On December 12, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., reported new data on its emerging breast cancer portfolio following its first-ever presentations at the San Antonio Breast Cancer Symposium (SABCS). Poster presentations included first-in-human data for BeiGene’s investigational cyclin-dependent kinase (CDK) 4 inhibitor BGB-43395 in hormone receptor- positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Press release, BeiGene, DEC 12, 2024, View Source [SID1234649069]). Two posters highlighting the designs of in-progress trials for BGB-43395 and CDK2 inhibitor BG-68501/EXT-197 and a poster detailing the preclinical characterization of BGB-43395 were also presented.

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"Despite treatment advances, breast cancer remains the fourth leading cause of cancer mortality worldwide and the number one cause of cancer death in women," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We are advancing a robust portfolio of investigational medicines for breast cancer and are pleased to share our first clinical data for our investigational CDK4 inhibitor BGB-43395 at SABCS. We’ve made tremendous progress with this program, having enrolled over 100 patients in the first year of clinical development, and the early results are encouraging. We look forward to continuing its development alongside other molecules in our breast cancer pipeline, including additional cell cycle dependent kinase inhibitors and ADCs."

BeiGene’s breast cancer pipeline features cell cycle dependent kinase inhibitors designed to potentially deliver better efficacy and reduced toxicity than currently available options, initially for HR+/HER2- disease. CDK inhibitors target checkpoint proteins that control cell division to stop the growth of cancer cells. Widely used CDK4/6 inhibitors have been shown to provide substantial clinical benefit for patients with certain breast cancers. However, dose-limiting toxicities, thought to be the result of CDK6 inhibition, and the development of resistance mutations, curb the utility of these medicines. BeiGene’s CDK4 inhibitor, BGB-43395, is highly potent and selective for CDK4 relative to CDK6, and it has the potential to reduce dose-limiting toxicities, improving tolerability while achieving comparable or better efficacy.

BGB-43395 is being investigated in an ongoing phase 1 study (NCT06120283). Early safety and tolerability data for 65 patients with metastatic HR+/HER2- breast cancer or other advanced solid tumors who received BGB-43395 either as monotherapy or in combination with fulvestrant or letrozole in escalating dose cohorts were presented in a poster at SABCS. To date, the results indicate that BGB-43395 has been generally well tolerated across different dose levels, with encouraging early signs of clinical activity emerging. The data support continued development; more than 100 patients have been enrolled to date across the program, and further results of ongoing studies will be presented at future scientific conferences.

Complementing BGB-43395, BeiGene’s CDK2 inhibitor, BG-68501/EXT-197, targets elevated CDK2 activity, which is a key resistance mechanism to CDK4/6 inhibition in HR+/HER2- breast cancer. BG-68501 is currently being evaluated in a first-in-human Phase 1 study (NCT06257264). In addition to small molecule cell cycle dependent kinase inhibitors, BeiGene’s pipeline in breast and gynecologic cancers includes novel antibody-drug conjugates (ADCs) and other molecularly targeted agents and modalities. BG-C9074, an ADC targeting the B7H4 protein, which is broadly expressed in breast and gynecologic cancers, is currently in Phase 1 development (NCT06233942). BeiGene also plans to evaluate the potential of BCL2 inhibition in breast cancer, with next-generation BCL2 inhibitor BGB-21447 expected to begin clinical testing in solid tumor indications soon. Multispecific antibodies and targeted protein degraders with potential applications in breast cancer are among the preclinical assets being developed.

BeiGene recently launched the Cancer Has No Borders podcast, featuring engaging discussions on the world of oncology and BeiGene. The first episode features Claire Saxton, Executive Vice President, Insights & Impact at Cancer Support Community (CSC), and BeiGene’s Dr. Lanasa discussing the unmet need in breast cancer, the realities of the current treatment landscape, and the need for innovation. CSC is a global nonprofit that uplifts and strengthens people impacted by cancer by providing support, fostering compassionate communities, and breaking down barriers to care. Listen on podcast platforms: Apple Podcasts, Spotify, iHeartRadio, Amazon, and YouTube.

BeiGene will host an investor conference call and webcast on Monday, December 16th, 2024, at 8:30 a.m. EST to discuss recent data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting and at SABCS. A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source, View Source, or View Source An archived replay will be available for 90 days following the event.

The Company recently announced its intent to change its name to BeOne, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.

