On November 6, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, reported that clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, an experimental treatment for indolent non-Hodgkin B-cell lymphoma (iNHL), will be presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Conference, to take place December 7-10, 2024, in San Diego, California, and online (Press release, Enterome, NOV 6, 2024, View Source [SID1234647810]).

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These presentations will disclose the first data from Phase 2 Cohort 2, evaluating EO2463 as monotherapy for newly diagnosed patients with asymptomatic follicular lymphoma, where EO2463 may offer a safe, proactive immune therapy alternative to the usual "watch-and-wait" observation strategy. The data also report initial findings on a biomarker with potential to predict long-term response to EO2463, both as monotherapy, and in combination with standard treatments, in relapsed/refractory iNHL.

Details of the poster presentations:

Abstract #1616

Title: EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab
Presenting Author: J.C. C. Villasboas Bisneto, M.D., Mayo Clinic
Session: 622. Lymphomas: Translational – Non-Genetic: Poster I
Session Date: Saturday, December 7, 2024
Presentation Time: 5:30 PM – 7:30 PM
Abstract #4395

Title: EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study
Presenting Author: Stephen Smith, M.D., Associate Professor, UW Medicine & Fred Hutchinson Cancer Center
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 PM – 8:00 PM
SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as a monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with iNHL. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

For more information on the study, visit www.Clinicaltrials.gov, reference: NCT04669171.

About EO2463:

EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms.

On November 6, 2024 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a fireside chat at the Guggenheim Inaugural Healthcare Innovation Conference on Wednesday, November 13, 2024, at 2:00 pm ET in Boston (Press release, Protara Therapeutics, NOV 6, 2024, View Source [SID1234647826]).

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A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

On November 6, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that the enrollment of the first patient at Penn State Health Children’s Hospital in its Phase I/II clinical study evaluating the efficacy of Silmitasertib (CX-4945) in combination with chemotherapy for children and young adults with relapsed or refractory solid tumors (Press release, Senhwa Biosciences, NOV 6, 2024, View Source [SID1234647855]). This innovative trial seeks to establish a recommended dose of Silmitasertib in combination with chemotherapy and assess the safety, tolerability and efficacy in patients with cancer, with a focus on neuroblastoma, Ewing’s sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.

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"This clinical trial is a critical piece in understanding the mechanism of how the medicine works and develop more precise treatments for our patients," said Dr. Chandrika Behura, study chair and principal investigator, Four Diamonds researcher and associate professor of pediatrics at the College of Medicine. "It’s very important to develop the right combination that can be the most toxic to cancer cells, but the least harmful to the normal cells around them."

The study is projected to enroll up to 114 participants nationwide through the Beat Childhood Cancer Research Consortium member hospitals. By evaluating the activity of the study treatments based on individual responses and duration of disease control, the trial aims to develop novel therapeutic approaches.

"We are thrilled to be able to move this important research forward on a larger scale," said Dr. Giselle Sholler, division chief of pediatric hematology/oncology and director of pediatric oncology research at the College of Medicine and chairperson of the Beat Childhood Cancer Research Consortium. "The insights gained from this trial will help not only local patients and their families but can lead to new therapies that can help children throughout the US and internationally."

With the College of Medicine serving as its home, the Beat Childhood Cancer Research Consortium is a worldwide network of more than 50 universities and children’s hospitals focused on saving lives and helping the Children’s Hospital make a lasting difference around the world. Funding for this clinical trial is provided by the Beat Childhood Cancer Foundation and the Little Warrior Foundation. Funding for Behura’s research which led to the clinical trial was provided by Four Diamonds.

"This is the culmination of the work of many people over the years," said Suzanne Graney, executive director of Four Diamonds. "Without the dedication of our physician-scientists and the generosity of our donors and community, this kind of essential work to improve treatments with an ultimate goal of curing cancer would not be possible."

The pediatric cancer care specialists at Beat Childhood Cancer Research Consortium hospitals and researchers at the College of Medicine are dedicated to turning groundbreaking discoveries into lifesaving treatments for childhood cancer.

