1stOncology™: Cancer Intelligence Service – Page 606 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Shattuck Labs Announces Closing of up to $103 Million Private Placement and Appointments to Board of Directors

On August 26, 2025 Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, reported the closing of Shattuck’s recently announced private placement of up to approximately $103 million, led by OrbiMed (Press release, Shattuck Labs, AUG 26, 2025, View Source [SID1234655485]). Proceeds from the financing, assuming full exercise of common stock warrants, are expected to fund operations into 2029 and advance SL-325 through multiple clinical milestones, including placebo controlled, randomized, Phase 2 trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

In association with the closing of the financing, Shattuck also announced the appointment of two new members to its Board of Directors (the Board): Daniel Baker, M.D., industry expert, and Mona Ashiya, Ph.D., Member at OrbiMed. As part of this transition, Directors Tyler Brous, Carrie Brownstein, M.D., Michael Lee, and Kate Sasser, Ph.D., have stepped down from the Board.

"Our recent clearance for the SL-325 IND, closing of the private placement, and Board additions mark an important repositioning of Shattuck as an immunology and inflammation focused organization," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "We believe SL-325 is a potentially first-in-class DR3 blocking antibody with the potential for superior efficacy and reduced immunogenicity relative to TL1A-blocking antibodies. We are grateful to our outgoing Directors, Dr. Carrie Brownstein, Dr. Kate Sasser, Michael Lee, and Tyler Brous, for their longtime support of Shattuck and this transition. We are very pleased to welcome Dr. Dan Baker, M.D., who brings more than 20 years of industry leadership experience, having contributed to the development of Remicade, Simponi and Stelara while serving as the VP of Immunology and Disease Area Stronghold Leader at Johnson & Johnson/Janssen, and also Dr. Mona Ashiya, Ph.D., an accomplished biotechnology industry expert and Member at OrbiMed, to our Board of Directors."

"I look forward to leveraging my immunology and drug development background to help advance a novel DR3 blocking antibody as part of Shattuck’s Board of Directors and working with management to execute on its exciting development program in inflammatory bowel disease," said Dr. Baker. "With SL-325 entering a Phase 1 trial this quarter, I am excited about the multiple data read outs ahead and the opportunity to help guide the program towards proof-of-concept studies."

"I am pleased to be joining the Shattuck Board of Directors and share the Company’s strong commitment to improving outcomes for patients with immune-mediated diseases," said Dr. Ashiya, General Partner of OrbiMed.

Daniel Baker, M.D.

Dr. Baker has over 20 years of drug development experience in the pharmaceutical industry. He currently serves as the interim Chief Development Officer at Cue Biopharma. He has also served as Chief Executive Officer and Founder of KiRa Biotech Pty Ltd., a biotechnology company, and as Venture Partner at OneVentures Investments Australia, a venture capital firm, since 2019. From 2000 to 2019, he served as Vice President, Immunology R&D at Johnson & Johnson (Janssen/Centocor) where he oversaw clinical development of Remicade, Simponi and Stelara and

contributed to more than 15 regulatory approvals in the US, Europe and Japan. Following his retirement from Janssen in 2019, Dr. Baker served as CEO and founder of Kira Therapeutics and more recently as Executive Director on the board of Galapagos Therapeutics from April 2022 until October 2024. Dr. Baker received his Medical Degree from the University of Pennsylvania and completed his Medical Residency at Hershey Medical Center and Fellowship in Rheumatology and Immunology at the University of Pennsylvania, followed by a Research Fellowship in Rheumatology at Mass General Hospital.

Mona Ashiya, Ph.D.

Dr. Ashiya is currently a Member at OrbiMed Advisors LLC, an investment firm, where she has served in various roles of increasing responsibility since 2010. She currently serves on the boards of directors of Disc Medicine, Inc. (NASDAQ: IRON) and several private companies. Dr. Ashiya received her B.A. from the University of California, Berkeley and her Ph.D. in Cellular, Molecular and Developmental Biology from the University of Pittsburgh.

About SL-325

SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. Shattuck expects to commence a Phase 1 clinical trial in healthy volunteers in the third quarter of 2025.

Sana Biotechnology to Present at September 2025 Investor Conferences

On August 26, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentations at four investor conferences in September (Press release, Sana Biotechnology, AUG 26, 2025, View Source [SID1234655484]). The presentations will feature a business overview and update.

Sana will present at Citi’s 2025 Biopharma Back-to-School Conference at 3:15 p.m. ET on Tuesday, September 2, 2025.
Sana will present at the 2025 Wells Fargo Healthcare Conference at 8:00 a.m. ET on Thursday, September 4, 2025.
Sana will present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 11:30 a.m. ET on Monday, September 8, 2025.
Sana will present at the HC Wainwright 27th Annual Global Investment Conference at 9:30 a.m. ET on Tuesday, September 9, 2025.

