On October 18, 2021 Avelas Biosciences, Inc. ("Avelas" or "the Company"), a clinical-stage drug-device company pioneering the field of fluorescence imaging for real-time cancer detection, reported that additions to its senior management team and Board of Directors and provides an update on the pegloprastide Phase III clinical program, due to start in 1H22 (Press release, Avelas Biosciences, OCT 18, 2021, View Source [SID1234591424]).

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!

Corporate Update

Avelas is pleased to announce it has strengthened its management team with the appointment of Ambareen "Amber" Sheriff as Vice President, Regulatory and Quality and further bolstered its Board of Directors with the appointment of Robin Stevens as a Non-Executive Director of the Company.

Ms. Sheriff is an expert in global regulatory strategies with more than 32 years of regulatory affairs and product development experience. Throughout her career, Ms. Sheriff has led US, EMEA and rest of the world regulatory and quality strategies supporting development and preparation of drug products, investigational studies and marketing authorisations. Prior to joining Avelas, Ms. Sheriff was the VP, Regulatory Affairs and Quality Assurance at Celerity Pharmaceuticals, where she obtained ten regulatory approvals in over six years in the role. Ms. Sheriff previously held roles at Marathon Pharmaceuticals, Winston Laboratories, Akorn, and Baxter Healthcare. Ms. Sheriff holds a B.S. in Pharmacy from the University of Karachi and a B.S. in Chemistry from Northeastern Illinois University.

Mr. Stevens has over 30 years’ experience advising private and public companies in a variety of functions, including corporate finance, capital markets and previously as an international audit partner, in a wide range of industries, operating in the UK and overseas. In addition to his role at Avelas, he is a Senior Advisor and Capital Markets Lead at MHA MacIntyre Hudson.

Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas, added: "As Avelas accelerates towards commencement of our Phase III clinical study for pegloprastide, I am delighted to be strengthening our team both at the management and Board level with the addition of Amber and Robin. We look forward to working closely with them."

Clinical Update

Avelas also announces that it is the Company’s intent to commence its registrational confirmatory Phase III trial for pegloprastide, its novel, best-in-class agent for visualizing breast cancer margins, in the first half of 2022, having received constructive and helpful feedback from the US Food and Drug Administration (the "FDA").

Avelas is developing pegloprastide (AVB-620), a novel fluorescent imaging agent used in combination with a fluorescence camera system, which has FDA Breakthrough Therapy Designation, for the intraoperative detection and visualization of positive margins during breast cancer surgery.

The goal of intraoperative image-guided surgery with pegloprastide is to increase the precision of cancer surgery and improve treatment outcomes for patients by fluorescently identifying cancer, in real-time during surgery, on the surfaces of excised tissue or residual cancer in the tumour bed not otherwise detected by surgeons and potentially left behind in a patient during an operation. Avelas has already demonstrated in prior studies that the use of pegloprastide, a fluorescent cancer marker, during surgery correctly identified cancer in up to 75% of patients who may have otherwise been candidates for a repeat (re-excision) surgery.

Through the benefits of Breakthrough Therapy Designation, Avelas has continued to collaborate with the FDA on the design of the Company’s registrational confirmatory Phase III trial. The design and protocol of the Phase III study will now be finalized in preparation for commencement of patient enrolment in the first half of 2022. Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas said "We believe that pegloprastide is a best-in-class novel agent for visualising breast cancer margins in real time during surgery. Following this constructive dialogue with the FDA, we are excited to continue the clinical development of this exciting candidate."

On October 18, 2021 Enzo Biochem, Inc. (NYSE:ENZ) ("Enzo" or the "Company"), a leading biosciences and diagnostics company, reported the appointment of Hamid Erfanian as Chief Executive Officer (Press release, Enzo Biochem, OCT 18, 2021, View Source [SID1234591445]). Following the succession plan announced in March and the engagement of Korn Ferry, Dr. Elazar Rabbani remains Chairperson of the Board of Directors and will assume the role of Chief Scientific Officer of the Company. Mr. Erfanian brings over 28 years of experience as a seasoned healthcare executive specializing in the diagnostic, medical devices, and life sciences industry. His demonstrated track record of implementing commercial strategies and building high performing teams at both global and smaller firms provides the ideal balance of qualifications to support Enzo as it evolves under the guidance of new leadership. Mr. Erfanian’s employment will begin in early November.

