On June 3, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported initiation of a Phase 1/2 clinical study of its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors (Press release, Avenzo Therapeutics, JUN 3, 2025, View Source [SID1234653666]).

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"HER3 is a key dimerization partner of EGFR, and their interaction is known to drive oncogenic signaling across a range of solid tumors, including non-small cell lung cancer, breast cancer, and head and neck cancer," said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. "Based on its preclinical data and differentiated design targeting this pathway, AVZO-1418 offers a promising approach for patients with advanced solid tumors."

The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

"We are excited to have initiated our company’s second clinical trial within 2 weeks of receiving IND clearance," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This is another important milestone in our journey to advance potentially differentiated drug candidates that help fight cancers with high unmet medical needs."

On June 3, 2025 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported that the Company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, in Miami. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 2:00 pm ET and host investor meetings throughout the day (Press release, Krystal Biotech, JUN 3, 2025, View Source [SID1234653682]).

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A webcast of the presentation will be available here beginning at 2:00 pm ET on Tuesday, June 10, 2025 and will be posted on the Investors section of the Company’s website.

On June 3, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported it will be presenting clinical study results at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, taking place June 12-15 in Milan, Italy (Press release, PharmaEssentia, JUN 3, 2025, View Source [SID1234653698]).

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The company’s results from the Phase 3 SURPASS-ET trial (NCT04285086) have been selected for an oral presentation during the plenary session—one of six top-ranked abstracts chosen by the EHA (Free EHA Whitepaper) 2025 Scientific Program Committee. The presentation, led by Dr. Harry Gill, hematologist and oncologist at the University of Hong Kong, will share data from the Phase 3 SURPASS-ET study demonstrating the efficacy and safety of ropeginterferon alfa-2b versus anagrelide in essential thrombocythemia (ET).

Earlier this year, PharmaEssentia announced positive topline SURPASS-ET Phase 3 results, with ropeginterferon alfa-2b-njft demonstrating a significantly higher durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001), along with a favorable safety profile and a greater reduction in JAK2 V617F allelic burden over 12 months.

"I’m deeply honored that the SURPASS-ET study results were selected for a plenary presentation at the EHA (Free EHA Whitepaper) Congress. This recognition underscores the significance of the data for patients living with ET," said Dr. Harry Gill, hematologist and oncologist at the University of Hong Kong. "The SURPASS-ET data offer compelling evidence that ropeginterferon alfa-2b could provide a much-needed new treatment option for the ET community."

In addition to the plenary presentation, Dr. Gill will also present results from the University of Hong Kong’s Phase 2 trial (NCT05731245) evaluating ropeginterferon alfa-2b in pre-fibrotic primary myelofibrosis (PMF) and DIPSS low/intermediate-risk myelofibrosis during an oral session focused on innovative treatment approaches in myeloproliferative neoplasms (MPNs).

"Ropeginterferon alfa-2b has already reshaped the treatment landscape for polycythemia vera, and the growing body of evidence in ET and pre-fibrotic PMF points to its broader potential across the spectrum of MPNs," said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia USA. "We’re proud to advance innovative science that may offer patients with an alternative treatment option."

Presentation Details

Plenary Session

Abstract Code: S102
Title: Better safety and efficacy with ropeginterferon alfa-2b over anagrelide as second-line treatment of essential thrombocythemia in the topline results of the randomized Phase 3 SURPASS-ET trial
Session: Plenary Abstracts
Date/Time: June 14, 11:45-13:15 CEST
Oral Presentation

Abstract Code: S222
Title: Ropeginterferon alfa-2b for pre-fibrotic primary myelofibrosis and DIPSS low/intermediate-risk myelofibrosis
Session: Innovative treatment approaches in MPN
Date/Time: June 12, 17:00–18:15 CEST
About Essential Thrombocythemia

Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism.

About BESREMi (ropeginterferon alfa-2b-njft) in Polycythemia Vera (PV)

Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi for the treatment of adults with polycythemia vera (PV). BESREMi has been recognized by the National Comprehensive Cancer Network (NCCN) as a preferred first-line cytoreductive therapy for adults with symptomatic, low-risk PV and the only preferred therapeutic option for both high-risk and low-risk (symptomatic) patients, regardless of treatment history. The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and anticipates submitting a BLA with the U.S. FDA.

BESREMi holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia and is manufactured at the company’s facility in Taichung. PharmaEssentia retains full global intellectual property rights across all indications.

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

Please see full Prescribing Information, including Boxed Warning.

On June 3, 2025 BerGenBio reported the reference is made to previous stock exchange announcements from the company ("BerGenBio" or the "Company") dated 25 February 2025 and 17 March 2025 regarding the Company’s ongoing strategic review process (Press release, BerGenBio, JUN 3, 2025, View Source [SID1234654253]).

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Strategic review process is ongoing

With reference to the announcement 17 March 2025, engaging DNB Carnegie as financial advisor for the strategic review process, the process remains ongoing. As previously communicated, the Board of Directors will, as part of this process, consider a range of options for the Company, including, among other things, a potential sale, merger, or other strategic transaction. There can be no assurance that this review will result in any transaction. The Company will announce further updates when appropriate and expects to conclude the process by the end of July.

Closedown of remaining bemcentinib activities

The Board of Directors has decided to discontinue all remaining development activities for bemcentinib as there are limited financial justification to pursue further activities.

