On September 4, 2024 Adaptin Bio, a biotechnology company focused on developing precision cancer therapies with improved delivery to the brain and other tissues, reported that it has emerged from stealth today with the announcement that FDA has cleared an Investigational New Drug (IND) application for its APTN-101 program in glioblastoma (GBM), the most common and aggressive primary brain tumor (Press release, Adaptin Bio, SEP 4, 2024, View Source [SID1234646361]). The clearance will enable the initiation of a first-in-human Phase 1 clinical trial to evaluate this investigational candidate in GBM.

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APTN-101 is a proprietary BRiTE (Brain Bispecific T cell Engager) therapeutic designed to target EGFRvIII, a specific protein linked to aggressive brain tumors. In preclinical studies, APTN-101 has shown a greater than 7-fold increase in distribution into the brain, with significant potential in eradicating malignant glioma tumors as a potentially best-in-class therapy. The Phase 1 clinical trial will assess the safety and efficacy of APTN-101 in patients diagnosed with WHO Grade IV Malignant Glioma, also known as GBM.

Current treatment options for GBM include surgery, radiotherapy, and chemotherapy, which aim to remove or destroy tumor cells within the brain but fail to completely eliminate the disease due to its invasive nature. GBM deeply infiltrates the brain and despite aggressive treatment, residual tumor cells often lead to disease recurrence. GBM represents one of the most aggressive and challenging forms of brain cancer, with a median survival rate of just 12-18 months post-diagnosis, with only 5% of patients surviving beyond five years. The disease accounts for approximately 15,000 new cases per year in the US. Secondary malignant brain tumors account for about 200,000 new cases annually. This critical unmet need demands innovative therapies that can overcome the limitations of current treatments that do not cross the blood brain barrier.

"The FDA clearance is a significant achievement for our collaboration with Adaptin. Based on results from preclinical models in orthotopic malignant glioma, we are excited to begin this clinical trial to evaluate the safety and efficacy of APTN-101," said Mustafa Khasraw, M.D., Professor of Neurosurgery, Medicine, Integrative Immunobiology, Cancer Biology and Pharmacology at Duke University. "APTN-101’s ability to cross the blood-brain barrier and target glioma cells directly offers a promising new approach."

"We’re thrilled to initiate clinical trials with APTN-101 following FDA clearance of our first-in-human trial," said Michael J. Roberts, Ph.D., CEO, Adaptin Bio. "Our proprietary BRiTE technology harnesses the immune system’s remarkable ability to target and deliver therapeutics to specific tissues, including the brain, potentially revolutionizing treatment for difficult-to-treat cancers. APTN-101 validates the BRiTE platform and its ability to enhance transfer of therapeutics into the brain. We are committed to advancing this novel therapy as a new potential therapy for glioblastoma patients who desperately need new therapies."

"Adaptin’s innovative delivery technology has the potential to revolutionize treatment for cancer and central nervous system disorders. We are proud to support Adaptin Bio as part of our ongoing commitment to partnering with visionary entrepreneurs and translating groundbreaking technologies from leading academic institutions into impactful solutions," said James Ahern, Managing Partner of Laidlaw & Company and Founding Partner of Lucius Partners, who is an investor in Adaptin Bio.

In preclinical studies, APTN-101 has shown impressive efficacy in eliminating malignant glioma tumors across various aggressive orthotopic models. The BRiTE platform, developed by researchers in the Department of Neurosurgery at Duke University under the leadership of Dr. John H. Sampson, harnesses the ability of T cells to precisely target and destroy glioma cells while effectively navigating the brain’s unique environment.

Adaptin Bio’s proprietary BRiTE technology leverages the enhanced "hitchhiking" capabilities of manipulated immune cells to deliver therapeutic agents directly to brain tumors. This innovative approach has demonstrated high specificity for EGFRvIII expressing glioma cells, dose-responsive efficacy against diverse patient-derived glioma cell lines, and a favorable safety profile. Additional BRiTE targets are being evaluated. By manipulating the immune system either in vivo or ex vivo, BRiTE aims to overcome traditional treatment barriers and offer a promising new therapeutic option for patients with intracerebral malignancies.

