On April 26, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that it will present data from its broad solid tumor and hematology portfolio at the upcoming American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 2-6, 2023 (Press release, BeiGene, APR 26, 2023, View Source [SID1234630512]).

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"Our accepted data presentations at ASCO (Free ASCO Whitepaper) demonstrate the resolve and productivity of BeiGene’s R&D team in our drive to improve treatment outcomes and access for patients worldwide," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We look forward to joining the oncology community in Chicago and sharing progress as we continue to advance our rich pipeline of first-in-class and potentially best-in-class programs."

Data to be presented at ASCO (Free ASCO Whitepaper) include:

Abstract Title

Abstract #

Presentation Details

Lead Author

Solid Tumors

Results from the Pivotal Phase 2b HERIZON-BTC-01 Study: Zanidatamab in Previously-treated HER2 amplified Biliary Tract Cancer

4008

Oral presentation: Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary

Fri., June 2,

2:45-5:45 p.m. CT

Shubham Pant

A phase 1 study of the OX40 agonist, BGB-A445, with or without tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors

2574

Poster presentation: Developmental Therapeutics—Immunotherapy

Sat., June 3,

8:00-11:00 a.m. CT

Jayesh Desai

Zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer: updated results from a Phase Ib/II study

1044

Poster presentation: Breast Cancer—Metastatic

Sun., June 4, 8:00-11:00 a.m. CT

Xiaojia Wang

Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: the RATIONALE-301 European/North American subgroup

4082

Poster presentation: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Mon., June 5, 8:00-11:00 a.m. CT

Arndt Vogel

Impact of risk factors on overall survival in patients with unresectable hepatocellular carcinoma treated with first-line tislelizumab

4083

Poster presentation: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Mon., June 5, 8:00-11:00 a.m. CT

Masatoshi Kudo

AdvanTIG-105: phase 1b dose-expansion study of ociperlimab + tislelizumab with chemotherapy in patients with stage IV gastric/gastroesophageal adenocarcinoma

4028

Poster presentation: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Mon., June 5, 8:00-11:00 a.m. CT

Se Hyun Kim

Hematology

A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of Bcl-2 inhibitor BGB-11417 in adult patients with mature B-cell malignancies

7558

Poster presentation: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Mon., June 5, 8:00-11:00 a.m. CT

Caixia Li

First interim analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma

7557

Poster presentation: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Mon., June 5, 8:00-11:00 a.m. CT

Huilai Zhang

Zanubrutinib plus obinutuzumab versus obinutuzumab in patients with relapsed/refractory follicular lymphoma: Updated analysis of the ROSEWOOD study

7545

Poster presentation: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Mon., June 5, 8:00-11:00 a.m. CT

Christopher Flowers

MAHOGANY: A phase 3 trial of zanubrutinib plus anti-CD20 antibodies vs lenalidomide plus rituximab in patients with relapsed or refractory follicular or marginal zone lymphoma

TPS7590

Poster presentation: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Mon., June 5, 8:00-11:00 a.m. CT

Loretta Nastoupil

Matching-adjusted indirect comparison of zanubrutinib versus ibrutinib in relapsed/refractory marginal zone lymphoma

e19527

Publication only

Catherine Thieblemont

Comparative efficacy of zanubrutinib versus rituximab in relapsed marginal zone lymphoma: matching-adjusted indirect comparison

e19526

Publication only

Catherine Thieblemont

Real-world treatment patterns of Bruton tyrosine kinase inhibitors in patients with mantle cell lymphoma in community oncology practices in the United States

e19525

Publication only

Bijal Shah

On April 26, 2023 Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, reported that a poster describing initial data from the Phase 1/2 trial of AB-101 will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6 in Chicago (Press release, Artiva Biotherapeutics, APR 26, 2023, View Source [SID1234630511]). AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell being investigated in combination with rituximab for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma.

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Details of the presentation are as follows:

Title: AB-101, an allogeneic, non–genetically modified, natural killer (NK) cell therapy, evaluated as monotherapy or in combination with rituximab in R/R non-Hodgkin lymphoma.
Abstract: 7529
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Day and Time: Monday, June 5, 8 am to 11 am CT
Presenter: Thorsten Graef, M.D., Chief Medical Officer, Artiva Biotherapeutics
About AB-101

AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Using the Company’s AlloNKTM platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other tumor-engaging receptors, without the need for engineering. We believe this makes AB-101 an optimal adjunct therapy to targeted, ADCC-mechanistic biologics.

Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy including CAR-T therapy. This study is progressing at multiple clinical sites across the U.S., and AB-101 is administered weekly in the out-patient setting over one-month cycles and with up to four cycles to assess therapeutic efficacy and durability. Artiva is also collaborating with Affimed N.V. in developing a combination therapy, comprised of AB-101 and the Innate Cell Engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

On April 26, 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 updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting June 2 – 6, 2023 in Chicago, Illinois (Press release, Allogene, APR 26, 2023, View Source [SID1234630510]).

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The ALPHA/ALPHA2 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 cell doses, these studies evaluated escalating 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 large B cell lymphoma (LBCL).

"We are looking forward to sharing updated data from our Phase 1 ALPHA/ALPHA2 trials," said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer. "Prior updates from the ALPHA/ALPHA2 trials provided clear proof-of-concept for the ability of an allogenic CAR T product candidate to induce deep and durable responses in LBCL, a crucial finding as we seek to establish a new era in CAR T."

Allogene presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting:

Phase 1 Results with Anti-CD19 Allogeneic CAR T ALLO-501/501A in 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
Session Title: Poster Discussion Session – Developmental Therapeutics – Immunotherapy
Abstract: #2517
Poster Board: #359
Poster Session Display Date and Time: June 3, 2023, 8:00AM-11:00AM CT
Poster Discussion Session Date and Time: June 3, 2023, 3:00PM-4:30PM CT

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 April 26, 2023 Alkermes plc (Nasdaq: ALKS) reported its financial results for the first quarter of 2023 (Press release, Alkermes, APR 26, 2023, View Source [SID1234630509]).

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"During the first quarter we made continued progress across our portfolio, including strong commercial execution driving growth for our proprietary products – LYBALVI, VIVITROL and ARISTADA – and important progress in the development of ALKS 2680, our orexin 2 receptor agonist, which is now poised to enter a phase 1b proof-of-concept study in patients with narcolepsy and idiopathic hypersomnia, with data expected later this year," said Richard Pops, Chief Executive Officer of Alkermes. "In addition, we made significant operational and strategic advances in the planned separation of our oncology business, which remains on track for completion in the second half of this year. We remain sharply focused on executing our strategic priorities to create significant value for shareholders."

"Our strong first quarter financial results were driven by 25% growth year-over-year in proprietary product net sales and continued focus on disciplined management of our cost structure," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are reiterating our financial expectations for 2023 and believe we are in a strong financial position to continue to execute our strategic priorities, including further driving the launch of LYBALVI, advancing our orexin 2 receptor agonist clinical development program and completing the planned separation of the oncology business later this year."

Quarter Ended March 31, 2023 Financial Results

Revenues

– Total revenues for the quarter were $287.6 million, compared to $278.5 million for the same period in the prior year.

– Net sales of proprietary products for the quarter increased approximately 25% to $214.7 million, compared to $171.3 million for the same period in the prior year.

Net sales of VIVITROL were $96.7 million, compared to $84.9 million for the same period in the prior year, representing an increase of approximately 14%.
Net sales of ARISTADAi were $80.1 million, compared to $72.5 million for the same period in the prior year, representing an increase of approximately 10%.
Net sales of LYBALVI were $38.0 million, compared to $13.9 million for the same period in the prior year, representing an increase of approximately 173%.
– Manufacturing and royalty revenues for the quarter were $72.9 million, compared to $105.2 million for the same period in the prior year.

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI (the long-acting INVEGA products) for the quarter were $13.6 million, compared to $37.1 million for the same period in the prior year. This decrease was driven primarily by Janssen Pharmaceutica N.V.’s (Janssen), a subsidiary of Johnson & Johnson, partial termination of the license agreement related to sales of the long-acting INVEGA products in the United States (U.S.), effective Feb. 2, 2022.
Manufacturing and royalty revenues from VUMERITY for the quarter were $28.9 million, compared to $30.6 million for the same period in the prior year.
Costs and Expenses

– Total operating expenses for the quarter were $335.1 million, compared to $305.1 million for the same period in the prior year. The increase was driven primarily by investment in the launch of LYBALVI and expenses associated with the planned separation of the oncology business.

