately-negotiated transactions, including accelerated share repurchase transactions, block trades, or pursuant to 10b5-1 trading plans. Any repurchases will be at management’s discretion and will be subject to market conditions, the price of the Company’s shares and other factors. The stock repurchase program may be modified, suspended or terminated by the Board of Directors at any time.

The Company has approximately $4.5 million available under the current program. As of its most recently reported quarter-end March 31, 2022, the Company had 12,951,453 shares of common stock outstanding.