On December 2, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported positive updated interim clinical data for its JANX007 clinical program. Janux will host a virtual event today at 4:30 PM ET (Press release, Janux Therapeutics, DEC 2, 2024, View Source [SID1234648718]).

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"These clinical data show substantial activity with JANX007 in 5L metastatic castration-resistant prostate cancer patients and provide compelling support for the doses we’ve selected for expansion trials directed at pre-PLUVICTO 2L and 3L patients," said David Campbell, Ph.D., President and CEO, Janux Therapeutics. "We look forward to rapidly advancing JANX007 into second and third-line therapy where a substantial unmet need remains and where we believe JANX007’s highly differentiated profile could allow for broad usage, if approved. This is an exciting day for Janux, but more importantly the prostate cancer patients we serve."

Updated interim, clinical data for PSMA-TRACTr JANX007 in mCRPC as of November 15, 2024

JANX007 is in a Phase 1a clinical trial in patients with advanced or metastatic prostate cancer (mCRPC). The patients enrolled in the trial were heavily pre-treated with a median of four prior lines of therapy. As of the November 15, 2024 data cutoff, 16 pre-PLUVICTO patients have been treated once-weekly at a target dose ranging from 2 mg to 9 mg in the Phase 1a clinical trial. High prostate-specific antigen (PSA) response rates and deep PSA declines were observed across all doses; 100% of patients achieved best PSA50 declines, 63% of patients achieved best PSA90 declines, and 31% of patients achieved best PSA99 declines. Durability of PSA declines at a target dose ≥ 2 mg were observed; 75% of patients maintained PSA50 declines at ≥ 12 weeks and 50% of patients maintained PSA90 declines at ≥ 12 weeks. Deep and durable PSA responses were observed irrespective of resistance driver aberration status, or prior treatments with a taxane or ARPi. In RECIST-evaluable patients, anti-tumor activity was observed with confirmed and unconfirmed partial responses in 50% (4/8) of patients.

JANX007 was well-tolerated with cytokine release syndrome (CRS) and CRS-related adverse events primarily limited to cycle 1 and grades 1 and 2. Similarly, treatment-related adverse events (TRAEs) not associated with CRS were primarily limited to cycle 1 and grades 1 and 2. The maximum tolerable dose for JANX007 has not yet been reached.

Based on these efficacy and safety results, two once-weekly step dose regimens have been identified for Phase 1b expansion trials directed at pre-PLUVICTO 2L and 3L patients. Janux anticipates providing another update on JANX007 in 2025.

Webcast Information

Janux will host a live webcast today at 4:30 PM ET. A live question and answer session will follow the formal presentation. To register for the event, please click here.

Participant Dial-In Details

USA & Canada: (800) 715-9871

International: 1 (646) 307-1963

Conference ID: 2229349

To access the live webcast, please visit the Investors section of the Company’s website. A replay of the webcast presentation will be available on the Company’s website at View Source for at least 30 days.

On December 2, 2024 Solu Therapeutics ("Solu Therapeutics" or "Solu"), a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that it will present the first preclinical data on STX-0712, its novel CCR2-CyTAC (Chemokine Receptor Type 2 Cytotoxicity Targeting Chimera) for the treatment of chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) (Press release, Solu Therapeutics, DEC 2, 2024, View Source [SID1234648734]). The data will be featured in two poster presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held December 7-10, 2024, in San Diego, California.

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STX-0712 is a CyTAC targeting the G-Protein Coupled Receptor (GPCR) CCR2, a selective marker expressed at high levels on malignant monocytes in these indications, which are key drivers in certain hematologic cancers. By targeting CCR2, STX-0712 is designed to selectively eliminate these malignant cells.

ASH Poster Presentation Details:

Abstract Title: Ex-Vivo Evaluation of STX-0712, a CCR2 Cytotoxicity Targeting Chimera (CCR2-CyTAC) for the treatment of Acute Myeloid Leukemia
Date: Saturday, December 7, 2024
Time: 5:30 PM-7:30 PM PT
Location: San Diego Convention Center, Halls G-H
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I
Abstract Number: 1380

Abstract Title: Preclinical Evaluation of STX-0712, a CCR2 Cytotoxicity Targeting Chimera (CCR2-CyTAC) for the treatment of Chronic Myelomonocytic Leukemia
Date: Sunday, December 8, 2024
Time: 6:00 PM-8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II
Abstract Number: 2771

On December 2, 2024 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will be hosting a virtual investor event at 8:00 a.m. ET / 5:00 a.m. PT on Monday, December 9, 2024, to discuss the KOMET-007 combination trial of the Company’s oral and selective menin inhibitor, ziftomenib, following the presentation of updated clinical data at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego (Press release, Kura Oncology, DEC 2, 2024, View Source [SID1234648719]).

