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City of Hope Reveals New Data on Cancer Immunotherapies, Microbiome and Other Innovative Topics at 2024 American Society of Hematology (ASH) Annual Meeting

On November 21, 2024 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States and ranked among the nation’s top 5 cancer centers by U.S. News & World Report, reported that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH (Free ASH Whitepaper) annual meeting from Dec. 7 to 10 in San Diego (Press release, City of Hope, NOV 21, 2024, View Source [SID1234648564]).

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City of Hope in ASH (Free ASH Whitepaper) Press Program

Two City of Hope researchers will present at ASH (Free ASH Whitepaper) press briefings, and one of its leaders is a senior author on an abstract that will be discussed in the press program as well.

Title: Increased Fiber Intake Results in Better Overall Survival and Lower GI-aGVHD in Allo-HCT Recipients and Pre-Clinical Gvhd Models
Oral Abstract Number: 259
Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST
Presenter: Jenny Paredes, Ph.D., City of Hope staff scientist, who will also receive an ASH (Free ASH Whitepaper) Outstanding Abstract Achievement Award for this research

Title: A High-Fiber Dietary Intervention (NUTRIVENTION) in Precursor Plasma Cell Disorders Improves Biomarkers of Disease and May Delay Progression to Myeloma
Oral Abstract Number: 671
Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST
City of Hope Senior Author: Marcel van den Brink, M.D., Ph.D., president, City of Hope Los Angeles/City of Hope National Medical Center and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D.

Title: Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of Epcore CLL-1
Oral Abstract Number: 883
Press Briefing Date/Time and Embargo Lift Time: Sunday, Dec. 8, 8 a.m. PST
Presenter: Alexey Danilov, M.D., Ph.D., City of Hope Marianne and Gerhard Pinkus Professor in Early Clinical Therapeutics, and associate director, Toni Stephenson Lymphoma Center

City of Hope ASH (Free ASH Whitepaper) Oral Presentations

In addition, City of Hope doctors will present 22 oral abstracts with the following highlights:

Title: 980 Results From the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients With Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization
Session Date and Time: Monday, Dec. 9, 4:45 p.m. PST
Presenter: Jasmine Zain, M.D., City of Hope professor, Division of Lymphoma, and director, T Cell Lymphoma Program

Title: 468 Randomized Phase 2 Trial of the Anti-PD-L1 Monoclonal Antibody Durvalumab Plus Lenalidomide Versus Single-Agent Durvalumab in Patients With Refractory/Advanced Cutaneous T Cell Lymphoma
Session Date and Time: Sunday, Dec. 8, 10:45 a.m. PST
Presenter: Christiane Querfeld, M.D., Ph.D., City of Hope professor, Division of Dermatology, and director, Cutaneous Lymphoma Program

Title: 211 Updated Results and Longer Follow-Up From the AUGMENT-101 Phase 2 Study of Revumenib in All Patients With Relapsed or Refractory (R/R) KMT2Ar Acute Leukemia
Session Date and Time: Saturday, Dec. 7, 2 p.m. PST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Title: 524 Real-World Outcomes of CD19CAR T Cell Therapy in Adult Patients With Relapsed Refractory Transformed Indolent Lymphoma
Session Date and Time: Sunday, Dec. 8, 9:45 a.m.
Presenter: Swetha Kambhampati Thiruvengadam, M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Title: 210 Disrupting Mitochondrial Dynamics and Metabolism in Leukemic Stem Cells through Mitochondrial PCNA Inhibition: The Role of AOH1996
Session Date and Time: Saturday, Dec. 7, 3:15 p.m. PST
Presenter: Hyunjun Kang, Ph.D., City of Hope staff scientist, Department of Hematologic Malignancies Translational Science

Title: 1043 Final Analysis of Phase 2a Study of Adding Itacitinib to Tacrolimus/Sirolimus Gvhd Prophylaxis After Fludarabine/Melphalan-Based Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, Myelodysplastic Syndrome (MDS), or Myelofibrosis (MF)
Session Date and Time: Monday, Dec. 9, 5:30 p.m. PST
Presenter: Haris Ali, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and section leader, Myeloproliferative Neoplasms Program

Title: 966 CD19-CAR T Cells As Definitive Consolidation for Older Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study
Session Date and Time: Monday, Dec. 9, 5:45 p.m. PST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Title: 685 The Composite Health Risk Assessment Model (CHARM) Predicts Risks of Toxicities, Functional and Cognitive Decline Among Survivors of Allogeneic Hematopoietic Cell Transplantation (allo-HCT): A Prospective BMT-CTN Study 1704
Session Date and Time: Sunday, Dec. 8, 4:30 p.m. PST
Senior Author: Andrew Artz, M.D., M.S., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and director, Aging and Blood Cancers Program