On September 4, 2024 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its antibody drug conjugate (ADC) portfolio with more than 25 abstracts across multiple types of cancer at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and the 2024 European Society for Medical Oncology (#ESMO24) (Press release, Daiichi Sankyo, SEP 4, 2024, https://www.businesswire.com/news/home/20240903292956/en/Daiichi-Sankyo-Unveils-New-Research-Across-Industry-Leading-ADC-Portfolio-in-Multiple-Cancers-at-WCLC-and-ESMO [SID1234646360]).

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Data at WCLC and ESMO (Free ESMO Whitepaper) showcasing Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer will include six late-breaking presentations, including two back-to-back presentations during Presidential Symposium 1 featuring datopotamab deruxtecan (Dato-DXd) data at WCLC, and the first presentation of clinical data of DS-9606, a CLDN6 directed modified pyrrolobenzodiazepine (PBD) ADC from Daiichi Sankyo’s second ADC platform, at ESMO (Free ESMO Whitepaper).

"New data in lung, breast, gastric, ovarian, endometrial and other cancers from several of our DXd antibody drug conjugates demonstrates how we are making substantial progress toward creating new standards of care for patients with cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to presenting initial clinical data from our second antibody drug conjugate platform at ESMO (Free ESMO Whitepaper), which underscores how Daiichi Sankyo is applying our expertise in this technology to craft new innovation for patients."

Progress in Lung Cancer at WCLC and ESMO (Free ESMO Whitepaper)
Late-breaking data at WCLC to be reported during back-to-back presentations at Presidential Symposium 1 will highlight the first interim results from the NeoCOAST-2 phase 2 platform trial evaluating novel perioperative treatment combinations including one arm studying datopotamab deruxtecan with durvalumab and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) non-small cell lung cancer (NSCLC).

The second Presidential Symposium 1 presentation will feature results from the application of quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, to measure TROP2 in tissue samples collected in the TROPION-Lung01 phase 3 trial that evaluated datopotamab deruxtecan versus docetaxel in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy. Overall survival results from TROPION-Lung01 also will be presented as a late-breaking oral presentation.

Other data at WCLC include two oral presentations featuring the interim results from the dose optimization part of the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer and results from the ENHERTU (trastuzumab deruxtecan) monotherapy arm of the DESTINY-Lung03 phase 1b trial in patients with previously treated HER2 overexpressing unresectable, locally advanced or metastatic NSCLC. A trial-in-progress poster from the NSCLC cohort of a phase 1b trial evaluating the combination of datopotamab deruxtecan and valemetostat, a dual inhibitor of EZH1 and EZH2, in previously treated locally advanced, unresectable or metastatic nonsquamous NSCLC with or without actionable genomic alterations also will be highlighted.

At ESMO (Free ESMO Whitepaper), additional data in lung cancer being reported include poster presentations featuring a post-hoc analysis of patients with nonsquamous NSCLC by baseline brain metastases status in the TROPION-Lung01 phase 3 trial of datopotamab deruxtecan and intracranial responses seen in the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan, as well as a trial-in-progress poster featuring the design of the IDeate-Lung03 phase 1b/2 trial of ifinatamab deruxtecan in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy in patients with extensive-stage small cell lung cancer.

Continued Innovation in Breast Cancer at ESMO (Free ESMO Whitepaper)
Late-breaking presentations in breast cancer at ESMO (Free ESMO Whitepaper) will include a proffered paper session featuring the primary results of the DESTINY-Breast12 phase 3b/4 trial evaluating ENHERTU in patients with HER2 positive advanced or metastatic breast cancer with or without brain metastases, and two mini oral sessions highlighting patient reported outcomes and determination of the HER2 low and HER2 ultralow status of tumors from the DESTINY-Breast06 phase 3 trial in patients with HR positive, HER2 low and HER2 ultralow metastatic breast cancer.

Two proffered paper sessions will highlight results from the ICARUS-BREAST01 phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR positive, HER2 negative advanced breast cancer with disease progression following two or more treatments and the investigator-initiated ERICA phase 2 trial evaluating olanzapine-based triplet antiemetic therapy for prevention of nausea and vomiting in combination with ENHERTU in patients with metastatic breast cancer. A mini oral session will feature a supplementary biomarker analysis from the DAISY phase 2 trial evaluating ENHERTU in three cohorts of patients with HER2 expressing metastatic breast cancer and a poster presentation will report on an exploratory biomarker analysis of ENHERTU in patients with HR positive, HER2 low metastatic breast cancer from the DESTINY-Breast04 phase 3 trial. A poster reporting on exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan versus chemotherapy in patients with previously treated HR positive, HER2 negative metastatic breast cancer also will be featured.

