On November 12, 2024 mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Egis Pharmaceutical PLC, reported a new strategic license agreement for the commercialization of biosimilar candidates across key Central and Eastern European markets, including Hungary, Poland, Czech Republic, Slovakia, Romania, Bulgaria, Latvia, and Lithuania (Press release, mAbxience, NOV 12, 2024, View Source [SID1234648178]). The partnership also includes the option to expand to additional territories in the future.

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Under the terms of the agreement, mAbxience will hold the marketing authorization for the biosimilars in these regions, while Egis will manage the commercialization and marketing activities. This collaboration underscores the commitment of both companies to broaden access to essential, high-quality therapies in markets where affordability and accessibility are critical.

José Ramón Millán, Global Partnering & Portfolio Director at mAbxience, commented on the partnership: "We are delighted to partner with Egis to bring our biosimilar candidate to patients in these important Eastern European markets. This agreement strengthens our presence in the region and reaffirms our dedication to ensuring that life-saving treatments are accessible and affordable. We look forward to working closely with Egis to make a significant impact on patient care."

Dr. Klara Marton, Business Development Director from Egis added: "This collaboration with mAbxience enables us to deliver high value treatments to patients across Central and Eastern Europe. We are proud to join forces with a trusted partner like mAbxience, whose commitment to high-quality, affordable healthcare solutions aligns with our mission to improve patient access and patient outcomes in our region."

This agreement marks a significant milestone in mAbxience’s expansion into new markets and further reinforces its commitment to providing accessible, high-quality biosimilar therapies to patients worldwide.

On November 12, 2024 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win platform, reported financial results for the third quarter ended September 30, 2024 (Press release, IO Biotech, NOV 12, 2024, View Source [SID1234648177]).

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"We continue to add to the body of evidence that our novel investigational therapeutic cancer vaccine, IO102-IO103, has the potential to bring clinical benefit to patients with strong signals of activity now observed in patients with three types of metastatic solid tumors," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "As we look to the primary endpoint data readout from our Phase 3 pivotal trial in the first half of next year, we plan to be prepared to submit a Biologics License Application (BLA) to the FDA in 2025 and potentially make our first therapeutic cancer vaccine available for patients in the US with advanced melanoma in 2026."

Dr. Zocca continued, "Our T-win platform generates off-the-shelf therapeutic cancer vaccine candidates with a unique mechanism of action, capable of both targeting immune-suppressive cells and cancer cells. This dual action is what drives the strong activity we see when we combine IO102-IO103 with an anti-PD-1 therapy. In addition to IO102-IO103, the T-win platform has generated other novel candidates including IO112, targeting arginase 1 with a unique mechanism of action. We are excited about the strength of the data supporting the potential of IO112 and plan to submit an Investigational New Drug (IND) application to the FDA for this program in 2025."

Recent Business Highlights

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The per-protocol interim analysis in the pivotal Phase 3 trial (IOB-013/KN-D18), which is evaluating IO102-IO103 in combination with KEYTRUDA (pembrolizumab) in advanced melanoma, was completed by the IDMC in the third quarter of 2024. Based on review of safety and efficacy data, the IDMC recommended the trial continue without modifications and noted that no new safety signals were observed. The outcome of the primary endpoint of PFS is projected to be available in the first half of 2025, potentially followed by a BLA submission in 2025 depending on the PFS outcome.

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Encouraging data for the fully enrolled squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC) cohorts of the Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of patients with metastatic disease were presented at the 2024 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September and the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November, respectively. [https://bit.ly/3zgzsoY; https://bit.ly/4fsVCno]

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The company continues to progress its perioperative Phase 2 basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab dosed before (neo-adjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN. Enrollment continues in both the single arm SCCHN cohort (cohort B) and the randomized melanoma cohort (cohort C), in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone.

Third Quarter 2024 Financial Results

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Net loss for the three months ended September 30, 2024, was $24.0 million, compared to $21.7 million for the three months ended September 30, 2023.

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Research and development expenses were $20.2 million for the three months ended September 30, 2024, compared to $17.7 million for the three months ended September 30, 2023. The increase was primarily related to timing of clinical trial-related activities for the company’s IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the company’s pivotal Phase 3 clinical trial. The company recognized $0.6 million in research and development equity-based compensation for the three months ended September 30, 2024, compared to $2.1 million for the three months ended September 30, 2023.

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General and administrative expenses were $6.3 million for the three months ended September 30, 2024, compared to $5.8 million for the three months ended September 30, 2023. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended September 30, 2024, compared to $0.9 million for the three months ended September 30, 2023.