Estimated free cash after closure of activities

The Company has implemented significant cost-containment and cash conservation measures. Free cash after closure of all activities and settlement of any potential liabilities is estimated to be in the range of NOK 40 – 45 million.

Contacts

Olav Hellebø, CEO BerGenBio ASA
[email protected]

Rune Skeie, CFO, BerGenBio ASA
[email protected]

Jan Lilleby, Investor Relations / Media Relations
[email protected]

On June 3, 2025 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing cancer therapies, reported that it presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy (NCT05599789), with financial support from Merck’s (Rahway, NJ USA) Investigator Studies Program and provision of study drug, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on May 31st, 2025 in Chicago, IL (Press release, BeyondSpring Pharmaceuticals, JUN 3, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-presents-efficacy-safety-data-from-a-phase-2-study-of-pembrolizumab-plus-plinabulin-docetaxel-in-metastatic-nsclc-after-progressing-on-first-line-immune-checkpoint-inhibitors-at-2025 [SID1234653667]).

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The single study finished enrollment of 47 patients with patients treated with Plinabulin, pembrolizumab and docetaxel on day 1 of each cycle until disease progression or intolerable severe adverse events. All patients progressed on PD-1/L1 inhibitors, including 78% who received pembrolizumab. Of the 47 patients, the median age was at 67 ranging from 44 to 83; 80.9% were male and 19.1% were female; 72.3% were current or former smokers. Histology included 63.8% patients with non-squamous cell carcinoma and 36.2% with squamous cell carcinoma. The median follow-up was 12.7 months. As of the data cut-off date of May 16, 2025, there are patients still responding to the therapy; therefore, the final data will be updated. The key results at the database lock are summarized below.

Median Progression-Free Survival (PFS):8 months — nearly double the 3.7 months seen with current standard of care (SOC) docetaxel1
Confirmed Objective Response Rate (ORR):2% — higher than the 12.8% seen with SOC docetaxel1
Disease Control Rate (DCR: PR + SD > 4 months):3% — indicating clinical benefit majority of patients who progressed on prior PD-1/L1 inhibitors
Median Duration of Response (DoR):2 months
6-Month PFS Rate:56%
15-Month Overall Survival (OS) Rate:78% (median OS not yet reached) – longer than median OS of 11.8 months for SOC docetaxel1
The combination was well tolerated. 1% of patients experienced grade 3 or higher treatment-related adverse effects, including GI side effects of 14.9% and transient hypertension of 14.9%. There were no treatment-related deaths.
"These promising Phase 2 results reinforce Plinabulin’s potential as a first-in-class therapy that addresses one of the most urgent challenges in oncology—acquired resistance to checkpoint inhibitors," said Dr. Lan Huang, PhD, Co-Founder, Chairman and CEO of BeyondSpring.

"By restoring immune sensitivity and improving progression-free survival, disease control rate and overall survival, Plinabulin opens a new therapeutic path for the more than 60% of patients who stop responding to PD-1/L1 therapies. We are encouraged by these data and committed to advancing Plinabulin in combination strategies to meet critical unmet needs in lung cancer and beyond."

A New Potential Pathway to Re-Sensitize Tumors to Immunotherapy
Immune checkpoint inhibitor (ICI)-based regimens have remained as the standard of care for first-line treatment of NSCLC, but over 60% patients could progress from ICI2. "Acquired resistance" to ICI could be caused by "T cell exhaustion" or "antigen presenting cell pathway mutation"2. Once progressed, it is not recommended to continue using ICI monotherapy. This underscores a substantial unmet need for more effective treatment options.

With over 700 cancer patients treated with good tolerability, Plinabulin is a first-in-class, late-stage, differentiated tubulin binder that activates GEF-H1, triggering dendritic cell (DC) maturation and T cell activation, and reduce chemotherapy induced neutropenia3,4,5. This dual innate and adaptive immune mechanism has demonstrated Plinabulin’s strong potential to reverse "acquired resistance to ICI" and to enhance the efficacy and tolerability of both PD-1/L1 inhibitors and chemotherapy-based regimens.

"This patient population—those who relapse after checkpoint inhibitors—faces a grim outlook with limited options," said Dr. Mengzhao Wang, Principal Investigator and Chief of Respiratory and Critical Care Medicine at Peking Union Medical College Hospital. "Second- and third-line NSCLC with no actionable driver mutation after progression of ICIs is a critical unmet medical need, with no new agent approval in the last decade. The current SOC docetaxel, approved 25 years ago, has limited efficacy and over 40% severe neutropenia. With Plinabulin’s benefit in significantly reducing severe neutropenia of docetaxel in a number of studies, this promising Phase 2 efficacy data suggests the triple combination may provide both efficacy and safety benefit in a meaningful way. We are encouraged and look forward to further study."

2025 ASCO (Free ASCO Whitepaper) Poster Presentation: Phase 2 Study of Pembrolizumab (Pembro) plus Plinabulin (Plin) and Docetaxel (Doc) for Patients (Pts) with Metastatic NSCLC after Progression on First-line Immune Checkpoint Inhibitor Alone or Combination Therapy: Initial Efficacy and Safety Results on Immune Re-sensitization

Presenter / Author: Yan Xu, Minjiang Chen, Xiaoxing Gao, Xiaoyan Liu, Jing Zhao, Wei Zhong, Ruili Pan, Mengzhao Wang
Poster Session: Lung Cancer – Non-Small Cell Metastatic
Abstract Number: 8560