On October 31, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that it has presented results from five programs by poster presentation, including two clinical programs on the anti-CD24 monoclonal antibody ATG-031 and the PD-L1/4-1BB bispecific antibody ATG-101; two preclinical programs on the LILRB4 antagonist antibody ATG-034 and the GPRC5D/CD3 T-cell engager ATG-021; and the Company’s proprietary novel AnTenGagerTM platform, at the 2023 Society of Immunology in Cancer Annual Meeting (SITC 2023) (Press release, Antengene, OCT 31, 2023, View Source [SID1234636574]). The SITC (Free SITC Whitepaper) Annual Meeting is a widely recognized and respected international event that brings together cutting-edge presentations by multidisciplinary experts in basic and applied cancer immunotherapy with a goal of improving outcomes for cancer patients.

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"Thanks to Antengene’s robust R&D capabilities and its proprietary technology platforms, we have released the exciting results from multiple studies at the SITC (Free SITC Whitepaper) Annual Meeting this year. Among them, preclinical results on the pharmacokinetics, pharmacodynamics, and toxicology of ATG-031, the world’s first anti-CD24 monoclonal antibody entering clinical development, deserve particular attention as they demonstrated ATG-031’s ability to systemically enhance antitumor immunity and its favorable safety profile. Moreover, CD24 is highly expressed in a variety of solid tumors and hematologic malignancies, thus indicating the drug’s broad therapeutic opportunity. The U.S. Food and Drug Administration (FDA) has already cleared an Investigational New Drug (IND) application for a Phase I study of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin lymphoma (B-NHL). The study, led by the MD Anderson Cancer Center, along with three other clinical centers in the U.S., is currently ongoing," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "Also at the meeting, we released results on AnTenGagerTM, an inhouse-developed and fully-patented T cell engager (TCE) platform that offers target-dependent T cell activation and enhanced antitumor activity with reduced risk of cytokine release syndromes. Building on the progress, we will continue to accelerate our development of cutting-edge therapies and showcase our innovative prowess on the global stage."

Details of the Poster Presentations:

ATG-031(anti-CD24 monoclonal antibody)
Title: The preclinical characterization and translational research of ATG-031, a first-in-class humanized anti-CD24 antibody, for the treatment of solid tumors and hematological malignancies
Abstract: 1337

CD24 is a small, highly glycosylated cell adhesion protein that functions as a novel "don’t eat me" target in cancer, where it is the dominant innate immune checkpoint. CD24 is extensively expressed in a variety of tumor types, whereas its distribution in normal tissues is limited.
Therapeutic antibodies blocking "don’t eat me" signals exhibited potent preclinical and early clinical efficacy against solid tumors and hematological malignancies.
As the first-in-class anti-CD24 monoclonal antibody entering clinical development, ATG-031 has demonstrated potent anti-tumor activity as a single agent and in combination with chemotherapies and checkpoint inhibitors, as well as excellent safety and PK properties in pre-clinical studies. It induces macrophage mediated phagocytosis of tumor cells, and boosts T cell dependent anti-tumor immunity in the tumor microenvironment.
These pre-clinical data support the further development and evaluation of ATG-031 in the Phase I, multicenter, dose escalating clinical trial in patients with solid tumors and hematological malignancies. To date, the U.S. Food and Drug Administration (FDA) has already cleared an Investigational New Drug (IND) application for a Phase I study of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin lymphoma (B-NHL). The study, led by the MD Anderson Cancer Center, along with three other clinical centers in the U.S., is currently ongoing.
ATG-101(PD-L1/4-1BB bispecific antibody)
Title: Single-cell RNA sequencing reveals the positive feedback activation loop between T and dendritic cells induced by PD-L1x4-1BB bispecific antibody
Abstract: 1112

Single-cell RNA-sequencing (scRNAseq) was used to better understand the biology of immune responses induced by ATG-101.
Transcriptional profiling of the tumor microenvironment (TME) revealed that ATG-101 reversed T cell exhaustion, increased T cell cytotoxicity, and reduced tolerogenic dendritic cells (DCs).
Due to the increased gene expression of PD-L1 in DCs and 4-1BB in T cells following ATG-101 treatment, it is anticipated that ATG-101 will promote greater T cell-dentritic cell crosslinking over time, further activating 4-1BB signalling, strengthening T cell-DC interaction, and generating a positive feedback loop.
Currently, ATG-101 is being assessed in a dose-escalation study in the Mainland of China, Australia, and the U.S.
ATG-034 (LILRB4 antagonist antibody)
Title: Antibody targeting a specific epitope of LILRB4 induces potent ADCC/ADCP effect against leukemia cells
Abstract: 1391