Data from Daiichi Sankyo’s Second ADC Platform and DXd ADC Data in Multiple Additional Cancers at ESMO (Free ESMO Whitepaper)
At ESMO (Free ESMO Whitepaper), a proffered paper session will highlight preliminary results from a phase 1 trial of DS-9606, a CLDN6 directed modified PBD ADC from Daiichi Sankyo’s second ADC platform, in patients with solid tumors known to express CLDN6. Results from the DESTINY-Gastric03 phase 1b/2 trial evaluating ENHERTU monotherapy or ENHERTU combinations with chemotherapy and/or immunotherapy in patients with HER2 expressing advanced/metastatic gastric or gastroesophageal junction carcinoma also will be presented at a proffered paper session.

A mini oral session will feature results from the TROPION-PanTumor03 phase 2 trial of datopotamab deruxtecan in patients with previously treated recurrent endometrial or ovarian cancer. Trial-in-progress poster presentations will highlight the HERTHENA-PanTumor01 phase 2 trial evaluating patritumab deruxtecan in patients with a broad range of solid tumors including bladder, cervical, endometrial, esophageal, gastric, head and neck, melanoma, ovarian, pancreatic and prostate and a phase 1 trial of DS-1471, a CD147 monoclonal antibody, in patients with locally advanced or metastatic solid cancers.

Investor Conference Call Following ESMO (Free ESMO Whitepaper)
Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, September 17, 2024 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the WCLC and ESMO (Free ESMO Whitepaper) research data and address questions.

WCLC and ESMO (Free ESMO Whitepaper) Data Highlights
Highlights of data from Daiichi Sankyo’s ADC portfolio at WCLC 2024 include:

Presentation Title

Author

Abstract

Presentation (PDT)

NSCLC

NeoCOAST-2: efficacy and safety of neoadjuvant durvalumab (D) + novel anticancer agents + CT and adjuvant D ± novel agents in resectable NSCLC

T. Cascone

PL02.07

Presidential Symposium 1
Sunday, September 8
8:30 – 10:00 am

Normalized membrane ratio of TROP2 by quantitative continuous scoring is predictive of clinical outcomes in TROPION-Lung01

M.C. Garassino

PL02.11

Presidential Symposium 1
Sunday, September 8
8:30 – 10:00 am

Datopotamab deruxtecan vs docetaxel in patients with non-small cell lung cancer: final overall survival from TROPION-Lung01

J. Sands

OA08.03

Oral Presentation
Monday, September 9
10:45 – 12:00 pm

Trastuzumab deruxtecan monotherapy in pretreated HER2 overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1

D. Planchard

OA16.05

Oral Presentation
Tuesday, September 10
1:30 – 2:45 pm

Valemetostat and datopotamab deruxtecan in previously treated, advanced, unresectable, or metastatic non-squamous NSCLC

A. Spira

P2.10A.04

Poster Session

Sunday, September 8

6:15 – 7:45 pm

SCLC

Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): interim analysis of IDeate-Lung01

C. Rudin

OA04.03

Oral Presentation
Sunday, September 8
2:00 – 3:15 pm

Exposure-response analyses to support phase 3 dose selection for I-DXd (ifinatamab deruxtecan) in extensive stage SCLC patients

N. Midde

P1.13A.12

Poster Session
Sunday, September 8
12:00 – 2:00 pm

Highlights of data from Daiichi Sankyo’s ADC portfolio at ESMO (Free ESMO Whitepaper) 2024 include:

Presentation Title

Author

Abstract

Presentation (CEST)

NSCLC

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in patients with advanced nonsquamous non-small cell lung cancer with brain metastases: results from TROPION-Lung01

E. Pons-Tostivint

1312P

Poster Session
Saturday, September 14

SCLC

Intracranial response in patients with baseline brain metastases and extensive-stage small cell lung cancer treated with ifinatamab deruxtecan (I-DXd) in the IDeate-Lung01 study

