On March 14, 2023 Seagen Inc. (Nasdaq: SGEN) reported the presentation of 17 abstracts featuring new clinical and preclinical data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando from April 14-19, 2023 (Press release, Seagen, MAR 14, 2023, View Source [SID1234628685]). The broad range of data being presented at this year’s meeting includes research from Seagen’s approved medicines, as well as data from early-stage clinical, preclinical, and discovery research programs.

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"Seagen’s robust presence at AACR (Free AACR Whitepaper) this year, highlighting progress across our diverse pipeline, underscores our commitment to improving and extending the lives of people living with cancer," said Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen. "As a pioneer in antibody-drug conjugates, we strive to optimize and expand the potential of our core technology, while also progressing innovative, targeted cancer approaches."

Highlights include an interim analysis from the innovaTV 207 Phase 2 study of tisotumab vedotin (TV) given every 2 weeks in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have progressed after prior platinum combination, immunotherapy, and targeted therapy, if eligible. TV, which is being developed in partnership with Genmab, is a tissue factor (TF)-directed antibody-drug conjugate (ADC). The innovaTV 207 study is currently ongoing and evaluating alternative dosing regimens of TV across multiple advanced solid tumors.

Other notable clinical data include initial results from a Phase 1 dose-escalation study of SEA-TGT monotherapy in patients with advanced malignancies. SEA-TGT is a novel investigational nonfucosylated human IgG1 antibody directed against TIGIT, an inhibitory immune checkpoint receptor that has emerged as a clinically relevant immuno-oncology target. SEA-TGT continues to be evaluated both as monotherapy and in combination with an anti-PD1 agent.

Seagen will also present new preclinical findings on the antitumor activity of disitamab vedotin, an ADC that targets cancers expressing HER2, as a monotherapy and in combination with tucatinib in breast and gastric cancer models, and on SGN-B6A, a wholly-owned, first-in-class vedotin ADC that targets integrin beta-6, which is highly expressed in a range of solid tumors.

Seagen and Sanofi will also unveil the first preclinical data from a novel topoisomerase I inhibitor ADC targeting CEACAM5, showing potent antitumor activity in patient-derived colorectal cancer models. These are the first data disclosed from the companies’ 2022 collaboration to develop and commercialize multiple novel ADCs.

Additional preclinical data disclosures are planned, highlighting vedotin programs and novel ADC and tumor targeting technologies, including payloads with immune stimulatory properties.

Details of Seagen Presentations at AACR (Free AACR Whitepaper) Annual Meeting 2023

Abstract Title

Abstract #

Presentation Time

Lead Author

ADCETRIS (brentuximab vedotin)

CD30 is a marker of activated effector regulatory T cells in solid tumors providing clinical rationale for the combination of brentuximab vedotin and PD-1 inhibitors

3253

Poster Presentation

Clinical Research Excluding Trials / Combination Immunotherapies 1

Mon., April 17

1:30 – 5:00 p.m. ET

B. Grogan

Exposure-response and age subgroup analyses to support body-weight (BW) dosing of brentuximab vedotin (BV) in newly diagnosed high-risk classical Hodgkin lymphoma (cHL) in children and young adults (aged 2-21 years [y]): A randomized Children’s Oncology Group phase 3 trial (AHOD1331)

6737

Poster Presentation

Clinical Research Excluding Trials / Preclinical Therapies and Clinical Observations in Pediatric Oncology

Wed., April 19

9:00 a.m. – 12:30 p.m. ET

Z. Zhang

PADCEV (enfortumab vedotin)

Enfortumab vedotin, a Nectin-4-directed antibody-drug conjugate, demonstrates compelling antitumor activity in non-muscle invasive bladder cancer models and accurately predicts minimal systemic exposure when administered by intravesical instillation in patients

LB246

Poster Presentation

Late-Breaking Research: Experimental and Molecular Therapeutics 2

Tues., April 18

1:30 – 5:00 p.m. ET

D. Olson

TIDVAK (tisotumab vedotin)

Tisotumab vedotin (TV) in squamous cell carcinoma of head and neck (SCCHN): interim analysis from innovaTV 207

CT164

Poster Presentation

Phase II Clinical Trials 1

Mon., April 17

1:30 – 5:00 p.m. ET

B. Cirauqui

TUKYSA (tucatinib)

Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial-in-progress)

CT065

Poster Presentation

Phase II and Phase III Clinical Trials in Progress

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

E. Hamilton

Tucatinib does not alter oxaliplatin PK or associated renal function: An OCT2/MATE transport inhibition study

5060

Poster Presentation

Experimental and Molecular Therapeutics – Theranostics and Radionuclides / Pharmacologic Approaches

Tues., April 18

1:30 – 5:00 p.m. ET

A. Topletz-Erickson

Disitamab Vedotin

Disitamab vedotin, an investigational HER2-directed antibody-drug conjugate, shows potent antitumor activity as a monotherapy and in combination with tucatinib in preclinical cancer models