"By expanding our research and increasing clinical trials, we are exploring immunotherapy, cellular therapy and precision medicine to deliver the most optimized care to each unique patient," said Dr. Dr. Yatin Vyas, pediatrician-in-chief and chair of the Department of Pediatrics at the Children’s Hospital.

"We are greatly honored to collaborate with the Penn State College of Medicine and Beat Childhood Cancer Research Consortium, which have been diligently fighting childhood cancers by infusing invaluable resources from over 50 universities and children’s hospitals across the United States for the clinical study," said Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc. "We appreciate for having the opportunity of providing Silmitasertib as a potential effective treatment and look forward to realizing its therapeutic value in this urgently needed field for childhood cancers though this study".

On November 6, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the third quarter ended September 30, 2024 (Press release, Adicet Bio, NOV 6, 2024, View Source [SID1234647871]).

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"Our commitment to delivering best-in-class gamma delta 1 T cell therapies for patients battling autoimmune diseases and cancer is reflected in the expansion of our clinical pipeline in the third quarter. We are now investigating ADI-001 across six autoimmune indications to provide potentially transformative curative therapies for these debilitating diseases. Additionally, in the fourth quarter we plan to open enrollment for our Phase 1 trial of ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC), our first gamma delta 1 CAR T cell therapy for solid tumors. This progress highlights the broad and important potential applications of our gamma delta platform," said Chen Schor, President and Chief Executive Officer. "Looking ahead, we anticipate advancing enrollment in these trials and expect to share preliminary clinical data from both lupus nephritis with ADI-001 and metastatic/advanced ccRCC with ADI-270 in the first half of 2025."

Third Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

Activated clinical sites in ADI-001 Phase 1 trial in autoimmune diseases. In September 2024, Adicet activated sites for its Phase 1 clinical trial of ADI-001 in autoimmune diseases. The company is exploring the potential of ADI-001 across six indications including LN, systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV). The Company opened enrollment for patients with LN in 4Q24 and expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in 1Q25, and for patients with AAV in 2H25. The Company plans to report preliminary clinical data from the Phase 1 clinical study of ADI-001 in LN in 1H25, and for other autoimmune diseases in 2H25, subject to study site initiation and patient enrollment.
FDA clearance of IND amendment to evaluate ADI-001 in IIM and SPS. In October 2024, Adicet announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) amendment application to evaluate ADI-001 in IIM and SPS as part of the Phase 1 clinical trial in autoimmune diseases.
Presented ADI-001 clinical biomarker data demonstrating robust tissue trafficking and complete B cell depletion in secondary lymphoid tissue. In September 2024, Adicet presented clinical biomarker data from the Phase 1 GLEAN trial of ADI-001 at the 9th Annual CAR-TCR Summit. The data demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor (CAR) T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. These findings further reinforce ADI-001’s potential as a best-in-class allogeneic cell therapy for autoimmune diseases.
Presentation of ADI-001 clinical data at the American College of Rheumatology (ACR) Convergence 2024. In November 2024, Adicet will present an oral abstract highlighting previously presented ADI-001 clinical biomarker data at ACR Convergence 2024 taking place November 14-19 in Washington, D.C.
Hematologic malignancies and solid tumor indications

ADI-270 Fast Track Designation in metastatic/ advanced ccRCC. In July 2024, Adicet announced that the FDA granted ADI-270 Fast Track Designation for the potential treatment of patients with metastatic/advanced ccRCC who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
Presented ADI-270 data at the American Society of Gene & Cell Therapy’s (ASGCT) (Free ASGCT Whitepaper) 2024 Advancing Gene + Cell Therapies for Cancer conference. In October 2024, Adicet presented ADI-270 data in an oral presentation at the ASGCT (Free ASGCT Whitepaper) 2024 Advancing Gene and Cell Therapies for Cancer conference.
Corporate Updates

Appointed Lloyd Klickstein, M.D., Ph.D. to Board of Directors. In August 2024, Adicet appointed Dr. Lloyd Klickstein to its Board of Directors. Dr. Klickstein brings over two decades of leadership experience in the biopharmaceutical industry and biomedical research, and expertise in rheumatology and immunology to Adicet. Dr. Klickstein currently serves as President and Chief Executive Officer of Koslapp Therapeutics, Inc. and is the Board Chair of the Lupus Foundation of New England.
Financial Results for Third Quarter 2024:

