On April 26, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that an abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, IL (Press release, Elevation Oncology, APR 26, 2023, View Source [SID1234630563]). The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093). Elevation Oncology remains on track to initiate a Phase 1 clinical trial in the U.S. evaluating EO-3021 in the second half of 2023.

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"Claudin 18.2 is a clinically validated oncology target that is expressed in several high unmet need cancers, including gastric, esophageal and pancreatic, among others, and there are currently no approved targeted therapies for Claudin 18.2-expressing tumors," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "We believe EO-3021 has the potential to address unmet needs for patients with Claudin 18.2-expressing tumors, and we look forward to our partner, CSPC, presenting at ASCO (Free ASCO Whitepaper) 2023."

ASCO 2023 Presentation Details:

Title: First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors.
Presenter: Dr. Yakun Wang
Session Type: Poster Discussion Session
Session Title: Molecularly Targeted Agents and Tumor Biology
Poster Session Date and Time: Saturday, June 3, 2023, 8:00 a.m. – 11:00 a.m. ET
Poster Discussion Date and Time: Saturday, June 3, 2023, at 1:15 p.m. ET
Abstract Number: 3016
Poster Number: 214

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is only expressed in gastric epithelial cells. During malignant transformation in many solid tumors, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.

On April 26, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2023 first quarter financial results on Wednesday, May 10, 2023, after the close of the U.S. financial markets (Press release, Jazz Pharmaceuticals, APR 26, 2023, View Source [SID1234630562]). Company management will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. IST to discuss 2023 first quarter financial results and provide a business and financial update.

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Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On April 26, 2023 Dizal reported that multiple clinical data of its two leading assets – sunvozertinib and golidocitinib have been selected for presentations at the 2023 ASCO (Free ASCO Whitepaper), June 2-6, 2023 in Chicago (Press release, Dizal Pharma, APR 26, 2023, View Source [SID1234630561]). A total of four abstracts will be presented, including two oral presentations and two poster presentations.

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Sunvozertinib (DZD9008), which was granted Breakthrough Therapy Designation by both the US FDA and China NMPA, is a rationally designed, oral, best-in-class tyrosine kinase inhibitors (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon 20 insertions (Exon20ins) mutations. The China NMPA has accepted new drug application (NDA) and granted priority review for sunvozertinib for the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR Exon20ins mutations after platinum-based chemotherapies. Dizal will present the updated results of WU-KONG6, the pivotal study of sunvozertinib in ≥ second line setting in an oral session at 2023 ASCO (Free ASCO Whitepaper). In addition, two other abstracts selected for poster presentations include the preliminary results of sunvozertinib in the treatment-naive EGFR Exon20ins NSCLC and anti-tumor activity of sunvozertinib in NSCLC patients with EGFR sensitizing mutations after failure of EGFR TKI treatment.

Golidocitinib (DZD4205) is an oral, highly selective Janus kinase 1 (JAK1) inhibitor currently being evaluated in a multinational, pivotal study in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL), which was granted Fast Track Designation by the US FDA in 2022. The clinical data from phase I/II study of golidocitinib in patients with r/r PTCL shows good safety and promising anti-tumor efficacy, which have been selected for oral presentations at multiple authoritative scientific conferences for three consecutive years (2023 ASCO (Free ASCO Whitepaper), 2022 EHA (Free EHA Whitepaper), 2021 ICML and 2021 CSCO). At 2023 ASCO (Free ASCO Whitepaper), Dizal will present the multinational pivotal study results orally for the first time.

*Note: 1. ASCO (Free ASCO Whitepaper) = American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper); 2. ESMO (Free ESMO Whitepaper) = European Society for Medical Oncology; 3. EHA (Free EHA Whitepaper) = The European Hematology Association (EHA) (Free EHA Whitepaper); 4. ICML = International Conference on Malignant Lymphoma Lugano; 5. CSCO = Chinese Society of Clinical Oncology

Dizal’s Presentations at 2023 ASCO (Free ASCO Whitepaper)

Lead Author

Abstract Title

Presentation Details

Prof. Mengzhao
Wang

Sunvozertinib for the
treatment of NSCLC with
EGFR Exon20 insertion
mutations: The first pivotal
study results

Abstract #9002

Session Type: Oral

Oral Abstract Session

Lung Cancer – Non-Small Cell Metastatic

Session

Date and Time: June 6, 2023, 09:45 AM-12:45
PM CDT

Prof. Qingqing
Cai

Golidocitinib in treating
refractory or relapsed
peripheral T-cell
lymphoma: Primary
analysis of the
multinational pivotal study
results (JACKPOT8)

Abstract #7503

Session Type: Oral

Oral Abstract Session

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session

Date and Time: June 6, 2023, 09:45 AM-12:45
PM CDT

Prof. Yan Xu

Efficacy and safety of
sunvozertinib in treatment
naïve NSCLC patients with
EGFR exon20 insertion
mutations

Abstract #9073

Poster Session

Lung Cancer – Non-Small Cell Metastatic

Session

Date and Time: June 4, 2023, 08:00 AM-11:00
AM CDT

Prof. James
Chih-Hsin Yang

Anti-tumor activity of
sunvozertinib in NSCLC
with EGFR sensitizing
mutations after failure of
EGFR TKI treatment

Abstract #9103

Poster Session

Lung Cancer – Non-Small Cell Metastatic

Session

Date and Time: June 4, 2023, 08:00 AM-11:00
AM CDT

About sunvozertinib (DZD9008)

Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is a rationally designed, irreversible EGFR inhibitor targeting various EGFR mutations with wild-type EGFR selectivity. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary endpoint, demonstrating superior antitumor efficacy in pre-treated NSCLC patients with EGFR Exon20ins mutations. The confirmed objective response (cORR) at 300 mg was 59.8% by Blinded Independent Central Review (BICR). In patients with pre-treated, stable and asymptomatic brain metastasis, the cORR was 48.4%. (Data cut-off date: July 31, 2022). Preliminary efficacy of sunvozertinib has also been observed in NSCLC with EGFR sensitizing mutations, T790M mutations, other EGFR mutation subtypes (such as G719X, L861Q, etc.), and HER2 exon20ins mutations.

