On January 27, 2025 ImmunoPrecise Antibodies Ltd. ("IPA" or the "Company") (NASDAQ: IPA), a leader in AI-driven antibody discovery and development, reported the successful completion of its previously disclosed USD $8.8 million "at-the-market" equity offering program (the "ATM Program") alongside the full conversion of its outstanding debenture with Yorkville Advisors, significantly enhancing the Company’s capital structure (Press release, ImmunoPrecise Antibodies, JAN 27, 2025, View Source [SID1234649887]).

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Strategic ATM Offering Raises USD $7.0 Million

Utilizing their ATM program, the Company generated approximately USD $7.0 million in gross proceeds. The Company utilized the ATM strategically, enabling them to dramatically reduce the cost of capital while reinforcing their financial position.

"The successful execution of our ATM Program underscores investor confidence in IPA’s vision and technology," said Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies. "By deploying this program strategically, we optimized our financing approach, reducing our cost of capital while maintaining the flexibility needed to accelerate innovation in AI-driven antibody discovery."

Yorkville Debenture Fully Converted

In addition to the ATM Program completion, IPA has now fully satisfied its outstanding obligations with Yorkville Advisors, as Yorkville has converted all principal amounts under the debenture agreement into common shares. This marks a significant milestone in eliminating near-term debt obligations, further strengthening IPA’s balance sheet.

"We greatly appreciate the partnership and flexibility provided by Yorkville Advisors throughout this process," added Dr. Bath. "Their structured investment approach has been instrumental in allowing us to execute on key strategic initiatives while maintaining operational momentum."

With the completion of the ATM Program and Yorkville’s full conversion, IPA is in a stronger financial position, allowing the Company to continue executing its growth strategy and advancing its AI-powered therapeutic discovery platform, LENSai.

On January 27, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors (Press release, ImmunityBio, JAN 27, 2025, View Source [SID1234649886]). The EMA covers 27 countries in the European Union (EU), as well as Iceland, Norway and Liechtenstein.

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"We are encouraged by the speed in which the EMA accepted our marketing authorization application and determined it would begin its assessment of our innovative treatment for this serious condition, just nine months after it was first approved by the FDA for use in the United States," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "Along with our submission to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), this action by the EMA is strong evidence of the momentum for putting ANKTIVA+BCG into the hands of physicians who are treating patients with NMIBC."

The EMA submission is based on the ongoing QUILT 3.032 study in which the complete response rate for the 100 evaluable patients in Cohort A as of the July 15, 2024 cut-off was 71%. In these responders, the range of duration of response is 0.03 to 54 months and is ongoing. These prolonged duration of complete response results beyond four years with ANKTIVA and BCG exceed the benchmark of 18 months for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group.

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

On January 27, 2025 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies (Press release, GT Biopharma, JAN 27, 2025, View Source [SID1234649885]).

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"We are thrilled to initiate patient dosing with GTB-3650 in the Phase 1 trial to evaluate the potential in patients with hematological malignancies, which represents a significant milestone for the company. As we continue to progress through clinical development, we eagerly anticipate sharing initial data from the study in 2025", said Michael Breen, Executive Chairman and interim Chief Executive Officer of GT Biopharma.

GTB-3650 is GT Biopharma’s wholly owned second-generation TriKE. It utilizes camelid nanobody technology, with the potential to improve potency and enhance binding affinity. The Phase 1 dose escalation study will evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.

On January 27, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the activation of clinical sites in Poland (Press release, Greenwich LifeSciences, JAN 27, 2025, View Source [SID1234649884]).

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According to the latest data collected by the European Cancer Information System (click here), a total of 24,599 new cases of breast cancer were diagnosed in Poland in 2022, which is the most common cancer diagnosed in women, representing approximately 25% of all cancers in women. Breast cancer is the second leading cause of death from cancer in women in Poland with 8,723 deaths in 2022.

