On April 24, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported forthcoming presentations during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4 in Chicago, IL (Press release, Black Diamond Therapeutics, APR 24, 2024, View Source [SID1234642275]). The two poster presentations describe data for BDTX-1535 in patients with recurrent glioblastoma (GBM) across two clinical trials: a Phase 1 dose escalation trial, for which topline data were released in December 2023, and a Phase 0/1 "trigger" ("window of opportunity") trial conducted as an Investigator Sponsored Trial at the Ivy Brain Tumor Center (NCT06072586).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation details are as follows:

Title: Phase 1 Study of BDTX-1535, an Oral 4th Generation Covalent EGFR Inhibitor, in Patients with Recurrent Glioblastoma: Preliminary Dose Escalation Results
Speaker/Author: Dr. Patrick Wen, Dana Farber Cancer Institute and Harvard Medical School
Date and Time: Saturday, June 1, 2024, 9:00 AM – 12:00 PM CDT
Abstract: 2068
Poster: #367

Title: A Phase 0/1 ‘Trigger’ Trial of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Patients with EGFR Alterations or Fusions
Speaker/Author: Yoshie Umemura, MD, BS, Ivy Brain Tumor Center and Barrow Neurological Institute
Date and Time: Saturday, June 1, 2024, 9:00 AM – 12:00 PM CDT
Abstract: 2069
Poster: #368

Posters will become available on June 1, 2024 at 10:00 AM EDT on the Black Diamond Therapeutics website here.

About BDTX-1535
BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC), including classical driver mutations, non-classical driver mutations, and the acquired resistance C797S mutation. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 oncogenic EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A "window of opportunity" trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients with NSCLC (NCT05256290).

On April 24, 2024 Biogen Inc. (NASDAQ: BIIB) reported first quarter 2024 financial results (Press release, Biogen, APR 24, 2024, View Source [SID1234642274]). Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are starting 2024 with an increase in earnings per share and solid execution across our new product launches along with the realization of meaningful cost savings and margin improvement. We see momentum building at a steady pace for LEQEMBI. In particular, we were encouraged that LEQEMBI in-market revenue for the first quarter nearly tripled sequentially and we saw a significant build in month-to-month new patient starts in the first quarter. As the launch progresses and infrastructure develops, we continue to believe in the potential longer-term commercial opportunity in Alzheimer’s disease. In rare disease, the U.S. launch of SKYCLARYS is advancing well and with the E.U. launch underway, we are beginning to realize the value of the Reata transaction. The uptake of ZURZUVAE in postpartum depression and QALSODY in SOD-1 ALS, two areas of significant unmet need, has also been encouraging. With a renewed culture focused on purpose and performance, we are advancing toward our goal of returning to sustainable growth while creating enhanced value for patients and our shareholders."
Financial Highlights
Q1 ’24 Q1 ’23 △
r (CC*)
Total Revenue (in millions) $2,290 $2,463 (7)% (7)%
GAAP diluted EPS $2.70 $2.67 1% —%
Non-GAAP diluted EPS $3.67 $3.40 8% —%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q1 ’24 Q1 ’23 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,076 $1,125 (4)% (4)%
Rare disease revenue(2)
$424 $443 (4)% (4)%
Biosimilars revenue $197 $192 2% 2%
Other product revenue(3)
$15 $2 538% 542%
Total product revenue $1,712 $1,763 (3)% (3)%
Revenue from anti-CD20 therapeutic programs $394 $399 (1)% (1)%
Contract manufacturing, royalty and other revenue $185 $300 (39)% (40)%
Total revenue $2,290 $2,463 (7)% (7)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA.
(2) Rare disease includes SPINRAZA, QALSODY and SKYCLARYS.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
•First quarter 2024 ZURZUVAE revenue was approximately $12 million.
Expense Summary
(in millions) Q1 ’24 Q1 ’23 △
GAAP cost of sales*
$542 $663 18%
% of Total Revenue 24% 27%
Non-GAAP cost of sales*
$500 $663 25%
% of Total Revenue 22% 27%
GAAP R&D expense $453 $571 21%
Non-GAAP R&D expense $447 $571 22%
GAAP SG&A expense $582 $605 4%
Non-GAAP SG&A expense $569 $603 6%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
* Excluding amortization and impairment of acquired intangible assets

•There were no idle capacity charges in the first quarter of 2024. First quarter 2023 GAAP and Non-GAAP cost of sales includes approximately $45 million of idle capacity charges. The decrease in first quarter 2024 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in revenue from new product launches and decrease in contract manufacturing revenue, as well as less idle capacity charges.