Cost of Goods Manufactured and Sold was $58.2 million, compared to $55.2 million for the same period in the prior year.
Research and Development (R&D) expenses were $93.6 million, compared to $96.0 million for the same period in the prior year.
Selling, General and Administrative (SG&A) expenses were $174.5 million, compared to $145.1 million for the same period in the prior year, primarily reflecting increased investment to support the launch of LYBALVI.
Profitability

– Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $41.8 million for the quarter, or a basic and diluted GAAP loss per share of $0.25. This compared to GAAP net loss of $35.9 million, or a basic and diluted GAAP loss per share of $0.22, for the same period in the prior year.

– Non-GAAP net income was $2.4 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.01. This compared to non-GAAP net income of $19.6 million, or a non-GAAP basic and diluted earnings per share of $0.12, for the same period in the prior year.

Balance Sheet

– At March 31, 2023, the company recorded cash, cash equivalents and total investments of $692.5 million, compared to $740.1 million at Dec. 31, 2022. The company’s total debt outstanding as of March 31, 2023 was $292.6 million.

Financial Expectations for 2023

Alkermes reiterates its financial expectations for 2023, as set forth in its press release dated Feb. 16, 2023.

Separation of Oncology Business

Alkermes continues to make meaningful progress on the previously announced planned separation of the company’s oncology business. The separation would allow Alkermes to maintain its focus on researching, developing and commercializing therapies for people living with complex neurological conditions and is expected to accelerate and enhance the profitability of the remaining neuroscience business.

– As previously announced, in April, Alkermes submitted a confidential draft Form 10 registration statement to the United States Securities and Exchange Commission (SEC) in connection with the planned separation of its oncology business into an independent, publicly-traded company. Upon completion of the planned separation, the new company would be known as Mural Oncology plc.

– Alkermes continues to expect to complete the separation in the second half of 2023, subject to various customary conditions, including final approval from Alkermes’ board of directors.

Recent Events

Corporate

– In April 2023, the company received a second favorable interim award (the Second Interim Award) from the arbitral tribunal (the Tribunal) in the company’s arbitration proceedings with Janssen in respect of Janssen’s partial termination in the U.S. of two license agreements with the company. The Second Interim Award, which builds on the first interim award that was issued in December 2022, provides that back royalties related to 2022 of approximately $194 million (inclusive of interest) are due to the company under the two agreements, and that a separate Know-How Royalty (as defined in the applicable license agreement) term applies for each of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA.

Neuroscience

– In February 2023, the company initiated a multiple ascending dose cohort in the phase 1 study of its ALKS 2680 orexin 2 receptor agonist, which is in clinical development for the treatment of narcolepsy and other hypersomnia conditions.

– In March 2023, the company announced the publication of results from its phase 3 ENLIGHTEN-Early study of LYBALVI in the peer-reviewed publication, the Journal of Clinical Psychiatry. ENLIGHTEN-Early evaluated the effect of LYBALVI compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 26, 2023, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

On April 25, 2023 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing breakthrough treatments for organ fibrosis and CLDN1+ tumors, reported results from the multiple-ascending dose (MAD) part of its first-in-human Phase 1 clinical study of ALE.F02 targeting Claudin-1 (CLDN1) (Press release, Alentis Therapeutics, APR 26, 2023, View Source [SID1234630480]).

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The trial enrolled 24 subjects: 18 received the active drug and six received placebo across three dose levels. Participants were dosed every two weeks.

Dr. Luigi Manenti, Chief Medical Officer at Alentis said: "This study is the first to target CLDN1 in humans. ALE.F02 showed good safety and tolerability at multiple dose levels. There were no serious events and no dose delays or reductions." Dr. Manenti added that the pharmacokinetics data confirmed the desired exposures, specifically, that the concentrations required for extracellular remodeling were achieved.

Speaking to the pharmacodynamics, Dr. Manenti said, "We not only confirmed the evidence of on-target biological activity that we witnessed in our single-ascending dose (SAD) study last June, but we also saw this enriched in the MAD part of the trial."

"We achieved what we set out to do in both the SAD and MAD studies," said Dr. Roberto Iacone, CEO of Alentis Therapeutics. "The successful conclusion of this trial validates that Claudin-1 is a safe target. With ALE.F02 being safe and well tolerated, Alentis can progress platform and indication expansion. This puts us in a strong position as we advance to the next phase of development starting with first-in-patient liver and renal studies this year."