On June 22, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the first patients were dosed in its global Phase 2 study of lirafugratinib in non-cholangiocarcinoma (CCA) solid tumors with FGFR2 fusion or rearrangement.

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"Elevar believes lirafugratinib has much potential as a strong anti-tumor therapy across a wider range of FGFR2 fusion or rearrangement driven tumors. We are committed to do our best to obtain meaningful study results to present to the FDA," said Dong-Gun Kim, chief executive officer of Elevar. "We are pleased that the first patients have been dosed and we look forward to completing enrollment."

The trial, known as ReFocus202 (Protocol ID ELE-4008-202; NCT07359820), is an open-label, single-arm study evaluating the efficacy and safety among a broad scope of tumors containing an FGFR2 fusion or rearrangement. The primary endpoint is objective response rate.

The first patient was dosed at Samsung Medical Center in Seoul, South Korea, and a second patient at Moffitt Cancer Center in Tampa, Florida. The multi-site study is set to take place in the U.S., Korea, the UK, Spain, and France.

"Patients with advanced solid tumors harboring FGFR2 fusions or rearrangements often have limited treatment options, particularly beyond cholangiocarcinoma," said Dr. Richard Kim, ReFocus202 principal investigator and service chief of medical gastrointestinal oncology at Moffitt Cancer Center. "This study gives us an important opportunity to better understand whether selective FGFR2 inhibition with lirafugratinib can benefit a broader group of patients whose tumors are driven by FGFR2 alterations. I am pleased that our team was able to enroll the first patient in the U.S. and contribute to this important effort."

Lirafugratinib received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for CCA. Priority review of its new drug application for the treatment of patients with CCA with FGFR2 fusion/rearrangement who have received prior therapy is ongoing by the FDA, which set a Prescription Drug User Fee Act date of Sep 27, 2026.

ReFocus202 aims to confirm the tumor-agnostic potential of lirafugratinib in patients with FGFR2 fusion/rearrangement.

In the Phase 1/2 ReFocus study, data from 42 non-CCA solid tumor patients with FGFR2 fusion/rearrangement (13 tumor types) showed meaningful antitumor activity of lirafugratinib. Elevar plans to leverage that dataset, along with data generated under ReFocus202, to conduct an interim analysis across at least seven tumor types with at least five patients per tumor type.

For more information about lirafugratinib, visit ElevarTX.com.

About Lirafugratinib

Lirafugratinib (RLY-4008) is a potent, selective, and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, JUN 22, 2026, View Source [SID1234668900])

On June 22, 2026 Laboratoires Pierre Fabre reported that the European Commission (EC) has approved BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The approval is based on the results from the Phase 3 BREAKWATER trial, which assessed the efficacy and safety of BRAFTOVI in combination with cetuximab and mFOLFOX6 in patients with previously untreated BRAFV600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.

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Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: "We are extremely pleased to be able to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant mCRC. Today’s EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited."

In the Phase 3 BREAKWATER trial, the regimen of BRAFTOVI in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with oxaliplatin-based chemotherapy with or without bevacizumab (median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P<0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary analysis set (60.9% vs. 40.0%; odds ratio 2.44; 95% CI: 1.40–4.25; P<0.001). A confirmed ORR was observed in 65.7% of patients (95% CI, 59.4 to 71.4) compared to 37.4% (95% CI, 31.6 to 43.7) in the oxaliplatin-based chemotherapy with or without bevacizumab group in the overall population.

(Press release, Pierre Fabre, JUN 22, 2026, View Source [SID1234668871])

On June 22, 2026 Hexagon Bio, a biopharmaceutical company pioneering the discovery of novel small molecule payloads for antibody-drug conjugates (ADCs), reported the formation of a clinical advisory board (CAB) consisting of leading experts in the treatment and investigation of new therapies for breast cancer.

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CAB Members:

Hope Rugo, M.D., Division Chief of Breast Medical Oncology and a Professor of Medical Oncology and Therapeutics Research at City of Hope, Los Angeles, California, USA
Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director of Breast Cancer Research at Sarah Cannon Research Institute, Nashville, Tennessee, USA
Javier Cortes, M.D., Ph.D., Co-founder and Scientific Director of IOB Institute of Oncology, Madrid, Spain

Hexagon Bio’s CAB members will provide strategic guidance as the company advances its lead development candidate, HEX-360, toward first-in-human study. HEX-360 is a HER2-targeting ADC that features a novel translation inhibitor payload discovered by Hexagon Bio.