M. Johnson

1787P

Poster Session
Saturday, September 14

IDeate-Lung03: a phase 1b/2 study of ifinatamab deruxtecan (I-DXd) plus atezolizumab with or without carboplatin as first line induction or maintenance in patients with extensive stage small cell lung cancer

C. Rudin

1812TiP

Poster Session
Saturday, September 14

BREAST

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: primary results from DESTINY-Breast12

N. Lin

LBA18

Proffered Paper Session
Friday, September 13
4:00 – 5:30 pm

HER2 low and HER2 ultralow status determination in tumors of patients with HR+ mBC in DESTINY-Breast06

G. Viale

LBA 21

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Effects of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice on patient-reported outcomes in hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) low/ultralow metastatic breast cancer: results from DESTINY-Breast06

X. Hu

LBA22

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Efficacy, safety and biomarker analysis of ICARUS-BREAST01: a phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR+/HER2- advanced breast cancer

B. Pistilli

340O

Proffered Paper Session
Friday, September 13
4:00 – 5:30 pm

A multicenter, randomized, double-blind, placebo-controlled study of olanzapine-based triplet antiemetic therapy for prevention of delayed and persistent nausea and vomiting induced by trastuzumab deruxtecan in patients with metastatic breast cancer: ERICA study

H. Sakai

1816O

Proffered Paper Session
Saturday, September 14
2:45 – 4:25 pm

Unraveling the mechanisms of action and resistance to trastuzumab deruxtecan (T-DXd): supplementary biomarker analyses from DAISY trial

F. Mosele

343MO

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Exploratory biomarker analysis of trastuzumab deruxtecan versus treatment of physician’s choice in HER2-low, hormone receptor-positive metastatic breast cancer in DESTINY-Breast04

N. Ueno

432P

Poster Session
Monday, September 16

Exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 study of datopotamab deruxtecan (Dato-DXd) vs investigator’s choice of chemotherapy in patients with pretreated, inoperable/ metastatic HR+/HER2- breast cancer

H. Rugo

431P

Poster Session
Monday, September 16

Treatment patterns and outcomes in HER2 low, HR+ metastatic breast cancer patients previously treated with endocrine therapy in the United States

S. Modi

399P

Poster Session
Monday, September 16

OTHER SOLID TUMORS

Preliminary results from a phase 1, first-in-human study of DS-9606a, a Claudin 6 (CLDN6) directed antibody drug conjugate, in patients with tumor types known to express CLDN6

M. Patel

610O

Proffered Paper Session
Sunday, September 15
2:45 – 4:15 pm

Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients with advanced/metastatic HER2 positive esophageal, gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric03

Y. Janjigian

1401O

Proffered Paper Session
Saturday, September 14
8:30 – 10:00 am

Datopotamab deruxtecan (Dato-DXd) monotherapy in patients with endometrial or ovarian cancer: results from the phase 2 TROPION-PanTumor03 study

A.

Oaknin

714MO

Mini Oral Session
Sunday, September 15
2:45 – 4:15 pm

HERTHENA-PanTumor01: A global phase 2 trial of HER3-DXd in metastatic solid tumors

T. Powles

690TiP

Poster Session
Saturday, September 14

A phase 1, first-in-human study of DS-1471 in patients with advanced/metastatic solid tumors

S. Koganemaru

682TiP

Poster Session
Saturday, September 14

Claudin-6 expression in primary and recurrent epithelial ovarian cancer: a potential therapeutic target for high-grade serous ovarian cancer

D. Shintani

771P

Poster Session
Saturday, September 14

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified PBD payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

On September 4, 2024 Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, reported the close of an oversubscribed $325 million Series C financing round (Press release, ArsenalBio, SEP 4, 2024, View Source [SID1234646359]). The funding round included new investors ARCH Venture Partners, Milky Way Investments Group, Regeneron Ventures, NVentures (NVIDIA’s venture capital arm), Luma Group, funds and accounts advised by T. Rowe Price Associates, Inc., Rock Springs Capital, among others, with ongoing support from existing investors the Parker Institute for Cancer Immunotherapy (PICI), SoftBank Vision Fund 2, Bristol-Myers Squibb Company, Westlake Village BioPartners, Kleiner Perkins, Byers Capital, and Hitachi Ventures.

