On December 9, 2023 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported new interim data from its Phase 1/1b clinical trial of soquelitinib in patients with relapsed PTCL (Press release, Corvus Pharmaceuticals, DEC 9, 2023, View Source [SID1234638322]). Soquelitinib demonstrated durable anti-tumor activity, evidenced by progression free survival, duration of response and overall survival rates that exceed current standard of care therapies for patients with relapsed PTCL. The data continues to support the advancement of soquelitinib into a Phase 3 registrational clinical trial in PTCL.

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"We have continued to enroll patients in the soquelitinib Phase 1/1b clinical trial to further confirm the eligibility requirements and design for our planned Phase 3 clinical trial," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "As anticipated, the additional patient data confirm that the number of prior therapies and immunocompetence are important patient eligibility requirements, with an optimum range of ≥1 to ≤3 prior therapies. The data also demonstrated anti-tumor activity, and in particular, durable responses, both of which continue to guide our plans to conduct a registration Phase 3 trial in relapsed peripheral T cell lymphoma. Overall, we are eager to initiate the Phase 3 clinical trial given the limited efficacy and challenging safety profile for the currently approved treatment options. If approved, soquelitinib would be the first approved agent for treatment of relapsed PTCL based on a randomized trial."

New Soquelitinib Interim Data from the Phase 1/1b Clinical Trial
Updated interim data as of November 27, 2023 (data shown below in Figures 1-3): A total of 36 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose, including 21 evaluable patients who would be eligible in the planned registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies (eligible patient population) and 11 evaluable in the corresponding ineligible population based on ˃3 prior therapies (ineligible patient population). In the Phase 1/1b clinical trial, the median number of prior therapies was 2 for the eligible patient population and 6 for the ineligible patient population. The rationale for enrolling these patient populations and the stratification analysis was to confirm the eligibility requirements planned for our Phase 3 clinical trial.

For the eligible patient population, objective responses (complete response, CR plus partial response, PR) were seen in 7 of 21 patients with disease control (CR, PR and stable disease) in 12 of 21 patients. The stable disease group included 5 patients who achieved tumor reductions that did not meet the criteria for a PR, with two of these patients continuing on therapy.
For the eligible patient population, the median duration of response (DOR) for the seven patients with objective response by Lugano criteria was 14.5+ months (ranged from 6.9-25.2 months); three of these patients continued on therapy.
A total of five patients in the eligible patient population remained on therapy, including one patient with a CR at 21+ months, two patients with a PR at 3+ and 8+ months, and 2 with stable disease at 3+ and 5+ months.
Kaplan Meier estimated median progression free survival was 6 months for the eligible patient population.
Kaplan Meier estimated overall survival at 2 years was 77% for all 36 patients.
One additional eligible patient, not shown here, was treated at a higher dose and achieved a PR. While in PR, this patient went on to receive a bone marrow transplant and achieved a CR, which has continued as of the data cutoff without any further therapy for 2+ years.
For the ineligible patient population, no objective responses were seen in 11 evaluable patients.

Molecular Studies on Patient Tumors Support Soquelitinib’s Novel Mechanism of Action
Additional new interim data from the Phase 1/1b clinical trial of soquelitinib will be presented today Ning Ding, Ph.D. from Peking University Cancer Hospital & Institute in Beijing, China, in a poster session (abstract #1442) at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is taking place in-person and virtually from December 9-12, 2023. The poster reports on the evaluation of blood samples and tumor biopsies from eight patients who participated in the trial, taken at baseline and during treatment (one patient was sampled during stable disease and again during response, and therefore was counted twice as reflected in the data below). The results support soquelitinib’s novel mechanism of action, and demonstrated increases in cytotoxic killer T cells and reductions in markers of T cell exhaustion:

Responding patients (N=2) showed a sustained increase in CD4+ Th1 cells in the blood and an increase in CD8+ TEMRA cells (T effector memory cells). TEMRA cells are T cells that have responded to an antigen and are able to mediate effector functions, such as the destruction of tumor cells.
Patients with stable disease (N=4) showed increases in these cell populations that were transient.
Patients who progress (N=3) showed no increase in these cells.
Single cell RNA sequencing of tumor biopsies showed soquelitinib treatment increased expression of cytolytic effector molecules and led to a reduction of T cell exhaustion markers.
Dr. Miller added, "We are pleased to see that the molecular studies presented at ASH (Free ASH Whitepaper) illustrate the importance of host immune system function and soquelitinib’s novel mechanism of action that acts by inducing a host anti-tumor immune response."

