On June 12, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported positive clinical data from the Company’s ongoing NX-5948-301 study, a Phase 1a/b clinical trial of bexobrutideg (NX-5948) in patients with relapsed or refractory B-cell malignancies (Press release, Nurix Therapeutics, JUN 12, 2025, View Source [SID1234653846]).

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The data include findings from the fully enrolled Phase 1a dose escalation study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and the ongoing Phase 1a/1b cohorts of patients with Waldenström macroglobulinemia (WM). Talha Munir, M.B. Ch.B, Ph.D., consultant hematologist at Leeds Teaching Hospitals NHS Trust, deputy chair of the United Kingdom National Cancer Research Institute CLL Study Group, and Dima El-Sharkawi, M.B., B.S., M.A., Ph.D., MRCP FRCPath, Consultant Haematologist, Royal Marsden NHS Foundation Trust, Sutton, U.K., will present these data at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA2025), taking place June 12–15, 2025, in Milan, Italy.

"These data demonstrate an impressive safety and efficacy profile for bexobrutideg with improvement in responses in patients over time, including the notable achievement of a complete response in a patient with CLL and a history of two lines of prior therapy who has been on bexobrutideg treatment for over two years," said Dr. Munir. "Patients with relapsed or refractory CLL and WM who have failed treatments with commonly prescribed BTK inhibitors and other agents due to intolerance or acquired resistance have few therapeutic options. Nurix’s bexobrutideg has the potential to address this unmet need and provide a life-changing treatment for patients with CLL and WM."

"With longer time on treatment, we are encouraged by the continued favorable safety profile and high ORR with deepening responses in CLL and WM, including those with clinical and genomic high risk features including CNS involvement," said Paula G. O’Connor, M.D., chief medical officer of Nurix. "We have further expanded our Phase 1b cohorts in select CLL populations and remain on track to initiate pivotal studies in 2025."

"Bexobrutideg offers a next-generation approach to BTK targeting with exquisite selectivity, superior preclinical potency, broad coverage of mutations and demonstrated clinical activity in areas of high unmet medical need," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We are not only preparing to initiate pivotal studies in the coming months but are also laying the foundation for the commercialization of bexobrutideg as a differentiated treatment option for patients with B-cell malignancies."

Data presented at EHA (Free EHA Whitepaper)2025 include efficacy and safety findings for patients with CLL/SLL in the fully enrolled Phase 1a dose escalation study (n=48). This cohort of CLL patients was a heavily pretreated population that had received a median of four prior lines of therapy (range = 2–12) including prior covalent BTK inhibitors (97.9%), prior BCL2 inhibitors (83.3%), and prior non-covalent BTK inhibitors (27.1%). At baseline, many patients had mutations associated with BTK inhibitor resistance, including mutations in BTK (38.3%) and PLC2G (14.9%). Poor prognostic features were common, including TP53 mutations (44.7%), and five patients (10.4%) had central nervous system (CNS) involvement.

Patients were treated with bexobrutideg at doses ranging from 50 mg to 600 mg once daily by oral administration in the Phase 1a dose escalation study. As of the March 12, 2025 data cut, the median follow up was 9.0 months with most patients still on treatment. Bexobrutideg was well tolerated across all doses evaluated with the most common treatment emergent adverse events of purpura/contusion (45.8%), neutropenia (29.2%) and thrombocytopenia (22.9%), primarily low grade. No new onset atrial fibrillation was observed. Among the efficacy evaluable patients with CLL (n = 47), bexobrutideg treatment resulted in a robust objective response rate (ORR) of 80.9% across all doses tested with a median time to first response of 1.9 months. Many patients experienced deepening of their response with longer time, with multiple conversions from stable disease to partial responses and one patient, who has been on treatment for over two years, experienced a complete response. The median duration of response has not been reached, with 18 patients on treatment for more than a year. Responses were observed across all populations regardless of prior treatment, baseline mutations, or CNS involvement.

The data presented at EHA (Free EHA Whitepaper) included patients with WM (n=22) treated with bexobrutideg at doses ranging from 50 mg to 600 mg once daily by oral administration from both the Phase 1a dose escalation and Phase 1b cohort expansion. Among the 22 WM patients, the median age was 72.5 years (range 58-86 years) and the median number of prior lines of therapy was 3 (range 2-5). All 22 patients previously had been treated with a covalent BTK inhibitor (100%), 21 had received prior chemotherapy/chemo-immunotherapy (95.5%), four had received prior non-covalent BTK inhibitor (18.2%), and one patient (4.5%) had received prior treatment with a BCL2 inhibitor. Baseline mutation status in MYD88 and CXCR4 was captured from patient records. 15 patients (68.2%) had mutations in MYD88, and five patients (22.7%) had mutations in CXCR4. Bexobrutideg was well tolerated in patients with WM with a profile that was consistent with the overall study population and previous disclosures. Adverse events (AEs) were predominantly low grade; with the most common being petechiae (27.3%), diarrhea (22.7%), purpura/contusion (18.2%), neutropenia (18.2%), and thrombocytopenia (18.2%). There were no dose limiting toxicities observed and no grade 5 AEs. Two treatment emergent AEs led to drug discontinuation. No new onset atrial fibrillation was observed.​ As of the March 12, 2025 data cut, 19 patients were evaluable for responses. Objective response was observed in 16 patients (84.2%), including two patients (10.5%) with very good partial response (VGPR), 11 patients (57.9%) with partial response (PR), and three patients (15.8%) with minor response (MR). Three patients (15.9%) had a best response of stable disease (SD). Responses were observed in patients regardless of their baseline mutations in MYD88 and CXCR4. Steady reductions in IgM levels were observed starting from the first assessment at four weeks, which continued to deepen, and three patients achieved IgM reductions of greater than 90%.

