On November 3, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported updated Phase 1 clinical, biomarker and translational data on HB-200 as a monotherapy in heavily pretreated patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancer (Press release, Hookipa Pharma, NOV 3, 2023, View Source [SID1234636884]). The data show HB-200 monotherapy induced robust, high-quality and durable tumor-specific T cell responses, which showed a trend of clinical benefit measured by a 44 percent disease control rate in a difficult-to-treat patient population. The data were presented in a poster presentation (abstract #679) at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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"The data presented at SITC (Free SITC Whitepaper) expand the body of evidence that HB-200 monotherapy has the ability to induce targeted T cells necessary for tumor control, which can translate into tumor shrinkage and encouraging clinical activity, especially in a difficult-to-treat population," said Joern Aldag, Chief Executive Officer at HOOKIPA. "As the data have matured, we have consistently delivered best-in-class T cell activation, and we continue to see the durability and functionality of tumor-specific T cells induced by HB-200. We look forward to sharing continued analyses of HB-200 across all arms of our trial in the future."

HB-200 Phase 1 biomarker results (NCT04180215)
As of March 31, 2023, 93 patients with HPV16+ recurrent/metastatic cancer were treated in the Phase 1 trial of HB-200. The goal of the trial was to determine the recommended dose for further evaluation in a Phase 2 study. All patients were heavily pretreated with a median of 3 prior therapies (range 1-11).

Biomarker and translational data results
HB-200 demonstrated a robust increase in tumor-specific CD8+ T cells in all evaluable patients with HPV16+ head and neck cancers. These results are from intracellular staining of blood samples from 35 patients across all four dose levels tested in Phase 1. An analysis of 29 of these patients—treated at either the recommended phase 2 dose (RP2D) or RP2D-1—showed that T cell increases were rapid and sustained for at least 8 months, and T cell function improved over time with repeat dosing. Quantity and quality of T cells are considered important for tumor infiltration and subsequent tumor control.

Importantly, paired biopsy data suggest an association between the induction of robust, high-quality, tumor-specific T cells after HB-200 treatment and best overall response. Paired biopsy data from 13 heavily pretreated patients show that patients who achieved disease control after treatment with HB-200 monotherapy generally had greater CD8+ T cell infiltration in tumors and the tumor microenvironment compared to patients with a best overall response of disease progression.

Additional Phase 1 data
The poster presentation also includes updated clinical activity and safety data from the Phase 1 study. As of the August 7 data cut-off, there were 27 evaluable patients with HPV16+ head and neck cancers who received HB-200 at the at RP2D or RP2D-1. Among these difficult-to-treat patients, HB-200 demonstrated a 44 percent disease control rate, with 1 confirmed partial response and 11 patients with stable disease. While overall survival is still maturing, median overall survival is approximately 13 months, with a median follow-up period of 6.3 months.

Phase 1 data also consistently demonstrate that HB-200 was generally well tolerated among 93 patients treated across all dose-level cohorts. Treatment-related adverse events grade 3 or above were reported in 11.8 percent of patients (n=11), while those leading to treatment discontinuation were reported in only 2.2 percent of patients (n=2). This favorable tolerability profile highlights the potential of HB-200—and arenaviral immunotherapies in general—to be safely combined with other immunotherapies.

Data presentation details:

Title: Characterization of tumor-specific CD8+ T cell responses in patients with recurrent/metastatic HPV16-positive head and neck cancer receiving HB-200 monotherapy as second or later-line treatment in a Phase 1 study
Presenter: Dr. Winston Wong, Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a trial investigator
Abstract: 679
About HB-200
HB-200 is HOOKIPA’s lead oncology candidate engineered with the company’s proprietary replicating arenaviral vector platform. It comprises two single-vector compounds with arenaviral backbones based on lymphocytic choriomeningitis virus and pichinde virus. Both express the same transgene encoding an E7E6 fusion protein derived from HPV16. HB-200 is an alternating 2-vector immunotherapy designed to further focus the immune response against the encoded antigen. HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line recurrent/metastatic HPV16+ head and neck cancers.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial evaluating HB-200 for the treatment of advanced HPV16+ cancers. Phase 1 assessed various dose levels, regimen, and modes of administration in a post-standard of care setting. Based on safety and tolerability, initial anti-tumor activity and T cell response data, HB-200 advanced for further development in Phase 2. The Phase 2 part of the trial is open label with primary endpoints of efficacy based on objective response and disease control rate as defined by RECIST 1.1 and iRECIST. The trial is evaluating HB-200 in combination with pembrolizumab in the 1st-line and 2nd-line plus settings, as well as HB-200 alone in the post-standard of care setting.

