On June 23, 2026 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, reported that the first patient has been dosed in a Phase Ib combination clinical trial evaluating VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The study is evaluating VVD-214 in combination with bevacizumab in patients with microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer whose disease has progressed following prior lines of therapy.

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"Colorectal cancer remains one of the most common and challenging cancers to treat worldwide, and a substantial proportion of cases are driven by underlying defects in DNA repair," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "VVD-214 reflects Vividion’s continued focus on uncovering and advancing therapies against critical cancer dependencies that have historically been difficult to target, including WRN, with the potential to deliver new precision medicines that address this urgent need."

VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme that has emerged as a highly sought-after synthetic lethal target for cancers with microsatellite instability. Tumors that are MSI-high or dMMR rely on WRN to maintain DNA replication and repair despite their underlying genomic instability. By inhibiting WRN, VVD-214 is intended to cause lethal DNA damage in cancer cells while minimizing harm to normal cells, offering a potential precision medicine approach for patients with cancers such as colorectal, endometrial, ovarian and gastric tumors.

"Advancing precision oncology therapies for cancers driven by specific molecular vulnerabilities is a key focus of Bayer’s oncology strategy," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division. "Targeting WRN represents a promising new therapeutic approach for genetically distinct subsets of some of the most common cancers worldwide, and we are encouraged to see VVD-214 continue to advance through clinical development."

The global Phase Ib clinical trial (NCT06004245) is planned to enroll patients at clinical sites across the U.S., Australia, Belgium, Canada, China, Denmark, France, Malaysia, South Korea, Spain, and the U.K. Preliminary data from the Phase Ia study presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting showed that VVD-214 was well tolerated with early signals of activity.

(Press release, Vividion Therapeutics, JUN 23, 2026, View Source [SID1234668896])

On June 23, 2026 AnHorn Medicines reported that its lead neuroprotective candidate AH-008, being developed for the prevention of chemotherapy-induced peripheral neuropathy (CIPN), has achieved two major regulatory milestones: Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and Index Case designation by the Taiwan Center for Drug Evaluation (CDE).

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These milestones validate the scientific and translational strategy behind AH-008 and mark a significant step toward advancing a first-in-class preventive therapy for CIPN into clinical development.

Addressing a Critical Unmet Need in Oncology

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and dose-limiting toxicities associated with widely used cancer treatments, including taxanes, platinum-based agents, vinca alkaloids, and antibody-drug conjugates (ADCs). CIPN can cause irreversible nerve damage, leading to pain, sensory dysfunction, and long-term impairment that severely impacts patients’ quality of life.

Beyond patient suffering, CIPN often forces chemotherapy dose reductions, delays, or discontinuation – compromising treatment outcomes. Despite its prevalence and burden, no approved therapies currently exist to prevent CIPN, highlighting a major unmet need in oncology supportive care.

Regulatory Milestones: IND Clearance and Index Case Designation

The U.S. FDA IND clearance authorizes AH-008 to advance into human clinical trials, following a comprehensive review of its preclinical pharmacology, toxicology, and manufacturing data. This clearance affirms the robustness of the program’s safety package and development strategy.

The Taiwan CDE Index Case designation recognizes AH-008 as a reference program for novel drug development in its category. This designation reflects the candidate’s scientific innovation and potential to address an unmet clinical need, while facilitating efficient regulatory interaction and advancement of innovative therapies.

Together, these milestones demonstrate strong regulatory alignment across major agencies and reinforce the translational strength of the AH-008 program.

Regulatory and Translational Validation

Preclinical studies for AH-008 were designed in accordance with the U.S. FDA Draft Guidance (January 2025), "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." This guidance outlines FDA expectations for CIPN preventive therapies, emphasizing the use of clinically relevant neurotoxicity models and translational endpoints that connect nerve protection to meaningful functional outcomes.

AH-008 consistently demonstrated robust neuroprotective effects across multiple chemotherapy-induced neuropathy models, preserving peripheral nerve integrity while maintaining chemotherapy efficacy. These prevention-first studies were designed to halt the onset of neuropathy rather than treating established symptoms, underscoring AH-008’s potential as a proactive therapeutic approach.

Coupled with U.S. FDA IND clearance, these data validate AH-008 as a first-in-class neuroprotective candidate ready for clinical evaluation under current regulatory expectations.

Rapid Translation from Preclinical to IND

AnHorn Medicines advanced AH-008 from preclinical stage to FDA IND clearance in just 12 months, underscoring the company’s integrated development capabilities. This accelerated timeline reflects AnHorn’s ability to unify translational science, regulatory strategy, and CMC development into a streamlined execution framework—demonstrating its strength in efficiently advancing first-in-class programs that address urgent unmet medical needs.

