On June 9, 2023 Amgen (NASDAQ:AMGN) reported that it will present at the Goldman Sachs 44th Annual Global Healthcare Conference at 2:20 p.m. ET on Wednesday, June 14, 2023 (Press release, Amgen, JUN 9, 2023, View Source [SID1234632604]). Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors, and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.Amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On June 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 that it will present data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) in an oral presentation at the International Conference on Malignant Lymphoma (ICML) on June 13–17, 2023 in Lugano, Switzerland (Press release, Allogene, JUN 9, 2023, View Source [SID1234632603]). This presentation will feature additional data on the 33 CAR T naïve patients treated with the Alloy manufacturing process across different CAR T dosing and lymphodepletion regimens. Earlier in June, data from the 12 patients who received a single ALLO-501/A cell infusion following the lymphodepletion regimen being utilized in the ongoing potentially pivotal Phase 2 trials was presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The ALPHA/ALPHA2 Phase 1 trials were designed to assess the safety, tolerability, and preliminary efficacy at increasing dose levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product candidates that target CD19. In addition to exploring multiple cell doses and dosing schedules (consolidation), these studies evaluated various doses of ALLO-647, Allogene’s proprietary lymphodepleting antibody designed to prevent premature rejection of AlloCAR T cells. Allogene is currently enrolling the potentially pivotal Phase 2 ALPHA2 trial of ALLO-501A in LBCL and expects to complete enrollment in 1H2024. The Company expects to open trial sites in Europe, Canada and Australia during 2023.

Allogene Presentation at the 2023 ICML Lugano:

Durable responses with anti-CD19 allogeneic CAR T ALLO-501/501A in phase 1 trials of relapsed/refractory large B-cell lymphoma (r/r LBCL)

Presenter: Dr. Frederick Locke, M.D., Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy; program co-leader, Immuno-Oncology, Moffitt Cancer Center Tampa, Florida
Abstract: #48
Oral Presentation Date and Time: June 15, 2023, 15:30 CEST / 9:30am EST / 6:30am PST

About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, 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 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 June 9, 2023 : Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reorted that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has progressed to the next cohort of the intravenous (IV) arms of both the monotherapy and combination study (Press release, Imugene, JUN 9, 2023, View Source [SID1234632597]). As noted in the below graphic, the trial has now cleared cohort 3 and opened cohort 4 of the IV arm of the monotherapy dose escalation. In addition, cohort 1 of the IV arm of the combination study with Pembrolizumab has been cleared, allowing cohort 2 to be opened.

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Imugene MD & CEO Leslie Chong said: "As we continue to move through the cohorts at pace, we’re aiming to have this high-quality science peer reviewed and recognised within publications or conferences befitting of its results and potential benefit to patients in need."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹.

Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia. The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources. Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.

On June 9, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress (Press release, BeiGene, JUN 9, 2023, View Source [SID1234632596]). BeiGene has ten accepted abstracts at EHA (Free EHA Whitepaper), which is taking place from June 8-11 in Frankfurt, Germany.

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"We are excited to share the latest research from our robust hematology portfolio and pipeline, including new results that further deepen our understanding of BRUKINSA across a number of hematologic malignancies," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "These data underscore our ongoing commitment to delivering treatments that have the potential to improve the lives of those living with blood cancers."

Expanding the Evidence Base for BRUKINSA

With extended follow-up from the pivotal, Phase 3 SEQUOIA study, BRUKINSA remains an important frontline treatment option for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA continued to demonstrate clinically meaningful efficacy in patients with treatment-naïve CLL/SLL without del(17p). In addition to the previously reported benefit in patients with the unmutated immunoglobulin heavy chain (IGHV) gene, longer follow-up now shows benefit in those with mutated IGHV as well, and patients with del(17p) continue to demonstrate progression-free survival (PFS) benefit consistent with the randomized cohort. BRUKINSA continues to be well tolerated over time, with low rates of treatment discontinuation. (Abstract #P639)

In post-hoc analyses, safety data were pooled from ten clinical trials of BRUKINSA monotherapy in patients with certain B-cell malignancies, including from the Phase 3 ASPEN and ALPINE trials, which compared BRUKINSA head-to-head with ibrutinib. These pooled safety analyses demonstrate that BRUKINSA is generally well tolerated, as BRUKINSA adverse events were generally mild-to-moderate in severity and tended not to lead to treatment discontinuation. Prevalence of adverse events of special interest (AESI) generally trended down over time without emergence of new safety signals, supporting BRUKINSA as a viable long-term treatment option. (Abstract #P631)

In an updated safety and efficacy analysis of BRUKINSA in patients with various B-cell malignancies, results showed that switching to BRUKINSA may provide clinical benefit to patients previously intolerant of ibrutinib and/or acalabrutinib. In total, 82 patients were evaluated (61 CLL/SLL, 13 Waldenström’s macroglobulinemia, 4 mantle cell lymphoma, 4 marginal zone lymphoma). (Abstract #P633)

Additionally, in an updated analysis of the Phase 2 ROSEWOOD study, BRUKINSA plus obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, demonstrated clinically meaningful activity and manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). The European Medicines Agency recently validated BeiGene’s Type II variation application for BRUKINSA for the treatment of adult patients with R/R FL. (Abstract #P1080)

On June 9, 2023 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, ImmunoGen, JUN 9, 2023, View Source [SID1234632592]). The data will be presented in an oral session on Sunday, June 11 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Congress in Frankfurt, Germany.