About Breast Cancer

Breast cancer accounts for close to one in four cancer cases and one in six cancer deaths in women worldwide.1 Globally, breast cancer is the second most common cancer and the fourth highest cause of cancer mortality as well as the leading cause of cancer death in women.1 More than 2.3 million patients were diagnosed with breast cancer in 2022, and over 666,000 deaths were reported globally.1 Approximately two-thirds of breast cancer cases are the HR+/HER2- subtype.

On December 12, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, reported the publication of preclinical data for Aptose’s lead hematology compound tuspetinib (TUS) in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Aptose Biosciences, DEC 12, 2024, View Source [SID1234649068]).

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The publication, entitled "Preclinical development of tuspetinib for the treatment of acute myeloid leukemia," is the first preclinical profiling of tuspetinib, a well-tolerated, once daily, oral kinase inhibitor currently in clinical development for treatment of acute myeloid leukemia (AML). The publication defines TUS activities on select oncogenic signaling targets, demonstrates enhanced activity and safety of TUS when combined with other agents, and illustrates synthetic lethality when combined with venetoclax (VEN). Pharmacokinetic and toxicology studies revealed that TUS is readily absorbed and achieves plasma concentrations sufficient to inhibit the target kinases, it has a plasma half-life that supports once daily dosing, and it demonstrates a favorable safety profile.

Aptose is now enrolling newly diagnosed AML patients in a Phase 1/2 clinical study to receive the tuspetinib + venetoclax + azacitidine (TUS+VEN+AZA) triplet combination (NCT03850574). Clinical studies in patients with relapsed or refractory AML receiving TUS single agent or the TUS+VEN combination have been completed.

"The non-clinical findings presented in the publication suggest that TUS will demonstrate favorable safety and a breadth of antileukemic activity across AML patient populations with a diversity of adverse mutations, and the initial clinical data is bearing that out," said William G. Rice, Chairman, President and Chief Executive Officer. "We are eager for the next set of data in our triplet combination trial of TUS+VEN+AZA."

Key findings:

Tuspetinib inhibits a defined cluster of oncogenic signaling kinases operative in AML
TUS inhibits SYK, JAK1/2, RSK2, mutant KIT, and wild type and mutant forms of FLT3
TUS potently killed AML lines (GI50 = 1.3 to 5.2 nM) and Ba/F3 cells expressing wildtype (GI50 = 9.1 nM) or various mutant forms of FLT3 (GI50 = 2.5 – 56 nM)
TUS dampens stroma-induced activation of FLT3-ITD signaling in AML cells
TUS prolongs survival in multiple AML models
Oral TUS markedly extended survival in subcutaneously and orthotopically inoculated xenograft models of FLT3 mutant human AML, was well tolerated, and delivered enhanced activity when combined with venetoclax or 5-azacytidine
TUS combines effectively with other classes of agents to kill AML cells with mutations in RAS and other difficult-to-treat adverse mutations
TUS was 2.1-15-fold and a 4.5-13-fold more potent than gilteritinib at blocking fibrinogen and immunoglobulin-mediated activation of SYK in KG-1a cells
The most notable observation was the marked and unexpected synthetic lethal vulnerability to venetoclax and two MCL1 inhibitors in the TUS-resistant cells

On December 12, 2024 ALX Oncology Holdings Inc. ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported that the company will host a virtual event on Tuesday, December 17, at 5:00 AM PST / 8:00 AM EST to discuss the first data from a Phase 1b/2 clinical trial evaluating the company’s investigational CD47-blocker evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab in heavily pretreated patients with metastatic breast cancer (Press release, ALX Oncology, DEC 12, 2024, View Source [SID1234649067]). The data were featured today in a spotlight poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS). The poster is now available on the ALX Oncology site under Publications.

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During the virtual company event, Alberto J. Montero, MD, MBA, Clinical Director, Breast Cancer Medical Oncology Program, Diana Hyland Endowed Chair for Breast Cancer, and Professor of Medicine at University Hospitals Seidman Cancer Center, Case Western Reserve University, and the study’s principal investigator, will provide an overview of the data presented at SABCS 2024 and participate in a fireside chat with Alan Sandler, MD, ALX Oncology’s Chief Medical Officer. Jason Lettmann, Chief Executive Officer at ALX Oncology, will provide opening and closing remarks, highlighting progress and upcoming milestones for the company’s evorpacept clinical program.

The event will be webcast live and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under News and Events. To participate in the live event, please register using this link: View Source An archived webcast will be available following the event.

