On May 21, 2024 Alloy Therapeutics, a biotechnology ecosystem company dedicated to democratizing access to biologics drug discovery platforms and services, reported a licensing agreement for its murine platforms for fully human antibody discovery with Eli Lilly and Company (Press release, Alloy Therapeutics, MAY 21, 2024, View Source [SID1234643573]). The non-exclusive license provides Lilly access to the ATX-Gx and ATX-CLC mouse platforms and broad rights to use the Alloy platforms for antibody drug discovery and development under this multi-year collaboration.

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Launched in 2019, the Alloy ATX-Gx platform has rapidly become the industry standard fully human transgenic mouse platform to enable therapeutic discovery programs utilized by over 170 partners. Alloy is dedicated to reinvesting its revenue into innovation and has continuously expanded its murine platforms, adding new strains such as ATX-GL with the full human lambda repertoire as well as ATX-GKH hyperimmune strain for increased generation of antigen-specific B-cells and enhanced IgG class switching. In 2023 Alloy launched the ATX-CLC platform expressing common light chain antibodies with full heavy chain diversity to enable efficient, modular bispecific discovery.

Access to Alloy’s platforms extends to Lilly’s Catalyze360 program, a comprehensive platform designed to enable drug discovery and development for biotech partners, including opportunities for capital investment, world-class lab space, and exceptional R&D capabilities and expertise. Under the arrangement, biotech companies that work with Lilly Catalyze360 will have the opportunity for Alloy antibody discovery platforms to be deployed to rapidly progress partnered discovery campaigns and accelerate medicines to the clinic for patients.

"Lilly is a great collaboration partner, and we are excited to further enable the company’s broader R&D ecosystem with access to Alloy’s best-in-class technologies for discovering superior fully human antibodies and bispecifics against even the most challenging targets," said Heather Schwoebel, CBO of Antibodies and Strategic Collaborations at Alloy. "This collaboration represents just one example of the many ways Alloy is flexible in enabling our partners with a breadth of discovery solutions to support their objectives and improve patient lives."

On May 21, 2024 U.S. Precision Medicine, Inc. (USPM), a biopharma company developing novel cancer therapeutics, reported it will use state-of-the-art artificial intelligence (AI) technology to bolster independent research that has proven the company’s small molecule candidate is highly effective in killing breast cancer (Press release, US Precision Medicine, MAY 21, 2024, View Source [SID1234643517]).

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U.S. Precision Medicine’s new cancer drug candidate has demonstrated the ability to reduce tumor weight and volume by 85% in just 30 days of treatment with no toxicity. The findings were corroborated in the independent Investigational New Drug (IND) research with small animal studies required by the FDA. The company’s contract research organization currently is developing the dosing plan and expanding the research to include an additional 100 cancer types, for which patents or patents pending are held.

"Now that the validity of AI in pharmaceutical drug development is gaining traction, we plan to conduct a comparative study leveraging AI platforms in parallel with our ongoing IND research to prepare for human clinical trials," said Frederick Fey, co-founder and CEO of USPM.

"The drug candidate shows great promise as a treatment for most, if not all, solid tumor cancers, which account for approximately 90 percent of adult cancers and 30 percent of all pediatric cancers."

The worldwide incidence of cancer continues to rise, with the American Cancer Society projecting a 77% increase in new cases by 2050 versus 2022 levels. Last year, there were approximately 20 million new cancer diagnoses and 9.7 million cancer deaths globally.

"Cancer represents a tremendous unmet medical need that is projected to reach $200 billion by 2025 for cancer drugs alone," said Christopher Fey, co-founder and COO of USPM. "My brother and I are passionate about turning cancer victims into survivors because our father passed away from colon cancer at age 29 when we were toddlers. We hope others will join us in improving outcomes for patients across all cancer types."

On May 21, 2024 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple cancers at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Scientific Program (#ASCO24) (Press release, Daiichi Sankyo, MAY 21, 2024, https://www.businesswire.com/news/home/20240520281085/en/Daiichi-Sankyo-Highlights-Progress-in-Creating-New-Standards-of-Care-for-Patients-Across-Multiple-Cancers-at-ASCO [SID1234643515]).

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Data at ASCO (Free ASCO Whitepaper) showcasing the company’s progress in creating new standards of care for patients with cancer will include the late-breaking positive results of the DESTINY-Breast06 phase 3 trial (LBA #1000) evaluating ENHERTU (trastuzumab deruxtecan) compared to standard of care chemotherapy in patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow [defined as IHC 0 with membrane staining; IHC >0 <1+] metastatic breast cancer following one or more lines of endocrine therapy. Data from DESTINY-Breast06 will be featured in an ASCO (Free ASCO Whitepaper) press briefing.