The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the conference.

Rigel to Participate in Upcoming September Investor Conferences

On August 26, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Raul Rodriguez, the company’s president and chief executive officer, and Dean Schorno, the company’s chief financial officer, will participate in the following investor conferences in September (Press release, Rigel, AUG 26, 2025, View Source [SID1234655483]):

Citi’s 2025 Biopharma Back to School Conference in Boston, MA
Rigel will participate in one-on-one meetings on Tuesday, September 2.

Cantor Global Healthcare Conference 2025 in New York, NY
Rigel will participate in one-on-one meetings and present a company overview on Wednesday, September 3, at 8:35 a.m. ET.

2025 Wells Fargo Healthcare Conference in Boston, MA
Rigel will participate in one-on-one meetings on Thursday, September 4.

H.C. Wainwright 27th Annual Global Investment Conference in New York, NY
Rigel will participate in one-on-one meetings and present a company overview on Tuesday, September 9, at 1:30 p.m. ET.
To access the live webcasts or archived recordings of the Cantor and H.C. Wainwright Conference presentations, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

EMA approves ODD for OXC-101 in AML

On August 26, 2025 Oxcia reported its drug candidate OXC-101 received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (Press release, Oxcia, AUG 26, 2025, View Source;utm_medium=rss&utm_campaign=ema-approves-odd-for-oxc-101-in-aml [SID1234655482]). Now, the European Medicines Agency (EMA) has also granted OXC-101 ODD approval for European markets.

This approval significantly strengthens Oxcia’s position, both from a strategic, regulatory and commercial standpoint, according to Oxcia’s CEO Ulrika Warpman Berglund:

-These dual approvals give us up to 10 years of market exclusivity in the EU and 7 years in the US, accelerated regulatory processes and significant cost savings. EMA’s approval also provides support and scientific advice from EMA’s expert committee (COMP) for orphan drugs which is a large advantage.

EMA is also evaluating whether the drug candidate can offer significant benefit compared to existing treatments. Obtaining ODD from both the FDA and EMA, two of the world’s largest drug regulatory authorities, strengthens scientific credibility and differentiation from competitors. It facilitates the work of raising additional venture capital and signing licensing agreements with pharmaceutical companies.

Briefly about OXC-101 in AML

Oxcia’s lead drug candidate OXC-101 is a so-called "first-in-class" mitotic MTH1 inhibitor. It has a dual mechanism of action that allows it to target a weakness of cancer cells – their high levels of oxidative stress and their propensity to develop DNA damage. In short, OXC-101 induces further oxidative stress and prevents the cancer cells from repairing the DNA damage.

Preclinical studies have shown that OXC-101 significantly reduces tumor growth and prolongs survival in models of acute myeloid leukemia (AML). In addition, there is support for further development from clinical results from a phase I study in patients with advanced hematological cancers. In addition to OXC-101 having potential as a monotherapy with better efficacy than cytarabine (which is one of the standard treatments for AML) in AML disease models, OXC-101 may also further improve the efficacy of treatment with various standard combinations (various chemotherapies).

Oxcia is currently conducting an expansion study, a combined phase I/II study, in a selected group of patients with relapsed/recurrent AML. The treatment is given in combination with one of the standard treatments (idarubicin). Oxcia has obtained a Vinnova grant for the expansion phase of the study. The aim of the study is to confirm the promising preliminary effects previously observed, and to lay the foundation for a pivotal phase II study that could form the basis for a regulatory accelerated approval. In several of the patients in the MAATEO study, clinical benefits have been observed with a partial response and some stable disease up to 5 months, which is a long time for this aggressive disease in this phase. Some improvement in quality of life has also been reported.

In collaboration with Dr. Tom Erkers and Nona Struyf, Scilifelab/Karolinska Institute, so-called precision medicine studies are being carried out on bone marrow samples from patients in the MAATEO study. These studies aim to identify the patients with the best response. The method may be used to stratify patients in future studies.

Marker Therapeutics Provides Update on Phase 1 APOLLO Study Highlighting Encouraging Overall Response Rates in Relapsed Lymphoma

On August 26, 2025 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported an update on the progress and clinical observations from the Phase 1 APOLLO study (Press release, Marker Therapeutics, AUG 26, 2025, View Source [SID1234655481]).

The Company’s Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) is a multicenter, open-label clinical study investigating MT-601, a Multi-Antigen Recognizing (MAR)-T cell product, in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom anti-CD19 CAR-T cell therapy is not an option. Today, Marker is reporting an update on the safety and efficacy data from the dose escalation portion of the study showing a favorable safety profile across all evaluated doses (dose range 100×106-400×106 cells) and a 66% objective response rate in patients with NHL, with 50% demonstrating complete response.