On December 12, 2024 Alessa Therapeutics, Inc., a clinical-stage drug development company pioneering an innovative and proprietary localized drug delivery technology for the early interception of cancer and other diseases, reported the closing of a $15M seed financing led by Mission BioCapital joined by Johnson & Johnson (through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc. (JJDC)., and a representative of JJDC will join the Board of Directors at Alessa Therapeutics Inc (Press release, Alessa Therapeutics, DEC 12, 2024, View Source [SID1234649066]).

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"We are appreciative of the support provided by this syndicate of leading life science industry investors," said Pamela Munster, M.D., Founder & Chief Executive Officer of Alessa. "Alessa is well positioned to advance our pipeline and leverage our platform of tissue-targeted drug delivery for the treatment of prostate cancer and other solid organ diseases. This funding enables us to pursue our mission and bring new medicines to patients who desperately need more effective treatments."

Alessa will use the funds to advance development of its lead program, Enolen, a novel enzalutamide-eluting seed implant for the treatment of localized prostate cancer. Alessa recently announced the start of a first-in-human trial with Enolen in collaboration with the NCI, and the company anticipates initial data to read out next year. Alessa’s Enolen program builds on the company’s successful proof of concept for the approach with Biolen, which were presented at the 39th Annual EAU Congress (EAU24, April 2024) in Paris, France and at the AUA Annual Meeting (May 2024) in San Antonio, TX.

Prostate cancer is the most common cancer among men in the United States. According to the American Cancer Society, an estimated 299,010 men will be diagnosed with prostate cancer in 2024 in the United States alone. Patients with low-risk prostate cancer face difficult treatment decisions today between potentially invasive surgical and ablative procedures or active surveillance. While many efficacious therapeutics have been developed for regional and metastatic disease, to date, they have failed to move forward to patients with localized low-risk disease given their adverse-event profiles. Alessa’s proprietary localized drug-delivering implants are designed for sustained release of an anti-androgen selectively to the prostate thus limiting systemic side effects despite providing therapeutic concentrations in the prostate.

On December 12, 2024 NEC Bio Therapeutics reported 24-week promising interim results from an ongoing Phase 1 basket clinical trial of an orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPI) for treating patients with solid tumors (Press release, NEC, DEC 12, 2024, View Source [SID1234649050]). The findings are being presented in a poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in Geneva, Switzerland from December 11 to 13, 2024.

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NECVAX-NEO1 is a personalized bacteria-based oral DNA therapeutic vaccine, developed using AI prediction of the most immunogenic patient-specific neoepitopes. This vaccine is designed to activate the patient’s immune system, prompting a T-cell response that can precisely target and eliminate tumor cells based on the individual’s unique neoantigens.

In the phase 1 study, 5 patients with melanoma, renal cell cancer, or head and neck cancer, who have been on CPI treatment for at least three months, were treated with NECVAX-NEO1. The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. An ELISPOT response was induced by 68% of neoepitopes, with 40% of patients showing significant neoantigen-specific signals. After a 24-week treatment period, 80% of patients had a stable disease status, indicating a high disease control rate.

On the results of the clinical study, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, commented, "We are very excited about our first proof-of-concept data showing signs of promising immunogenicity and associated biomarker changes in patients. This is very encouraging, especially in light of new clinical trials currently ongoing at various locations in early and late-stage cancer patients. We are looking forward to generating more data for NECVAX-NEO1 as an additional treatment option for patients with difficult to treat cancer in the future."

Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, further commented, "We are certainly excited to present the progress of the NECVAX-NEO1 trial demonstrating safety and signs of immunogenicity. NECVAX-NEO1 is the first cancer vaccine asset to be clinically developed at NEC. This development ties in with the larger NEC mission of providing healthcare solutions globally using the state of art technologies developed in-house."

Details of the poster are below:

Poster title: Oral DNA vaccination targeting personalised neoantigens in immune checkpoint inhibitor treated solid tumor patients – Interim results.

Authors: Domas Vaitiekus, E. Juozaityte, L. Puzauskienė, S. Tulyte, L. Gatijatullin, M. Platten, I. Poschke, I.Hulsmeyer, A. Kuhn, A. Aranguren, H. Lubenau, H. Fontenelle, B. Simovski, Y. Yamashita, C.Chaput, A. Meiser, V. Urbonas

Poster Number: 160P

Date: 12 December 2024

The poster may also be found here: Link to PDFNEC Bio website. Trial details can also be viewed at: new windowNCT05354323

NECVAX-NEO1 is currently under evaluation at additional clinical trial sites in Lithuania, Germany, and Spain. These sites are actively recruiting patients and are open for enrollment.