On May 27, 2025 Coherus BioSciences, Inc. ("Coherus," NASDAQ: CHRS), reported a clinical collaboration with STORM Therapeutics, Ltd. ("STORM") to evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor, in a Phase 1b/2 study for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer (Press release, Coherus Biosciences, MAY 27, 2025, View Source [SID1234653391]).

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"We are excited to partner with STORM on the development of the LOQTORZI/STC-15 combination, with patient dosing underway in the Phase 1b/2 study," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus. "This collaboration is another example of our strategy for expanding potential LOQTORZI indications beyond NPC through cost-efficient drug supply agreements and evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others."

The phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI to determine the safety and efficacy of the combination. The phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, endometrial cancer and melanoma, in up to 188 patients in the United States. (NCT06975293)

Under the terms of the clinical trial collaboration and supply agreement, Coherus will provide LOQTORZI to STORM, which will be the sponsor of the Phase 1b/2 clinical combination trial. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies.

On May 27, 2025 Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, reported the presentation of preclinical data on CID-078 at the Advances in Neuroblastoma Research (ANR) Meeting in Washington, D.C., May 25 -28, 2025 (Press release, Circle Pharma, MAY 27, 2025, View Source;utm_medium=rss&utm_campaign=preclinical-data-on-circle-pharmas-cid-078-featured-in-poster-presentation-at-advances-in-neuroblastoma-research-meeting [SID1234653390]). The data, which explore the therapeutic potential of CID-078 in neuroblastoma (NB), were presented in a poster entitled:

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"Cyclin A/B-RxL Inhibition as a Novel Therapeutic Strategy in Neuroblastoma"
Dylan M.M. Jongerius et al.
Poster #P010

The poster highlights the work of researchers from the Princess Máxima Center for Pediatric Oncology (Utrecht, the Netherlands), the Hopp Children’s Cancer Center Heidelberg (KiTZ) (Heidelberg, Germany), and Circle Pharma, demonstrating the potent anti-tumor activity of CID-078 in preclinical neuroblastoma (NB) models.

CID-078 is a first-in-class oral macrocycle cyclin A/B RxL inhibitor that selectively disrupts RxL-mediated interactions between cyclin A2/B1 and their substrates, a novel mechanism of action that targets cell cycle dysregulation in cancer. In neuroblastoma, where CDK-RB-E2F axis deregulation and oncogenic E2F activity are common, this mechanism is particularly relevant.

Key Findings Presented:

Potent Single agent CID-078 activity was observed across multiple neuroblastoma cell line models.

Mechanism of action studies confirmed induction of DNA damage, G2/M arrest and the activation of the spindle assembly checkpoint (SAC).

Deletion of CDKN2A sensitized cells to CID-078 suggesting CDKN2A status maybe be used as a potential patient stratification strategy.

"A greater understanding of the biology of neuroblastoma, the most common extra-cranial solid tumor diagnosed in children, has shown specific genomic alterations which deregulate the cell cycle leading to E2F activation," said Michael C. Cox, PharmD, MHSc, BCOP, SVP and head of early development of Circle Pharma. "Circle’s collaboration with these two premier pediatric oncology research institutions has shown again the potential of our macrocycle platform to develop new therapies for historically challenging targets. The exciting CDKN2A deletion biomarker data, as well as the in vitro data in a pediatric tumor with a need for better treatments support our clinical development plans for CID-078."

The full poster is available here.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program

CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients.

On May 27, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present clinical trial data from select pipeline candidates across the Company’s diversified oncology portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, to be held in Chicago, IL, from May 30 to June 3, 2025 (Press release, BioNTech, MAY 27, 2025, View Source [SID1234653389]). The data highlight continued progress of the Company’s clinical programs consisting of complementary therapeutic modalities, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, including antibody-drug conjugates ("ADCs").

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"We believe that the next era of cancer medicine will be defined by the interplay of complementary mechanisms and innovative molecules, unlocking their full potential through synergy. Our data presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting show how we aim to help shape this era," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We will present clinical progress with two of our therapeutic modalities: our next generation immunomodulators, most notably our investigational anti-PD-L1xVEGF-A antibody BNT327, and for one of our ADC programs, which are an important pillar of our combination strategy. These data underline the potential of our assets to improve outcomes for patients."