About Human Papillomavirus-driven Cancers
Human Papillomavirus, or HPV, is a common viral infection estimated to cause about 5 percent of the worldwide cancer burden. This includes up to 60 percent of head and neck, 89 percent of cervical, 78 percent of vaginal, 88 percent of anal, 67 percent of vulvar and 50 percent of penile cancers.

While there are numerous HPV types associated with cancer, HPV16 is the most common cause of cancer. Most HPV infections are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.

On November 3, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported its financial results and highlights for the third quarter ended September 30, 2023. Cash and cash equivalents as of September 30, 2023 were $49.4 million (Press release, GlycoMimetics, NOV 3, 2023, View Source [SID1234636883]).

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"We look ahead to 2024 with anticipation and excitement. Topline results for our pivotal Phase 3 study of uproleselan in relapsed/refractory AML remain on track by the end of Q2 and together with our potential NDA filing before the end of 2024 represent a transformational opportunity for patients, clinicians, and our company," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "Our progress toward these important milestones, along with the upcoming presentation of independent data on uproleselan at ASH (Free ASH Whitepaper) and the expected initial results of our Phase 1a GMI-1687 study by end of Q1 2024, demonstrate our ability and ambition to deliver our development strategy and move closer to becoming a commercial stage company."

Operational Highlights

Uproleselan

In Q2, GlycoMimetics announced U.S. Food and Drug Administration (FDA) clearance of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for R/R AML. This amendment provides for a time-based analysis of the primary endpoint of overall survival after a defined cutoff date, if the 295 survival events of the originally planned event-driven analysis have not been observed by that date. With the addition of the time-based analysis, the company expects topline results by the end of Q2 2024.
The National Cancer Institute (NCI) Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2/3 clinical trial (NCI protocol A041701) evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. Enrollment of the Phase 2 portion of the study was completed in December of 2021. The company reiterates that when available, it will share these results.
The company agreed with the European Medicines Agency on a Pediatric Investigational Plan (PIP), which followed the prior agreement with the FDA in Q2 2023 on an initial Pediatric Study Plan (iPSP). The PIP and iPSP each include a deferral for study completion, and a waiver for children less than 28 days of age. As part of the pediatric plans, an NCI sponsored Phase 1/2 pediatric trial is currently being conducted by the Children’s Oncology Group Pediatric Early Phase Clinical Trials Network. The Phase 1/2 dose escalation study (NCI protocol PEPN2113) evaluates the safety and preliminary activity of uproleselan plus fludarabine and high dose cytarabine in pediatric AML patients after two or more prior therapies. The first patient in the Phase 1 portion of the study has been dosed with an expected enrollment of 18 patients.
Updated clinical data from an investigator-initiated trial studying the use of uproleselan in combination with chemotherapy for patients with treated secondary AML has been accepted for poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December. Investigators at MD Anderson Cancer Center are conducting the Phase 1b/2 clinical trial to evaluate safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and low dose cytarabine in patients with this difficult to treat subset of AML.
GMI-1687

In August, GlycoMimetics initiated a Phase 1a double-blind, single-center, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. It is expected to enroll approximately 40 subjects. Eligible subjects will receive a single dose of GMI-1687 or placebo (6:2 ratio) via subcutaneous injection. Safety, tolerability, and pharmacokinetics of up to five dose levels (3.3, 10, 20, 40, and 80 mg) will be evaluated. GMI-1687 is a highly potent E-selectin antagonist that has potential application in inflammatory diseases with initial focus on sickle cell disease. Initial results are expected by the end of Q1 2024.
Third Quarter 2023 Financial Results:

