Alecensa Approved by FDA as the First Adjuvant Treatment for People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer

On April 19, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the U.S. Food and Drug Administration (FDA) has approved anaplastic lymphoma kinase (ALK) inhibitor Alecensa (generic name : alectinib) for adjuvant treatment following tumor resection for patients with-ALK positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test (Press release, Chugai, APR 19, 2024, View Source [SID1234642172]). Alecensa is now the only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor. Outside the U.S., the medicine is currently under review for the indication by health authorities including in Europe, Japan, and Taiwan.

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"We are very pleased that Alecensa, a Chugai originated medicine, is now approved by the FDA as the first adjuvant therapy for ALK-positive early-stage NSCLC. Alecensa has shown in a clinical trial to reduce the risk of death or recurrence by 76%. Bringing patients a new treatment option with the possibility of cure, may become a turning point in the treatment of ALK-positive early-stage NSCLC. We will work closely with Roche to deliver this treatment to patients awaiting all over the world, as soon as possible," said Chugai’s President and CEO, Dr. Osamu Okuda.

The approval is based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.001) compared with platinum-based chemotherapy in people with completely resected IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.1 An exploratory analysis also showed improvement of central nervous system (CNS)-disease-free survival, reducing the risk of disease recurrence or death by 78% (HR=0.22; 95% CI: 0.08-0.58) compared with platinum-based chemotherapy.1 The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.1 These data were presented as a late-breaking oral at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 Presidential Symposium in October 2023 and were also recently published in the New England Journal of Medicine in April 2024.

Alecensa is a kinase inhibitor currently approved as first- and second -line treatment for ALK-positive metastatic NSCLC. It has demonstrated efficacy in patients, including those with CNS metastases, and now with this approval, these benefits could extend to people with early-stage NSCLC. Routine testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and select IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines), to support clinicians’ decision-making. Approximately5% of people with NSCLC are ALK-positive, equating to approximately 90,000 people worldwide diagnosed each year.2,3,4

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa (alectinib) compared with platinum-based chemotherapy in people with completely resected stage IB (tumor ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study includes 257 patients who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is disease-free survival (DFS). Secondary outcome measures include overall survival, central nervous system-DFS and percentage of patients with adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, Kamakura Research Laboratories for people with non-small cell lung cancer (NSCLC) whose tumors are identified as anaplastic lymphoma kinase (ALK) positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan and China. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.5 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.5 In Japan, 127 thousand people are affected by this disease (2019).6 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85% of all cases.7 Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.8 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.9

Trademarks used or mentioned in this release are protected by law.

Source:

Wu Y-L et al. Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer. N Engl J Med 2024;390:1265-1276
Barlesi, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet 2016. 387(10026):1415-1426.
Tian, et al. Clinical characteristics and sequence complexity of anaplastic lymphoma kinase gene fusions in Chinese lung cancer patients. Lung Cancer 2017. 114:90-95.
Cancer.Net. Lung Cancer – Non-Small Cell: Statistics. [Internet; cited April 2024]. Available from: View Source
Thandra KC, et al. Epidemiology of lung cancer. Contemp Oncol. 2021;21(1):45-52.
Cancer Statistics, Cancer Information Service, National Cancer Center, Japan (National Cancer Registry) [Internet; cited 2024 April] Available from: View Source (Japanese Only)
American Cancer Society: What Is Lung Cancer? [Internet; cited 2024 April] Available from: View Source
Pignon JP et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.
Hendricks LE et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO (Free ESMO Whitepaper) Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4): 339-357.

EditCo Bio, Inc. Unveils Novel Knockout CD4+ T-cell Pools to Transform Cancer and Autoimmune Research

On April 18, 2024 EditCo Bio, Inc., a pioneer at the forefront of genome engineering innovation, reported the launch of its Knockout CD4+ T-cell Pools (Press release, EditCo Bio, APR 18, 2024, View Source [SID1234642167]). This latest addition to EditCo Bio’s product lineup marks a significant leap forward in CRISPR-mediated gene editing, providing the scientific community with an advanced tool for primary T-cell editing that surpasses the capabilities of traditional methodologies.

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With the advent of CRISPR-Cas9 technology, genetic engineering has entered a new era of precision, particularly in the realm of primary immune cell editing. T-cells, pivotal in the immune response, hold immense promise for elucidating the pathways of various diseases, including cancer and autoimmune conditions. Yet, conventional T-cell editing techniques have often fallen short, plagued by scalability issues and inconsistent outcomes.