A total of 24 B-cell lymphoma patients have been treated with MT-601 across 7 U.S. clinical sites, including 15 patients with Non-Hodgkin Lymphoma (NHL) and 9 patients with Hodgkin Lymphoma (HL). At the time of the data cutoff (June 2025), 12 NHL and 9 HL patients have been assessed. Patients with NHL and HL received doses ranging from 100×106-400×106 cells and showed objective responses and a favorable safety profile.

"We are very excited and encouraged by the progress of the study," said Juan Vera, M.D., President and CEO of Marker Therapeutics. "The safety and preliminary efficacy data from our Phase 1 APOLLO study underscore the potential of MT-601 in heavily pre-treated patients with lymphoma, who have relapsed after multiple lines of therapy, including CAR-T cells and bispecific antibodies. While CAR-T cells have gained acceptance in the treatment of lymphoma, with approximately 8,000 patients treated globally in 2024, 40-60% of such patients have disease progression within the first year of treatment. We believe that MT-601 could address this critical unmet need and offer new hope to patients who have exhausted multiple lines of treatment, including CAR-T cell therapy."

Efficacy and Duration of Response

The 12 NHL patients received doses ranging from 100×106-200×106 cells and had undergone multiple lines of therapy (median of 5 prior lines of therapy), including anti-CD19 CAR-T cells (n=9) and bispecific antibodies (n=4); dual exposed patients (n=4). 8 out of 12 NHL patients had objective responses (66%), with 6 patients demonstrating complete response (CR) as best response (50%). Durable responses were observed (range 3-24 months) with 5 patients showing continued response ≥6 months, including 3 patients with ≥12 months durability.

HL patients received doses ranging from 200×106-400×106 cells and had undergone a median of 8 prior lines of therapy. Seven out of 9 HL patients had objective responses (78%), with 1 patient demonstrating CR (11%) highlighting the versatility of MT-601 across multiple histologies.

Safety Profile

The dose escalation portion of the study tested doses ranging from 100×106-400×106 cells in patients with B-cell lymphoma. To date, no DLTs have been reported at the highest dose (400×106 cells). Infusion of MT-601 was well tolerated in all study participants, with no observation of ICANS and two reported Grade 1 cytokine release syndrome (CRS) events (fever; no treatment was required). Patients were treated with or without lymphodepleting chemotherapy prior to receiving infusions of MT-601. No change in DLTs or ICANS was observed between patients treated with and without lymphodepletion. Data collected from the 24 patients treated demonstrated a robust safety profile with no reported serious adverse events reinforcing the benefit of MT-601.

Study Design and Dose Expansion

The Phase 1 APOLLO study is composed of a dose escalation phase, followed by a dose expansion phase. The dose escalation cohort evaluated the safety and optimum dose level of MT-601 with doses ranging from 100×106-400×106 cells. On June 17, the Safety Review Committee (SRC) cleared the pre-specified maximum dose (400×106 cells) for the dose expansion portion of the trial. The dose expansion will enroll patients with DLBCL who have relapsed after anti-CD19 CAR-T cells or who are ineligible for CAR-T therapy.

"The observed outcomes in NHL demonstrate that certain patients can achieve clinically meaningful responses with MT-601 even at lower doses of 100×106 or 200×106 cells," commented Dr. Vera. "We look forward to advancing the study to the dose expansion phase, where we will investigate MT-601 at the maximum dose of 400×106 cells in patients with relapsed DLBCL to potentially build upon these promising results."

Dr. Vera continued, "The encouraging efficacy in patients with NHL was achieved at doses ranging from 100×106-200×106 cells. We believe that investigating MT-601 at the maximum dose of 400×106 cells in the dose expansion cohort could have the potential to further improve the clinical efficacy and durability we are currently observing in patients with NHL. It is particularly encouraging that even at the highest dose level no DLTs were reported in the dose escalation phase. We will continue to closely monitor the safety and efficacy of MT-601 in treated patients and anticipate to provide another data update in the first half of 2026."Webcast Details

Marker will host a live, online-only webcast today at 8:30 am E.D.T. to discuss the clinical results and provide a corporate update. To attend the live event, please use this link to register. During the event, attendees will have the opportunity to submit written questions via the webcast platform’s Q&A feature. After the event, a recording will be made available for replay on the Company’s IR website under Events & Presentations for approximately 30 days.

About MT-601

The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapies.

About APOLLO

The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma who have either failed anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are not candidates for anti-CD19 CAR-T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. The APOLLO study is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA291521.

About MAR-T cells

The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.