Acute myeloid leukemia (AML) patients, especially those with monocytic AML subtypes have poor treatment outcomes. Existing therapies targeting CD33 and CD123 has demonstrated hematological toxicities. Moreover, the antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis (ADCC/ADCP) effect of current therapeutic mAbs targeting LILRB4 antigen on AML is relatively weak.
ATG-034-S3 potentiates NK-mediated ADCC, macrophage-mediated ADCP, cytotoxicity of CD8+ T cells and reverses AML-mediated T cell suppression, thus enhancing anti-tumor immunity and demonstrating potent in vivo anti-tumor efficacy.
ATG-034-S3 may be a promising strategy for the treatment of monocytic M4/M5 AML and other LILRB-positive hematological malignancies.
ATG-021 (GPRC5D/CD3 T-cell engager)
Title: ATG-021, a novel 2+1 CD3-based T-cell engager (TCE) targeting GPRC5D, demonstrates potent in vivo anti-tumor efficacy with low cytokine release
Abstract: 1191

GPRC5D is expressed on malignant bone marrow plasma cells, whereas normal tissue expression is limited to the hair follicle; Upregulation of GPRC5D expression has been associated with unfavorable prognosis.
As a novel 2+1 GPRC5DxCD3 T cell engager, ATG-021 has demonstrated optimum efficacy and safety through its GPRC5D-dependent CD3 binding. It has demonstrated potent in vivo anti-tumor efficacy with reduced cytokine release in pre-clinical studies.
These pre-clinical data warrant further clinical evaluation of ATG-021 against multiple myeloma.
AnTenGager Platform
Title: A novel "2+1" bispecific T cell engager platform, enables enhanced anti-tumor activity with reduced risk of CRS
Abstract: 1190

Multiple T-cell engaging bispecific antibodies have demonstrated promising therapeutic efficacy in the treatment of hematological malignancies. However, suboptimal efficacy in the treatment of solid tumors and the risk of cytokine release syndrome (CRS) continue to be major challenges.
AnTenGagerTM is a novel "2+1" T cell engager platform developed by Antengene, and molecules developed through this platform have exhibited limited binding to CD3-positive cells before tumor-associated-antigen (TAA) crosslinking, suggesting reduced risk of CRS caused by systemic CD3 activation.
Compared to clinical benchmarks targeting the same tumor associated antigen (TAA), molecules developed by the AnTenGagerTM platform demonstrated substantially lower binding capacity to CD3+ before TAA-crosslinking, while inducing increased cytotoxicity against target-positive tumor cells, less ex-vivo cytokine release by human peripheral blood mononuclear cells (PBMCs), and enhanced in vivo efficacy in a PBMC humanized mouse tumor model.
These results suggest that AnTenGagerTM is a promising platform to develop next generation T cell engagers, with improved efficacy and safety profiles.

On October 31, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the first quarter ended September 30, 2023 (Press release, Bio-Techne, OCT 31, 2023, View Source [SID1234636572]).

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First Quarter FY2024 Highlights

First quarter organic revenue increased by 2% (3% reported) to $276.9 million.

GAAP earnings per share1) (EPS) was $0.31 versus $0.55 one year ago. Delivered adjusted EPS1) of $0.41 compared to $0.45 one year ago.

Our ExoDx prostate test and GMP proteins continued their growth trajectories with test volume increasing 49% and revenue increasing 39%, respectively.

Our ProteinSimple branded portfolio of instruments and consumables services increased 9% in the quarter and grew over 18% excluding China.

Strong commercial execution in EMEA led to first quarter organic growth of 15% in the region.

Cash flow generated from operations increased to $59.4 million, a 6% increase from the prior year.

On October 19, 2023, announced the appointment of current Diagnostics and Genomics President, Kim Kelderman, as CEO effective February 1, 2024.
1)On November 29, 2022, the company executed a four-for-one split of Bio-Techne’s common stock in the form of a stock dividend to all shareholders of record on November 14, 2022. All references made to share or per share amounts in this press release have been retroactively adjusted to reflect the effects of the stock split.

The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"The Bio-Techne team continues to execute in a challenging market, with our durable portfolio delivering 2% organic growth despite the soft biotech funding environment and evolving macroeconomic landscape in China. Our European team’s performance was particularly impressive with 15% growth in the region," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We delivered these results with a continued focus on profitability, as our disciplined approach led to an adjusted operating margin of 31.4%, in-line with our expectations."