Research and Development (R&D) Expenses: R&D expenses were $26.3 million for the three months ended September 30, 2024, compared to $26.2 million during the same period in 2023. The increase in R&D expenses was primarily due to a $0.9 million increase in laboratory expenses, a $0.8 million increase in payroll and personnel expenses as well as a less than $0.1 million increase in professional fees for the period. This increase was partially offset by a $1.3 million decrease in expenses related to contract development manufacturing organizations and other externally conducted research and development and a $0.4 million decrease in allocated facility expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended September 30, 2024, compared to $6.6 million during the same period in 2023. The increase in general and administrative expenses was primarily due to a $0.3 million increase in payroll and personnel expenses.
Net Loss: Net loss for the three months ended September 30, 2024 was $30.5 million, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $6.8 million, as compared to a net loss of $49.9 million, or a net loss of $1.16 per basic and diluted share, including non-cash goodwill impairment expense of $19.5 million and non-cash stock-based compensation expense of $5.6 million during the same period in 2023.
Cash Position: Cash, cash equivalents and short-term investments in treasury securities were $202.1 million as of September 30, 2024, compared to $159.7 million as of December 31, 2023. The Company expects that current cash, cash equivalents and short-term investments as of September 30, 2024, will be sufficient to fund its operating expenses into the second half of 2026.

On November 6, 2024 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the third quarter and first nine months of 2024 (Press release, Qiagen, NOV 6, 2024, View Source [SID1234647827]).

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Net sales rose 5% to $502 million in Q3 2024 over Q3 2023, while results at constant exchanges rates (CER) of $502 million rose 6% and were above the outlook for at least $495 million CER. The adjusted operating income margin rose three percentage points to 29.6% on benefits from the recent decision to discontinue the NeuMoDx system as well as broader efficiency gains that have improved profitability and freed up resources for targeted reinvestment. Adjusted diluted earnings per share (EPS) were $0.57, and results at CER of $0.58 were above the outlook for at least $0.55 CER.

QIAGEN has reaffirmed its FY 2024 sales outlook for at least $1.985 billion CER based on the solid core business performance in the first nine months of the year. The outlook for adjusted diluted EPS has been increased to at least $2.19 CER (previously $2.10 CER at start of 2024), while the adjusted operating income margin target has been reaffirmed for at least 28.5% compared to 26.9% in 2023.

"QIAGEN delivered another solid performance in the third quarter of 2024, exceeding our goals for net sales and adjusted earnings thanks to the strong trends in our business and the resilience of our portfolio with over 85% of sales from highly recurring revenues. We are executing quarter after quarter in this challenging macro environment on delivering sales growth combined with market share gains and operational efficiency thanks to a differentiated portfolio," said Thierry Bernard, CEO of QIAGEN.

"The value of our portfolio was again underscored with three QIAGEN customers recently being awarded Nobel Prizes for their groundbreaking contributions to advancing science and improving healthcare. Our teams are constantly enhancing this portfolio, and recent developments include the launch of 100 new assays for the QIAcuity digital PCR system along with the new QIAcuityDx version for clinical applications. We have expanded the utility of our QIAstat-Dx system beyond syndromic testing through new pharma partnerships with AstraZeneca and Eli Lilly. This progress in 2024 to achieve our goals marks a key step toward achieving our 2028 targets and delivering on our commitment to solid profitable growth," Bernard said.

"Our 2024 results to date reflect a positive quarterly trend in sales and adjusted earnings, along with a 73% increase in free cash flow. We are well-positioned to achieve the updated outlook for 2024 as we once again increase our adjusted EPS target," said Roland Sackers, CFO of QIAGEN. "We are implementing initiatives to simplify QIAGEN and increase efficiency, and these initiatives are putting us on track to increase our adjusted operating income margin above 31% by the end of 2028, reaffirming our commitment to solid profitable growth."

Please find the full press release incl. tables as a PDF for download at the top of this page.
Investor presentation and conference call

A conference call is planned for Thursday, November 7, 2024 at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a recording will also be made available after the event. A presentation will be available before the conference call at View Source