On December 7, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it will present a total of 23 company-sponsored abstracts at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 11-14, 2021 in Atlanta, Georgia (Press release, Takeda, DEC 7, 2021, View Source [SID1234596569]). Takeda’s latest research in hematologic diseases focuses on optimizing patient care, while advancing novel approaches for patients with limited or ineffective treatment options.

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Takeda Oncology will present data in multiple myeloma, lymphoma and leukemia from the company’s marketed products as well as provide early insights into the potential of therapies leveraging the innate immune system. In hematology, Takeda will present prospective, post-hoc and real-world data across a range of hematological disorders, aimed at addressing the breadth of needs within the bleeding disorders community, while investigating potentially transformative treatment options.

"At Takeda Oncology, improving patient care is the foundation for all we do," said Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "At this year’s ASH (Free ASH Whitepaper), we look forward to showcasing our deep legacy and leadership in the treatment of hematologic cancers by sharing data that will help to inform the optimal use of our established medicines and presenting research from two pipeline programs designed with the potential to drive potent and effective immune attacks against cancer. While early-stage, we continue to explore these new treatment pathways as we seek to outsmart cancer."

"The hematological data we are highlighting at ASH (Free ASH Whitepaper) this year demonstrates our commitment to furthering personalized care strategies, and leading scientific innovation to address unmet needs within the global bleeding disorders community," added Neil Inhaber, Head of Global Medical Affairs, Rare Genetics and Hematology. "In addition to developing our promising pipeline of investigative molecules, which may have transformative potential for multiple rare and life-threatening hematological conditions, we remain focused on expanding the use of our current portfolio to benefit more people living with rare bleeding disorders."

A full list of company-sponsored abstracts can be found here.

rADAMTS13 (TAK-755), modakafusp alfa (TAK-573), and subasumstat (TAK-981) are investigational compounds that have not been approved for use by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory authorities.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

Takeda’s Commitment to Hematology

Takeda is a leader in hemophilia with the longest heritage and market-leading portfolio, backed by established safety and efficacy profiles with decades of real-world experience. We have 70+ years driving innovation for patients and a broad portfolio of 11 products across multiple bleeding disorders. Our experience as a leader in hematology means we are well prepared to meet today’s needs as we pursue future developments in the care of blood disorders. Together with the hematology community, we are raising expectations for the future, including earlier diagnosis, earlier and full protection against bleeds, and more personalized patient care.

On December 7, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported that members of management will participate in a fireside chat hosted by Cantor Fitzgerald Analyst Brian Cheng on Wednesday, December 8, 2021 at 1:00 p.m. ET (Press release, Immunome, DEC 7, 2021, View Source [SID1234596567]).

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The live call is reserved for institutional clients of Cantor Fitzgerald. A replay of the webcast can be accessed from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available at the conclusion of the live presentation for approximately 30 days.

On December 7, 2021 SynDevRx, Inc., a clinical-stage biotechnology company leading the development in treatments for obesity-accelerated cancers, reported a research collaboration with Australia’s Queensland University of Technology (Press release, SynDevRx, DEC 7, 2021, View Source [SID1234596566]). The collaboration with Professor Colleen Nelson, PhD, and her team will study the role of methionine aminopeptidase 2 (MetAP2) inhibition in tumor growth in castration resistant and other treatment resistant forms of prostate cancer.

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Obesity and systemic metabolic dysfunction like pre-diabetes and type 2 diabetes are known to make many solid tumors more aggressive, including prostate cancer. MetAP2 inhibitors, such as evexomostat (SDX-7320), have been clinically shown to improve systemic metabolic hormone dysregulation1 and to possess direct anti-tumor, anti-metastatic and anti-angiogenic properties2. This combination of attributes may be well suited to sever the link between metabolic dysfunction and cancer, and may prove to be effective in treating advanced prostate cancer in combination with standard-of-care therapies.

