On October 17, 2024 Hansa Biopharma Reports Third Quarter and Interim January – September 2024 Financial Results (Press release, Hansa Biopharma, OCT 17, 2024, View Source;september-2024-financial-results-302278809.html [SID1234647258]).

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Søren Tulstrup, President and CEO, Hansa Biopharma said, "The third quarter of 2024 marks the highest ever IDEFIRIX sales performance to date, resulting in four consecutive quarters of strong sales performance. The launch of IDEFIRIX in Europe continues to advance with adoption in international organ allocation systems and an increase in new and repeat utilization in leading transplant clinics. Equally, we see strong momentum in our clinical development programs in autoimmune, gene therapy and transplantation. Enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM has reached 86%. In the Post Authorization Efficacy and Safety (PAES) study in kidney transplant enrolment has reached 78%. Finally, just after quarter end, we communicated positive results from the 12-month analysis of NICE-01, demonstrating that HNSA-5487 can robustly and very rapidly reduce IgG levels, has clear redosing potential, and a favorable safety and tolerability profile. Initial clinical development will focus on neuromyelitis optica (NMO), myelin oligodendrocyte glycoprotein antibody disease (MOGAD), and myasthenia gravis (MG)."

Financial Performance

The Company recorded total revenue of 78.4 MSEK. Of this, 69.5 MSEK is attributed to IDEFIRIX sales, marking the highest ever quarterly in-market sales. This excludes the impact of a 29.7 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. Of the total provision only 4.9 MSEK was related to Q3 sales. Net of the provision, Q3 2024 IDEFIRIX sales were 39.8 MSEK and total year to date IDEFIRIX sales were 114.5 MSEK. Previously, the Company recorded a provision of 19.9 MSEK in Q2 2024. Of this, 2.0 MSEK was related to sales in Q2 2024. Of the total provision taken in Q2 and Q3 2024, 42.7 MSEK relates to previous periods since launch in 2020.

Pipeline Progress

Progress across the pipeline included the strong momentum in enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM (86%), and in the Post Authorization Efficacy and Safety (PAES) study in kidney transplantation (78%). Further efficacy data from the 15-HMedIdes-09 Phase 2 trial in Guillain-Barré Syndrome (GBS) is scheduled to read out by the end of 2024. The ConfIdeS trial continues to progress following completed randomization in May and data from the study is expected to provide the basis for a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in the second half of 2025. On 7 October 2024, Hansa announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential.

Financial Summary

MSEK, unless otherwise stated – unaudited

Q3 2024

Q3 2023

9M 2024

9M 2023

Total Revenue

78.4

22.8

188.6

83.7

Provision1

(29.7)

–

(49.6)

–

Net revenue after provision

48.7

22.8

139.0

83.7

SG&A expenses

(75.8)

(111.7)

(255.3)

(344.5)

R&D expenses

(79.6)

(95.6)

(274.3)

(303.1)

Loss from operations

(116.9)

(202.2)

(463.7)

(613.0)

Loss for the period

(103.8)

(250.7)

(530.3)

(707.3)

Net cash used in operations

(148.8)

(193.8)

(527.1)

(582.7)

Cash and short-term investments

553.5

908.2

553.5

908.2

EPS before and after dilution (SEK)

(1.53)

(4.78)

(8.67)

(13.49)

Number of outstanding shares

67,814,241

52,671,796

67,814,241

52,671,796

Weighted average number of shares before and after dilution

67,814,241

52,597,502

61,162,934

52,495,705

No of employees at the end of the period

135

168

135

168

1 Product sales in the third quarter 2024 totaled 69.5 MSEK. Sales were offset by a provision totaling 29.7 MSEK for potential credits associated with volume discounts and rebates. Year to date 2024 IDEFIRIX product sales totaled 164.1 MSEK and were offset by a provision totaling 49.6 MSEK. Net of the provision, year-to-date 2024 product sales totaled 114.5 MSEK.

Conference Call Details

Hansa Biopharma will host a telephone conference today Thursday, October 17, 2024, at 14:00 CET / 8:00 am ET.

The event will be hosted by Søren Tulstrup, President and CEO, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO. The call will include a review of the interim results and a business and pipeline update. It will be held in English.

Slides used in the presentation will be live on the company website during the call under Events & Presentations and will also be made available online after the call.

