On June 4, 2019 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics targeting essential kinases, reported the completion of clinical trial supply manufacture for PMD-026 (Press release, Phoenix Molecular Designs, JUN 4, 2019, View Source [SID1234536888]).

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PhoenixMD’s lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). The clinical trial supply was undertaken by STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, and is being used to support IND-enabling toxicology studies and an upcoming Phase I/Ib study in women with breast cancer.

In March 2018, the companies entered into a major manufacturing agreement, and have since produced a multi kilogram drug supply for PMD-026 under GMP manufacturing practices. This represents a significant milestone, accelerating PhoenixMD’s Phase I readiness.

In order to further the collaboration, WuXi STA expanded its USA operations to include capsule production under GMP regulatory compliance. Dr. Minzhang Chen, CEO of WuXi STA, commented "The opportunity to enable PhoenixMD’s first-in-man studies came at an opportune moment for STA’s San Diego facility."

"Our partnership with WuXi STA has been critical for PhoenixMD to advance this stage of our development. Working with such a high quality, globally recognized manufacturing partner has allowed us to rapidly advance PMD-026 through IND-enabling GLP toxicology studies and has enabled us to be ready to initiate our Phase I/Ib study with high quality API in capsules," said Sandra E. Dunn, CEO of PhoenixMD. "The rapid achievement of this milestone brings us one step closer to initiating our study for women suffering from breast cancer. More specifically, metastatic triple-negative breast cancer, which is the most deadly type of breast cancer. RSK2 is a promising new drug target for the treatment of TNBC, and PMD-026 is the first drug to ever reach clinical use against this novel target."

"The secret sauce in our success – teamwork. We truly appreciate the collaborative approach and commitment that WuXi STA has brought to the PMD-026 project," notes Dr. Dunn.

The drug supply is sufficient to treat all of the patients in the Phase 1 study. This is coupled with the completion of PhoenixMD’s CDx for measuring activated RSK2 in tumors signals, enabling the two key elements needed for this precisely designed clinical trial to advance.

About RSK kinases in refractory cancers such as Triple Negative Breast Cancer (TNBC)

RSK is commonly associated with refractory cancers such as TNBC, hormone-refractory prostate cancer and resistant melanoma. Beyond these cancers, it is commonly activated in ovarian and colorectal cancers. RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2 mRNA and at the protein level RSK2 is activated in ~89% of primary tumors. Inhibiting RSK2 induces cell death in TNBC cells and is synergistic with standard of care chemotherapies such as paclitaxel. PhoenixMD, with its novel, targeted approach, is focused on creating patented RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. This refractory disease is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are limited targeted therapies available for TNBC making RSK a leading opportunity.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

Currently, there are a limited number of approved targeted therapies for TNBC, however tumor progression continues to be eminent in most patients. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

About PMD-026 for TNBC

PhoenixMD’s lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase that drives the growth of this breast cancer subtype relative to hormone positive or Her-2 positive breast cancers. RSK2 was identified in a functional screen profiling 519 potential kinases. PMD-026 is the first drug to specifically arise from functional dependency screens in TNBC. PMD-026 is applicable to greater than 14 different types of cancers including those resistant to a wide range of therapies.

The first in human clinical trial for PMD-026 is a Phase I/Ib that is scheduled to initiate in Q3- 2019. Importantly, the clinical trial will include a companion diagnostic (CDx) that links PMD-026 to RSK2 activation in tumors, which PMD is developing in collaboration with Roche. In preclinical studies, PMD-026 shrinks tumors by over 70% as a single agent after only two weeks of treatment in tumors with high RSK2 activation using their CDx for model selection.

PMD-026 is shown to unlock the potential of tumor resistance by synergizing with chemotherapies such as paclitaxel. More recently, PMD-026 demonstrated the potential to reprogram the way that TNBC is recognized by the immune system, in part, by inhibiting PD-L1.

On June 4, 2019 Eisai reported additional data from an ongoing Phase 1 trial exploring the investigational combination of eribulin and balixafortide, a CXCR4 antagonist, in patients with HER2-negative metastatic breast cancer (Abstract #2606), were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from May 31-June 4 (Press release, Eisai, JUN 4, 2019, View Source [SID1234536887]).

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This open-label, single-arm, Phase 1 trial enrolled 56 HER2-negative, CXCR4-positive women age 18 years or older with metastatic breast cancer (MBC), and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who had previously received one to three chemotherapy regimens for MBC. The primary endpoints were incidence of dose-limiting toxicities; type, frequency, and severity of adverse events; establishment of the maximum tolerated dose or the highest dose if no dose-limiting toxicity was observed; and pharmacokinetic parameters. Secondary objectives were progression-free survival, overall survival, and the proportion of patients who achieved an objective response.1 Initial data were published in The Lancet Oncology and initial median OS data were presented at ESMO (Free ESMO Whitepaper) 2018. New at ASCO (Free ASCO Whitepaper) are the landmark overall survival (OS) data.