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!

"I am thrilled to be joining Enzo, an established innovator in the diagnostics space, at this pivotal stage of development," stated Mr. Erfanian. "I firmly believe the Company’s GENFLEX platform, and its broad menu of molecular products are very well positioned to continue to serve the diagnostics market. The vision of new molecular product development and service expansion into new clinical settings is a vital mission as the Company evolves in this post pandemic environment. I look forward to leading these efforts and the Enzo executive management team."

Mr. Erfanian was most recently Chief Commercial Officer of EUROIMMUN, a PerkinElmer Company. He previously served as Chief Executive Officer of its US subsidiary, a position he held from June 2014 through August 2021, where he was responsible for growing sales by more than 20-fold in five years. EUROIMMUN is a world leader in the field of medical diagnostics. In his role, he commercialized several diagnostic product offerings including those that enable the detection of antibodies associated with autoimmune and infectious diseases. Prior to EUROIMMUN, Mr. Erfanian held executive and senior positions at several notable diagnostics companies including Diagnostica Stago, Beckman Coulter, and Abbott Laboratories. Earlier in his career, Mr. Erfanian worked at leading diagnostic laboratory testing companies, Quest Diagnostics and Laboratory Corporation of America. He received his Bachelor’s Degree in Science and Mathematics from North Dakota State University and a Masters of Business Administration from the Cox School of Business at Southern Methodist University.

"The Board is excited that Mr. Erfanian is joining the Company to lead us through this next stage of commercialization and growth as we capitalize on our molecular diagnostics platforms for central lab and point of care uses," stated Dr. Rabbani, Enzo’s Chairperson. "We have the deepest confidence that Mr. Erfanian will leverage Enzo’s proprietary and innovative platforms, strong asset base, and approximately 475 global patents. He joins the Company at an exciting juncture of growth and opportunity."

On October 18, 2021 ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, and Canadian Nuclear Laboratories (CNL), Canada’s premier nuclear science and technology organization, reported that the companies have signed a Memorandum of Understanding (MoU) to explore the development and industrial-scale production of Actinium-225, an extremely rare alpha-emitting radioisotope with heightened potential in precision oncology (Press release, ITM Isotopen Technologien Munchen, OCT 18, 2021, View Source [SID1234591461]). Under the terms of the agreement, the organizations will collaborate on the development, manufacturing, and distribution pathways for the medical radioisotope. Further details of the agreement have not been disclosed.

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!

Targeted Alpha Therapy (TAT) has been rapidly gaining growing interest from the scientific and medical community. Alpha-emitters, particularly Actinium-225, are in high demand for their ability to cause irreparable damage to cancer cells. Notably, Actinium-225 emits powerful, high-energy alpha particles with a short penetration range, which enables highly precise treatment of tumor cells, including hard-to-target micro metastases, with minimal impact to surrounding healthy tissue. In preclinical studies, TAT has shown remarkable results, destroying cancer cells by effectively breaking the bonds in their DNA. Actinium-225 can be labelled to a variety of peptide ligands or antibodies to specifically target cancer cells in a wide range of tumor indications.

As the current annual global production of Actinium-225 is miniscule, one of the biggest challenges in harnessing the full potential of the alpha-emitter is ensuring its supply. CNL and ITM have the expertise and infrastructure in place to work to sufficiently bypass the supply hurdle to develop and produce this coveted radioisotope with huge therapeutic potential.