To participate in the telephone conference, please use the dial-in details provided below:

Participant Dial In (Toll Free): 1-877-270-2148
Participant International Dial In: 1-412-902-6510
*Please ask to be joined into the Hansa Biopharma call

On October 17, 2024 University Medical Center Groningen (UMCG) and SHINE Europe reported a €10.5 million grant from the Dutch government to advance the Terbium for Life project, an initiative aimed at bolstering Europe’s cancer treatment capabilities and enhancing supply chain security within the European Medical Isotope market (Press release, SHINE Technologies, OCT 17, 2024, View Source [SID1234647257]). The initiative will establish a European supply chain for terbium isotopes, reducing reliance on foreign sources and securing a stable supply of critical isotopes for cancer theranostics – a field that combines diagnosis and therapy in one targeted approach.

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Early-onset cancers – cancer cases diagnosed in people under 50 – have increased globally by a staggering 79%. As a result, increasing access to treatment has become critical as cancer cases continue to rise. The Terbium for Life project will serve cancer patients by enabling access to innovative treatment options. Terbium-161 (Tb-161), a primary isotope in the project, has been shown to have the potential to extend lifetimes, improve quality of life, and result in fewer side effects. Additional terbium isotopes, such as Tb-155, Tb-152, and Tb-149, also hold potential for diagnostic and therapy applications. Establishing a reliable and high-quality supply chain for terbium isotopes, independent of foreign sources, is now more important than ever.

The Terbium for Life project is made possible through the partnership between UMCG and SHINE Europe. The project will play a critical role in advancing Europe’s cancer-fighting efforts by promoting research into terbium isotopes with both therapeutic and diagnostic applications. This effort supports Europe’s broader cancer-fighting initiatives and aligns with the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA), which plays a crucial role in guiding the development and implementation of radiological and nuclear technology in Europe.

"This exciting collaboration between UMCG, Department of Nuclear Medicine and Molecular Imaging, PARTREC, and SHINE brings together unique expertise in nuclear medicine, molecular imaging, and radiotheranostics. Our goal is to develop innovative treatments that offer new hope for cancer patients," said Dr. Philip H. Elsinga, professor of PET Radiochemistry at UMCG.

"We thank the Dutch government and the European Commission for their support in our terbium efforts," said Harrie Buurlage, VP of Strategic Alliances at SHINE Europe. "This grant will go a long way in supporting our work, alongside UMCG, to provide European patients with easier access to promising new therapies that can support their ongoing fight against cancer."

A project proposal for Terbium for Life was submitted to and approved by the Dutch government, and subsequently awarded to the UMCG-SHINE joint Terbium for Life project. SHINE Europe maintains a strategic partnership with UMCG, focused on advancing research and development in medical isotopes. This partnership is at the heart of the project, leveraging UMCG’s extensive research expertise and state-of-the-art facilities to drive progress in cancer research and treatment in the region.

On October 17, 2024 SHINE Technologies, a next-generation fusion company, and WARF Therapeutics, a drug discovery program by the Wisconsin Alumni Research Foundation (WARF), reported promising pre-clinical research results from collaborative efforts with Advanced Radiotheranostics Lab at the University of Wisconsin-Madison (Press release, SHINE Technologies, OCT 17, 2024, View Source [SID1234647256]). The studies showed that WT-7695 and ART-101 – treatments that leverage SHINE’s non-carrier added lutetium-177 (Lu-177) chloride, Ilumira – have the potential to increase life span and be more effective in treating kidney and prostate cancer, respectively.

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This groundbreaking research stems from a collaboration between the Advanced Radiotheranostic Lab, led by Dr. Reinier Hernandez at the University of Wisconsin-Madison, WARF Therapeutics, and SHINE Technologies. WARF Therapeutics has heavily invested to accelerate the development of theranostic radiopharmaceutical programs at UW-Madison, like WT-7695 and ART-101, while SHINE Technologies provides the high-quality lutetium-177 integral to this innovative cancer treatment approach.

When paired with innovative cancer-seeking radiopharmaceutical agents that precisely target tumors and metastases, Lu-177 delivers a potent dose of radiation to kill cancer cells while minimizing harm to healthy tissue. Research has shown that radiopharmaceuticals have the potential to reduce the risk of side effects from treatment compared to other cancer therapies.

The initial pre-clinical results of 177Lu-WT-7695 show unprecedently high tumor uptake at 24h and significant tumor retention at seven days. Consequently, treatment studies lead to significant tumor regression and 100% survival in a mouse model of kidney cancer. WT-7695 is a best-in-class CA9 radiopharmaceutical and is moving into IND-enabling studies in early 2025.