•In the first quarter 2024 as compared to the first quarter of 2023, the decrease in GAAP R&D and SG&A expense of approximately $118 million and $24 million, respectively, and the decrease in Non-GAAP R&D and SG&A expense of approximately $124 million and $33 million, respectively, was primarily due to savings achieved from our Fit for Growth and R&D portfolio prioritization initiatives. First quarter 2023 GAAP and Non-GAAP SG&A expense includes approximately $31 million related to
2

the termination of the co-promotion agreement with Eisai for Biogen’s multiple sclerosis products in Japan.
Other Financial Highlights

•First quarter 2024 GAAP and Non-GAAP collaboration profit sharing was a net expense of $66 million, which includes $61 million related to Biogen’s collaboration with Samsung Bioepis, and $5 million to Sage Therapeutics related to the commercialization of ZURZUVAE in the U.S.

•First quarter 2024 GAAP other expense was $94 million, primarily driven by net interest expense and net unrealized losses on strategic equity investments of $31 million. First quarter 2024 Non-GAAP other expense was $63 million, primarily driven by net interest expense.

•First quarter 2024 GAAP and Non-GAAP effective tax rates were 15.4% and 15.9%, respectively. First quarter 2023 GAAP and Non-GAAP effective tax rates were 11.6% and 13.5%, respectively, and benefited from the resolution of an uncertain tax matter and higher non-cash tax benefits from changes in the value of our equity investments.
Financial Position

•First quarter 2024 net cash flow from operations was $553 million. Capital expenditures were $46 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was $507 million.

•As of March 31, 2024, Biogen had cash, cash equivalents, and marketable securities totaling approximately $1.1 billion and approximately $6.5 billion in total debt, resulting in net debt of approximately $5.5 billion. As of March 31, 2024 $750 million of the 2023 Term Loan which was put in place at the time of the Reata acquisition had been repaid, with the remaining $250 million expected to be repaid during the second quarter of 2024.

•Subsequent to the end of the first quarter of 2024, Biogen received its scheduled installment payment of approximately $437 million from Samsung BioLogics related to Biogen’s sale of its JV equity stake in Samsung Bioepis.

•No shares of the Company’s common stock were repurchased in the first quarter of 2024. As of March 31, 2024, there was $2.1 billion remaining under the share repurchase program authorized in October 2020.

•For the first quarter of 2024 the Company’s weighted average diluted shares were 146 million.

Full Year 2024 Financial Guidance

For the full year 2024, Biogen continues to expect a Non-GAAP diluted EPS guidance range as follows:
Reaffirmed Full Year 2024 Guidance
Non-GAAP diluted EPS
$15.00 to $16.00
Reflecting growth of ~5% at the mid-point*

*Versus reported full year 2023

While total revenue is expected to decline by a low- to mid-single digit percentage, Biogen continues to expect core pharmaceutical revenue, defined as product revenue plus Biogen’s 50% share of net LEQEMBI product revenue and cost of sales, including royalties, to be relatively flat for 2024 compared to 2023 as further declines in multiple sclerosis product revenue are expected to be offset by increases in revenue from new product launches.

Biogen continues to expect an improvement in the cost of sales as a percentage of total revenue for 2024 compared to 2023 driven by product mix and significantly lower idle capacity charges.

For 2024 compared to 2023, Biogen continues to expect operating income to grow at a low-double digit percentage. This is expected to be driven by improved cost of sales as a percentage of revenue, as well as lower operating expenses as a result of the Company’s Fit for Growth program.

This guidance also assumes that foreign exchange rates as of April 19, 2024, will remain in effect for the remainder of the year, net of hedging activities. Other modeling considerations will be provided on the conference call and webcast.