About AH-008

AH-008 is a first-in-class neuroprotective therapeutic candidate designed to prevent chemotherapy-induced peripheral neuropathy by targeting the underlying mechanisms of chemotherapy-related nerve damage. Unlike symptomatic treatments, AH-008 intervenes early in the disease cascade to preserve peripheral nerve function during cancer therapy.

(Press release, AnHorn Medicines, JUN 23, 2026, View Source [SID1234668851])

On June 22, 2026 Oxford BioTherapeutics ("OBT"), a clinical-stage oncology company specialising in proteomics-driven target discovery for antibody-based therapies enabled by its OGAP-Verify platform, reported two new clinical milestones with Boehringer Ingelheim-partnered programmes, BI 3820768 (OB33) and obrixtamig (OBT620).

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BI 3820768 is the third programme from OBT’s multi-target collaboration with Boehringer Ingelheim to achieve first-patient dosing (A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours) – NCT07306559), triggering a milestone payment to OBT. The BI 3820768 target was identified using OBT’s proprietary OGAP-Verify platform and represents the second development milestone for this programme, following the initiation of IND-enabling studies one year earlier.

Further illustrating the strength and maturity of the collaboration, OBT also highlighted the advancement of obrixtamig (OBT620), an investigational DLL3-targeting bispecific T-cell engager originating from its discovery platform. Obrixtamig has entered global Phase 3 development in two trials: DAREON-Lung-1 is investigating obrixtamig in combination with chemotherapy and atezolizumab versus chemotherapy and atezolizumab in previously untreated extensive-stage small cell lung cancer, where the first patients have recently been dosed. DAREON-NEC-1 is evaluating obrixtamig in combination with chemotherapy versus chemotherapy alone as first-line treatment for patients with DLL3-positive unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma. A second Boehringer Ingelheim-partnered programme from OBT’s work, the investigational B7-H6-targeting T-cell engager BI 765049, is also in clinical development for advanced solid tumours.

DLL3 was originally identified by OBT using its OGAP-Verify platform as a tumour-selective T-cell engager target. The antigen is expressed in approximately 80–85% of small cell lung cancer and certain neuroendocrine carcinomas, supporting its potential as a promising therapeutic target in aggressive cancers with high unmet need.

The collaboration began in 2013 and was subsequently expanded in 2020 and 2023. OBT has applied its OGAP-Verify platform to identify novel oncology targets in solid tumours. The partnership has generated multiple development-stage assets, including three clinical programmes and a fourth target optioned in January 2025.

Christian Rohlff, PhD, Chief Executive Officer of OBT, said: "Establishing another clinical-stage programme with BI 3820768 further validates the robustness of our OGAP-Verify discovery platform and the quality of the oncology targets it delivers. The fact that three of the four programmes optioned by Boehringer Ingelheim have now entered the clinic underscores the strength and productivity of this longstanding collaboration. In parallel, the advancement of obrixtamig into Phase 3 highlights the long-term value-creation potential of our platform and our ability to translate novel targets into clinically advanced therapies for patients with high unmet need."

Vittoria Zinzalla, Global Head of Experimental Medicine at Boehringer Ingelheim, said: "Our long-standing collaboration with Oxford BioTherapeutics demonstrates the value of linking complementary scientific expertise to transform outcomes for people living with difficult-to-treat cancers. By combining OBT’s strength in target discovery with our expertise in therapeutic antibody development, we connect insights across the R&D continuum, advancing differentiated treatment approaches while strengthening a more efficient and connected oncology ecosystem to create unprecedented impact."

OBT’s OGAP-Verify platform enables highly sensitive and precise target identification, supporting the development of differentiated antibody-based therapies and the successful progression of multiple programmes into clinical development.

Under the collaboration, Boehringer Ingelheim is responsible for global development and commercialisation of all programmes.

(Press release, Oxford BioTherapeutics, JUN 22, 2026, View Source [SID1234668903])

On June 27, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, reported a strategic portfolio expansion via a license agreement for exclusive ex-China rights with Haisco Pharmaceutical Group ("Haisco") to two potentially best in-class clinical-stage compounds. Nuvectis will hold a conference call today at 8:30 AM ET to introduce its newly in-licensed products.