"Results to be shared at ASCO (Free ASCO Whitepaper) from DESTINY-Breast06 demonstrate how ENHERTU continues to challenge the traditional classification and treatment of breast cancer, building on the practice-changing results seen with DESTINY-Breast04," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These significant data along with updated survival results from DESTINY-Breast03 highlight how ENHERTU is a transformative medicine for the treatment of certain patients with metastatic breast cancer."

Updated survival results from the DESTINY-Breast03 phase 3 trial (#1025) of ENHERTU versus trastuzumab emtansine (T-DM1) in patients with previously treated HER2 positive metastatic breast cancer along with interim results from the dose expansion portion of DESTINY-Breast07 phase 1b/2 trial (#1009) evaluating ENHERTU monotherapy as well as ENHERTU plus pertuzumab in patients with previously untreated HER2 positive metastatic breast cancer also will be presented.

Additional ENHERTU data at ASCO (Free ASCO Whitepaper) includes the final results of the DESTINY-Lung02 phase 2 trial (#8543) in patients with previously treated HER2 mutant non-small cell lung cancer (NSCLC) as well as three sub-analyses from the DESTINY-PanTumor02 phase 2 trial in patients with HER2 expressing metastatic biliary tract and pancreatic cancer (#4090), bladder cancer (#4565) and head and neck cancer (#6037). Data from DESTINY-PanTumor02 was one of three phase 2 trials that led to the recent accelerated approval in the U.S. of ENHERTU for a tumor agnostic indication in unresectable or metastatic HER2 positive (IHC 3+) solid tumors.

Additional Data and Trials-in-Progress Across Daiichi Sankyo’s DXd ADC Portfolio at ASCO (Free ASCO Whitepaper)
Additional sub-analyses from the TROPION-Lung02 phase 1b trial (#8617) evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy as a first-line treatment for patients with advanced or metastatic NSCLC, the intracranial efficacy of datopotamab deruxtecan in patients with advanced or metastatic NSCLC with actionable genomic alterations from the TROPION-Lung05 phase 2 trial (#8593), and patient reported outcomes from the TROPION-Breast01 phase 3 trial (#1006) of datopotamab deruxtecan versus chemotherapy in patients with previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer will be presented.

Trials-in-progress presentations include the IDeate-Lung02 phase 3 trial (TPS8126) evaluating ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer, the REJOICE-Ovarian01 phase 2/3 trial (TPS5625) evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer, the HERTHENA-PanTumor01 phase 2 trial (TPS3164) evaluating patritumab deruxtecan (HER3-DXd) in patients with locally advanced or metastatic solid tumors, and the first-in-human phase 1/2 trial (TPS3165) of DS-3939 in patients with advanced solid tumors.

Additional trials-in-progress featuring combinations of Daiichi Sankyo’s DXd ADCs and a novel medicine in development include a phase 1b trial (TPS4180) evaluating valemetostat, a dual inhibitor of EZH1 and EZH2, in combination with ENHERTU or datopotamab deruxtecan in patients with solid tumors and a phase 1b trial (TPS1120) evaluating valemetostat in combination with ENHERTU in HER2 low, ultralow and null metastatic breast cancers.

Daiichi Sankyo will hold a virtual conference call for investors on Monday, June 3, 2024 from 6:00 to 7:00 pm CDT / Tuesday, June 4, 2024 from 8:00 to 9:00 am JST. Executives from Daiichi Sankyo will provide an overview of the ASCO (Free ASCO Whitepaper) research data and address questions.

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

Presentation Title

Author

Abstract

Presentation (CDT)

ENHERTU (trastuzumab deruxtecan; T-DXd)

Breast

Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) low or HER2 ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): primary results from DESTINY-Breast06 (DB-06)

G. Curigliano

LBA1000

Oral Presentation

Sunday, June 2

7:30 – 8:00 am

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients with HER2+ mBC: updated survival results of DESTINY-Breast03

E. Hamilton

1025

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

DESTINY-Breast07: dose-expansion interim analysis of T-DXd monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ mBC

F. Andre

1009

Oral Presentation

Saturday, June 1

3:00 – 6:00 pm

Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients with HER2+ mBC from DESTINY-Breast-01, 02, and 03

C. Saura

1023

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

Lung

Trastuzumab deruxtecan in patients with HER2 mutant metastatic non-small cell lung cancer: final analysis results of DESTINY-Lung02

P. Janne

8543

Poster Session

Monday, June 3

1:30 – 4:30 pm

Tumor Agnostic

Trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing biliary tract cancer and pancreatic cancer: outcomes from DESTINY-PanTumor02

D. Oh

4090

Poster Session

Saturday, June 1

1:30 – 4:30 pm

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing solid tumors: results from the bladder cohort of DESTINY-PanTumor02 study