The ASH (Free ASH Whitepaper) poster is available to ASH (Free ASH Whitepaper) attendees in the poster hall and via the virtual event platform, and is also available on the Publications and Presentations page of the Corvus website.

On December 9, 2023 Bristol Myers Squibb (NYSE: BMY) reported updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl(luspatercept-aamt) versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes (MDS) (Oral Presentation #193) who may require red blood cell (RBC) transfusions (Press release, Bristol-Myers Squibb, DEC 9, 2023, View Source [SID1234638321]). These data are being presented in an oral presentation at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, from December 9-12.

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"These data from the COMMANDS trial, including additional patients and longer follow-up from the data shown at ASCO (Free ASCO Whitepaper), confirm the positive outcome of the interim analysis with superior efficacy and durability compared to ESAs and exemplify how Reblozyl may impact the treatment of anemia related to MDS," said Guillermo Garcia-Manero, M.D., lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center. "Further, beyond the intent-to-treat population, the analysis confirms that Reblozyl demonstrated clinical benefit across subgroups."

Results from COMMANDS are under review with the European Commission and served as the basis of a priority review approval by the United States Food and Drug Administration in August 2023 for Reblozyl as a treatment for anemia in ESA-naïve adult patients with very low- to intermediate-risk MDS who may require regular RBC transfusions. Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021.

COMMANDS Primary Results
At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa. Results from the primary analysis of the intent to treat (ITT) population showed:

60.4% (n=110) of patients receiving Reblozyl vs. 34.8% (n=63) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean hemoglobin (Hb) increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001).
Erythroid response (HI-E) increase of at least 8 weeks was achieved by 74.2% (n=135) of Reblozyl patients vs. 53% (n=96) of epoetin alfa patients (p<0.0001).
RBC transfusion independence (RBC-TI) of at least 12 weeks was achieved by 68.1% (n=124) of Reblozyl patients vs. 48.6% (n=88) of epoetin alfa patients (p<0.0001).
Duration of response was 126.6 weeks (99-NE) for Reblozyl in patients who achieved TI for at least 12 weeks (achieved weeks 1-24) compared to 89.7 weeks (61.9-123.9) for epoetin alfa (Hazard Ratio [HR]: 0.586; 95% Confidence Interval [CI]: 0.380-0.904, p=0.0147).
"As patients with lower-risk MDS often receive limited benefit from current standard therapies, including ESAs, these confirmatory data further show how Reblozyl has the potential to create a paradigm shift in the treatment of anemia associated with this disease," said Anne Kerber, senior vice president, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb.

Safety results were consistent with previous MDS studies, and progression to acute myeloid leukemia and total deaths were similar between arms of the study. The most common treatment-emergent adverse events in at least 10% of patients were diarrhea, fatigue, COVID-19, hypertension, dyspnea, nausea, peripheral edema, asthenia, dizziness, anemia, back pain and headache. Rates of reported fatigue and asthenia were shown to decrease over time.

In addition to the overall benefit observed in the ITT population, sub-analyses confirmed similar or greater RBC-TI of Reblozyl compared to epoetin alfa regardless of mutational profile, IPSS-M status, ring sideroblast status, transfusion burden and serum erythropoietin (sEPO) level. Duration of RBC-TI favored Reblozyl across all subgroups, including ring sideroblast status.

Finally, three posters will be presented highlighting additional analyses of the COMMANDS study and the mechanism of Reblozyl.

Reblozyl showed favorability over epoetin alfa in various mutational background observed in lower-risk MDS in an analysis of response by mutational burden (Poster Presentation #4591).
An analysis of clonal-hematopoiesis related mutations (Poster Presentation #3214) showed that 85% of patients in the COMMANDS study had at least one CHIP-related mutation. Further, Reblozyl was associated with the downregulation of inflammatory gene signatures and upregulation of anti-inflammatory pathways.
In another analysis (Poster Presentation #1845), Reblozyl was associated with modulation of inflammation and restoration of effective erythropoiesis in bone marrow samples from the COMMANDS study, reinforcing its role in the expansion and maturation of early and late-stage erythroid precursors.
About COMMANDS
COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve.