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The virtual event will feature members of the management team along with investigators from the KOMET-007 trial. The live call may be accessed by dialing (800) 715-9871 for domestic callers and (646) 307-1963 for international callers and entering the conference ID: 4326549. A live webcast will be available here and in the Investors section of Kura’s website, with an archived replay available shortly after the event.

On December 2, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in upcoming investor relations events (Press release, Ideaya Biosciences, DEC 2, 2024, View Source [SID1234648735]).

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Citi’s 2024 Global Healthcare Conference
Tuesday, December 3rd, 2024 at 8:00 AM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech Analyst
7th Annual Evercore HealthCONx Conference
Wednesday, December 4th, 2024 at 1:20 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Jonathan Miller, Managing Director, Biotech and Pharma Equity Research
A live audio webcast of the conference event, as permitted by the conference host, will be available at the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcast will be accessible for 30 days following the live event.

On December 1, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of an abstract regarding petosemtamab, a Biclonics targeting EGFR and LGR5, in previously treated (2L+) patients (pts) with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) on the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress website (Press release, Merus, DEC 1, 2024, View Source [SID1234648708]). The abstract presents updated clinical data on petosemtamab from the initial expansion cohort (1500 mg) and a new dose-comparison cohort (1100 mg vs. 1500 mg) in 2L+ HNSCC for presentation at the ESMO (Free ESMO Whitepaper) Asia Congress 2024 taking place in Singapore, Dec. 6-8, 2024.

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The presentation will be discussed on a conference call on Saturday, December 7, at 9:00 a.m. ET. The presentation will include interim data from a later data cutoff date with additional patients evaluable for response and more mature duration of treatment information.

"Petosemtamab 1500 mg monotherapy continues to demonstrate consistent, durable, and clinically meaningful efficacy in 2L+ r/m HNSCC, underscoring its potential to become a new standard of care," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. "We are looking forward to our upcoming presentation which will include new information with updated efficacy and safety of the larger, combined 2L+ dataset."

Presentation title: Petosemtamab (MCLA-158) monotherapy in previously treated (2L+) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial

Observations in the abstract include:

As of a November 6, 2023 data cutoff date 54 pts were treated with 1500 mg Q2W in the expansion cohort reported initially at AACR (Free AACR Whitepaper) 2023
47* pts were evaluable for response (≥4 months follow up prior to data cutoff date and ≥1 post baseline scan, or early progressive disease (PD)) and overall response rate was 40.4% (19/47 and 1 unconfirmed partial response (PR) that confirmed post cutoff, 20/47) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment
7.2 months median duration of response
5.1 months median progression free survival
12.5 months median overall survival
As of a March 6, 2024 data cutoff date, 42 pts were randomized to the 1500 mg vs. 1100 mg dose comparison cohort
At 1500 mg, 12 pts were evaluable for response, 5 responses were observed including 1 complete response, 3 PRs, and 1 unconfirmed PR (confirmed post cutoff)
At 1100 mg, 10 pts were evaluable for response with 1 confirmed PR observed
Petosemtamab was well tolerated at both dose levels; no new safety signals observed
No grade 5 treatment emergent adverse events were reported
*6 pts were excluded per protocol (as previously presented at AACR (Free AACR Whitepaper) 2023): 5 pts withdrew due to infusion related reactions on Day 1; 1 pt had exclusion criteria deviation; 1 pt had <4 months follow up at the data cutoff

Title: Petosemtamab (MCLA-158) monotherapy in previously treated (2L+) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
Abstract #: 411MO
Session Title: Mini Oral session: Head and Neck cancers
Session Date and Time: December 7, 2024; 14:30 – 16:10 p.m. SGT
Location Hall: 404

As the full presentation becomes available at the ESMO (Free ESMO Whitepaper) Asia Congress 2024, it will contemporaneously be available on the Merus website.

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on December 7, 2024 at 9:00 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.

Date & Time: Dec. 07, 2024 at 9:00 a.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: 1 (800) 715-9871/ International: 1 (646) 307-1963
Conference ID: 1978503

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.¹ The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.² HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.

¹ Sung et al. CA Cancer J Clin, 71:209-49, 2021; ² Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 6, 92 (2020)

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.