Leveraging the power of EditCo Bio’s cutting-edge, automated platform, researchers can now bypass the challenging optimization steps and access highly functional edited T-cells ready for immediate use. This innovation not only accelerates the journey from research discovery to clinical application but also delivers several key benefits:

Rapid Results: A novel 7-day protocol harnesses EditCo Bio’s unique multi-guide technology to achieve knockout efficiencies beyond 90% in primary human CD4+ T-cells.
Dependable Performance: Post-editing, CD4+ cell pools maintain over 80% viability before cryopreservation and can expand 40-fold over 14 days, regardless of TCR stimulation.
Optimal Functionality: After cryo-recovery, these CD4+ T-cell pools exhibit remarkable functional integrity, matching control cells in IL2, IFNG, and TNFA protein production post-PMA/ionomycin stimulation. Further, cultured cells retain over 90% viability and maintain editing efficiency for at least 14 days.
"For too long, the potential of primary T-cell editing has been constrained by the technical limitations of existing methods," said Travis Maures, CSO of EditCo Bio. "With the launch of our Knockout CD4+ T-cell Pools, EditCo Bio is breaking down these barriers, offering researchers the precision, efficiency, and scalability needed to advance the frontiers of immunotherapy and cellular research while allowing them the benefit of bypassing tedious protocol optimization. This innovation is a testament to our commitment to empowering scientists worldwide, driving forward the possibilities of gene editing to address some of the most pressing challenges in research today."

The introduction of Knockout CD4+ T-cell Pools is a strategic extension of EditCo Bio’s comprehensive Engineered Cell portfolio. It further solidifies the company’s position as a leader in cell engineering solutions that includes knockout and knock-in technologies for immortalized cells and iPSCs. EditCo Bio plans to expand the range of its edited primary cells products beyond CD4+ T-cells into other primary cell subsets that will be commercially available to researchers worldwide later this year.

For more information regarding EditCo Bio’s CD4+ T-cell Pools, visit www.EditCo.bio/contact.

Azitra, Inc. to Present New Data at Three Upcoming Scientific Conferences in May 2024

On April 18, 2024 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported it will be presenting promising new preclinical data from its platform built (or optimized) to discover treatments for serious skin diseases at three upcoming scientific and medical conferences (Press release, Azitra, APR 18, 2024, View Source [SID1234642166]):

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ASGCT (American Society of Gene and Cell Therapy)
Baltimore, MD

Title: Engineered Staphylococcus Epidermidis as a Protein Delivery System for Treating Skin Diseases
Format: Oral presentation
Date: May 10th, 4:00pm – 4:15pm EDT

Title: Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome
Format: Oral presentation
Date: May 10th, 5:15pm – 5:30pm EDT

SID (Society of Investigative Dermatology)
Dallas, TX

Title: Cutaneous delivery of LEKTI via an engineered strain of Staphylococcus epidermidis for the treatment of Netherton syndrome
Format: Oral presentation
Date: Friday May 17th, 2024 8:30 AM – 11:00 AM CDT

Title: Staphylococcus epidermidis for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity
Format: Oral presentation
Date: Friday May 17th, 2024 8:30 AM – 11:00 AM CDT

Title: Clinical study of Netherton syndrome treated topically with a Staphylococcus epidermidis strain expressing recombinant human LEKTI-D6 (ATR12-351)
Format: Poster presentation
Date: Friday May 17th, 2024 4:00 – 6:00 PM CDT

ASCO (American Society of Clinical Oncology)
Chicago, IL

Title: Preclinical development of ATR04-484, an auxotrophic strain of Staphylococcus epidermidis, for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity
Format: Online abstract
Date: Thursday, May 23rd, 2024 5:00 PM EDT

Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

On April 18, 2024 Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, reported the U.S. Food & Drug Administration (FDA) approved the company’s New Drug Application (NDA) for its LUMISIGHT (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell Direct Visualization System (DVS), together referred to as LumiSystem (Press release, Lumicell Diagnostics, APR 18, 2024, View Source [SID1234642165]).

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With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries.1-2 The LumiSystem combination is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

"We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS – we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes,"3 said Howard Hechler, President and Chief Operating Officer, Lumicell. "With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity."