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Haisco (SHE ticker code: 002653) is a leading fully-integrated pharmaceutical company with approximately 50 marketed products and 70 research programs, most recently recognized for successfully executing licensing deals with Eli Lilly and AbbVie (both in 2Q2026), and the phase 3 success of envudeucitinib in plaque psoriasis (1Q2026), a compound which Haisco discovered and advanced through development until it was licensed to Alumis, Inc.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "The in-licensing of the two clinical stage drug candidates with best-in-class potential represents an expansion of Nuvectis’ pipeline and strategy." Mr. Bentsur continued, "NXP100 is a late-stage Factor B inhibitor with the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for these diseases requiring life-long treatment. With regards to NXP200, the paradox-breaker BRAF inhibitor, the ability to overcome the limitations of older generation BRAF inhibitors, a validated pharmaceutical class, is an area of great interest and we are very pleased to add NXP200 to our oncology pipeline, in which NXP900, our incumbent drug candidate, is progressing toward important clinical inflection points from the ongoing Phase 1b starting in this summer." Mr. Bentsur concluded, "With tremendous in-house drug development capabilities and two recently completed licensing deals with Eli Lilly and AbbVie, Haisco is recognized as a premier drug development company with global reach. We are thankful for this opportunity and are privileged to partner with Haisco as we look forward to our collaboration and advancing these development programs."

Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, "This licensing deal, in addition to our recently completed deals, further strengthens Haisco’s global research and development presence and we are excited to collaborate with Nuvectis on these two projects. We believe that Nuvectis has the relevant experience and capabilities required to advance these projects and that together we can accelerate and offer high-quality treatment options to patients worldwide."

Clinical / Regulatory Status in China and Key Data Summaries for NXP100 and NXP200

NXP100 (HSK39297)

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Two MAAs for NXP100 have been submitted to the Chinese National Medical Products Administration (NMPA) and are currently under review:

The first MAA is based on positive data from a completed randomized, open-label, active comparator-controlled, Phase 3 study (clinicaltrials.gov NCT06799546). In this study, 73 adult Chinese treatment naïve PNH patients were randomized 1:1 to receive either NXP100 or Soliris (eculizumab), a Complement C5 inhibitor, for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving hemoglobin (Hgb) levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of red blood cell (RBC) transfusions. Treatment with NXP100 was superior to treatment with eculizumab in the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100
(n=37) Eculizumab
(N=36)
Primary Endpoint
Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion
% (95% CI) 59.5 (43.2, 75.7) 8.3 (2.8, 19.4)
p-Value < 0.001
The second MAA is based on positive data from a completed single-arm, Phase 3 study (clinicaltrials.gov NCT07052838). In this study, 36 adult Chinese patients with PNH and persistent anemia who failed treatment with C5 inhibitors were treated with NXP100 for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving Hgb levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of RBC transfusions from Week 2, with efficacy prospectively defined as having the lower bound of the 95% CI for the response rate exceeding 20%. The study met the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100
(n=36)
Primary Endpoint
Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion % (95% CI) 52.8 (35.5, 69.6)
Immunoglobulin A Nephropathy (IgAN)

In China, a Phase 3 clinical trial (NCT07390123) is ongoing in IgAN following positive data from a randomized, placebo-controlled Phase 2 (NCT06670352). In the Phase 2 study, the efficacy of treatment with NXP100 was investigated in a 24-week treatment period versus placebo with efficacy defined as reduction in the ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment. Treatment with NXP100 resulted in clinically meaningful reduction in 24h-UPCR after 4 weeks, and the magnitude of the treatment effect increased over time. NXP100 also demonstrated excellent estimated Glomerular Filtration Rate (eGFR) control (a secondary endpoint) vs placebo in the study.

Parameter Week 4 Week 12
(Primary Endpoint) Week 24
Reduction in 24h-UPCR relative to baseline vs. placebo

NXP100 N=24
Placebo N=21 -33% -45.3% -57.7%
In addition, a Phase 2 of NXP100 for the treatment of LN is also ongoing in China.

NXP100 Competitive Landscape and Market Analysis

The PNH market size is expected to be >$5.0BN in 2026 with the injectable C5 inhibitor drugs Soliris and Ultomiris, marketed by Alexion/AstraZeneca Rare Disease, projected to be approximately $4.5BN of the total market. The PNH market is expected to more than double to >$10BN within 8 years. Soliris and Ultomiris were the centerpiece of Astra Zeneca’s acquisition of Alexion in 2021 for $39BN.
Fabhalta (iptacopan, launched in 2024), marketed by Novartis, is the only FDA approved Complement Factor B inhibitor with approvals in PNH, IgAN and C3G.
Fabhaltais administered orally, twice per day, vs NXP100 which is administered once a day.
Fabhalta is currently also being investigated in several clinical trials, including LN, Myasthenia Gravis (MG) and dry Age-related Macular Degeneration (dAMD).
Fabhalta peak annual revenue in the currently approved indications is projected by analysts to reach $5B to $10B. The PNH and IgAN markets are estimated to reach >$20BN combined within the next 10 years.
In randomized Phase 3 clinical trials in patients with PNH, treatment with either NXP100 or Fabhalta was superior to treatment with C5 inhibitors, with comparable treatment effect for NXP100 and Fabhalta across studies, positioning CFBis to potentially dominate the PNH market over time.
In IgAN, the Phase 2 data suggests that NXP100 has the potential to be comparable to the best injectable APRIL/BAFF inhibitors on the key renal function endpoints, including 24-hour UPCR and eGFR control.
In cross study comparisons, the observed safety profile of NXP100 appears to be similar to that of Fabhalta.
NXP200 (HSK42360)