Kummeth continued, "Our growth pillars continue to perform well, including 49% ExoDx Prostate test volume growth, a 39% increase in our GMP proteins business, as well as 9% growth in our ProteinSimple branded portfolio of instruments and consumables. In fact, excluding China, our ProteinSimple portfolio increased over 18% in the quarter."

Kummeth concluded, "I also want to personally congratulate Kim Kelderman on his appointment as CEO effective February 1, 2024. I am looking forward to working with Kim in his interim role as Chief Operating Officer and will continue to support him as a Senior Advisor until my retirement on July 1, 2024. One thing is certain, Kim is inheriting an experienced and talented team, and I am confident he is the right leader to execute our strategic playbook and drive results going forward. I am excited for the future of Bio-Techne and believe our portfolio, strategy and leadership position the Company incredibly well for the future."

First Quarter Fiscal 2024

Revenue

Net sales for the first quarter increased 3% to $276.9 million. Organic growth was 2% compared to the prior year, with acquisitions contributing 1% and foreign currency exchange having an immaterial impact.

GAAP Earnings Results

GAAP EPS was $0.31 per diluted share, versus $0.55 in the same quarter last year. GAAP operating income for the first quarter of fiscal 2024 decreased 1% to $55.9 million, compared to $56.3 million in the first quarter of fiscal 2023. Prior year GAAP EPS was favorably impacted by a non-recurring gain of $37.2 million on the sale of our ChemoCentryx investment and a non-recurring gain of $11.7 million on the sale of our Eminence investment. GAAP operating margin was 20.2%, compared to 20.9% in the first quarter of fiscal 2023. Current year GAAP operating margin was unfavorably impacted by the Lunaphore acquisition and by year-over-year increases in strategic growth investments.

Non-GAAP Earnings Results

Adjusted EPS decreased to $0.41 per diluted share compared to $0.45 in the same quarter last year. Adjusted operating income for the first quarter of fiscal 2024 decreased 7% compared to the first quarter of fiscal 2023. Adjusted operating margin was 31.4%, compared to 34.8% in the first quarter of fiscal 2023. Adjusted operating margin was unfavorably impacted by the acquisition of Lunaphore this year and other strategic growth investments.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s first quarter fiscal 2024 net sales were $204.7 million, an increase of 2% from $199.9 million for the first quarter of fiscal 2023. Organic growth for the segment was 2%, with foreign currency exchange having an immaterial impact. Protein Sciences segment’s operating margin was 43.2% in the first quarter of fiscal 2024 compared to 43.0% in the first quarter of fiscal 2023.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides spatial biology products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s first quarter fiscal 2024 net sales were $72.8 million, an increase of 4% from $69.9 million for the first quarter of fiscal 2023. Organic revenue growth was flat for the first quarter of fiscal 2024, with acquisitions having a 3% impact and foreign exchange having a favorable impact of 1%. The Diagnostics and Genomics segment’s operating margin was 0.7% in the first quarter of fiscal 2024 compared to 12.4% in the first quarter of fiscal 2023. The segment’s operating margin decreased primarily due to the acquisition of Lunaphore this year along with other strategic growth investments and unfavorable product mix.

Conference Call

Bio-Techne will host an earnings conference call today, October 31, 2023 at 8:00 a.m. CDT. To listen, please dial 1-877-407-9208 or 1-201-493-6784 for international callers, and reference conference ID 13741775. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13741775. The replay will be available from 11:00 a.m. CDT on Tuesday, October 31, 2023, until 11:00 p.m. CST on Thursday, November 30, 2023.

On October 31, 2023 Kite, a Gilead Company (Nasdaq: GILD)and Epicrispr Biotechnologies ("Epic Bio"), reported the companies have entered into a research collaboration and license agreement using Epic Bio’s proprietary gene regulation platform to develop next-generation cancer cell therapies (Press release, Gilead Sciences, OCT 31, 2023, View Source [SID1234636571]). The agreement will allow Kite to leverage the licensed technology to modulate certain genes to potentially enhance CAR T-cell functionality.

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"Cell-based cancer immunotherapies have reshaped modern cancer care, but we have still only scratched the surface of their potential benefit for patients. At Kite, we are committed to developing next generation CAR T-cell therapies with the goal of reaching more patients with cancer who could benefit," said David Barrett, Vice President of Cell Biology and Translational Medicine at Kite. "We look forward to collaborating with Epic Bio with the goal of further advancing today’s cell therapies and potentially expanding their reach and impact on patients."