Professor Nelson is the founder and executive director of the Australian Prostate Cancer Research Centre – Queensland (APCRC-Q) and Chair of Prostate Cancer Research at Queensland University of Technology (QUT). APCRC-Q, is one of the leading global research facilities investigating the connection between prostate cancer and dysregulated metabolic hormones and pathways, and how these affect prostate cancer progression and metastasis. "The downstream effects of obesity change the tumor microenvironment in ways highly favorable to prostate cancer recurrence, progression and metastasis. Hyperleptinemia and hyperinsulinemia are well-established, negative side effects of androgen deprivation therapy (ADT) and other treatments that block the androgen axis in prostate cancer. The APCRC-Q has been investigating this relationship using targeted drugs in preclinical models that inhibit metabolic pathways induced by ADT, through tumor promoting pathways activated systemically, and through direct tumor cell adaptation," said Colleen Nelson, PhD, lead investigator. "We’re very excited to study SynDevRx’s SDX-7320 inhibition of MetAP2 in our well-vetted models of treatment resistant advanced prostate cancer models."

The APCRC-Q team’s research focuses on pathways activated by ADT, including alterations in metabolism that are druggable with novel targeted agents. They recently showed that pharmacological blockade of leptin receptor or the activation of adiponectin signaling was efficacious in significantly reducing tumor burden and in delaying progression to castration resistance in animal models. The APCRC-Q team has also been targeting metabolic pathways directly through mitochondrial activity or lipid synthesis in models of CRCP and ENZ resistance.

"Professor Nelson team’s work has clearly demonstrated the central role that leptin and adiponectin play in the feedback loop of androgen deprivation and results in the emergence of treatment resistance," said Peter Cornelius, PhD, senior director of translational research at SynDevRx. "Her lab has some of the best models for studying the deleterious effects of inhibition of the androgen receptor axis in prostate cancer, identifying mechanisms of resistance and then targeting those proteins driving the resistance in pre-clinical prostate cancer models. Given our clinical results showing evexomostat (SDX-7320) significantly lowers leptin and increases adiponectin in late-stage cancer patients, we’re thrilled to work with Professor Nelson and her expert team on testing the potential beneficial effects that SDX-7320/MetAP2 inhibition could play in these validated models."

"SynDevRx is establishing global collaborations with leading research institutions focused on the downstream effects that obesity and dysregulated metabolic hormones have on cancer progression and metastasis. We invite other researchers to work with us as we untangle these complex and critical interactions between cancer and dysregulated metabolic hormones," said SynDevRx’s co-founder and Chief Business Officer James Shanahan.

(Proietto et al., Diabetologia 2018 Sep;61(9):1918-1922)
(Mann-Steinberg et al., "TNP-470: The Resurrection of the First Synthetic Angiogenesis Inhibitor." (2008).)
About SDX-7320

SynDevRx believes that evexomostat (SDX-7320) is the first drug being developed specifically for cancer patients with metabolic complications, such as obesity, diabetes, high blood glucose or HbA1c, pre-diabetes or insulin/leptin resistance. For certain tumor types, metabolic hormones stimulate oncogenic pathways, making the cancer more aggressive and deadlier. Evexomostat acts by binding irreversibly to its target enzyme MetAP2, triggering downstream improvements in the metabolic hormones insulin, leptin and adiponectin, improvements in key lipids, and inhibition of the important angiogenic proteins bFGF and VEGF-C, as was demonstrated in a Phase 1 clinical study in late-stage cancer patients. In preclinical studies, evexomostat also directly inhibited multiple cell cycle signaling pathways, provided synergistic anti-tumor effects in combination with a PI3K inhibitor, reduced angiogenesis, controlled aberrant metabolic hormone signaling, and reversed obesity-induced immune suppression within the tumor micro-environment of tumor-bearing obese mice. Evexomostat (SDX-7320) is being developed for use in combination with clinically indicated standard-of-care cancer therapies for breast and prostate cancers.

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 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.