Current ADCs primarily deliver chemotherapeutic payloads for cancer cell killing, which often are associated with poor tolerability and patients’ development of resistance mechanisms. Conversely, HEX-360’s payload is designed to suppress oncogenic protein production, offering the potential for enhanced tolerability and the ability to overcome resistance mechanisms. In preclinical studies, HEX-360 has demonstrated a differentiated profile compared to topoisomerase inhibitor- and tubulin inhibitor-based ADCs.

"We are excited to welcome our distinguished Clinical Advisory Board members, and look forward to their expert input and guidance as we rapidly advance HEX-360 toward planned clinic entry next year," said Maureen Hillenmeyer, Ph.D., Chief Executive Officer at Hexagon Bio. "By targeting translation, a key vulnerability in oncogene-driven tumors, HEX-360 has a mechanistically distinct ADC payload and the potential to be a much-needed therapeutic option for patients who have progressed on or cannot tolerate current treatments for HER2-positive cancers."

"ADCs represent a significant advance in cancer care. But, unfortunately, most patients with advanced breast cancer treated with today’s approved ADCs will eventually relapse primarily due to the development of payload resistance. The development of novel payload mechanisms to overcome these resistance mechanisms is critical to improving patient outcomes," said Hope Rugo, M.D., Chief of Breast Medical Oncology at City of Hope. "I look forward to working with the Hexagon Bio team and my fellow Clinical Advisory Board members as HEX-360 transitions to a clinical-stage candidate for the treatment of breast cancer."

HEX-360 is currently in IND-enabling studies with anticipated initiation of clinical investigation in 1H of 2027.

HEX-360 Preclinical Data Presented at AACR (Free AACR Whitepaper) Annual Meeting 2026

Hexagon Bio recently reported preclinical efficacy and safety data for HEX-360 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlighting the potential of its novel payload to address critical gaps in the current ADC landscape.

Transition inhibitor payload results:

Demonstrates potency at low (≤ 10 nM) concentrations in the majority (>90%) of nearly 200 cell lines tested, including cell lines resistant to topoisomerase and tubulin inhibitors
Has low vulnerability to key mechanisms of payload resistance (e.g., drug efflux)
Has good properties (e.g., permeability, lipophilicity), enabling bystander tumor-cell killing similar to topoisomerase inhibitors

HEX-360 results:

Shows equivalent or superior efficacy to a comparator analogous to ENHERTU administered at matched payload exposure in cell line- and patient-derived xenograft models
Achieves deep and durable response in models resistant to topoisomerase inhibitors
Has favorable PK properties in preclinical species, supporting Q3W dosing in humans
Demonstrates good tolerability in both rat and non-human primates, without the hallmark toxicities observed with topoisomerase inhibitor-based ADCs

(Press release, Hexagon Bio, JUN 22, 2026, View Source [SID1234668901])

On June 21, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first patient has been dosed in the Chinese pivotal Phase 3 clinical trial (TriadicMM-1) of its self-developed innovative anti-GPRC5D, BCMA and CD3 tri-specific antibody IBI3003 for the second to fifth-line treatment of patients with relapsed or refractory multiple myeloma (R/R MM). IBI3003 is China’s first self-developed anti-GPRC5D/BCMA/CD3 tri-specific antibody to enter the pivotal registrational Phase III clinical trial, aiming to bring a promising next-generation immunotherapy option for Chinese R/R MM patients.

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TriadicMM-1 (NCT07623798) is a multicenter, randomized, controlled, open-label Phase 3 clinical trial designed to evaluate the efficacy and safety of IBI3003 versus investigator’s choice of regimen (pomalidomide, bortezomib and dexamethasone [PVd] or daratumumab, pomalidomide and dexamethasone [DPd]). The primary endpoint of the study is progression-free survival (PFS) assessed by the Independent Review Committee (IRC).