The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks. The majority of study participants (>90%) were outside of the United States and a non-U.S.-licensed epoetin alfa product was used in the control arm for such patients.

About MDS
Myelodysplastic syndromes (MDS) are a group of closely related blood cancers characterized by ineffective production of healthy red blood cells (RBC), white blood cells and platelets, which can lead to anemia and frequent or severe infections. People with MDS who develop anemia often require blood transfusions to increase the number of healthy RBCs in circulation. Frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections.Patients who become RBC transfusion-dependent have a significantly shorter overall survival than those who are not dependent on transfusions, partially due to iron overload or to more severe bone marrow disease than in non-transfusion dependent patients.

About Reblozyl(luspatercept-aamt)
REBLOZYL (luspatercept-aamt), a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models. REBLOZYL is being developed and commercialized through a global collaboration and North American co-promotion with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. REBLOZYL is indicated in the U.S. for the treatment of:

anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. In the U.S., REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

U.S. Important Safety Information
WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension
Hypertension was reported in 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed SBP ≥130 mm Hg and 23 (16%) patients developed DBP ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Extramedullary Hematopoietic (EMH) Masses
In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study).

In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.

Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta-Thalassemia
Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

ESA-naïve adult patients with Myelodysplastic Syndromes
Grade ≥3 (≥2%) adverse reactions included hypertension and dyspnea.

The most common (≥10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes
Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.

The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

LACTATION
It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

DRUG ABUSE POTENTIAL
Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

Please see accompanying U.S. Full Prescribing Information for REBLOZYL.

On December 9, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported the presentation of data from a comprehensive safety review of patients treated in the Phase 1 ALPHA/ALPHA2 trials with ALLO-501/501A at the 65th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA (Press release, Allogene, DEC 9, 2023, View Source [SID1234638317]).

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The safety review, which encompasses all 87 Phase 1 patients treated in both relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL), demonstrates that investigational ALLO-647 added to standard lymphodepletion can safely provide a window for the expansion and persistence of AlloCAR T cells, and has the potential to induce deep and durable remissions in relapsed and treatment-refractory cancers.

"We believe in the immense potential of off-the-shelf CAR T products to not only address the limitations of current autologous CAR T cell therapy, but to also provide greater access to patients in need," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "We fully understand the importance of lymphodepletion to achieving optimal outcomes, and ALLO-647 is just the first generation of our innovative approaches to enhancing lymphodepletion to promote expansion of CAR T cells."

The inclusion of our ALLO-647 candidate in the lymphodepletion regimen is designed to selectively prevent host rejection of allogeneic CAR T cell products. As previously presented in the Phase 1 ALPHA/ALPHA2 studies1, CAR T cell-naive patients with r/r LBCL were able to obtain a durable response, including a complete remission rate of 42% and a median duration of response of 23.1 months.

In the studies, lymphodepletion consisted of three daily doses of fludarabine 30 mg/m2 and cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of ALLO-647 in divided doses prior to ALLO-501/501A infusion. The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.

No unexpected safety concerns were observed. Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs. Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients. Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy.2-4

Safety: TEAEs of Special Interest

TEAEs, n (%)
All (N=87)
LBCL FL (n=26)
All LBCL
(n=61) CAR T Cell–Naive Pts Who Received
ALLO-501/501A Manufactured With
The Phase 2 Selected Process (n=33)
Any Grade Grade ≥3 Any Grade Grade ≥3 Any Grade Grade ≥3 Any Grade Grade ≥3
CRS 21 (24) 1 (1) 17 (28) 1 (2) 8 (24) 0 4 (15) 0
ICANS 1 (1) 0 1 (2) 0 0 0 0 0
Neurotoxicity 24 (28) 3 (3) 19 (31) 3 (5) 13 (39) 2 (6) 5 (19) 0
GvHD 0 0 0 0 0 0 0 0
IRR 48 (55) 5 (6) 31 (51) 4 (7) 16 (48) 3 (9) 17(65) 1 (4)
Infections 50 (57) 18 (21) 34 (56) 13 (21) 19 (58) 5 (15) 16 (62) 5 (19)

