On June 17, 2025 Lisata therapeutics presented its corporate presentation (Press release, Lisata Therapeutics, JUN 17, 2025, View Source [SID1234653944]).

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On June 17, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported the presentation of results from its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel (Press release, Lutris Pharma, JUN 17, 2025, View Source [SID1234653961]). The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for use by patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The clinical data will be released in an oral presentation during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, being held July 2-5 in Barcelona, Spain.

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Presentation Details:

Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies
Presenting Author: Dr. Ofer Purim, Head of Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, Israel
Abstract Number: 50
Session Title: Proffered Paper Session
Session Date: Friday July 4, 2025
Session Time: 5:30 – 5:40 pm CET
Session Location: Madrid Room
About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

On June 17, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported the company has appointed Roger Sidhu, MD, as Chief Medical Officer (Press release, Cardiff Oncology, JUN 17, 2025, View Source [SID1234653945]). Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy. Dr. Sidhu succeeds Dr. Fairooz Kabbinavar who will remain with the company in an advisory role. The company also announced it will share additional clinical data from its lead program in RAS-mutated mCRC on July 29, 2025.

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"We are pleased to welcome Dr. Sidhu to lead the clinical program for onvansertib through the next phase of development. Dr. Sidhu is a respected clinician and seasoned executive with a proven track record of advancing innovative therapies through late-stage clinical development across multiple therapeutic areas including in first-line mCRC. As we move forward, we thank Dr. Kabbinavar for his leadership in progressing onvansertib’s clinical development across multiple tumor types," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "In addition to today’s medical leadership transition, we are announcing our plan to share an update of clinical data from the ongoing CRDF-004 trial on July 29, at which point we expect to release a substantive dataset."

"I am honored to join the executive team at Cardiff Oncology as we advance onvansertib through late-stage clinical development, and make a meaningful impact for patients living with cancer," said Roger Sidhu, MD. "With a strong foundation already in place, I’m stepping into this role at an exciting time as we prepare to share a clinical update on our lead program in RAS-mutated mCRC next month."

Dr. Sidhu was most recently the Chief Medical Officer and acting CEO at Treadwell Therapeutics. Previously, Dr. Sidhu spent nearly 10 years at Amgen in roles of increasing responsibility in the Hematology/Oncology therapeutic area where he advanced multiple therapeutic candidates. In mCRC, he led multiple phase 3 clinical trials of panitumumab (Vectibix) in monotherapy and in combination with chemotherapy leading to approvals in the U.S. and globally. Dr. Sidhu was also a leader in advancing the science of RAS biology and therapeutics in mCRC and has published work in several peer reviewed journals including the New England Journal of Medicine.

In addition, Dr. Sidhu served as Executive Vice President and Chief Medical officer at Roivant Sciences. He was also the Chief Medical Officer at Eterna Therapeutics, Inc. and Cell Design Labs, up until its acquisition by the Gilead subsidiary Kite, where he subsequently served as VP, Clinical Development.

Dr. Sidhu is a Fellow of the Royal College of Physicians and Surgeons of Canada in both internal medicine and medical oncology. He earned his medical degree from Queen’s University in Kingston, Ontario Canada and his bachelor’s degree in biochemistry from the University of Alberta in Edmonton, Alberta. Dr. Sidhu trained in internal medicine at Queen’s University and medical oncology at the British Columbia Cancer Agency in Vancouver, British Columbia and the Cross Cancer Institute in Edmonton, Alberta.

Conference Call and Webcast on Additional Clinical Data from CRDF-004 in mCRC

Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share additional clinical data from the CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at View Source A replay will be available in the investor relations section on the company’s website following the completion of the call.

Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

In connection with Dr. Sidhu joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 600,000 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Dr. Sidhu becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of June 16, 2025 and has an exercise price of $3.86 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36-months, subject to Dr. Sidhu’s continued employment with Cardiff Oncology on such vesting dates.

On June 17, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its executive team will participate in the upcoming investor conferences, detailed below (Press release, Innate Pharma, JUN 17, 2025, View Source [SID1234653962]).

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H.C. Wainwright 3rd Annual Immune Cell Engager Virtual Conference
Dates: June 24, 2025 | Virtual

Wolfe Research Virtual Biotech Day
Dates: June 26, 2025 | Virtual

On June 17, 2025 eXmoor Pharma, the integrated cell and gene therapy CDMO with embedded consultancy expertise, and Signadori Bio, a French biotechnology company developing next-generation cancer therapies, reported a new collaboration to accelerate the development of gene-modified monocyte-derived macrophage cell therapy targeting solid tumours (Press release, Signadori Bio, JUN 17, 2025, View Source [SID1234656408]).

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Signadori Bio, a Sofinnova Partners-backed spin-out, is advancing a promising gene-modified monocyte therapy platform aimed at overcoming the challenges of treating solid cancers, developed at the Gustave Roussy Institute, one of the world’s leading oncology centres.

Under the agreement, eXmoor Pharma will undertake a comprehensive technology translation and development programme at its Cell & Gene Therapy Centre, supporting Signadori Bio in the critical transition from discovery through to GMP-compliant manufacturing of their lead candidate. eXmoor will also provide an interim Head of CMC to integrate into Signadori Bio’s leadership team and support a structured programme of technology translation, process development and CMC planning.

This collaborative approach is designed to guide the therapy through key development milestones, with a focus on progressing the lead candidate toward GMP-compliant manufacturing and readiness for first-in-human clinical trials.

The partners will operate under a shared decision-making framework, aligning scientific, technical and commercial planning with Signadori Bio’s investment trajectory. The programme is set to transition into full process development with a long-term view toward GMP manufacturing, leveraging eXmoor’s GMP manufacturing capabilities.

Angela Osborne, CEO of eXmoor Pharma, commented:

"We are delighted to partner with Signadori Bio on such a promising and sophisticated cell therapy programme. Their approach to targeting solid tumours with gene-modified monocytes is innovative and well-grounded in translational science. At eXmoor, we are committed to supporting cell and gene therapy pioneers through the complex journey from discovery to clinical impact. This collaboration reflects our shared belief in the potential of advanced therapies to deliver meaningful outcomes for patients."

Matthieu Coutet, CEO of Signadori Bio and Partner at Sofinnova Partners, said:

"Partnering with eXmoor is a decisive step in our mission to bring next-generation monocyte-based therapies to patients with solid tumours. Their deep expertise in early-stage process development and GMP translation is exactly what we need at this critical inflection point. I’m also very pleased to welcome Evelien Stalmeijer as interim Head of CMC. Her leadership and experience will be key as we accelerate our path toward the clinic. We’re excited to work hand-in-hand with a team that understands the complexity and urgency of advancing pioneering science into impactful therapies."