Cash position: As of September 30, 2023, GlycoMimetics had cash and cash equivalents of $49.4 million as compared to $47.9 million as of December 31, 2022.
R&D Expenses: The company’s research and development expenses increased to $5.3 million for the quarter ended September 30, 2023, as compared to $4.9 million for the same period in 2022. The increased expenses were primarily due to the clinical development costs related to the Phase 1a trial of GMI-1687 in healthy adult volunteers, which was initiated in August 2023; the increase was partially offset by decreased personnel-related and stock-based compensation costs due to a lower number of personnel than in the prior year.
G&A Expenses: The company’s general and administrative expenses increased to $4.5 million for the quarter ended September 30, 2023, as compared to $3.8 million for the same period in 2022. The increased expenses were primarily due to higher personnel-related expenses and higher professional fees as the company advances uproleselan and prepares for potential regulatory filing and commercialization.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2023 were 64,368,843.
The company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link, and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a broad development program including a late-stage Phase 3 trial in acute myeloid leukemia (AML), has received Breakthrough Therapy and Fast Track designations from the FDA and Breakthrough Therapy designation from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect. Uproleselan is intended to enable a novel approach to disrupting established mechanisms of leukemic cell resistance.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that has been shown in animal models to be fully bioavailable following subcutaneous administration. This second-generation compound is currently being studied in a Phase 1a double-blind, single-center, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. GMI-1687 is believed to have potential application in inflammatory diseases, and the company’s initial development focus is treatment of sickle cell disease (SCD). E-selectin is believed to play a major role in vaso-occlusive crisis (VOC), the vascular clots and blockages that cause pain crises in people living with SCD. Administration of GMI-1687 via subcutaneous injection, if successfully developed in the clinic, may enable the drug to address current challenges of IV therapies for SCD as well as offer a potential point-of-care treatment option at the onset of VOC.

On November 3, 2023 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), reported that data from three immuno-oncology pipeline programs at the 38th Annual Meeting of SITC (Free SITC Whitepaper) taking place November 1 – 5, 2023 at the San Diego Convention Center in San Diego, CA (Press release, Coherus Biosciences, NOV 3, 2023, View Source [SID1234636882]). Preclinical data presented support differentiated mechanisms of its next-generation immunotherapies potentially enabling the antitumor immune activation in more cancer patients and enhanced treatment outcomes.

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"These data presented at SITC (Free SITC Whitepaper) highlight the complementary mechanisms that we have in our innovative immunotherapy portfolio, including anti-PD-1, anti-IL27 and anti-CCR8, and the promise of novel immuno-oncology treatment combinations that may overcome the challenging tumor microenvironment," said Theresa LaVallee, Ph.D., Coherus’ chief development officer. "LOQTORZI is the first approved treatment option for patients with nasopharyngeal carcinoma (NPC), and we will continue to generate and use data to optimize our clinical development plans through the selection of additional tumor types and immuno-oncology combinations that can have the greatest impact on extending survival for cancer patients."

Casdozokitug (CHS-388, formerly SRF388), a first-in-class anti-IL-27 antibody
Interleukin (IL)-27 is an immunoregulatory cytokine involved in resolving inflammation and inhibiting anti-tumor immune responses. Blocking IL-27 with casdozokitug in clinical trials has led to monotherapy tumor growth inhibition and partial responses in patients with non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) (NCT04374877) and ongoing trials are studying combinations with PD-1/PD-L1 pathway blockade in NSCLC and hepatocellular carcinoma (HCC). Data presented at SITC (Free SITC Whitepaper) 2023 demonstrate IL-27-mediated gene expression, highlighting its critical role in immune suppressive mechanisms in the tumor microenvironment and importance as a new target for cancer treatment, as well as an opportunity to identify biomarkers that could determine patients most likely to respond to anti-IL-27 treatment.