Other studies led by Dr. Hernandez’s lab show that 177Lu-ART-101, a new treatment for advanced prostate cancer, performs better than the current therapy, PSMA-617 (another radiopharmaceutical). The study showed that ART-101 demonstrated superior tumor growth inhibition compared to existing radiopharmaceuticals targeting the prostate specific membrane antigen. This novel compound targets cancer cells more effectively, with approximately three times more Lu-177 reaching the tumors and remaining there for an extended period. Notably, ART-101 maintained its efficacy even at lower administered activities, potentially leading to reduced side effects for patients in future clinical applications. These promising results set the stage for human trials to validate the treatment’s potential to improve outcomes for prostate cancer patients.

"We’re witnessing an increasing role for radiopharmaceuticals as a pillar of cancer treatment given their meaningful clinical activity and high tolerability compared to chemotherapy," said Dr. Reinier Hernandez, Assistant Professor of Medical Physics and Radiology at the University of Wisconsin-Madison, and principal investigator of the studies. "This is very exciting for the future of cancer treatment, and we have just begun to scratch the surface. We look forward to continuing to leverage radiopharmaceuticals, through our collaboration with WARF Therapeutics and SHINE, to enable new avenues to treat the most aggressive types of cancer."

"These close relationships between industry and academia are the heart and soul of WARF Therapeutics," said Jon Young, Head of WARF Therapeutics. "This partnership demonstrates how productively and efficiently we can move from concept to prototype, from bench to bedside, and get drugs in the hands of clinicians to improve patient outcomes."

Hernandez’s lab chose SHINE as its partner for sourcing Lu-177 given Ilumira’s superior quality and US-based production. This ensures faster, flexible delivery, lower costs, and the ability to scale. It also enables research and clinical trials to stay on schedule, and for patients to benefit sooner, as this US supply helps bring innovative cancer therapies to market faster. SHINE has the highest production capacity in the U.S for Lu-177, enabling production of hundreds of thousands of cancer-fighting doses annually.

"This is further validation that Ilumira is more effective than the standard of care for cancer treatment," said Greg Piefer, CEO and founder of SHINE. "We’re on the verge of an amazing frontier in cancer treatment. I believe we’re going to move from merely fighting disease progression to actually curing patients. We’re thrilled to support the University of Wisconsin in its groundbreaking work and excited to play even a small role in world-changing programs like these. We look forward to our continued collaboration to create a brighter future for patients."

The group plans to have WT-7695 and ART-101 move on to human trials within the next year. WARF, the proprietor of both technologies, is seeking partners for continued development and commercialization to advance these promising radiopharmaceuticals. Dr. Hernandez’s team will give presentations on these and other findings at the 2024 Annual Congress of the European Association of Nuclear Medicine (EANM).

On October 17, 2024 Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) reported to have submitted the company’s Investigational New Drug (IND) application for CS231295 tablets, a Class 1 innovative drug for the treatment of tumors (Press release, Shenzhen Chipscreen Biosciences, OCT 17, 2024, View Source [SID1234647255]). The application has been accepted by the Center for Drug Evaluation of National Medical Products Administration of China (Application Number: CXHL2401105, CXHL2401107, CXHL2401108).

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Malignant tumors are one of the main causes leading to human death. Although clinical treatments have been significantly improved, most tumors are still incurable. The drug resistance, tumor recurrence and metastasis still are the biggest threat to long-term survival of patients. Particularly, Malignant brain tumors and brain metastasis not only brings direct life hazards but also has a natural barrier for drug efficacy due to the blood-brain barrier. Therefore, developing new anti-tumor drugs with good brain permeability has become a hot and difficult topic in improving the current tumor therapy.

CS231295 is a novel brain-penetrating small-molecule, multi-target protein kinase inhibitor independently developed by Chipscreen Biosciences, with proprietary intellectual property rights. This drug candidate exhibits significant synthetic lethal effects on tumors carrying particular genetic defects, providing a new treatment option for patients with such tumors. Additionally, it demonstrates potent anti-tumor angiogenesis activity, resulting in broad-spectrum anti-tumor efficacy. In the future, CS231295, either as a monotherapy or in combination with other anti-tumor drugs, is expected to offer differentiated and innovative treatment options for various types of cancer. Due to its excellent blood-brain barrier permeability, CS231295 possesses significant therapeutic advantages for Malignant brain tumors and metastatic brain tumors, with particularly strong potential for treating primary and metastatic brain tumors. In preclinical studies, CS231295 has shown significant pharmacodynamic activity, favorable pharmacokinetic properties, and a good safety profile.