The Company is collaborating with Dr. Piotr Wysocki, who is leading one of the largest academic and private breast cancer research networks in Poland, where 9 to 11 sites have agreed to participate in FLAMINGO-01. These sites were approved by Polish authorities, which has led to site initiation visits and the treatment of the first patient in Poland in 2024.

Dr. Wysocki is Professor of Medicine and Head of Department of Oncology at Jagiellonian University Hospital in Krakow Poland. He has research interests in the development of novel apheresis-based cancer therapies, clinical application of metronomic chemotherapy, metronomic chemo-endocrine and chemo-targeted therapies for the treatment of breast, prostate, and ovarian cancers.

CEO Snehal Patel commented, "Poland has a reputation for large treatment centers with high enrollment and standard of care. We look forward to working with Dr. Wysocki who is serving as the national principal investigator for Poland in FLAMINGO-01. We have been impressed with the sites that we have visited to date. In addition, we may have an opportunity to offer our study to Ukrainians who may have been displaced and now reside in Poland."

The Polish clinical sites will be listed here with an interactive map and are shown below.

Konin
KOMED Oncology Center

Kraków (2)
Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Opole
Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Poznań
Uniwersytecki Szpital Kliniczny w Poznaniu

Rzeszów
Centrum Medyczne MrukMed

Slupsk
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

Warszawa (2)
Wojskowy Instytut Medyczny,Państwowy Instytut Badawczy
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

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 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 is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. 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 250 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.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (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 January 27, 2025 GSK plc (LSE/NYSE: GSK) and the University of Oxford (Oxford) reported that they have entered a new research collaboration focused on the potential of cancer prevention through vaccination (Press release, GlaxoSmithKline, JAN 27, 2025, View Source [SID1234649883]). The GSK-Oxford Cancer Immuno-Prevention Programme will conduct translational research, exploring precancer biology to generate key insights on how cancer develops in humans that could inform new approaches to cancer vaccination. GSK will invest up to £50 million over a minimum of three years to support this early research.

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Evidence shows that most cancers take years or even decades to develop from normal cells to precancerous cells (or precancer) to cancer. Oxford University has world-leading expertise in the study of precancer biology including the identification and sequencing of neoantigens, or tumour-specific proteins that prompt the immune system to recognise cancer.1 This unique focus could help target the vulnerabilities of precancerous cells through an active intervention like a vaccine or targeted medicine to prevent them from progressing to cancer.

Tony Wood, Chief Scientific Officer, GSK, said: "We’re pleased to further strengthen our relationship with Oxford University and to combine the deep knowledge of Oxford and GSK scientists. By exploring precancer biology and building on GSK’s expertise in the science of the immune system, we aim to generate key insights for people at risk of developing cancer."

Professor Irene Tracey, Vice-Chancellor of the University of Oxford, said: "This partnership represents a step forward in cancer research. By working with GSK to unite experts in clinical trials, immuno-oncology, vaccinology and precancer research from across the University of Oxford, we aim to unlock the potential of cancer vaccines and bring hope to patients worldwide."

Science and Technology Secretary, Peter Kyle, said: "Cancer is a disease that has brought pain and heartbreak to every family in the country, including my own. But through our world-leading universities and businesses working in lockstep, like Oxford and GSK are doing here, we can harness science and innovation to transform what’s possible when it comes to diagnosing and treating this disease. As part of our Plan for Change, the Government is determined to back our £108 billion life sciences sector to deliver research like this – which could transform our health – whilst boosting our economy too."

Building on GSK’s ongoing relationship with Oxford, this collaboration will continue to combine GSK’s expertise in the science of the immune system and global development capability with Oxford’s cutting-edge research, clinical capabilities and world-leading scientists.

In 2021, GSK and Oxford established the Institute of Molecular and Computational Medicine. The Institute, based at the University of Oxford, has demonstrated progress at improving the success and speed of research and development of new medicines, specifically in the field of neurodegeneration, building on insights from human genetics and using advanced technologies such as functional genomics and machine learning.