"CNL is very excited to enter into this agreement with ITM, an industry leader that shares our ambition of bringing the next-generation of medical radioisotopes to the global market," commented Joe McBrearty, CNL’s President and CEO. "It is also an exciting evolution of CNL’s work in the field of medical radioisotopes, and makes use of our capabilities in target development, radiochemistry, radioisotope analysis and by-product management. Working with ITM, we hope to leverage these capabilities to accelerate the development of this promising new isotope, and to establish a commercial pipeline for what we believe will be a ground-breaking new cancer treatment."

"It is always a pleasure to work alongside another radiotherapeutic industry leader like CNL in the development of a radioisotope with the potential to address a high unmet need. We look forward to sharing our expertise in the global production and supply of the highest quality radioisotopes in our shared mission of exploring the otherwise untapped potential of Actinium-225, commonly referred to as the ‘rarest drug on earth’. We are eager to unveil the therapeutic value of this radioisotope which we believe has the potential to unlock revolutionary TAT treatments," said Steffen Schuster, CEO of ITM.

ITM is a world leader in the development, production and global supply of radiotherapeutics and diagnostics, and maintains an evolving precision oncology pipeline. Coupled with CNL’s extensive scientific infrastructure and vast experience in developing and distributing medical radioisotopes, the companies are very well-positioned to produce and provide this highly sought-after radioisotope to the global industry.

Under the terms of the agreement, CNL will be responsible for the research and development as well as the production of Actinium-225. The company is already developing and producing Actinium-225 in research-scale quantities using Thorium-229 generators. ITM will be responsible for further processing Actinium-225 to Good Manufacturing Practices (GMP) standard and will subsequently have the primary responsibility for associated regulatory processes, marketing and sales of the product. CNL and ITM aim to leverage their capabilities towards establishing a continuous commercial supply of GMP-grade Actinium-225 for the global market. Both parties are working towards signing a more formal agreement in the form of a Collaborative Venture.

On October 18, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that a research team led by Prof. Shaomeng Wang, Ph.D., Co-Founder and Chief Scientific Advisor of Ascentage Pharma, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, University of Michigan, has recently published a paper in the renowned Journal of Medicinal Chemistry demonstrating the highly promising therapeutic potential of the embryonic ectoderm development (EED) inhibitor, EEDi-5273 (APG-5918), and the compound’s ability to achieve complete and persistent tumor regression by modulating the epigenetics and microenvironment of tumors and overcoming drug resistance (Press release, Ascentage Pharma, OCT 18, 2021, View Source [SID1234591479]). Ascentage Pharma has obtained the exclusive global development rights to EEDi-5273 and is currently actively preparing to submit an Investigational New Drug (IND) application for this drug candidate.

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 paper published by Dr. Shaomeng Wang’s research team was titled Discovery of EEDi-5273 as an Exceptionally Potent and Orally Efficacious EED Inhibitor Capable of Achieving Complete and Persistent Tumor Regression. The study found that the oral administration of EEDi-5273 is capable of achieving complete and persistent tumor regression in the KARPAS422 xenograft model in mice. As an exceptionally potent novel EED inhibitor that is capable of epigenetic modulations, EEDi-5273 has broad therapeutic potential in the treatment of multiple hematologic malignancies, solid tumors, and non-oncologic indications.

According to the paper, the polycomb repressive complex 2 (PRC2) is a protein complex that consists core subunits including the enhancer of zeste homolog 2 (EZH2), EED, and suppressor of zeste 12 (SUZ12). Of these components, EED allosterically stimulates the methyltransferase activity of EZH2 through its binding to H3K27me3. Therefore, EED inhibitors can theoretically produce antitumor effects similar to that of EZH2 inhibitors, and deliver even more potent antitumor activity by overcoming resistance to EZH2 inhibitors while simultaneously inhibiting EZH2 and EZH1. In 2017, scientists from Novartis and AbbVie reported their discovery of A-395 and EED226, respectively, as allosteric inhibitors of EED. To date, only two EED inhibitors, MAK683 from Novartis and FTX-6058 from Fulcrum Therapeutics, have progressed into clinical development.

