On January 7, 2025 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer and infectious diseases, reported an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to supply etakafusp alfa (formerly known as AB248), Asher Bio’s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, to be evaluated in combination with rilvegostomig, AstraZeneca’s investigational PD-1/TIGIT immuno-oncology bispecific antibody, in patients with advanced or metastatic NSCLC (Press release, Asher Biotherapeutics, JAN 7, 2025, View Source [SID1234649489]).

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"This exciting agreement with AstraZeneca is a reflection of the emerging clinical data from our Phase 1 study of etakafusp alfa. Initial data demonstrate a highly differentiated clinical pharmacodynamic profile with unprecedented levels of selective CD8+ T cell activation as well as initial evidence of anti-tumor effect including confirmed objective responses," said Don O’Sullivan, Ph.D., Chief Business Officer of Asher Bio. "We look forward to collaborating with AstraZeneca to expand the potential impact of our lead cis-targeted immunotherapy in patients worldwide."

As part of this agreement, AstraZeneca will sponsor and operationalize a global study to evaluate the safety and early efficacy of etakafusp alfa as a first-line treatment in combination with rilvegostomig in patients with advanced or metastatic NSCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply AstraZeneca with etakafusp alfa at no cost.

About NSCLC

NSCLC is the most common type of lung cancer, accounting for 80-85% of the ~235,000 new cases in the US this year1. NSCLC originates in cells that line the airways and can invade surrounding tissues or metastasize to other parts of the body. The condition is often diagnosed at an advanced stage when it is harder to treat and is associated with a poor prognosis. Treatment options for NSCLC are tailored to the stage, subtype, and biomarker status of the disease, and may include surgery, radiation, chemotherapy, targeted therapies, immunotherapy, or a combination of these. Lung cancer has a 5-year relative survival rate of only 26.7% 2, representing a significant unmet need for additional treatment options for people living with advanced or metastatic NSCLC.

About Etakafusp Alfa (AB248)

Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. Asher Bio is currently evaluating etakafusp alfa in a Phase 1a/1b clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of etakafusp alfa alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. Initial pharmacokinetic and pharmacodynamic data from the ongoing Phase 1a/1b clinical trial support etakafusp alfa’s proof of mechanism and activity with a highly differentiated clinical profile. Early data shows potent and selective CD8+ T cell activation without substantial changes to Treg and NK cell numbers and initial evidence of anti-tumor activity, including confirmed objective responses, with a generally well-tolerated safety profile. Please refer to www.clinicaltrials.gov (NCT05653882) for additional details related to this Phase 1a/1b clinical trial.

On January 7, 2025 Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, reported that John S. Yu, M.D., Chief Executive Officer, and Neil Bhowmick, Chief Scientific Officer, will present a corporate overview at the Lytham Partners Investor Healthcare Summit (Press release, Kairos Pharma, JAN 7, 2025, View Source [SID1234649488]). The conference is being held virtually on January 13, 2025.

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Event:

Lytham Partners Investor Healthcare Summit

Presentation Date:

Monday, January 13, 2025

Time:

2:00 PM ET

Webcast Link:

View Sourcekapa" target="_blank" title="View Sourcekapa" rel="nofollow">View Source

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners or register for the event at View Source

The webcast will also be available for replay following the event.

On January 7, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications (Press release, MAIA Biotechnology, JAN 7, 2025, View Source [SID1234649486]). The single arm pivotal Phase 2 trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC).

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MAIA’s preclinical results in HCC, with THIO in combination with a CPI, showed complete, durable and highly potent anti-tumor immune response. Preclinical results of THIO treatment in SCLC showed profound activation of innate and adaptive anti-tumor responses. In CRC pre-clinical studies, THIO administered in sequence with a CPI resulted in 100% complete response and anticancer immune memory was induced, resulting in no recurrence after rechallenge with 10x more CRC cells and no additional therapy. In all preclinical studies, THIO converted immunologically cold and non-responsive tumors into hot tumors that are responsive to a CPI.

"Based on excellent pre-clinical results, THIO was awarded orphan drug designation (ODD) for the treatment of both HCC and SCLC. Along with a third ODD in glioblastoma, the FDA has clearly recognized THIO’s potential as an effective treatment for multiple cancer indications. Comparatively, most oncology compounds at this stage of development have only one indication," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "BeiGene’s tislelizumab has also demonstrated its potential to deliver clinically meaningful outcomes across a range of tumor types. We are pleased to partner with BeiGene for these important studies, two of which address the top three most lethal cancers worldwide."