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The CADENZA trial is enrolling frontline BPDCN patients, including those with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM). As announced in August 2022, ImmunoGen aligned with the US Food and Drug Administration (FDA) that the efficacy analysis will be conducted in de novo BPDCN patients with CR/CRc as the primary endpoint. The secondary endpoint is duration of CR/CRc. With enrollment in the R/R cohort complete, ImmunoGen expects to complete enrollment in the pivotal frontline de novo cohort this year and report top-line data in 2024.

"BPDCN is a rare and aggressive blood cancer characterized by extremely low survival rates and limited treatment options that are often associated with significant toxicities," said Naveen Pemmaraju, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center and co-investigator of the Phase 2 study. "We are encouraged by these updated data in a larger population of patients, which demonstrated impressive anti-tumor activity and durable responses in both frontline and R/R patients. These efficacy data, coupled with outpatient administration, reinforce the potential of pivekimab as a promising, novel option for this challenging disease. I look forward to its continued evaluation in the trial."

INTERIM ANALYSIS OF A REGISTRATION-ENABLING STUDY OF PIVEKIMAB SUNIRINE, A CD123-TARGETING ANTIBODY-DRUG CONJUGATE, IN PATIENTS WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM
Lead Author: Naveen Pemmaraju, MD
Presentation ID: S139
Session Date: Sunday, June 11
Session Time: 11:30am-12:45pm CEST / 5:30am-6:45am EDT

Pivekimab is administered at 0.045 mg/kg on day 1 of a 21-day cycle as an outpatient infusion of approximately 30 minutes. As of the May 19, 2023 data cutoff, data were available for 79 BPDCN patients (30 frontline, 49 R/R). Key interim and updated safety and efficacy findings include:

Efficacy

In frontline-treated patients including those with de novo and PCHM, the objective response rate (ORR [CR, CRc, CRh, CRi, PR]) is 80% (24/30 patients) with a composite complete remission (CCR [CR, CRc, CRh, CRi]) rate of 73% (22/30 patients), and an additional patient achieving a CR post-transplant.
Median duration of response (DOR) for all responders in frontline-treated patients was 12.7 months.
In R/R patients, the ORR was 33% (16/49 patients), with a CCR rate of 20% (10/49 patients), including those who previously failed intensive chemotherapy and/or transplant.
Median DOR for all responders in R/R patients was 7.1 months.
Safety

Pivekimab continues to exhibit manageable safety; no new safety signals were observed.
The most common treatment-emergent adverse events (TEAEs) (all grades [grade 3+ events]) occurring in 15% or more of patients were peripheral edema (46% [10%]), thrombocytopenia (27% [19%]), fatigue (25% [4%]),infusion-related reactions (25% [4%]), constipation (23% [0%]), nausea (22% [0%]) anemia (20% [8%]), headache (19% [4%]), neutropenia (18% [17%]), diarrhea (17% [0%]), hypokalemia (17% [3%]), dyspnea (15% [1%]), hyperglycemia (15% [6%]) and pyrexia (15% [1%]).
No capillary leak syndrome or cytokine release syndrome are reported.
Discontinuations due to pivekimab-related adverse events are 3%.
30-day mortality is 0% in frontline-treated patients and 4% (2 deaths due to disease progression) in R/R patients.
"We look forward to completing enrollment in CADENZA this year and are pleased with the interim data in frontline BPDCN, particularly the 73% CCR rate observed in this population, as well as the responses seen in those patients with more advanced R/R disease," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With promising anti-tumor activity, manageable safety including no observed capillary leak or cytokine release syndrome, and the convenience of potential outpatient administration, we believe pivekimab could serve as a critical option for BPDCN patients."

Additional information can be found at www.ehaweb.org.

ABOUT PIVEKIMAB SUNIRINE

Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML. Pivekimab uses one of ImmunoGen’s novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020. Pivekimab also holds this designation in the US. In October 2020, the FDA granted pivekimab Breakthrough Therapy designation in relapsed/refractory BPDCN.

ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)

BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the approval of a CD123-targeting therapy, the unmet need remains high for patients, both in the frontline and in the relapsed/refractory setting.