It is well tolerated with a manageable AE profile. Global pivotal studies are ongoing for ≥ 2nd line and 1st line treatment of NSCLC with EGFR Exon20ins mutation. Pre-clinical and clinical Results of sunvozertinib were published in peer-reviewed journal of Cancer Discovery (IF:39.397) in Apr 2022. The China NMPA has accepted NDA and granted priority review for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies.

About Golidocitinib (DZD4205)

Golidocitinib (DZD4205), which was granted Fast Track Designation by US FDA, is an oral, potent, JAK1 specific inhibitor. The results from the phase I/II trial, which is evaluating the efficacy and safety of golidocitinib in patients with r/r PTCL, showed golidocitinib yielded an ORR of 42.9% (Data cut-off date: May 31, 2021). The agent is currently being studied in the global pivotal study for the treatment of r/r PTCL.

On April 26, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that the results of the Phase I/II TORCH-2 study will be presented as a poster discussion during the American Society for Clinical Oncology Annual Meeting (ASCO 2023), taking place from June 2nd to 6th at the McCormick Place Convention Center in Chicago, IL (Press release, Antengene, APR 26, 2023, View Source [SID1234630560]).

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The TORCH-2 study is an open-label dose escalation and expansion study to evaluate ATG-008, an mTORC1/2 inhibitor, in combination with the anti-PD-L1 antibody, toripalimab, in patients with advanced solid tumors.

"We believe that combining ATG-008 with an immune checkpoint inhibitor could lead to more effective and durable control of tumors, because the mTOR signaling pathway plays multiple roles in immune cell biology. We look forward to sharing the results of the TORCH-2 study with the oncology community at ASCO (Free ASCO Whitepaper) 2023." said Dr. Amily Zhang, Antengene’s Chief Medical Officer.

Details of the poster to be presented:

Title: A phase I/II study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors

Abstract: 2526

Session: Developmental Therapeutics – Immunotherapy

Poster Session Display Date and Time: 8:00 AM – 11:00 AM, June 3, 2023 (Central Time) / 9:00 PM, June 3 – 12:00 AM, June 4, 2023 (Beijing Time)

Poster Board Number: 368

Poster Discussion Session Date and Time: 3:00 PM – 4:30 PM, June 3, 2023 (Central Time) / 4:00 AM – 5:30 AM, June 4, 2023 (Beijing Time)

On April 26, 2023 Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that an abstract highlighting updated interim results from Part A of the ongoing Phase 2, registration-directed RAMP 201 trial evaluating avutometinib (VS-6766) and defactinib in patients with low-grade serous ovarian cancer (LGSOC) has been selected for a presentation in a Poster Discussion Session at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2–6, 2023 in Chicago, IL (Press release, Verastem, APR 26, 2023, View Source [SID1234630559]).

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The objective of Part A (selection Phase) of the RAMP201 LGSOC study was to determine the go forward regimen between avutometinib monotherapy or the combination of avutometinib and defactinib to be studied in Part B (expansion Phase) of the study. The efficacy and safety of each regimen were assessed in both KRAS mutant and KRAS wild-type recurrent LGSOC. The ongoing expansion Phase of the trial, which is fully enrolled, will evaluate the efficacy and safety of the regimen selected.

"Building on our breakthrough therapy designation, we are pleased with the continued progress of our LGSOC program and look forward to the presentation of these updated results from the RAMP 201 trial at ASCO (Free ASCO Whitepaper) 2023," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "LGSOC is a difficult disease to treat and one in need of improved therapies to address this unique ovarian cancer. We are working to bring forward what may be the first therapy specifically approved for patients with LGSOC as quickly as possible."

The Company is in ongoing discussions with the U.S. Food and Drug Administration (FDA) on confirmatory study plans and intends to provide an update after agreement with the FDA. Continued enrollment in the combination arm of RAMP 201 is planned to expand the clinical experience in anticipation of initiation of a confirmatory study.

Details for the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting presentation are as follows:

Title: Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC).
Lead author: Susana Banerjee, Institute of Cancer Research and The Royal Marsden
Abstract #: 5515
Session: Gynecologic Cancer
Poster Session Display Date and Time: 6/5/2023, 1:15 PM-4:15 PM
Poster Discussion Session Date and Time: 6/5/2023, 4:30 PM-6:00 PM
Poster Board Number: 210

About Low-Grade Serous Ovarian Cancer (LGSOC)

Low-grade serous ovarian cancer (LGSOC) is a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate. Approximately 6,000 women in the U.S. and 80,000 worldwide are living with this disease. Mutations in the KRAS gene are present in 30% of cases of LGSOC. LGSOC is most often diagnosed in women between the ages of 45-55 years and has a median survival of approximately ten years. The majority of patients experience severe pain and complications as the disease progresses. Chemotherapy is the standard of care for this disease, with limited treatment options currently available.

About Avutometinib (VS-6766)

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.

In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS- driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. As part of the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, Verastem Oncology is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.