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Proceeds from the financing will be used to advance ArsenalBio’s lead programs through development as the company continues to build its pipeline of therapeutic candidates for solid tumor cancers based on its proprietary T cell engineering technology, including logic gating. The funds will also drive further innovation in developing tools and processes for identifying new candidate cell therapies, helping ArsenalBio remain at the forefront of the rapidly evolving field of cell therapy, and bringing it closer to its goal of addressing unmet needs across the oncology category.

"Our initial clinical trials and preclinical studies have shown the promise of our T cell engineering approach and have given us the confidence to broaden the application of our technology to address additional cancer types," said Ken Drazan, M.D., ArsenalBio’s co-founder, CEO and Chairman. "This new investment enables us to continue our development roadmap, scale up our manufacturing capabilities, and invest in new avenues for innovation in T cell medicine."

ArsenalBio’s robust pipeline includes potential therapies in development for ovarian, kidney, and prostate cancers, as well as other solid tumors being co-developed through a collaboration with Bristol-Myers Squibb Company. The fundraising follows ArsenalBio’s recent entry into clinic with its second T cell product candidate, AB-2100, being studied in a Phase 1/2 clinical trial for clear-cell renal cell carcinoma (ccRCC). The candidate has been granted Fast Track designation by the U.S. Food and Drug Administration.

On September 4, 2024 Tempus AI, Inc. (NASDAQ: TEM, "Tempus"), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a multi-year collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases (Press release, Tempus, SEP 4, 2024, View Source [SID1234646358]). This collaboration leverages Tempus’ robust multimodal datasets in support of BioNTech’s next-generation oncology pipeline.

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Under this collaboration, Tempus is providing analytical support and computational biology expertise to BioNTech across its comprehensive research and development oncology pipeline. BioNTech will work collaboratively with Tempus to leverage Tempus’ real-world multimodal database to generate novel insights into the biological mechanisms supporting the discovery of new therapies and aiming to enhance the development of BioNTech’s clinical oncology pipeline.

"We are looking forward to collaborating with BioNTech to combine our real-world multimodal data and cutting-edge computational technology to help advance their differentiated oncology pipeline," said Ryan Fukushima, Chief Operating Officer of Tempus. "By applying Tempus’ extensive real-world multimodal data to BioNTech’s AI capabilities and multi-platform discovery engine, we believe we can generate a real impact by working to bring novel therapies to those cancer patients who could potentially benefit the most."

On September 4, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported they will collaborate with the Icahn School of Medicine at Mount Sinai on a precision medicine clinical study in multiple myeloma (MM) (Press release, BostonGene, SEP 4, 2024, View Source [SID1234646357]). The study aims to evaluate and improve cancer sequencing for the characterization of tumor molecular vulnerabilities and the identification of novel therapeutics, paving the way for developing targeted therapies and personalized treatment approaches for MM patients.

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Samir Parekh, MBBS, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and fellow researchers at Mount Sinai will utilize BostonGene’s CLIA-certified, CAP-accredited and NY State-approved next-generation sequencing technologies, including whole exome and whole transcriptome sequencing, to support clinical care and discovery efforts for patients with MM.

"Collaborating with BostonGene enables us to leverage their advanced next-generation sequencing to gain deeper insights into the molecular and immune characteristics of multiple myeloma," said Cesar Rodriguez, MD, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai. "This partnership will help us identify novel therapeutic targets and develop more effective, personalized treatment strategies for our patients. By recognizing the unique features a patient and their disease have, we may be able to select optimal regimens that may translate to better outcomes."

BostonGene’s cloud-based solutions, bioinformatics capabilities and analytical tools offer a robust platform for integrated analysis of the patient and their tumor. This comprehensive approach delivers data-driven results, transforming patient care and revolutionizing precision medicine practices.

"We are excited to partner with Mount Sinai on this study," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our AI-powered solutions and comprehensive analytical tools provide unparalleled insights into the molecular underpinnings of cancer and we are committed to advancing precision medicine to improve outcomes for multiple myeloma patients."