City of Hope doctors will also lead in the following ASH (Free ASH Whitepaper) events:

The 13th Annual BMT & Cell Therapy Winter Workshop, co-chaired by Dr. Van den Brink, will be held on Friday, Dec. 6, 2024, prior to the ASH (Free ASH Whitepaper) conference. The workshop focuses on innovative research pertinent to hematopoietic stem cell transplantation and cell therapy.
Dr. Van den Brink will also speak at a scientific symposium titled "Placing the Brakes on Accelerated Aging" about targeting rejuvenation therapies to decelerate aging on Monday, Dec. 9, 2024.
Jianjun Chen, Ph.D., Simms/Mann Family Foundation Chair in Systems Biology, will speak at a scientific workshop titled "Therapy Resistance Mechanisms in Blood Malignancies Program" about RNA modification and therapy resistance in acute leukemia on Friday, Dec. 6, 2024.

AbCellera to Present at Upcoming Investor Conferences in December and January

On November 21, 2024 AbCellera (Nasdaq: ABCL) reported that executives from the Company will present at the following investor conferences (Press release, AbCellera, NOV 21, 2024, View Source [SID1234648563]):

Piper Sandler 36th Annual Healthcare Conference in New York, NY on Tuesday, December 3, 2024, at 11:30 a.m. Pacific Time (2:30 p.m. Eastern Time)
43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 15, 2025, at 4:30 p.m. Pacific Time (7:30 p.m. Eastern Time)

Live audio webcasts of the presentation may be accessed through the link that will be posted on AbCellera’s Investor Relations website. Replays of the webcast will be available through the same links following the presentations.

DP Technology and Lepu Biopharma Announce Milestone Collaboration: Leveraging Advanced Computational Methods to Accelerate ADC Drug Innovation

On November 20, 2024 Lepu Biopharma Co., Ltd. (Lepu Biopharma) and Beijing DP Tech Co., Ltd. (DP Technology) reported a significant milestone in their Antibody-Drug Conjugate (ADC) drug collaboration (Press release, Lepu Biopharma, NOV 21, 2024, View Source [SID1234648561]). This partnership has effectively integrated DP’s ADC Linker-Payload design platform with Lepu’s ADC technology development platform, capitalizing on their respective strengths. The overall optimization of the ADC drug has been achieved in a relatively short time. This project has reached an important milestone, further validating the approach of accelerating ADC innovative drug development through computational design. Moving forward, both parties will continue to deepen their R&D collaboration in this field, jointly committed to promoting the continuous optimization and advancement of innovative drug development processes.

The ADC Linker Payload design platform, meticulously crafted by DP Technology, utilizes "RiDYMO", an AI-for-Science driven hit discovery platform. Furthermore, "AI + first principles" based computational methods are employed to predict linker cleavage sites and ensure the correct payload release, achieving outstanding cell-killing and bystander effects. Additionally, the designed antibody-drug conjugates (ADCs) maintain excellent hydrophilicity and plasma stability. Leveraging Lepu’s mature and complete ADC development system, candidates developed by the new ADC platform have demonstrated significant efficacy in CDX models targeting multiple targets. This project has been successfully validated in animal models and is currently advancing the candidate ADC to the clinical stage.

Lei Fang, Ph.D., Vice President of Lepu Biopharma and CEO of CtM Bio Co., Ltd., expressed high appreciation for this cooperation: "Introducing advanced computational methods to solve scientific problems and jointly pioneering breakthrough explorations is our goal in the ADC project collaboration. As a leader in ‘AI for Science’, DP Technology has played a crucial role in this project with its newly developed ADC design platform. By integrating Lepu Biopharma’s advanced ADC development platform with AI-driven design, we proposed novel perspectives on ADC development while significantly expediting the process. By complementing each other’s strengths, we jointly provide new inspiration and ideas for innovative ADC drug design."

Weijie Sun, CEO of DP Technology, expressed great anticipation for future collaboration: "Lepu Biopharma, as an innovative biopharmaceutical company focused on cancer treatment, particularly in the areas of targeted therapy and immunotherapy, has extensive experience and a long-standing track record in developing innovative ADC drugs. We firmly believe that our close cooperation will significantly accelerate the design and development of ADC drugs, and we are optimistic about the potential to develop innovative, highly effective, and differentiated new ADC therapies. I am eagerly anticipating the ongoing and deepened collaboration between both companies in the field of pharmaceutical innovation!"