560

Poster Presentation

Experimental and Molecular Therapeutics / Oncogenes and Tumor Suppressor Genes as Targets for Therapy 1

Sun., April 16

1:30 – 5:00 p.m. ET

K. Willis

Early-Stage Programs

SGN-BB228, a CD228-directed costimulatory antibody anticalin bispecific provides potent and conditional 4-1BB costimulation to T cells in vivo and in an in vitro model of T-cell exhaustion

5676

Poster Presentation

Clinical Research Excluding Trials / Therapeutic Antibodies, Including Engineered Antibodies

Tues., April 18

1:30 – 5:00 p.m. ET

B. Updegraff

SGN-B6A induces immunogenic cell death as an additional mechanism of action

1522

Poster Presentation

Experimental and Molecular Therapeutics / Antibody-Drug Conjugates

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

V. Trang

Generation of an antibody-drug conjugate-optimized TLR7/8 agonist payload

1542

Poster Presentation

Experimental and Molecular Therapeutics / Antibody-Drug Conjugates

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

K.P. Wang

Phase 1 dose-escalation study of SEA-TGT monotherapy in patients with advanced malignancies

CT265

Poster Presentation

Phase I Clinical Trials 2

Tues., April 18

1:30 – 5:00 p.m. ET

E. Garralda Cabanas

Using a clinical utility index (CUI) to determine the optimal biological dose of a nonfucosylated anti-TIGIT antibody: A proposed alternative to maximum tolerated dose (MTD)

5668

Poster Presentation

Clinical Research Excluding Trials / Therapeutic Antibodies, Including Engineered Antibodies

Tues., April 18

1:30 – 5:00 p.m. ET

G. Patilea-Vrana

A preclinical model of acquired anti-PD-1 resistance is responsive to SEA-TGT, an effector-function enhanced anti-TIGIT monoclonal antibody

6361

Poster Presentation

Immunology / Immune Checkpoints

Wed., April 19

9:00 a.m. – 12:30 p.m. ET

D. Gruber

A novel topoisomerase I inhibitor antibody-drug conjugate targeting CEACAM5 has potent antitumor activity in colorectal cancer models

4890

Poster Presentation

Experimental and Molecular Therapeutics / Anticancer Approaches: Antibody-Drug Conjugates, Epigenetics, and Tumor Environment

Tues., April 18

1:30 – 5:00 p.m. ET

Y. Baudat

Discovery Research

Oxidized anthracycline payloads induce antitumor immunogenic cell death and show linker-dependent tolerability when delivered as ADCs

2013

Poster Presentation

Chemistry / Drug Delivery

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

J. Hamilton

Reversible chemical modification of antibodies: A complementary approach to tuning FcγR binding that maintains antitumor activity while mitigating peripheral immune activation

2656

Poster Presentation

Experimental and Molecular Therapeutics / Antibody Technologies

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

P. Moquist

MMAE drives immunomodulatory changes in a preclinical xenograft model that are distinct from other clinical-stage ADC payloads

4892

Poster Presentation

Experimental and Molecular Therapeutics / Anticancer Approaches: Antibody-Drug Conjugates, Epigenetics, and Tumor Environment

Tues., April 18

1:30 – 5:00 p.m. ET

M. Ulrich

On March 14, 2023 PharmaLogic Holdings Corp. ("PharmaLogic" or "the Company"), a contract development and manufacturing organization and radiopharmaceutical manufacturer, reported the signature of a Master Services Agreement with Viewpoint Molecular Targeting, Inc., a wholly-owned subsidiary of Perspective Therapeutics, Inc. ("Perspective") (NYSE AMERICAN: CATX), for the development and production of theranostic candidates VMT-01 and VMT-α-NET (Press release, Perspective Therapeutics, MAR 14, 2023, View Source [SID1234628684]). The radiopharmaceuticals are currently in development for the diagnosis and treatment of metastatic melanoma and neuroendocrine tumors (NETs), respectively.

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Under the terms of the agreement, PharmaLogic will produce and supply doses of VMT-01 and VMT-α-NET for use in Perspective’s early-stage clinical trials. This will complement the existing radiopharmaceutical GMP capability that Perspective already has at its mid-west site.

Scott Holbrook, PharmaLogic’s Chief Strategy Officer and General Manager, stated "Targeted alpha therapy (TAT) with Pb-212 labeled radioligands offers one of the most exciting platforms for novel cancer therapy within the rapidly expanding precision radiotherapy ecosystem. The expertise of Perspective Therapeutics and PharmaLogic are well aligned to yield a successful collaboration around VMT-01 and VMT-α-NET."