There were no reports of graft-versus-host disease (GvHD) or Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS). In total, 24% of patients experienced low-grade CRS, and there was 1 Grade 3 CRS event. Infection events were primarily low grade and manageable, with the most common being cytomegalovirus reactivation with an any-grade incidence of 25% and a Grade 3 or higher incidence of 9%. Incidence of infections were consistent with that reported for autologous therapy following lymphodepletion (12%-33% percent of patients).3-5 Eight patients experienced fatal adverse events not related to study treatment.

The EXPAND trial, currently enrolling in the United States and Europe, is expected to support licensure of ALLO-647, used in conjunction with standard low-dose FC lymphodepletion regimens. The trial will enroll approximately 70 patients with r/r LBCL who will be randomized to lymphodepletion with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The primary endpoint of the study is progression free survival (PFS).

Separately, the Company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) for the investigation of ALLO-647 in adult patients with r/r LBCL based on its potential to enhance standard lymphodepletion. FTD designation is intended to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available. ALLO-647 is investigated as a lymphodepleting agent in combination with flu/cy prior to infusion of allogeneic CD19-directed CAR T cells with genomes edited to knock out CD52.

About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR TTM investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR TTM product, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.

On December 8, 2023 Halia Therapeutics reported to start a Phase II trial of its pipeline candidate HT-6184 in myelodysplastic syndrome (MDS) early next year (Press release, Halia Therapeutics, DEC 8, 2023, View Source [SID1234638565]).

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CEO Dr Dave Bearss told the Clinical Trials Arena that the US-based company will be testing the candidate in MDS patients for the first time, with the first dosing due to take place in the US.

HT-6184 targets the protein NEK7 by blocking its ability to bind to NLRP3, which reduces the inflammatory response. The activation of NLRP3 drives the onset and progression of various conditions, including neurological and rheumatological diseases.

Phase II trial plans
The Phase II trial will measure endpoints including the level of creation of white and red blood cells. Patients will also be evaluated with a bone marrow biopsy.

The trial will enrol around 50 patients with MDS who are or are on the borderline of being transfusion-dependent.

Investigators will be looking for improvement in haemoglobin and whether there is improvement in transfusion dependency, with Bearss adding that the goal would be for patients to no longer be dependent, which he described as a meaningful endpoint. The planned trial is taking place internationally with screening for eligible patients ongoing. Site selection and initiation will take place in the US before the company expands to multiple countries, with plans for parts of Asia and Europe.

On December 8, 2023 ImmunoPrecise Antibodies Ltd. ("ImmunoPrecise" or "IPA" or the "Company"), reported the closing of its $1.265 million underwritten public offering of 1,265,000 common shares, including 165,000 common shares issued pursuant to the full exercise by the underwriter of its over-allotment option (Press release, ImmunoPrecise Antibodies, DEC 8, 2023, View Source [SID1234638399]). The public offering price for each common share, before the underwriter’s discount and commissions, was $1.00. All of the securities in the underwritten public offering were sold by the Company.

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The Company intends to use the net proceeds from the proposed offering for research and development; capital expenditures, including expansion of existing laboratory facilities; and working capital and general corporate purposes.

The Benchmark Company acted as the sole Book-Running Manager and R.F. Lafferty acted as Co-Manager for the offering.

Dorsey & Whitney LLP and Norton Rose Fulbright Canada LLP served as US and Canadian legal counsel, respectively, to the Company. Sheppard, Mullin, Richter & Hampton LLP served as legal counsel to The Benchmark Company, LLC.

The securities were offered and sold pursuant to a shelf Registration Statement on Form F-3 (File No. 333-273197) that was declared effective by the United States Securities and Exchange Commission (the "SEC") on July 14, 2023. A copy of the final prospectus supplement and accompanying prospectus describing the terms of the offering has been filed with the SEC and are available on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting The Benchmark Company, LLC, 150 East 58th St., 17th Floor, New York, NY 10155, by telephone at 212-312-6700 or by email at [email protected].

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