On October 17, 2024 Nektar Therapeutics (Nasdaq: NKTR) reported the publication of the first clinical data from a Phase 1 study evaluating NKTR-255 in combination with an autologous bispecific chimeric antigen receptor (CAR)-T cell therapy targeting CD19 and CD22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) in Blood, the peer-reviewed medical journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Nektar Therapeutics, OCT 17, 2024, View Source [SID1234647254]).

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NKTR-255 is a novel IL-15 receptor agonist currently being studied in clinical trials in combination with cellular therapies and immune checkpoint inhibitors. NKTR-255 has shown in previous clinical studies that it can proliferate a range of immune cells and augment lymphocyte trafficking.1,2

The data published in Blood showed favorable efficacy with eight out of nine patients (89%) whom successfully received CAR19-22 followed by NKTR-255 achieving measurable residual disease (MRD) negative remission. The study further demonstrated that, at 12 months, relapse-free/progression-free survival for NKTR-255 in combination with the CD19-22 CAR-T cell therapy was double that of historical controls (67% vs 38%).

"We are encouraged by these first clinical data that clearly demonstrate the ability of NKTR-255 to potentiate CAR-T cell therapy," said Mary Tagliaferri, MD, Senior Vice President and Chief Medical Officer at Nektar. "Data showed NKTR-255 in combination with CD19-22 CAR-T cell therapy resulted in a 67% 12-month relapse-free survival rate in relapsed or refractory B-ALL and investigators observed significant increases in proinflammatory cytokines and chemokines which suggest lymphocyte trafficking to tissues."

The Phase 1 single-center, single-arm dose-escalation study was conducted by Stanford Medicine and evaluated NKTR-255 in combination with CD19-22 CAR-T cell therapy in patients with relapsed or refractory B-ALL (NCT03233854).

"While CAR-T cell therapies have transformed the treatment landscape for B-cell malignancies, there remains a significant unmet need to drive durable treatment outcomes as relapse occurs in the majority of patients," said David Miklos, MD, Chief of BMT and Cell Therapy Program at Stanford Medicine, Division of Blood and Marrow Transplantation and Cellular Therapy.

The primary outcomes of this study were feasibility and safety. Secondary endpoints were assessed for patients who received NKTR-255 (n=9) and included pharmacokinetics of NKTR-255 as measured by IL-15 levels in blood and efficacy as measured by remission free survival (RFS). Exploratory endpoints included cytokine profiling, CAR19-22 expansion in blood, bone marrow, and cerebrospinal fluid (CSF), and long-term CAR-T persistence.

Key findings are summarized below:

No dose-limiting toxicities related to NKTR-255 were observed. The most common adverse events in patients receiving NKTR-255 in combination with the CD19-22 CAR-T cell therapy were fevers, chills, and myelosuppression, which were either self-limiting or manageable with supportive care. The toxicities observed with the combination treatment were similar to those seen after CD19-22 CAR-T cell therapy alone.
Cytokine and chemokine profiling showed significant increases in IL-15 levels. Increase in CXCL9 and CXCL10 were associated with decreases in absolute lymphocyte counts and CD8+ CAR T-cells in blood, and ten-fold increases CAR-T cells in CSF, suggesting lymphocyte trafficking to tissue.
Favorable efficacy was observed in patients with relapsed or refractory B-ALL treated with NKTR-255 in combination with CD19-22 CAR-T. Eight out of nine patients achieved complete remission with or without hematologic recovery, all without detectable MRD.
Compared to Stanford’s control group previously treated with the CD19-22 CAR-T cell therapy, NKTR-255 when added to the cell therapy increased the 12-month relapse free survival from 38% to 67%. The median RFS for the CAR T cell only cohort was 3.9 months. For the cohort treated with NKTR-255 and the CD 19-22 CAR-T cell therapy, the median RFS has not been reached with over 14 months of follow up. Only three patients who received combination therapy (33%) relapsed, suggesting administration of NKTR-255 to the CD19-22 CAR-T cell therapy helps prevent early disease recurrence.
The full citation of this article can be accessed here (Volume 144, Issue 16, Pages 1649-1753).

About NKTR-255

NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body’s innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response.

In addition to studies in combination with CAR T cell therapies, NKTR-255 is being studied in a Phase 1 clinical trial sponsored by AbelZeta Pharma, Inc., which is evaluating C-TIL051, a tumor-infiltrating lymphocyte therapy, in anti-PD1 resistant metastatic non-small cell lung cancer (NCT05676749). The JAVELIN Bladder Medley study (NCT05327530), sponsored by Merck KGaA, is also ongoing to evaluate NKTR-255 in combination with avelumab as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma.(NCT05327530)