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Cash and cash equivalents as of September 30, 2024 were $80.2 million, compared to $143.2 million at December 31, 2023. During the three months ended September 30, 2024, the company used cash, cash equivalents and restricted cash of $20.8 million. The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 2025.

About IO102-IO103

IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival, an event-driven analysis conducted when 226 events, defined as disease progression or death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response rate (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR), disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial

IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The study completed enrollment of 15 patients with melanoma in cohort A and continues to enroll 15 patients with SCCHN in cohort B as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C, melanoma patients will be randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

On November 12, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported an upcoming plenary oral presentation at the 29th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), being hosted November 21 – 24, 2024 in Houston, TX (Press release, In8bio, NOV 12, 2024, View Source [SID1234648176]). IN8bio will provide longer-term follow-up and additional data demonstrating the activity of its DRI gamma-delta T cell approach in solid tumors from the Phase 1 trial of INB-200. In June 2024, preliminary clinical data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating that 92% of evaluable patients treated in the investigator-initiated trial exceeded the median progression-free survival of 7 months typically observed using standard-of-care therapy with concomitant temozolomide (TMZ).

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Details for the SNO oral presentation are as follows:

Title: INB-200: Fully Enrolled Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)

Presenter: Mina Lobbous, MD, MSPH, Assistant Professor, Cleveland Clinic Lerner College of Medicine
Abstract #: CTIM-09
Session Name: Abstract Session – Clinical Trials
Date and Time: Saturday, November 23, 2024, 11:25 AM – 11:35 AM CST

The abstract will be available online and can be accessed via the conference website at SNO 29th Annual Meeting & Education Day.

On November 12, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, reported financial results for the third quarter ended September 30, 2024, and recent corporate highlights (Press release, In8bio, NOV 12, 2024, View Source [SID1234648175]).

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"This past quarter marked a critical moment for IN8bio. We streamlined our operations and refined our pipeline to focus our resources. This strategic realignment enhances our capacity to deliver on the potential of gamma-delta T cell therapies, which are increasingly gaining recognition for their significant contributions to immunity." said William Ho, CEO and co-founder of IN8bio. "INB-100 is our allogeneic therapy in development for the treatment of patients with leukemias. The FDA’s guidance received in a Type B meeting over the summer provides a clear path forward for a potential registrational trial. We’ve secured additional funding to advance INB-100 through the ongoing expansion cohort in the Phase 1 study that will provide additional data to further de-risk the program. With a leaner, more focused organization, we are advancing INB-100 and seeking opportunities to potentially partner assets in our pipeline."

Corporate Highlights and Recent Developments

IN8bio will present updated clinical trial results from INB-200 in a Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) in November 2024.
A poster presentation updating patient data from the INB-100 trial will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2024.
Secured net proceeds of $11.6 million from a private placement that is expected to provide cash runway into the first quarter of 2026.
Funding is expected to be used to continue to advance development of INB-100, future product candidates and for working capital and other general corporate purposes.
Focusing on continued enrollment in the Phase 1 expansion cohort of up to approximately 25 patients at the RP2D of INB-100, with plans to potentially add additional centers and include a parallel observational arm to provide control data.
Received FDA guidance in a Type B meeting, on the registrational path for INB-100 in AML, an allogeneic gamma-delta T cell therapy demonstrating early signs of activity in high-risk leukemia patients.
All AML patients treated with INB-100 have remained in CR as of August 31, 2024.
Older, high-risk leukemia patients receiving non-myeloablative, reduced intensity conditioning (RIC), have exceeded the expected one-year progression-free survival (PFS) rate of approximately 40-50% post-haploidentical transplantation.
These data continue to demonstrate the broad clinical potential of gamma-delta T cells for difficult-to-treat cancers and provides support for the advancement of these therapies into pivotal trials.
Significant dose-dependent in vivo expansion and long-term persistence of circulating gamma-delta T cells has been observed up to 365 days.
IN8bio implemented a plan to optimize resource allocation through pipeline prioritization and a strategic workforce reduction that was completed in the third quarter of 2024. IN8bio also suspended enrollment in its Phase 2 clinical trial of INB-400 for newly diagnosed glioblastoma (GBM) but will continue monitoring previously treated GBM patients in both the Phase 2 INB-400 and the Phase 1 INB-200 clinical trials to assess progression-free and overall survival. Updated data to be presented at future medical meetings.
Third Quarter 2024 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $3.3 million, compared to $3.8 million for the comparable prior year period. The decrease of $0.5 million was primarily due to a decrease of $0.6 million in personnel expenses, including salaries and stock-based compensation (SBC) as a result of our workforce reduction and a decrease of $0.1 million in facility-related and other expenses primarily due to decreases in R&D activities in connection with our pipeline prioritization, partially offset by an increase of $0.2 million in direct costs related to our clinical trials, primarily related to the INB-400 program. As part of the Company’s pipeline prioritization announced in September 2024, further clinical development on INB-400 has been suspended.