Concerning the various demands from industry partners in the ADC field, DP Technology’s ADC platform has successfully empowered various scenarios and projects. For instance, it utilizes AI combined with first-principles calculations to predict linker cleavage sites and improve attachment stability. By integrating pre-trained models with fine-tuning strategies and expert insights, the platform can predict and modify physicochemical properties such as payload efflux and bystander effects. Additionally, there is ongoing exploration and collaboration in the overall evaluation of properties like aggregation effects in ADCs.

Intensity Therapeutics, Inc. Announces Pricing of $3 Million Registered Direct Offering and Concurrent Private Placement

On November 21, 2024 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or the "Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the issuance and sale of 1,237,113 shares of its common stock in a registered direct offering at a purchase price of $2.425 per share (Press release, Intensity Therapeutics, NOV 21, 2024, View Source [SID1234648559]).

In a concurrent private placement (the "Private Placement" and together with the Registered Offering, the "Offerings"), the Company also agreed to issue to the same investor warrants to purchase up to 1,237,113 shares of its common stock (the "Common Warrants"). The Common Warrants have an exercise price of $2.95 per share, will be exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.

The gross proceeds from the Offerings, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $3 million. The Company expects to use the net proceeds from the Offerings for general working capital.

A.G.P./Alliance Global Partners is acting as lead placement agent for the Offerings and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-placement agent for the Offerings.

The Offerings are expected to close on or about November 22, 2024, subject to the satisfaction of customary closing conditions.

The shares (or common stock equivalents in lieu thereof) offered to the institutional investor described above are being offered pursuant to a registration statement on Form S-3 (File No. 333-280681), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 11, 2024. The Offering is being made only by means of a prospectus which is a part of the effective registration statement. The Common Warrants will be issued in a concurrent private placement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected], or Brookline Capital Markets, a division of Arcadia Securities, LLC, 600 Lexington Avenue, 20th Floor, New York, NY 10022, or by telephone at (646) 256-5258, or by email at [email protected].

The private placement of the Common Warrants and the shares underlying the Common Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placements may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this Offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

InxMed FAK Inhibitor Ifebemtinib Received Breakthrough Therapy Designation by China National Medical Products Administration for First-Line Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation

On November 21, 2024 InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against cancer treatment resistance and metastasis, reported that China National Medical Products Administration (NMPA) has granted Ifebemtinib (IN10018) Breakthrough Therapy designation (BTD) for the first-line (1L) treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation (Press release, InxMed, NOV 21, 2024, View Source [SID1234648558]). This is the second BTD ifebemtinib received. In April 2022, ifebemtinib was granted its first BTD for the treatment of platinum-resistant ovarian cancer (PROC) in combination with PEG-liposomal doxorubicin (PLD).

Ifebemtinib is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has demonstrated significant clinical synergies with targeted therapies, immunotherapies, and standard chemotherapies.

The BTD is supported by the data from the Phase Ib/II study evaluating the efficacy and safety of ifebemtinib in combination with garsorasib for the 1L treatment of NSCLC with KRAS G12C mutation (NCT06166836). The results of the clinical trial were featured at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The dual-oral regimen showed promising antitumor efficacy with a well-tolerated safety profile in 1L KRASG12C NSCLC. The objective response rate (ORR) was 90.3% and the disease control rate (DCR) was 96.8%. A total of 28 confirmed partial responses (PRs) and two stable diseases (SDs) were reported from 31 efficacy evaluable patients. All treated patients have achieved a follow-up visit of 9 months so far, and the median PFS has not been reached at the time of this report.

Beyond KRAS G12C inhibitors, Ifebemtinib has also shown significant therapeutic synergies when combined with a wide range of standard and emerging cancer treatments, such as anti-PD-(L)1 antibodies, other RAS-targeted inhibitors, EGFR inhibitors, and ADCs. InxMed is actively pursuing collaborations with innovating partners globally。

InxMed is currently conducting a registrational trial in platinum-resistant ovarian cancer in China, for which the company plans to submit a New Drug Application to the NMPA in 2025. InxMed also has multiple proof-of-concept trials ongoing in lung, colorectal, melanoma, and pancreatic cancers, some of which will progress into pivotal studies. Thus far, more than 600 subjects have been treated with ifebemtinib, and a favorable safety and tolerability profile has been observed.