Conference Call Details
On June 12, 2025, at 8:00 a.m., ET (2:00 p.m., CEST), Nurix will host a conference call and webcast to discuss data from the bexobrutideg clinical trial. The live webcast, with an accompanying presentation, will be accessible under the Events and Presentations page in the Investors section of the company’s website here. To participate in the live conference call, the dial-in number in the United States is 877-346-6112. For participants outside the United States, the dial-in number is 1-848-280-6350. A replay of the webcast and call will be archived on the Nurix website for approximately 30 days after the event.

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. Bexobrutideg is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).

On June 12, 2025 Fapon Biopharma, a clinical-stage biotech company innovating therapeutic antibodies and fusion proteins, reported its participation in the BIO International Convention 2025 (BIO 2025), taking place June 16-19 in Boston Convention & Exhibition Center (Press release, Fapon Biopharma, JUN 12, 2025, View Source [SID1234653862]). The company will exhibit at Booth #1851, presenting its differentiated pipeline, including the flagship Phase 1 immunocytokine FP008, a portfolio of promising early-stage candidates for oncology and autoimmune diseases, and its suite of proprietary technology platforms, while actively seeking global partnerships.

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FP008, Fapon Biopharma’s lead asset, is a first-in-class immunocytokine currently in Phase 1 clinical trials, designed to address significant unmet needs in solid tumor patient refractory to anti-PD-1 therapy. The company will also feature promising preclinical candidates targeting oncology (FP010, FP011, FPE021) and autoimmune diseases (FPE022, FPE024), highlighting its expanding research capabilities.

Fapon Biopharma will feature its proprietary and innovative technology platforms, engineered to overcome complex drug development challenges:

Bi/Tri-TCE Platform: Human-monkey cross-reactive TCR/CD3 nanobody, enabling the design of potent multi-specific antibodies for targeted cancer immunotherapy.
FILTEN (IL-10M Fusion Protein Platform): Overcoming IL-10 limitations for broad applications in cancer and autoimmune diseases
PROTiNb (Proteolysis Targeting Intra-Nanobody): A pioneering platform targeting previously "undruggable" intracellular targets, demonstrating a strong competitive edge.
FIND Mammalian Cell Display Platform: Accelerating antibody discovery by combining mammalian cell expression with high-throughput screening.
"We are excited to connect with the global biopharma community at BIO 2025," said Vincent Huo, President of Fapon Biopharma. "We look forward to demonstrating the exciting progress of our internal pipeline and how our technology platforms can empower external partners to bring transformative therapy to patients faster."

Engagement Opportunities:
Exhibition Booth: #1851
Company Presentation:
Time: 11:30 a.m., Tuesday, June 17, 2025
Location: Room 153A, Boston Convention & Exhibition Center

On June 12, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX) ("Quince" or the "Company"), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ("Warrants") that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses (Press release, Quince Therapeutics, JUN 12, 2025, View Source [SID1234653847]).

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The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash.

At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions.

Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement.

The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

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

On June 12, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) in Milan, Italy (Press release, ADC Therapeutics, JUN 12, 2025, View Source [SID1234653863]). The Company will host a conference call and webcast featuring LOTIS-7 trial principal investigator and EHA (Free EHA Whitepaper) presenting author, Juan Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine today at 8:00 a.m. ET to discuss the results. To access the conference call, please register here.

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"The data seen in this study with the combination of ZYNLONTA and glofitamab has shown a manageable safety profile along with strong efficacy data from patients with relapsed or refractory DLBCL, with complete responses observed regardless of prior therapy, including CAR-T," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "The combination of these two anti-cancer agents holds significant promise for advancing the treatment landscape and addressing unmet need in patients with these hard-to-treat lymphomas."

The presentation highlights updated data as of April 14, 2025, in which r/r LBCL patients received dose levels of 120 µg/kg or 150 µg/kg of ZYNLONTA plus the bispecific antibody glofitamab, with 41 patients evaluable for safety and 30 patients evaluable for efficacy.