Overview, Competitive Landscape and Market Analysis

BRAF is a validated therapeutic target in oncology with first generation drugs such as Tafinlar (dabrafenib, marketed by Novartis) and Braftovi (encorafenib, marketed by Pfizer) approved in multiple indications. These first-generation BRAF inhibitors effectively inhibit the V600-mutated BRAF, which results in initial antitumor activity, but also leads to paradoxical activation through stimulation of the MAPK signaling pathway, causing treatment resistance and development of secondary malignancies, primarily skin squamous cancer and other skin-related side effects. The current solution to the paradoxical activation problem is concomitant administration of MEK inhibitors, but while the skin side effects are reduced, they are not eliminated and acquired resistance still emerges. In addition, Class II and III BRAF mutations are not inhibited by first generation BRAF inhibitors. Designed to overcome this paradoxical activation, paradox-breaking BRAF inhibitors represent the next generation approach to targeting BRAF. There are currently several paradox breakers BRAF inhibitors in clinical development, none are FDA approved.

Available data to date suggests that NXP200 is the only paradox-breaker BRAF inhibitor that has consistently demonstrated single agent activity in CNS tumors but, importantly, also in additional solid tumor types that harbor BRAF mutations. In a completed dose escalation study of NXP200 as monotherapy in heavily pre-treated patients with BRAF V600-mutated solid tumors, including ones previously treated with BRAF/MEK inhibitors, NXP200 demonstrated an acceptable safety profile and single-agent durable clinical activity in various tumor types, including a >40% response rate in low- and high-grade adult glioma, including one Complete Response. Durable responses were also demonstrated in non-small cell lung cancer (NSCLC), colorectal and papillary thyroid cancers.

In this dose escalation program, treatment with a first-generation, free base form of NXP200 was used. A second-generation salt form of NXP200 was recently developed to enhance the pharmacokinetic (PK) profile of NXP200, and early data indeed demonstrate a marked improved PK and greater single agent clinical activity. Thus, with favorable pharmacology, promising early clinical data and possible applicability across V600, Class I and Class II-altered solid tumors, NXP200 could emerge as a best-in-class next-generation BRAF inhibitor. NXP200 is currently in a Phase 1b study in China.

The combined annual revenue for the first-generation BRAF inhibitors, typically administered in combination with a MEK inhibitor to overcome paradoxical activation, is estimated at approximately $4BN.

Of note, in April 2026, Servier acquired Day One Biopharmaceuticals for $2.5BN with its only FDA approved drug, Ojemda (tovorafenib), a first generation BRAF inhibitor which is indicated for the treatment of relapsed or refractory pediatric in BRAF-altered low-grade glioma. With projected 2026 sales of $225-250M, sales of Ojemda represent only 6% of the current BRAF market.

Intellectual Property

Both compounds have strong intellectual property protection including composition of matter patents for NXP100 and NXP200 which expire in 2043 and 2042, respectively.

Transaction Terms

Nuvectis in-licensed exclusive worldwide Ex-China rights for two drug candidates from Haisco. Haisco also retains rights for NXP100 in India and certain Southeast Asia territories. Haisco will receive upfront and near-term payments totaling up to USD $40 million and is eligible to receive up to USD $1.421BN in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. The agreement is subject to certain financing conditions which Nuvectis is required to meet to ensure sufficient capital for the development of the licensed products.

Conference Call and Webcast Information

Date: Monday, June 22, 2026, at 8:30 AM ET
Participant Dial-in (U.S.): 1-877-407-0752
Participant Dial-in (International): 1-201-389-0912
Webcast Access: Click Here
A replay of the webcast will be available on the Investors section of the Nuvectis website at: View Source

Third-party products mentioned herein are the trademarks of their respective owners.

(Press release, Nuvectis Pharma, JUN 22, 2026, View Source [SID1234668902])

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])