This financial guidance does not include any impact from potential acquisitions or large business development transactions or pending and future litigation, as all are hard to predict, or any impact of potential tax or healthcare reform. Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2024 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; and the ultimate outcome of pending or future significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:30 a.m. ET on April 24, 2024 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

On April 24, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the acceptance of two abstracts for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4 in Chicago (Press release, Bicycle Therapeutics, APR 24, 2024, View Source [SID1234642273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Presentation Details:

Title: Breaking from the paradigm of antibody-drug conjugates: Evaluation of clinical pharmacokinetics and safety of Bicycle Toxin Conjugates (BTCs)
Poster Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Saturday, June 1, at 9 a.m. CT
Abstract Number: 3088
Speaker/Lead Author: Justin Bader, Pharm.D., MBA, Bicycle Therapeutics

Title: A phase 2/3 study of Bicycle Toxin Conjugate BT8009 targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2
Poster Session Title: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, June 2, at 9 a.m. CT
Abstract Number: TPS4619
Speaker/Lead Author: Yohann Loriot, M.D., Ph.D., Institut de Cancérologie Gustave Roussy, Université Paris-Saclay

The posters will be made available in the Publications section of bicycletherapeutics.com following the presentations.

On April 24, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 31 – June 4, 2024 (Press release, BeiGene, APR 24, 2024, View Source [SID1234642272]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our presentations at this year’s ASCO (Free ASCO Whitepaper) highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors," Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "The exciting data we will share during ASCO (Free ASCO Whitepaper) showcase BRUKINSA’s uniquely differentiated clinical profile and add to the growing body of evidence supporting its role across the blood cancer treatment paradigm."

BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include:

A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and
A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications.
Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include:

New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and
Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA.
"Our data at ASCO (Free ASCO Whitepaper) are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC."

BeiGene Presentations During ASCO (Free ASCO Whitepaper) 2024

Abstract Title

Abstract #

Presentation Details

Lead Author

Hematology

Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis (NMA)

7048

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Shadman

Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL)

11158

Session Type and Title: Poster Session – Quality Care/Health Services Research

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Krackeler

Risk of hypertension in patients with CLL/SLL who participated in ALPINE: a post hoc analysis

N/A

Online

D. Ramirez

Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated with Bruton tyrosine kinase inhibitors (BTKi): A real-world data study using the Symphony Health Solution database

N/A

Online

T. Kou

Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL

N/A

Online

J. Pinilla-Ibarz

Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma

N/A

Online

B. Shah

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

N/A

Online

T. Munir

Clinical and financial burden of mental health (MH) conditions in patients (pts) with low-grade non-Hodgkin lymphoma (LG-NHL)

7072

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

K. Yang

Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)

N/A

Online

S. Gaballa

Real-world Bruton tyrosine kinase inhibitor (BTKi) treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices

N/A

Online

J. Hou

BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia

TPS7090

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

H. Lee

CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL

TPS7087

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Shadman

Solid Tumor/IO

Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): minimum 3-year survival follow-up

4032

Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date and Time: June 1 at 1:30-4:30 PM CDT

H. Yoon

BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors

2610

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

L. Yufei

Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study

3599

Session Type and Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal

Session Date and Time: June 1 at 1:30-4:30 PM CDT

K. Ding

Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305

2605

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

D. Serrano

A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors

2585

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

S. Deva

Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

N/A

Online

C. Zhou

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

Please see full U.S. Prescribing Information for BRUKINSA (zanubrutinib), including U.S. Patient Information or visit www.brukinsa.com.

About TEVIMBRA (tislelizumab-jsgr)
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Please see full U.S. Prescribing Information for TEVIMBRA (tislelizumab-jsgr), including Medication Guide.

About Sonrotoclax (BGB11417)
Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations.

On April 24, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that updated Phase 1/2 data for AU-007 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting (Press release, Aulos Bioscience, APR 24, 2024, View Source [SID1234642271]). AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. It is the first AI-designed human monoclonal antibody to be tested in a clinical trial. The ASCO (Free ASCO Whitepaper) meeting is being held online and at McCormick Place in Chicago, Illinois, from May 31–June 4, 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the poster presentation are as follows:

Poster Title: Updated results of a phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors.
Abstract: 2527
Session Type/Title: Poster Session/Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday, June 1, 2024, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in the Exhibit Hall at McCormick Place. An electronic version will also be available on the ASCO (Free ASCO Whitepaper) 2024 online meeting platform.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).