"Breast cancer is all too common, and sadly, 1 in 8 women will develop it during their lifetime,"4 said Kelly Hunt, MD, Chair of the Department of Breast Surgical Oncology at MD Anderson Cancer Center and President of the Society of Surgical Oncology. "Our most common surgical procedure to treat these women is lumpectomy. Unfortunately, the intraoperative tools we have are limited and do not identify the extent of tumor accurately enough, making it challenging to achieve a complete tumor resection, leading to as many as 36% of patients needing a second surgery."5

"Up to 65% of the time, we do not find residual cancer in the second surgery and are left wondering if we performed an unnecessary surgery due to a false positive margin assessment or if the cancer was missed again in the second surgery,"6 said Irene Wapnir, MD, Breast Surgical Oncologist and Professor of Surgery, Stanford University School of Medicine.

"During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation,"7 said Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School. "With LumiSystem, we will now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy that could help some patients avoid a second surgery."2

The safety of the system was established using data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers across the U.S. The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine. LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence.

"We want to thank our clinical investigators and the hundreds of women who participated in our breast program for LUMISIGHT and Lumicell DVS," said Jorge Ferrer, Chief Scientific Officer, Lumicell. "Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the United States shortly."

Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS.

Actinium Highlights Ability of Iomab-B to Overcome High-Risk TP53 Mutation Resulting in Significant Improvement in Overall Survival in Patients with Active Relapsed Refractory AML at the European Bone Marrow Transplant Annual Meeting

On April 18, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that results from the Phase 3 SIERRA trial of Iomab-B were presented in an oral presentation at the 50th Annual European Bone Marrow Transplant Society Meeting (EBMT) held in Glasgow, Scotland on April 14-17 (Press release, Actinium Pharmaceuticals, APR 18, 2024, View Source [SID1234642164]). The results showed that an Iomab-B led bone marrow transplant (BMT) results in higher rates of remissions and durable Complete Remission (dCR), which is the primary endpoint of the SIERRA trial, as well as significant improvement in overall survival in TP53 positive patients. Iomab-B is a targeted radiotherapeutic comprised of an anti-CD45 monoclonal antibody with the Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients age 55 and above with active relapsed or refractory acute myeloid leukemia (AML) and compared outcomes of patients receiving Iomab-B BMT to those of patients receiving physician’s choice of care in the control arm. In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is associated with limited treatment options and poor outcomes.

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Data highlighted in the ASH (Free ASH Whitepaper) oral presentation, which can be accessed on the investor relations page of Actinium’s website, included:

Response rates by TP53 Mutation Status:

Iomab-B & Crossover

Control Arm

TP53 Positive

N=27

N=10

CR

55.56% (15/27)

0 %

dCR

14.81% (4/27)

0 %

TP53 Wildtype

N=93

N=23

CR

58.06% (54/93)

17.39% (4/23)

dCR

16.13% (15/93)

0 %

Overall Survival in Patients with a TP53 Mutation:

Iomab-B & Crossover

Control Arm

Median OS

5.49 months

1.66 months

Number of Patients

27

10

Hazard Ratio

0.23

p-value

0.0002

Median OS was 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B’s ability to overcome TP53 gene mutations.

Dr. Hannah Choe, Assistant Professor of Medicine at Ohio State University and SIERRA trial investigator, commented, "TP53 mutations are associated with very poor outcomes due to resistance to anti-leukemic therapies with patients rarely offered access to potentially curative transplantation. The SIERRA trial showed that Iomab-B was well tolerated and can enable unprecedented access to transplant in this patient population and induce high complete remission rates despite active, relapsed/refractory disease and a TP53 mutation. These results were very well received at EBMT and demonstrate the novelty and safety of a CD45-directed antibody radiation conjugate. More importantly, we see that these response rates translated into improved overall survival, overcoming the increased risk associated with TP53 mutation while no other viable treatment options exist. We are excited for Iomab-B’s potential use and safety for disease control in patients with a TP53 mutation."

About the EBMT Annual Meeting

The Annual Meeting of the EBMT is attended by more than 5,500 participants, including physicians, nurses, data managers, statisticians, quality managers, cell therapists, paediatricians, pharmacists, psychologists, psychiatrists and psychoanalysts, transplant coordinators, lab scientists, trainees, and patients. This important congress ensures and encourages dialogues and information exchange, education and scientific productivity.

The full annual meeting program is available online at:

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