Abstract #1351: Identifying IL-27 dependent biomarkers in lymphocytes, NK cells, and myeloid cells in peripheral blood and the tumor microenvironment
Date and Time: Friday, November 3, 9 a.m.–7 p.m. Pacific Daylight Time (PDT)
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation data are summarized as follows:

In human immune cells from peripheral blood, IL-27 induces the expression of interferon (IFN)-stimulated genes, which are associated with drug resistance in cancer
Although many known IFN-responsive genes were induced by both IFNs and IL-27 treatment, distinct gene expression was observed in different immune cell types
IL-27 and IFNs induce unique gene expression in different cell types, for example, GBP5 (guanylate-binding protein 5) and IRF1 (interferon regulatory factor 1), two interferon stimulated genes, are preferentially elevated by IL-27 in NK cells and CD8+ T cells
Immunohistochemistry (IHC) analysis of treatment-naïve NSCLC tumor samples showed that IL-27+ macrophages are co-localized with GBP5+ T-cell-rich areas in the TME
These studies lend insights into the immune interplay between IFNs and IL-27 signaling across different immune cells and within the TME and ascertain the immunosuppressive role of IL-27 and may inform casdozo clinical development.
CHS-114 (formerly SRF114), an anti-CCR8 antibody
CCR8 is a chemokine receptor predominantly expressed by tumor infiltrating Tregs that suppress the body’s natural anti-cancer immune response. Targeting CCR8 is a promising potential therapeutic strategy designed to deplete Tregs, reshape the tumor microenvironment and enhance anti-tumor immune response. CHS-114 is designed to selectively target human CCR8 and preferentially depletes CCR8+ Treg cells and not T effector (Teff) cells in tumors or normal tissue. Data presented demonstrate the role of CCR8+ Tregs as dominant immunosuppressive cells in the TME and highlight head and neck squamous cell carcinoma (HNSCC) as a promising tumor type in which CHS-114 could have anti-tumor activity as monotherapy or in combination with an anti-PD1 antibody. CHS-114 is currently being evaluated in a Phase 1 clinical trial (NCT05635643).

Abstract #1354: Anti-CCR8 antibody SRF114 depletes tumor-infiltrating regulatory T cells in dissociated tumors from patients with head and neck squamous cell carcinoma
Date and Time: Saturday, November 4, 9 a.m.–8:30 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation data are summarized as follows:

Chemokine receptor 8 (CCR8) expression is highly enriched on intratumoral Tregs within the TME cells, particularly in HNSCC
In multiple model systems, CHS-114, a cytolytic antibody selective for CCR8, activates natural killer (NK) cells and specifically induces NK-mediated cytotoxicity against tumor-infiltrating CCR8+ Tregs and results in the expansion of effector CD8 T cells
Enhanced antitumor immunity is observed with combination of Anti-CCR8 and anti-PD-1 combination treatment
CHS-114, a CCR8-specific cytotoxicity-inducing antibody that preferentially depletes CCR8+ Treg cells and not T effector (Teff) cells, is currently being evaluated in a Phase 1 clinical trial (NCT05635643).
LOQTORZI (toripalimab-tpzi), a next generation anti-PD-1 antibody
PD-L1 is a protein found on the surface of some cancer cells that can help evade the body’s immune system by suppressing T cell activation and inhibiting the T cell’s ability to kill cancer cells. LOQTORZI is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site with high affinity to activate antitumor immunity. Data presented compare mechanistic data for LOQTORZI to commercially available anti-PD-1 monoclonal antibodies and demonstrate higher expression of key immune system biomarkers with LOQTORZI. Additionally, LOQTORZI in combination with chemotherapy shows enhanced clinical efficacy irrespective of PD-L1 status across multiple tumor types in post hoc analyses of 3 randomized controlled clinical trials in NPC, NSCLC and esophageal squamous-cell carcinoma (ESCC). LOQTORZI (toripalimab-tpzi) was recently approved by the U.S. Food and Drug Administration (FDA) for metastatic or recurrent NPC as first-line treatment in combination with chemotherapy or as second- or greater-line monotherapy treatment.