Previous preclinical and clinical studies have shown the broad therapeutic potential of EZH2/EED inhibitors in the treatment of multiple tumor types and non-oncologic indications. EZH2/EED inhibitors also have immunomodulatory functions that can render "cold" tumor "hot" through mechanisms such as antigen presentation, thus enhance tumor response to immune-checkpoint inhibitors, leading to improved antitumor efficacy. Clinical studies investigating the immunomodulatory functions of EZH2/EED inhibitors are currently ongoing. By bolstering the expression of fetal hemoglobin (HbF), EEH inhibitors may also achieve therapeutic effects in the treatment of multiple subtypes of anemia associated with low levels of hemoglobin.

Compared to A-395 and EED226, EEDi-5273 has higher binding affinity to EED and more potent cell growth inhibitory activity in the KARPAS422 cell line carrying a Y641N EZH2 mutation. In the KARPAS422 xenograft model, EEDi-5273 at 50mg/kg achieved complete tumor regression after 5 weeks of treatment and maintained the complete regression until at least day 114, thus demonstrated persistent antitumor activity. Meanwhile, ADME and PK studies of EEDi-5273 have demonstrated excellent drugability. In these studies, EEDi-5273 did not display obvious inhibitory and inducive activity in cytochrome P450 (CYP) enzymes, signaling a low risk of drug-drug interactions. In the plasma of all tested preclinical species and human, EEDi-5273 has demonstrated a half-life of over 2 hours, showing an excellent plasma stability. Collectively, data from this study showed that EEDi-5273 represents a highly promising EED inhibitor.

Dr. Shaomeng Wang said: "ED inhibitors have the promising therapeutic potential for the treatment of human cancers carrying EZH2 mutations and other types of human cancers, as well as other human diseases such as sickle cell anemia. Our data suggest that EEDi-5273 (APG-5918) possess an excellent profile as a development candidate and has the potential to become the best-in-class EED inhibitor."

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, commented: "These findings by Dr. Wang’s team are indeed very exciting, as they further validated APG-5918 as a highly promising EED inhibitor with the most potent vitro activity and impressive in vivo efficacy, thus provide solid preclinical data supporting our future clinical development of the compound. EED inhibitors have broad clinical applications and enormous therapeutic potential especially in the treatment of non-oncologic indications. We will press forward with the development of APG-5918 and advance the compound to the clinical-stage as soon as possible in effort to bring a novel therapeutic to patients in need."

On October 18, 2021 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that Bristol Myers Squibb has licensed a fifth TriNKET Immunotherapy drug candidate, bringing the total drug candidates licensed by Bristol Myers Squibb to six including Dragonfly’s novel IL-12 cytokine DF6002/BMS-986415 (Press release, Dragonfly Therapeutics, OCT 18, 2021, View Source [SID1234596017]). Since their original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations which include oncology and neuroinflammation targets.

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!

Dragonfly also announced that the first patients have been dosed in Phase 1 clinical trials of both the CC-96191 and CC-92328 investigational immunotherapies, which are licensed to Bristol Myers Squibb. Following Dragonfly’s wholly-owned HER2-targeted NK cell engager therapy, DF1001, these are the second and third TriNKET drug candidates in the clinic, along with DF6002/BMS-986415 novel IL12-Fc fusion protein.

"We believe this recent opt-in decision by Bristol Myers Squibb further validates our drug discovery platform," said Bill Haney, Dragonfly’s CEO. "We are also delighted that Bristol Myers Squibb has brought our partnered targeted NK cell engager therapies to their first patients. The ongoing clinical trials of four Dragonfly-developed drugs, including our first cytokine, underscores the breadth of Dragonfly’s portfolio of innovative therapeutics, and the pace with which our team is bringing important new treatment options to patients with cancer and autoimmune disease."

The Phase 1 clinical trial for the CC-96191 TriNKET is a first-in-human study which will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of relapsed or refractory acute myeloid leukemia (R/R AML). Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04789655).

The Phase 1 clinical trial for the CC-92328 TriNKET is a first-in-human study which will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04975399).