Clinical data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 7, 2025 [Link], demonstrated a tolerable safety profile and promising efficacy signals for IBI3003 in patients who had failed ≥2 prior lines of myeloma therapy:

Thirty-nine patients with R/R MM who had previously received at least a PI, an IMiD, and an anti-CD38 monoclonal antibody were treated with IBI3003 at dose levels ranging from 0.1 μg/kg to 800 μg/kg and underwent at least one tumor assessment after baseline. As of the data cutoff date of November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4–7.4), and the median treatment duration was 12.14 weeks (range: 1.0–33.0).
Among patients treated at doses ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR). In this cohort, the ORR was 80% among 10 patients with extramedullary disease (EMD) and 77.8% among 9 patients previously treated with BCMA- and/or GPRC5D-directed therapies. Among patients who achieved complete response or better, the minimal residual disease (MRD) negativity rate was 100% (n=4), as assessed by validated next-generation sequencing, with a threshold of 10-5, performed at a central laboratory.
All cases of cytokine release syndrome (CRS) were Grade 1-2, with only 2 cases of Grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS) reported. Most treatment-emergent adverse events (TEAEs) related to GPRC5D targeting, including those affecting the oral cavity, skin, and nails, were Grade 1–2, with two patients experiencing Grade 3 rash.
Relevant dose optimization data (including RP2D selection) from this Phase 1/2 study will be presented at future academic conferences.
In addition, IBI3003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) earlier this year. This designation applies to the treatment of R/R MM in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. The Phase I/II clinical trial in the United States is currently underway.
Professor Peng Liu from Zhongshan Hospital Affiliated to Fudan University, the Principal Investigator of the TriadicMM-1 Study, stated: "We are delighted that the first patient has been enrolled in TriadicMM-1 at our hospital. This is the first domestic pivotal Phase 3 clinical trial of a tri-specific antibody with independent intellectual property rights for the treatment of R/R/MM in China. Furthermore, IBI3003 is also the second tri-specific antibody globally to have advanced into pivotal Phase III clinical development in the R/R MM setting. Although multiple myeloma has multiple treatment options, the disease still recurs most frequently and is incurable. With each recurrence, symptoms reappear, quality of life declines, and both the likelihood and duration of treatment response typically decrease. Therefore, there remains a significant and urgent unmet medical need for novel therapeutic agents targeting alternative mechanisms of action to better control the disease, achieve deeper and more durable responses, and improve long-term outcomes including maintaining health-related quality of life. We highly anticipate that the Phase III study TriadicMM-1 will validate the potential of IBI3003 and establish IBI3003 as a new standard of care for 2-5 line R/R MM."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent Biologics, stated: "The successful completion of the first patient’s first dose in the Chinese pivotal Phase III study TriadicMM-1 of IBI3003 is an important milestone for Innovent in advancing its first tri-specific antibody program into the registrational stage. IBI3003 is built on Innovent’s proprietary Sanbody platform. The promising efficacy data and manageable safety profile observed in preclinical and clinical studies are expected to bring a promising next-generation immunotherapy option for patients with multiple myeloma. Looking ahead, Innovent will deepen its dual innovation in ADC and immunotherapy, and is committed to delivering cutting-edge therapies to patients worldwide."

About Multiple Myeloma

Multiple Myeloma is a malignant hematological malignancy originating from plasma cells in the bone marrow, ranking as the second most common blood cancer globally. Abnormal, clonal expansion of these malignant plasma cells crowding the bone marrow disrupts normal hematopoiesis and secretes abnormal monoclonal immunoglobulins (M protein). This process leads to a series of severe clinical complications, classically characterized by bone destruction, anemia, renal impairment, and hypercalcemia.

Driven by an aging global population, the incidence of multiple myeloma is continuously rising. Although the introduction of innovative therapies—such as proteasome inhibitors, immunomodulatory drugs, and targeted agents—has significantly improved patient prognosis over the past decades, multiple myeloma remains largely incurable. The vast majority of patients who initially achieve remission will inevitably experience a relentless cycle of relapse and drug resistance.

For patients with relapsed/refractory multiple myeloma who have already progressed through 1-4 lines of therapy, subsequent treatment options become severely limited. With each successive line of therapy, the duration of remission shortens, and the prognosis worsens drastically. Consequently, there is a critical and unmet medical need for novel therapeutic regimens with superior efficacy, manageable safety profiles, and distinct mechanisms of action to overcome resistance, prolong overall survival, and preserve patient quality of life.