P. Wysocki

4565

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

Trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing head and neck tumors: outcomes from DESTINY-PanTumor02

F. Meric-Bernstam

6037

Poster Session

Monday, June 3

9:00 am – 12:00 pm

Datopotamab Deruxtecan (Dato-DXd)

Breast

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer: Patient-reported outcomes from the TROPION-Breast01 study

S. Pernas

1006

Oral Presentation

Saturday, June 1

3:00 – 6:00 pm

Lung

Datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy as first-line therapy for advanced non-small cell lung cancer: subgroup analysis from TROPION-Lung02

B. Levy

8617

Poster Session

Monday, June 3

1:30 – 4:30 pm

Intracranial efficacy of datopotamab deruxtecan in patients with previously treated advanced/metastatic non-small cell lung cancer with actionable genomic alterations: results from TROPION-Lung05

A. Lisberg

8593

Poster Session

Monday, June 3

1:30 – 4:30 pm

Patritumab Deruxtecan (HER3-DXd)

Pan-Tumor

HERTHENA-PanTumor01: a global, multicohort phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors

A. Bhatia

TPS3164

Poster Session

Saturday, June 1

9:00 am -12:00 pm

Patritumab deruxtecan (HER3-DXd) in active brain metastases from metastatic breast and non–small cell lung cancers, and leptomeningeal disease from advanced solid tumors: the TUXEDO-3 phase II trial

R. Bartsch

TPS2091

Poster Session

Saturday, June 1

9:00 am -12:00 pm

Ifinatamab Deruxtecan (I-DXd)

Lung

IDeate-Lung02: a phase 3, randomized, open-label study of ifinatamab deruxtecan (I-DXd) vs treatment of physician’s choice in relapsed small cell lung cancer

T. Owonikoko

TPS8126

Poster Session

Monday, June 3

1:30 – 4:30 pm

Raludotatug Deruxtecan (R-DXd)

Ovarian

REJOICE-Ovarian01: a phase 2/3 study of raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer

I. Ray-Coquard

TPS5625

Poster Session

Monday, June 3

9:00 am –12:00 pm

DS-3939

Pan-Tumor

A phase 1/2, first-in-human study of DS-3939 in patients with advanced solid tumors: a new DXd ADC targeting TA-MUC1

N. Yamamoto

TPS3165

Poster Session

Saturday, June 1

9:00 am – 12:00 pm

Valemetostat with DXd ADCs

Breast

Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in patients with HER2 low/ultra low/null metastatic breast cancer

T. Iwase

TPS1120

Poster Session

Sunday, June 2

9:00 am – 12:00 pm

Pan-Tumor

A phase 1b, multicenter, open-label study of valemetostat in combination with DXd antibody drug conjugates, trastuzumab deruxtecan (T-DXd) or datopotamab deruxtecan (Dato-DXd), in patients with solid tumors

J. Sands

TPS4180

Poster Session

Saturday, June 1

1:30 – 4:30 pm

About the DXd ADC Portfolio of Daiichi Sankyo
The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, 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.

Designed using Daiichi Sankyo’s proprietary DXd ADC Technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, 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.

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

On May 21, 2024 Incyte (Nasdaq:INCY) reported that it will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 8:00 a.m. (EDT) in Miami (Press release, Incyte, MAY 21, 2024, View Source [SID1234643514]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On May 21, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, reported that Cancer Prevention and Research Institute of Texas (CPRIT) has granted the company a competitive product development research award (Press release, Indapta Therapeutics, MAY 21, 2024, View Source [SID1234643513]). The $4.5 million grant will support Indapta’s ongoing clinical development of its lead product, IDP-023, for patients with advanced non-Hodgkin’s lymphoma and multiple myeloma.

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"We greatly appreciate that CPRIT has recognized the promise of Indapta’s allogeneic g-NK cell therapy for the treatment of advanced cancer patients," said Dr. Mark Frohlich, CEO of Indapta. "We are highly encouraged to be seeing early evidence of clinical activity in the safety run-in portion of the trial at the lowest cell dose and without the addition of a monoclonal antibody. We look forward to using the CPRIT funds to treat additional patients in order to reach clinical proof-of-concept in our Phase 1 dose escalation trial."

Patients enrolled in the Phase I clinical trial to date have received up to three planned doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive escalating doses of IDP-023 in combination with the monoclonal antibodies, rituximab and daratumumab, respectively.

Indapta’s Differentiated g-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "g minus" NK cells, or "g-NK" cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source)

Based on evidence that endogenous g-NK cells are protective against the development of multiple sclerosis, as well as slow disease progression in patients with multiple sclerosis, Indapta plans to file an IND in Q3 to initiate a clinical trial of g-NK cells in patients with multiple sclerosis.