Key highlights of the LOTIS-7 data presentation are as follows:

Best overall response data among the 30 efficacy evaluable patients shows overall response rate (ORR) of 93.3% (28/30 pts) as assessed by Lugano Criteria
Complete response (CR) rate of 86.7% (26/30 pts)
Of these, 25/26 patients achieving CR remain in CR as of the data cut-off
Median time to CR in 120 µg/kg = 80 days
Median time to CR in 150 µg/kg = 42 days
12 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 11 pts respectively)
Of the 6 patients previously treated with CAR-T and undergoing response assessment, 5 achieved a CR
Among the 41 safety evaluable patients, the combination was generally well tolerated with a manageable safety profile and no DLTs across dose levels
Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (24.4%), anemia (9.8%), AST increased (7.3%), GGT increased (7.3%), and thrombocytopenia (7.3%)
In the 150 µg/kg dose, cytokine release syndrome (CRS) (23.8%), all of which were Grade 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) (4.8%), with one case of Grade 2, were observed
In the 120 µg/kg dose, CRS all grades (55%), all of which were Grade 1/2 except one case of Grade 3, and ICANS (10%), with one case of Grade 1 and one case of Grade 2, were observed
TEAEs leading to discontinuation included 3 each for ZYNLONTA and glofitamab
There were no Grade 5 TEAEs observed
"We believe these new data are differentiating and further reinforce the potential of ZYNLONTA plus the bispecific glofitamab to improve outcomes for DLBCL patients who need it most," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This early safety and efficacy data support the ongoing expansion of this study to 100 patients at the 150 µg/kg dose of ZYNLONTA plus glofitamab. We look forward to discussing the results with Dr. Alderuccio during our conference call today in addition to the presentation of the data set across two key conferences."

This data will be shared at EHA (Free EHA Whitepaper)2025 during a poster presentation on June 14 at 6:30 p.m. CEST and also as an oral encore presentation at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20 at 9:00 a.m. ET. The Company plans to share additional data before the end of 2025.

Conference Call Information
To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

About LOTIS-7
LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L/2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab). Primary endpoints of the study include safety and tolerability. Secondary efficacy endpoints include ORR, DOR, CRR, PFS, RFS, and OS as well as pharmacokinetics and immunogenicity.

For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901).

About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On June 12, 2025 FivepHusion, an advanced clinical-stage biotechnology company, reported the successful completion of the phase 1 (Part A) component of the phase 1/2 Deflexifol at Relapse Trial (DART) proudly supported by the Kids with Cancer Foundation, an Australian-led study of a new brain cancer treatment for children (Press release, FivepHusion, JUN 12, 2025, View Source [SID1234653831]).

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The phase 1/2 DART study is an Australian investigator-initiated trial, led by Principal Investigators Professor David Ziegler and Dr Marion Mateos and sponsored by the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) in collaboration with FivepHusion. The trial is designed to investigate Deflexifol monotherapy as a treatment for paediatric ependymoma and other childhood brain cancers. All major paediatric oncology centres in Australia are participating in the trial, and major trial funding has been provided by the Kids with Cancer Foundation, through Sydney Children’s Hospitals Foundation, and the Robert Connor Dawes Foundation. An abstract summarising the results of the Phase 1 component has been submitted to the Society of Neuro-Oncology for consideration of presentation at their international meeting in November.

Dr Christian Toouli, CEO and Managing Director of FivepHusion commented, "Completion of Part A of the DART study, and confirmation of a safe and tolerable phase 2 dose, are major milestones in our plans to develop Deflexifol as a potential treatment for paediatric ependymoma and other brain cancers. We thank the patients and their families for their participation in this trial, and our collaborators and partners for conducting this important study."

Deflexifol is an advanced clinical-stage, next-generation co-formulation of 5-fluorouracil (5-FU) and leucovorin (LV), a drug that significantly enhances 5-FU activity. Deflexifol has previously been evaluated in two successfully completed clinical trials in adults with a variety of solid tumours; the DART study is the first clinical evaluation of Deflexifol in paediatric patients. FivepHusion is harnessing the proven cytotoxic activity of 5-FU together with the unique, optimised attributes of the Deflexifol co-formulation to pursue Deflexifol development in a range of strategic solid tumour indications presenting with significant unmet medical needs, including paediatric ependymoma.

Ependymomas are rare central nervous system tumours (annual incidence of ~4 patients per million) that are more common in young children 0-4 years of age. The current standard treatment for ependymoma is surgery and radiotherapy, though relapse occurs in one third of all paediatric patients and is associated with a poor prognosis. Currently, there are no drugs approved for the treatment of ependymoma, presenting a significant unmet medical need for the development of safe and efficacious new treatments for this disease.

Previously, 5-FU has been reported as a promising drug candidate for the treatment of paediatric ependymoma by independent research groups1,2, and in a clinical trial conducted at the St Jude Children’s Research Hospital (Memphis, Tennessee, USA)3. Recently, independent studies have gained further insights into understanding the susceptibility of paediatric ependymoma to 5-FU4. Research by FivepHusion collaborators indicates that Deflexifol, as an optimised co-formulation of 5-FU and LV, may be efficacious against paediatric ependymoma and other brain cancers. Due to its improved safety, tolerability, and potentially superior anti-tumour efficacy, Deflexifol offers the exciting opportunity of addressing the limitations of current 5-FU formulations to enable development as potentially the first approved drug for ependymoma and possibly other brain tumours.