On December 2, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported that it will showcase its latest research through 100 abstracts and presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place in Orlando, Florida and virtually from December 6-9. SCRI’s expansive network is represented by more than 50 researchers who serve as first authors and co-authors across over 15 research locations.

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!

A comprehensive list of SCRI abstracts and presentations at this year’s Annual Meeting & Exposition can be found here.

"This year’s ASH (Free ASH Whitepaper) Annual Meeting & Exposition marks a milestone for SCRI, with the largest number of accepted abstracts and presentations in our history," said David Spigel, MD, Chief Scientific Officer, SCRI. "This achievement reflects not only the significance of the research, but also the meaningful collaboration and unwavering commitment of the investigators across our network, all united to advance the science that transforms care for people facing blood cancers and blood disorders."

Noteworthy Presentations

Β-Thalassemia & Sickle Cell Disease

Haydar Frangoul, MD, MS, SCRI at TriStar Centennial Children’s Hospital, will present "First Results of Exagamglogene Autotemcel in Pediatric Patients Aged 5-11 Years with Transfusion-Dependent Β-Thalassemia or Sickle Cell Disease with Recurrent Severe Vaso-Occlusive Crises" in an oral presentation on Saturday, December 6 at 4:00 p.m. EST in OCCC – Chapin Theatre (W320).
Dr. Frangoul is also first author on an oral presentation titled, "Enhanced CD34+ Cell Mobilizations, Collections, and Comparable Safety Profile with Fixed Dose versus Weight-Based Plerixafor Dosing in Patients with Sickle Cell Disease Receiving Autologous CD34+ Base-Edited Hematopoietic Stem Cells in the Ongoing BEACON Study" on Monday, December 8 at 5:30 p.m. EST in Hyatt – Regency Ballroom R.
Leukemia

Nosha Farhadfar, MD, SCRI at Methodist Healthcare, is first author on an oral presentation alongside Stephen Strickland, MD, MSCI, SCRI, and Alireza Eghtedar, MD, SCRI at Colorado Blood Cancer Institute, titled, "Promising Results from an Ongoing Phase I Multicenter Study of Senti-202, a First-In-Class, CD33 and/or FLT3 & Not Endomucin, Selective Off-The-Shelf Logic Gated CAR NK Cell Therapy in Adults with Relapsed/Refractory Acute Myeloid Leukemia" on Monday, December 8 at 5:45 p.m. EST in OCCC – Valencia Room W415BC.
Lymphoma

Jeff Sharman, MD, SCRI at Willamette Valley Cancer Institute & Research Center I The US Oncology Network, serves as first author alongside co-authors John Burke, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, and Shachar Peles, MD, SCRI at Florida Cancer Specialists & Research Institute I The US Oncology Network, on an oral presentation titled, "Fixed Treatment Duration Subcutaneous Mosunetuzumab Monotherapy in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Interim Results from The Phase II MorningSun Study" on Saturday, December 6 at 9:45 a.m. EST in OCCC – Tangerine Ballroom F2.
Dr. Burke is first author alongside co-author Dr. Sharman on an oral presentation titled, "Fixed-Duration Subcutaneous Mosunetuzumab, with Maintenance Therapy, in Patients with Previously Untreated High-Tumor Burden Follicular Lymphoma: Longer Follow-Up and Exploratory Circulating Tumor DNA Analysis of The Phase II MorningSun Study" on Saturday, December 6 at 3:15 p.m. EST in OCCC – Tangerine Ballroom F2.
Other

James Essell, MD, SCRI at OHC I The US Oncology Network, is first author on an oral titled, "Remote Therapeutic Monitoring Reduces Hospitalization due to Infection in Patients Being Treated for Hematological Malignancy" on Saturday, December 6 at 10:30 a.m. EST in OCCC – W230.
Dr. Farhadfar will deliver "Safety and Feasibility of 0.6 mg/kg Every 4 Weeks Dosing of Axatilimab in Patients Treated in the AGAVE-201 Study" in an oral presentation on Saturday, December 6 at 2:15 p.m. EST in OCCC – W331.
In addition to scientific presentations, SCRI researchers will participate in and lead ASH (Free ASH Whitepaper) Annual Meeting & Exposition sessions, including:

Hans Lee, MD, SCRI, will moderate the session, Multiple Myeloma: Pharmacologic Therapies: Advances in Treatment Strategies for Relapsed/Refractory Multiple Myeloma, on Saturday, December 6 at 2:00 p.m. EST in OCCC – West Hall D1.
Dr. Burke will present "Engagement of Community Physicians in Clinical Trials" during the session, How Can Community-Based and Academic Hematologists Foster Clinical Trial Participation as Part of Patient Care? on Sunday, December 7 at 9:40 a.m. EST in Hyatt – Plaza Int’l HIJK.
Additional Poster Presentations with SCRI First Authors

Saturday, December 6

"Real-World Treatment Patterns, Factors Associated with Discontinuation and Toxicity Across Covalent BTK Inhibitors in First-Line Tx of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma," Dr. Burke, 5:30 p.m. – 7:30 p.m. EST, OCCC – West Halls B3-B4.
Sunday, December 7

"First-Line Consolidation with Cemacabtagene Ansegedleucel in Patients with Large B-Cell Lymphoma and Minimal Residual Disease after Response to Standard Therapy: The Pivotal, Randomized, Open‑Label Phase 2 ALPHA3 Study" and "Correlation Between Real-World Progression-Free Survival and Overall Survival among Patients with First-Line Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Receiving Covalent Bruton Tyrosine Kinase Inhibitors or B-Cell Lymphoma 2 Inhibitors," Dr. Burke, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.
"Asciminib in Chronic Myeloid Leukemia in Chronic Phase: Efficacy and Safety Results of the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients with 1 Prior Tyrosine Kinase Inhibitor," M. Yair Levy, MD, SCRI at Texas Oncology I The US Oncology Network, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.
Monday, December 8