Highlights of BioNTech’s oncology programs to be presented at ASCO (Free ASCO Whitepaper) 2025:

•Three presentations on BNT3271, an investigational anti-PD-L1xVEGF-A antibody, will detail data from ongoing later-stage and potentially registrational clinical trials: An oral presentation will feature the first data from a Phase 2 clinical trial (NCT05918107) of BNT327 in combination with chemotherapy as first-line treatment for patients with unresectable malignant mesothelioma. Malignant mesothelioma is a type of cancer that develops in the tissue that covers the lung or the abdomen. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two posters will detail the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) in extensive-stage small cell lung cancer ("ES-SCLC") and ROSETTA Lung-02 (NCT06712316) in non-small cell lung cancer ("NSCLC"). BNT327 combines the two complementary anti-tumor mechanisms of PD-L1 checkpoint and VEGF-A signaling blockade in the tumor microenvironment, thereby aiming to enhance anti-tumor activity.

•Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, from an ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer ("CRPC") will be presented during an oral session. The data indicated early clinical activity and a manageable safety profile. BNT324/DB-1311 received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for this patient population in 2024 and is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").

•Preliminary data on BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, from two ongoing Phase 1/2 clinical trials evaluating the antibody candidate in combination with current standard of care treatments will be presented. Data from the PRESERVE-001 clinical trial (NCT04140526) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. The data included an analysis of overall survival ("OS") and an ad-hoc analysis of next-treatment free survival ("NTFS"), a measure for potential long-lasting benefit after initial treatment. Data from the PRESERVE-006 clinical trial (NCT05682443) in patients with metastatic CRPC indicated a manageable safety profile and preliminary efficacy. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. ("OncoC4").

•Data on BNT142 from an exploratory Phase 1/2 dose finding trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation. BNT142 is an investigational lipid nanoparticle-formulated mRNA immunotherapy that encodes a CD3xCDLN6 T cell engager antibody. Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies.

BioNTech has established a diversified oncology portfolio to develop novel treatment approaches for patients living with cancer. The Company is advancing its oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the ASCO (Free ASCO Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentations

Asset: BNT327
Session Title: Clinical Science Symposium | Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Abstract Title: First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line (1L) treatment in unresectable malignant mesothelioma 
Location: E451
Abstract Number: 8511
Date: June 3, 2025
Time: 9:45 AM – 11:15 AM CDT

Asset: BNT324/DB-1311
Session Title: Rapid Oral Abstract Session | Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: DB-1311/BNT324 (a novel B7H3 ADC) in patients with castrate-resistant prostate cancer (CRPC)
Location: Hall D2
Abstract Number: 5015
Date: June 1, 2025
Time: 4:30 PM – 6:00 PM CDT

Asset: BNT142
Session Title: Oral Abstract Session | Developmental Therapeutics—Immunotherapy
Abstract Title: First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors.
Location: Hall D2
Abstract Number: 2501
Date: May 31, 2025
Time: 3:00 PM – 6:00 PM CDT

Poster Presentations

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: A global Phase 3 double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)
Poster Board: #242a
Abstract Number: TPS8129
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: Phase 2/3, global, multisite, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)
Poster Board: #138b
Abstract Number: TPS8670
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Melanoma/Skin Cancers
Abstract Title: Gotistobart in combination with pembrolizumab in patients with advanced melanoma who have progressed on PD-1 inhibitors with or without CTLA-4 inhibitors
Poster Board: #34
Abstract Number: 9551
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Poster Board: #266
Abstract Number: 5067
Date: June 2, 2025
Time: 9:00 AM – 12:00 PM CDT

On May 27, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update (Press release, BioLineRx, MAY 27, 2025, View Source [SID1234653388]).

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"Following our announcement last November that we out-licensed APHEXDA, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."

"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.

Financial Updates

Completed financing in January 2025 raising gross proceeds of $10 million.
Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company’s U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions.
Reaffirms cash runway through the second half of 2026.
APHEXDA Performance Update

APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million.
Clinical Updates

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on Saturday, May 31st. Key highlights include:
Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy

Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children’s Research Hospital.
Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis.
Financial Results for the Quarter Ended March 31, 2025

Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company’s operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales.
Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction.
General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company’s share price.
Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits.
Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024.
As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million
Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On May 27, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following conferences (Press release, BioCryst Pharmaceuticals, MAY 27, 2025, View Source [SID1234653386]):

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Jefferies Global Healthcare Conference in New York on Wednesday, June 4, 2025, at 4:55 p.m. ET.

Goldman Sachs 46th Annual Global Healthcare Conference in Miami on Monday, June 9, 2025, at 8:40 a.m. ET.
Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at www.biocryst.com.