Laser Focus World is an industry bedrock—first published in 1965 and still going strong. We publish original articles about cutting-edge advances in lasers, optics, photonics, sensors, and quantum technologies, as well as test and measurement, and the shift currently underway to usher in the photonic integrated circuits, optical interconnects, and copackaged electronics and photonics to deliver the speed and efficiency essential for data centers of the future.

Our 80,000 qualified print subscribers—and 130,000 12-month engaged online audience—trust us to dive in and provide original journalism you won’t find elsewhere covering key emerging areas such as laser-driven inertial confinement fusion, lasers in space, integrated photonics, chipscale lasers, LiDAR, metasurfaces, high-energy laser weaponry, photonic crystals, and quantum computing/sensors/communications. We cover the innovations driving these markets.

Laser Focus World is part of Endeavor Business Media, a division of EndeavorB2B.

Laser Focus World Membership

Never miss any articles, videos, podcasts, or webinars by signing up for membership access to Laser Focus World online. You can manage your preferences all in one place—and provide our editorial team with your valued feedback.

Magazine Subscription

Can you subscribe to receive our print issue for free? Yes, you sure can!

Newsletter Subscription

Laser Focus World newsletter subscription is free to qualified professionals:

The Daily Beam

Showcases the newest content from Laser Focus World, including photonics- and optics-based applications, components, research, and trends. (Daily)

Product Watch

The latest in products within the photonics industry. (9x per year)

Bio & Life Sciences Product Watch

The latest in products within the biophotonics industry. (4x per year)

Laser Processing Product Watch

The latest in products within the laser processing industry. (3x per year)

Get Published!

If you’d like to write an article for us, reach out with a short pitch to Sally Cole Johnson: [email protected]. We love to hear from you.

Photonics Hot List

Laser Focus World produces a video newscast that gives a peek into what’s happening in the world of photonics.

Following the Photons: A Photonics Podcast

Following the Photons: A Photonics Podcast dives deep into the fascinating world of photonics. Our weekly episodes feature interviews and discussions with industry and research experts, providing valuable perspectives on the issues, technologies, and trends shaping the photonics community.

Editorial Advisory Board

  • Professor Andrea M. Armani, University of Southern California
  • Ruti Ben-Shlomi, Ph.D., LightSolver
  • James Butler, Ph.D., Hamamatsu
  • Natalie Fardian-Melamed, Ph.D., Columbia University
  • Justin Sigley, Ph.D., AmeriCOM
  • Professor Birgit Stiller, Max Planck Institute for the Science of Light, and Leibniz University of Hannover
  • Professor Stephen Sweeney, University of Glasgow
  • Mohan Wang, Ph.D., University of Oxford
  • Professor Xuchen Wang, Harbin Engineering University
  • Professor Stefan Witte, Delft University of Technology

Incyclix Bio Announces Interim Clinical Data from the Phase 1/2 Clinical Trial of INX-315 in Patients with CDK4/6 Inhibitor Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors

INX-315 was safe and well tolerated in monotherapy dose escalation

INX-315 monotherapy demonstrated antitumor activity in heavily pretreated patients with ER+/HER2- breast cancer and CCNE1-amplified ovarian cancer

Monotherapy and combination dose expansions are ongoing

RESEARCH TRIANGLE PARK, N.C., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, announced interim clinical data from the dose escalation portion of INX-315-01, the Phase 1/2 clinical trial of INX-315 in patients with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer or CCNE1-amplified solid tumors. The data were presented at the 2024 San Antonio Breast Cancer Symposium (SABCS).

Highlights of the first-in-human trial include:

  • Across 31 patients with CDK4/6i resistant ER+/HER2- breast cancer or CCNE1-amplified solid tumors, INX-315 monotherapy was safe and well tolerated with one dose-limiting toxicity and no treatment discontinuations due to adverse events.
  • INX-315 monotherapy demonstrated antitumor activity in heavily pretreated patients with ER+/HER2- breast cancer and CCNE1-amplified ovarian cancer
    • Among all response-evaluable patients in Part A, 3 (10%) had a partial response (PR) and 19 (63%) had stable disease (SD)
    • In patients with ER+/HER2- breast cancer, PR was observed in 1 (10%) and SD was observed in 5 (50%)
    • In patients with CCNE1-amplified high grade serous ovarian cancer (HGSOC)/fallopian, PR was observed in 2 (20%) and SD was observed in 8 (80%)
  • Monotherapy safety and antitumor activity data support continued investigation of INX-315 as monotherapy in CCNE1-amplified solid tumors and in combination with standard of care therapies for ER+/HER2- breast cancer

“We are excited to unveil these compelling data, which underscore the safety, tolerability, and encouraging antitumor activity of our CDK2 inhibitor, INX-315, in heavily pretreated patients with advanced, treatment-resistant breast and ovarian cancers. Sharing these results with leading oncologists at SABCS is a significant milestone,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “This progress reinforces the best-in-class potential of INX-315 and brings us closer to delivering a transformative treatment option for patients facing some of the most challenging cancer diagnoses.”

INX-315-01 (NCT05735080) is a Phase 1/2, open-label, dose-escalation, combination and dose-expansion trial to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including ER+/HER2- breast cancer who progressed on a prior CDK4/6i regimen and patients with CCNE1-amplified HGSOC or other solid tumors, who progressed on prior standard of care treatment. The dose escalation portion of the trial (Part A) enrolled 31 patients, all of whom were evaluated for safety while 30 were evaluated for efficacy. Median age was 60 years old (range 29-78), 74% were female. Tumor types studied include ER+/HER2- breast cancer (n=10), HGSOC (n=10), and other solid tumors (n=11). Median prior lines of therapy were 4 (range of 1-9). INX-315-01 monotherapy and combination dose-expansion portions are ongoing. More information on the trial can be found at clinicaltrials.gov.

The full poster presented at SABCS 2024 is available in the ‘Publications’ section of the Incyclix website: https://incyclixbio.com/publications/.

About Incyclix Bio

Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.

Media Contact
Tony Plohoros
908-591-2839
tplohoros@6degreespr.com


Primary Logo

Stock Quote API & Stock News API supplied by www.cloudquote.io
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms Of Service.