Abstract #468: Characteristics of toripalimab: a next generation anti-PD-1 antibody with potent T cell activation and enhanced clinical efficacy irrespective of PD-L-1 status
Date and Time: Saturday, November 4, 9 a.m.–8:30 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation data are summarized as follows:

Toripalimab in combination with chemotherapy demonstrates clinical efficacy irrespective of PD-L1 status
Toripalimab exhibits a 12-fold higher binding affinity to PD-1 compared to pembrolizumab
Toripalimab promotes a stronger Th1-mediated response than pembrolizumab in vitro in human peripheral blood mononuclear cells (PBMCs)
Toripalimab induced an elevated IFN- gene signature in NSCLC dissociated tumor cells with different kinetics and higher intensity compared to pembrolizumab
In comparison to other commercially available anti-PD-1 antibodies, toripalimab exhibits the lowest potential for partial agonism by recruiting low levels of SHP1 and SHP2, negative regulators of T cell activation
About LOQTORZI (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.
For more information, please see LOQTORZI.com for FDA-approved indications and full prescribing information.

About Casdozokitug
Casdozokitug (formerly SRF388) is a first-in-class human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Particular tumor types have been identified where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, a potential biomarker associated with IL-27 has been identified that may be useful in helping identify patients most likely to respond to casdozokitug. It is the first IL-27 antibody to enter the clinic.

About CHS-114
CHS-114 (formerly SRF114) is a human, cytolytic anti-CCR8 antibody designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment and not T effector (Teff) calls in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) pathways to deplete intertumoral Treg cells. In addition, CHS-114 reduced tumor growth in murine models. CHS-114 is currently being evaluated in a Phase 1 clinical trial (NCT05635643) as a therapeutic candidate that holds the potential to drive anti-tumor immunity in patients.

On November 3, 2023 Cimeio Therapeutics, a biotechnology company that is the leader of the field of epitope editing, reported the acceptance of two abstracts to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2023 in San Diego (Press release, Cimeio Therapeutics, NOV 3, 2023, View Source [SID1234636881]).

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The first abstract is titled "Hematopoietic Stem Cells Expressing Engineered CD45 Enable a Near Universal Targeted Therapy for Hematologic Diseases." These data demonstrate that CD45 antibody-drug conjugate (ADC) therapy effectively treated aggressive AML tumors in mouse models. The CD45 ADC therapy was enabled by epitope-edited blood stem cells (HSPCs), which maintain their function but resist depletion by the ADC. This combination therapy could have therapeutic potential in AML and other hematologic malignancies.

The second abstract is titled "Base Edited HSPCs Are Shielded from Targeted CD33 Therapy but Preserve CD33 Expression." This abstract outlines the development of an edited epitope for CD33, which also resists depletion by paired CD33-directed immunotherapies while maintaining its expression. CD33 represents the fourth target Cimeio has demonstrated it can effectively shield from immunotherapy depletion.

"These data represent important steps in our quest to develop a novel therapy with the potential to cure patients with AML," said Cimeio CEO Thomas Fuchs. "This work gives us high confidence that our immunotherapies have the potential to transform the treatment of AML and other hematologic malignancies."

Presentation Details
Title: Hematopoietic Stem Cells Expressing Engineered CD45 Enable a Near Universal Targeted Therapy for Hematologic Diseases
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM-8:00 PM
Location: San Diego Convention Center Halls G-H

Title: Base Edited HSPCs Are Shielded from Targeted CD33 Therapy but Preserve CD33 Expression
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM-8:00 PM
Location: San Diego Convention Center Halls G-H

On November 3, 2023 Cerus Corporation (NASDAQ:CERS) reported that the Company will participate in two upcoming investor conferences (Press release, Cerus, NOV 3, 2023, View Source [SID1234636880]):

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William "Obi" Greenman, Cerus’ president and chief executive officer, is scheduled to participate in a fireside chat at The Stifel 2023 Healthcare Conference on Tuesday, November 14th, at 4:10 p.m. EST, at the Lotte New York Palace Hotel. A live webcast of the fireside chat will be available here. A replay will be available after the event.
Kevin Green, Cerus’ vice president and chief financial officer, is scheduled to participate in a fireside chat at The Stephens Annual Investment Conference on Wednesday, November 15th, at 1:00 p.m. EST, at the Grand Hyatt in Nashville, TN. A live webcast of the fireside chat will be available here. A replay will be available after the event.