"We are proud to partner with Kite to extend the potential application of Epic Bio’s platform for cancer treatment. Epic Bio’s approach is not only promising for in vivo medicines, but may also enable next-generation cell therapies to reach a wide range of patient populations," said Amber Salzman, Ph.D., Chief Executive Officer of Epic Bio. "We look forward to applying our expertise in gene modulation to help advance CAR T-cell therapies."

Under the terms of the agreement, Epic Bio will develop constructs for Kite-selected targets for use in CAR T-cell therapies directed to blood cancers. Kite will make an upfront payment to Epic Bio and Epic Bio will be eligible to receive performance-based development, regulatory and sales milestone payments. Epic Bio is also eligible to receive tiered royalties on any approved products that result from the collaboration.

The transaction with Epic Bio is expected to have a de minimis financial impact on Gilead’s 2023 GAAP and non-GAAP EPS.

On October 31, 2023 XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported that it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG) (Press release, Xoma, OCT 31, 2023, View Source [SID1234636570]). The FDA has granted tovorafenib Priority Review and established a Prescription Drug User Fee Act (PDUFA) date of April 30, 2024.

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"Tovorafenib has the potential to address a key unmet need in children whose low-grade gliomas with BRAF alterations have relapsed or progressed," stated Owen Hughes, Executive Chairman of XOMA. "A novel, targeted, orally available option has the opportunity to set a new standard-of-care in this patient population."

In March 2021, XOMA paid $13.5 million upfront plus a share of a future event-based milestone, to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

On October 31, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company, reported that it will present novel findings for its lead product, pepinemab, in two presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in San Diego, CA November 1-5, 2023 (Press release, Vaccinex, OCT 31, 2023, View Source [SID1234636558]). Vaccinex reports consistent findings from two independent studies demonstrating novel activity of pepinemab antibody to induce the formation of lymphoid structures in tumors that promote efficient immune responses and are known to be associated with improved outcomes to immune checkpoint inhibitors (ICI). In a pre-specified interim analysis of the Phase 2 KEYNOTE-B84 study (NCT04815720) evaluating pepinemab in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for immunotherapy of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), these structures were associated with an approximate doubling of objective responses (ORR) and progression free survival (PFS) relative to historical results with checkpoint monotherapy in patients with hard-to-treat tumors that express low levels of PD-L1 (CPS<20). Similarly, findings will be reported from a separate study with collaborators at Emory University indicating that pepinemab in combination with nivolumab and/or ipilimumab (BMS), appeared to induce tertiary lymphoid structures in tumors. Remarkably, patients receiving neoadjuvant treatment with the triple combination have not experienced tumor recurrence for more than 2 years following treatment (ongoing response in 8/8 patients) (NCT03769155).

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The potential of immune checkpoint therapies to sustain cytotoxic T cells is limited by insufficient support from other immune cell interactions, including with myeloid cells and B cells. The tumor microenvironment creates barriers to efficient immune cell communication, including by expression of semaphorin 4D (SEMA4D), which binds receptors on myeloid cells to inhibit the migration and maturation of dendritic cells (DC) that are crucial for priming and expanding T cells in adaptive immune responses. Preclinical and clinical studies have previously demonstrated improved trafficking of DC and T cells and reduction of immature myeloid derived suppressor cells in tumor following treatment with pepinemab SEMA4D blocking antibody. Data from two independent studies to be presented at SITC (Free SITC Whitepaper) provide new evidence that pepinemab induces the formation of lymphoid structures within treated tumors and that this is associated with enhanced immune interactions and durable responses. These results highlight pepinemab’s novel mechanisms to overcome limitations of ICI.

"Neoadjuvant SEMA4D inhibitor pepinemab combination with nivolumab increases crosstalk between B cell and CD26hi T cell in patients with resectable stage III melanoma" will be presented by Dr. Ayana Ruffin of Emory University together with Vaccinex authors on Friday, November 3, 2023.

"Pepinemab, anti semaphorin 4D antibody, in combination with pembrolizumab induced formation of organized lymphoid aggregates and enhanced response to treatment in CPS<20 R/M HNSCC tumors (KEYNOTE-B84)" will be presented by Dr. Terrence Fisher together with Merck authors and study investigators on Saturday, November 4, 2023.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and glial cells in the brain. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.