"We are delighted to select PharmaLogic as a trusted CDMO partner at this important juncture of the Viewpoint’s clinical development journey" said Thijs Spoor, Perspective Therapeutics’ CEO. "Radiopharmaceutical diagnostic imaging and therapeutic agents have a limited shelf life from time of manufacture to patient administration in the clinical setting. PharmaLogic’s domain expertise in radiopharmaceuticals and broad national distribution footprint helps address our need for specialty radiopharmaceutical manufacturing at the highest level. As we have been given the safe to proceed authorizations from the U.S. Food and Drug Administration, we look forward to commencing enrollment of the Company’s two image guided alpha-particle therapy studies at multiple clinical trial centers around the country. Furthermore, we look forward to reporting preliminary results from the clinical trials later in the year."

"PharmaLogic is excited to partner with Perspective Therapeutics on the production and distribution of these personalized alpha-particle theranostics." said Chris Parr, PharmaLogic’s Vice President of Radiochemistry and Technical Operations. "We value Perspective’s scientific leadership in this area and believe it aligns perfectly with our mission of delivering clinically relevant precision medicine products to patients in the communities we serve."

On March 14, 2023 Onchilles Pharma, a private biotech company developing new cancer therapeutics that leverage myeloid biology, reported the presentation of preclinical data for N17350 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, to be held April 14 to 19 at the Orange County Convention Center in Orlando, Florida (Press release, Onchilles Pharma, MAR 14, 2023, View Source [SID1234628681]). Onchilles’ lead drug development candidate, N17350, is a first-in-class biologic therapeutic that is inspired by the immunobiology of neutrophils, a key part of the innate immune system, with the potential to be effective against a wide range of cancer types. The company is targeting to start first-in-human clinical trials in 2024.

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Presentation Details

Poster Title: N17350 Selectively Kills Cancer Cells with Far Reaching Anti-Cancer Effects
Date and Time: Wednesday, April 19, 9:00 AM to 12:30 PM ET
Session Category: Immunology
Session Title: Immune Mechanisms Mediated by Other Therapies
Session Location: Section 24
Poster Board Number: 3
Abstract number: 6390
About N17350 and the ELANE Pathway

First described in research published in Cell from the lab of Onchilles’ Co-Founder Lev Becker, human neutrophils release catalytically active neutrophil elastase, called ELANE, to selectively kill many cancer cell types while sparing non-cancer cells. As part of innate immunity, neutrophils have broad efficacy and specificity to eliminate genetically diverse cellular threats. Research shows that ELANE initiates a complex killing mechanism that culminates in cancer cell apoptosis at the initial tumor site as well as increases adaptive immunity that attacks distant metastases. ELANE consistently activated this cancer-killing program in more than 45 different cancer cell lines but not in any non-cancer cells tested. To advance this research into a therapeutic, Onchilles generated N17350, a first-in-class biologic, to mobilize the ELANE-mediated cancer-killing pathway.

On March 14, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will provide an operational update and report its financial results for full-year ending December 31, 2022, on Tuesday, March 28, 2023, after the close of the US market (Press release, Nanobiotix, MAR 14, 2023, View Source [SID1234628680]).

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This release will be followed by a conference call and live audio webcast on Wednesday, March 29, 2023, at 2:00 PM CET/8:00 AM EDT, prior to the open of the US market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s year-end results and provide an update on business activities before taking questions from analysts and investors. Investors are invited to email their questions in advance to [email protected].

Details for the call are as follows:

Dial-In Information:

Live (US): 1-877-423-9813

Live France: 0 800 912 848

Live (international): 1-201-689-8573

A live webcast of the call may be accessed by visiting the investors section of the Company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored Phase 1 dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a Phase 3 global registrational study was launched in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored Phase 1 clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC, or lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

On March 14, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM, HKEX:​13) reported that, further to its announcement on January 23, 2023 and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:​4502, NYSE:​TAK) to further the global development, commercialization and manufacture of fruquintinib outside China has closed (Press release, Hutchison China MediTech, MAR 14, 2023, View Source [SID1234628679]).

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With a strong preclinical and clinical profile, fruquintinib offers a potential new treatment option for patients with refractory metastatic colorectal cancer ("CRC"), supporting the shared goal of Takeda and HUTCHMED to improve the lives of those living with cancer worldwide. Takeda is now responsible for the development, commercialization and manufacture of fruquintinib in all included territories worldwide excluding mainland China, Hong Kong and Macau, where it is marketed by HUTCHMED.

Following the closing of the exclusive license agreement, HUTCHMED Limited will receive US$400 million shortly, and is eligible to receive up to US$730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. Marketing authorization submissions in the U.S., Europe and Japan are planned to complete in 2023, with the rolling submission to the U.S. Food and Drug Administration ("FDA") initiated in December 2022.

About Fruquintinib
Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date, and is being investigated in combinations with other anti-cancer therapies.