Under the terms of the collaboration, MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab. MAIA maintains global development and commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications.

MAIA is targeting accelerated FDA approvals in each of the three indications to be studied along with non-small cell lung cancer (NSCLC), the focus of a current Phase 2 clinical trial of THIO with a CPI.

Market Trends

Hepatocellular carcinoma is the third most common cause of cancer-related deaths globally. The market for HCC was valued at $780 million in 2023 and is expected to increase to grow at a CAGR of 6.3% to $1.5 million by 2034.1

Small cell lung cancer accounts for an estimated 15% of all lung cancer globally. The global SCLC therapeutics market is valued at approximately $6.5 billion in 2024 and is expanding at an estimated CAGR of 12.3% from 2024 to 2034.2

Colorectal cancer is the second leading cause of cancer-related deaths globally.3 Approximately 85% of all CRC cases are classified as microsatellite stable. MSS tumors are "cold tumors" that typically do not trigger the body’s immune system. The global CRC therapeutics market size was $9.26 billion in 2018 and is projected to reach $26.49 billion by 2032.4

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On January 7, 2025 Biocytogen (HKEX: 02315) and Acepodia (6976:TT), reported a groundbreaking strategic partnership to jointly assess a dual-payload bispecific antibody-drug conjugate (BsAD2C) program (Press release, Biocytogen, JAN 7, 2025, View Source [SID1234649485]).

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This collaboration combines Biocytogen’s RenLite platform with Acepodia’s Antibody-Dual-Drugs Conjugation (AD2C) technology to tackle some of the toughest challenges in oncology—tumor heterogeneity and drug resistance. This novel approach aims to address these complexities by utilizing dual-payloads that target multiple therapeutic or disease pathways. These payloads are delivered with bispecific antibodies that enable enhanced precision and functionality.

As part of the strategic partnership, Biocytogen will provide a bispecific antibody derived from its proprietary RenLite platform, which is designed to produce fully human bispecific antibodies with unique binding properties. To this antibody, Acepodia will integrate two different payloads using its Antibody-Dual-Drugs Conjugation (AD2C) platform. This platform enables site-selective conjugation of multiple payloads to an antibody using bio-orthogonal click chemistry with no required antibody engineering, maintaining antibody integrity and binding capacity, and allowing strategic and precise control over the Drug-to-Antibody Ratio (DAR) for optimal potency and safety.

"We are thrilled to partner with the Acepodia team who brings deep expertise in bio-orthogonal click chemistry and the unique opportunity to combine our RenLite bispecific antibodies with site-selective dual-payload conjugates," said Dr. Yuelei Shen, President and CEO of Biocytogen. "We look forward to bridging our platforms to explore the therapeutic potential of highly potent BsADCs."

"Biocytogen’s superior bispecific antibodies and highly collaborative team make them an ideal partner for advancing our AD2C payload platform," said Sonny Hsiao, Ph.D., Co-Founder and CEO of Acepodia. "This partnership redefines the possibilities of ADC design, with the potential to deliver breakthrough therapies to patients in desperate need of new options."

This strategic partnership underscores the commitment of both companies to addressing the critical unmet needs in ADC drug development for solid tumors, paving the way for innovative therapies that improve patient outcomes

On January 7, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the company’s New Drug Application (NDA) for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Dizal Pharma, JAN 7, 2025, View Source [SID1234649481]).

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The FDA grants priority review to drugs that, if approved, would be significant improvements in the safety or effectiveness over existing treatment for a serious disease. This decision follows the FDA’s earlier Breakthrough Therapy Designations for Sunvozertinib in treatment naïve and relapsed or refractory settings. Currently, no small molecule drug has been approved in the U.S. or Europe to treat this serious disease.

The NDA submission is supported by efficacy and safety results from the multinational pivotal WU-KONG1 Part B study, evaluating sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins from Asia, Europe, North America, and South America. These data, presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrated statistically significant clinical benefits.

"Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options," said Xiaolin Zhang, PhD, CEO of Dizal. "Sunvozertinib’s Priority Review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are promising. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins."

In 2023, Sunvozertinib was granted accelerated approval by the National Medical Products Administration (NMPA) of China, making it the world’s first and only oral treatment for NSCLC patients with EGFR exon20ins.

About Sunvozertinib (DZD9008)
Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.