"Diverse Preferences for Treatment Options in Relapsed/Refractory Follicular Lymphoma: Survey Results from Patients in The United States," "Optimizing Processes for Adverse Event Management for Bispecific Antibodies for Diffuse Large B-Cell Lymphoma in Community Practice: Insights from a Quality Improvement Initiative," and "A First-In-Human Phase 1 Trial of LY4152199, A B-Cell Activation Factor Receptor T-Cell Engager Bispecific Antibody, in Patients with Previously Treated B-Cell Malignancies" Krish Patel, MD, SCRI, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.

(Press release, Sarah Cannon Research Institute, DEC 2, 2025, View Source [SID1234661069])

On December 2, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025.

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!

The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative.

Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg).

Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-γ). Data cut-off date for efficacy results was 15 September 2025.

Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center noted, "Evaluating two biologically active doses allowed us to integrate clinical response data with meaningful pharmacodynamic readouts. In keeping with Project Optimus principles, the study generated rigorous comparative data in heavily pretreated metastatic breast cancer patients showing consistent efficacy measures and immune-activation signals across both arms, reinforcing efti’s novel mechanism of action and the clinical potential of this immunotherapy-chemo combination."

Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD.

(Press release, Immutep, DEC 2, 2025, View Source [SID1234661102])

On December 2, 2025 Pasithea Therapeutics Corp. ("Pasithea" or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported the closing of its previously announced public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management.

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!

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company expects its cash position to extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission ("SEC") on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Pasithea Therapeutics, DEC 2, 2025, View Source [SID1234661051])

On December 2, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported the initiation of the TheraPb Phase 2 expansion trial (NCT05720130) evaluating its lead investigational candidate, ADVC001, in metastatic prostate cancer. The news follows the encouraging Phase 1b dose escalation results presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 congress that showed a favorable safety profile and compelling anti-tumor activity for ADVC001 in patients with mCRPC (see press release).

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!

ADVC001 is a first-in-class 212Pb-PSMA RLT in clinical development, with early data indicating a differentiated and competitive profile both within and beyond its class. Development is advancing rapidly; the Phase 1b therapeutic cohorts were enrolled within ten months, and the commencement of Phase 2 expansion sustains this strong program momentum.

The TheraPb Phase 2 expansion will evaluate ADVC001 at two therapeutic dose levels – 160 MBq and 200 MBq – using a randomized, multi-dose-response design aligned with the US Food and Drug Administration (FDA) guidance on dose optimization for oncology therapeutic radiopharmaceuticals1. The study will incorporate novel dosing strategies and the option for treatment with more than six cycles, supported by the favorable dosimetry and pharmacokinetics data from Phase 1b, to optimize clinical outcomes across three key prostate cancer indications:

mHSPC: patients with metastatic hormone-sensitive prostate cancer
mCRPC, pre-chemotherapy: patients with mCRPC who have not received prior chemotherapy for mCRPC
mCRPC, post-177Lu-PSMA RLT: patients with mCRPC who have been previously treated with 177Lu-PSMA
Enrollment for the TheraPb Phase 2 expansion is expected to commence initially at clinical sites in Australia, with planned expansion to sites in the United States in 2026.

"We are excited to initiate the Phase 2 expansion, marking an important milestone in advancing our novel alpha therapy for prostate cancer," said Anna Karmann, MD PhD, Chief Medical Officer at AdvanCell. "Our Phase 1 results enable us to evaluate optimal dosing regimens that support a precision treatment strategy aligned with tumor biology and individual response, underscoring our commitment to deliver better clinical outcomes and quality of life for patients living with metastatic prostate cancer."

"As ADVC001 enters Phase 2, I am eager to begin enrollment in this study," said Aaron Hansen, MD, Principal Investigator at the Princess Alexandra Hospital. "ADVC001 has demonstrated a highly promising safety and efficacy profile in Phase 1, supporting its investigation in multiple settings. The adaptive dosing and the ability to treat with more than six cycles offer the potential to meaningfully improve clinical benefit and are a step towards more personalized treatment for patients with prostate cancer."

AdvanCell plans to present additional details on the TheraPb Phase 2 expansion trial design at a major oncology conference in the first half of 2026.

US Food and Drug Administration (2025, August) "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development – Guidance for Industry (Draft Guidance)"

(Press release, Advancell, DEC 2, 2025, View Source [SID1234661070])

On December 2, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month.

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!

The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The request is based on positive final results from the Company’s VERSATILE-002 trial, which showed promising median overall survival (mOS) and durable progression-free survival (PFS) in patients with CPS ≥ 1. The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with significant statistical power, potentially forming the basis for accelerated approval of PDS0101. mOS will remain as the primary endpoint for full approval as originally recommended by FDA.

"We believe the positive PFS data from VERSATILE-002 offers an important opportunity to shorten duration to a primary endpoint and potentially accelerate our path to regulatory submission, while still preserving mOS and safety assessment as the endpoint for full FDA approval," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We are confident that the accelerated pathway we are seeking could expedite the availability of this promising treatment to patients in need, and we look forward to exploring this approach in greater detail with the FDA. We will provide further updates once we receive the FDA’s meeting minutes in January 2026."

(Press release, PDS Biotechnology, DEC 2, 2025, View Source [SID1234661052])