General and Administrative (G&A) expenses: G&A expenses were $2.7 million, compared to $3.4 million for the comparable prior year period. The decrease of $0.7 million was primarily due to a decrease in salaries and bonus expense in connection with our workforce reduction and cost savings related to directors’ and officers’ insurance premiums, partially offset by an increase in professional services.

Severance and related charges: Severance and related charges were $1.1 million for the three months ended September 30, 2024, compared to zero for the comparable prior year period. The increase of $1.1 million was due to one-time costs related to the September 2024 workforce reduction, including SBC expense of $0.8 million resulting from acceleration in full of outstanding unvested stock options at the separation date for the impacted employees, and $0.3 million related to severance payments.

Net loss: Net loss was $7.1 million, or $0.15 per basic and diluted common share, compared to a net loss of $7.2 million, or $0.23 per basic and diluted common share, for the comparable prior year period.

Cash position: As of September 30, 2024, the Company had cash of $4.0 million, compared to $10.2 million, as of June 30, 2024. Subsequently in October 2024 closed a Private Placement of $11.6 Million in net proceeds.

On November 12, 2024 ImmunityBio, Inc. (NASDAQ: IBRX) reported its financial results for the third-quarter ended September 30, 2024 (Press release, ImmunityBio, NOV 12, 2024, View Source [SID1234648173]).

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ANKTIVA received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025.
ANKTIVA (FDA-approved and commercially available in the U.S. since May 2024) is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies.
ImmunityBio achieved a net product revenue of approximately $6.0 million during the three months ended September 30, 2024, surpassing net product revenue of $1.0 million in the prior quarter and analyst estimates.
ImmunityBio has extended the shelf life of ANKTIVA from two years to three years, with over 125,000 doses, providing ample product for the market and for clinical trials.
ImmunityBio submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) a Marketing Authorization Application (MAA) for ANKTIVA in the United Kingdom on November 1, 2024.
ImmunityBio intends to submit to the European Medicines Agency (EMA) an MAA for ANKTIVA in the European Union (EU) in Q4 2024, covering 30 countries, including 27 in the EU and 3 in the European Economic Area (Iceland, Norway, Liechtenstein).
"The U.S. launch of ANKTIVA for NMIBC CIS continues to gain momentum, and we are pleased to see the clinical impact for patients," said Richard Adcock, President and CEO of ImmunityBio. "Our permanent J-code has been issued by Centers for Medicare and Medicaid Services and will be effective January 1, 2025. Our submission of ANKTIVA for NMIBC CIS to the MHRA in the UK for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter."

"The response from the urologists and clinical practices with regard to the utility of ANKTIVA in NMIBC CIS has been gratifying. ImmunityBio’s clinical trial in BCG naïve NMIBC is enrolling well, and clinical sites have been expanded from the U.S. to multiple global locations. In the urology space, initial clinical trials of ANKTIVA are being designed for high-risk prostate cancer," said Dr. Patrick Soon-Shiong, Executive Chairman, Global Chief Scientific & Medical Officer of ImmunityBio. "With the approval of ANKTIVA and the label of activating NK cells, CD4+ CD8+ T cells with memory T cells, ImmunityBio is focusing the regulatory development of ANKTIVA in BCG naïve bladder cancer and non-small cell lung cancer (NSCLC) patients who have failed checkpoint inhibitors."

Third-Quarter Ended September 30, 2024 Financial Summary

Cash and Marketable Securities Position

As of September 30, 2024, the Company had consolidated cash and cash equivalents, and marketable securities of $130.4 million.

Research and Development Expenses

Research and development (R&D) expenses increased $2.0 million to $50.4 million during the three months ended September 30, 2024, as compared to $48.4 million during the three months ended September 30, 2023. The increase was primarily driven by personnel-related and other R&D costs, partially offset by a decrease in external R&D expense driven by lower CMO fees and material purchases.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased $4.1 million to $35.9 million during the three months ended September 30, 2024, as compared to $31.8 million during the three months ended September 30, 2023. The increase was primarily driven by higher salaries and benefits expense as a result of a reversal of discretionary compensation not paid in the prior period and an increase in consulting costs associated with commercial activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $85.7 million during the three months ended September 30, 2024, compared to $95.6 million during the three months ended September 30, 2023.

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.