About IBI3003

IBI3003, constructed on Innovent’s proprietary Sanbody platform, is a novel trispecific antibody targeting G protein–coupled receptor, family C, group 5, member D (GPRC5D), B-cell maturation antigen (BCMA) and CD3. This molecular design aims to overcome single tumor antigen escape. Its antitumor activity in preclinical mouse models is superior to that of marketed bispecific antibody benchmarks, and it exhibits particularly potent tumor killing efficacy in in vitro cell models with low expression of BCMA and GPRC5D.

Currently, a Phase I/II clinical trial of IBI3003 is underway in China, Australia and U.S. (NCT06083207) to explore the safety, tolerability and efficacy of IBI3003 in subjects with R/R MM. In China, the program has advanced into pivotal registration stage with TriadicMM‑1 (NCT07623798), a randomized, controlled, open‑label Phase III study comparing IBI3003 to investigator’s choice of regimens (DPd or PVd). The primary endpoint is progression‑free survival (PFS) assessed by an independent review committee (IRC).

(Press release, Innovent Biologics, JUN 21, 2026, View Source [SID1234668815])

On June 21, 2026 Antengene Corporation Limited ("Antengene", SEHK: [6996 HK]), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that it has entered into an exclusive license agreement ("License Agreement") with K2 Therapeutics for ATG-106, a preclinical CDH6 x CD3 bispecific T cell engager (TCE) in development for solid tumors. Antengene also announced that it has entered into an option agreement ("Option Agreement") to grant K2 Therapeutics the option to obtain exclusive global rights to develop and commercialize an undisclosed preclinical bispecific TCE candidate. Across both the License Agreement and the Option Agreement, K2 Therapeutics’ rights extend globally, excluding Greater China.

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K2 Therapeutics, established by MPM BioImpact, is a biotech company and scalable hub-and-spoke engine built for global impact, with search and development capabilities unconstrained by modality or geography. MPM BioImpact is a world-leading biotechnology investment firm, with over 30 years’ experience creating and investing in innovative companies.

"We are very pleased to expand our partnerships with our TCE pipeline with this important collaboration around our AnTenGager platform," said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "We believe ATG-106, our CDH6 x CD3 bispecific TCE reflects the differentiated design of AnTenGager TCEs and their potential in solid tumors. AnTenGager TCEs are designed to address key challenges that have historically limited first-generation TCEs in solid tumors, particularly with respect to safety and tolerability. By combining steric hindrance-based masking with our proprietary fast on/off CD3 binder, AnTenGager TCEs are designed to activate T cells in a disease-associated antigen-gated manner, with the potential to reduce cytokine release syndrome and T cell exhaustion while maintaining potent anti-tumor activity."

Both ATG-106 and the undisclosed program leverage Antengene’s proprietary AnTenGager platform, which offers a differentiated TCE approach, where binding of the TCE arm (CD3) is sterically masked in the absence of target antigen binding providing potent activity and better tolerability.

"We are excited to license ATG-106, a highly differentiated CDH6 x CD3 bispecific TCE, as well as a second promising TCE program enabled by the cutting-edge AnTenGager platform," said Frank Neumann, M.D., Ph.D., Chief Medical Officer of K2 Therapeutics. "CDH6 is an attractive target given its overexpression in tumors such as ovarian and renal cancers, and its limited expression in normal adult tissues. We believe the unique design of ATG-106 has the potential to meaningfully advance the field of solid tumor TCEs. We look forward to advancing ATG-106 toward the clinic and to delivering meaningful benefit to patients."

Under the License Agreement, Antengene is entitled to upfront and near-term considerations of approximately USD 20 million, consisting of cash and a minority equity stake in a newly established asset company and subsidiary of K2 Therapeutics, subject to the satisfaction of certain near-term conditions. Antengene is also eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to ATG-106, plus tiered royalties on future net sales.

Under the Option Agreement, upon exercise of the option, Antengene is entitled to receive upfront and near-term considerations of approximately USD 20 million, consisting of an option exercise fee, near-term payment and upfront payment, as well as a minority equity stake in the related asset company. Antengene would also be eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to the undisclosed TCE program, plus tiered royalties on future net sales.

(Press release, Antengene, JUN 21, 2026, View Source [SID1234668816])