For patients who received the combination of eribulin and balixafortide second line or later in the expanded cohort (EC), the landmark OS at 18 months was 50% (95% CI: 29.1-67.8) and at 24 months was 33.3% (95% CI: 15.9-51.9). For these patients in the overall efficacy population (OEP), the landmark OS at 18 months was 42.4% (95% CI: 28.9-55.2) and at 24 months was 25% (95% CI: 14.3-37.3).
For patients who received the combination of eribulin and balixafortide third line or later in the EC, the landmark OS at 18 months was 40% (95% CI: 19.3-60.0) and at 24 months was 25% (95% CI: 9.1-44.9). For these patients in the OEP, the landmark OS at 18 months was 32.5% (95% CI: 18.3-47.6) and at 24 months was 19% (95% CI: 8.4-32.9).
The landmark 18 month and 24 month overall survival data are consistent with the efficacy data previously observed from this study; safety information is consistent with previous reports. In the study, the most frequently (>40%) reported adverse events were fatigue (79%), neutropenia (57%), infusion-related reactions (48%), constipation (46%), alopecia (46%) and nausea (45%).

"We are encouraged by the results of this study for patients who received the combination of eribulin and balixafortide as second line or later therapy for the treatment of HER-2 negative metastatic breast cancer," said David D’Adamo, MD, PhD, Senior Director, Clinical Research, Oncology at Eisai. "With up to 6 percent of new breast cancer cases diagnosed as metastatic, this combination merits further investigation in patients with HER-2 negative metastatic breast cancer as we continue our quest for potential new treatment options."

CRX4 plays a critical role in tumor growth, survival, angiogenesis and metastasis. High CXCR4 levels are correlated with aggressive metastatic phenotypes and poor prognosis in breast cancer.2 Preclinical evidence suggests that disrupting CXCR4-dependent pathways prevents development of breast cancer metastases, enhances the cytotoxic effect of chemotherapy and immunotherapy, and counteracts tumor cell evasion of the immune system.3

This release discusses an investigational compound and investigational use for an FDA-approved product. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

About the Study
In this open-label, single-arm, Phase I trial, patients received HALAVEN (eribulin) with increasing doses of balixafortide (0.5−5.5mg/kg) using a standard 3+3 dose escalation design followed by an expanded cohort at the highest dose of balixafortide as no dose limiting toxicity was observed. The majority of patients received eribulin 1.4mg/m2, although Cohorts 2 and 3 received eribulin 1.1mg/m2. This trial enrolled 56 HER2-negative, CXCR4-positive females age ≥ 18 years with MBC, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who had previously received 1−3 chemotherapy regimens for MBC. All cohorts received 21-day Cycles of eribulin on Days 2 and 9, and balixafortide on Days 1−3, and 8−10. Cohorts 2−4 also received a 28-day run-in Cycle to better assess safety and potential pharmacokinetic interactions. All patients received treatment until disease progression or unacceptable toxicity.

The primary endpoints were incidence of dose-limiting toxicities; type, frequency, and severity of adverse events; establishment of the maximum tolerated dose or the highest dose if no dose-limiting toxicity was observed; and pharmacokinetic parameters. Secondary objectives were progression-free survival, overall survival, and the proportion of patients who achieved an objective response. In patients who received the combination of eribulin and balixafortide as second line or later therapy, the objective response rate (ORR) was 38% (95% CI: 19 – 59), median progression free survival (PFS) was 6.2 months (95% CI 2.9–8.1), and median OS was 18 months for the EC, and 30% (95% CI: 18 – 44), 4.6 months (95% CI: 3.1 – 5.7) and 16.8 months for the OEP, respectively. The association between various baseline biomarkers and treatment outcomes (including OS) were investigated in a multivariate analysis. Safety information was consistent with previous reports, and the most frequently (>40%) reported adverse events were fatigue (79%), neutropenia (57%), infusion-related reactions (48%), constipation (46%), alopecia (46%) and nausea (45%). Initial data were published in The Lancet Oncology and presented at ESMO (Free ESMO Whitepaper) 2018. Further data from the multivariate analysis will be presented in full later this year.

About HALAVEN (eribulin mesylate) Injection
HALAVEN (eribulin mesylate) Injection is a microtubule dynamics inhibitor indicated for the treatment of patients with:

Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.

Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

For more information about HALAVEN, click here for the full Prescribing Information.

HALAVEN is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

On June 4, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the research data on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) by sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, was presented in an oral session at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #7504; Tuesday, June 4, 10:57 AM -11:09 AM CDT] (Press release, Innovent Biologics, JUN 4, 2019, View Source [SID1234536886]). ORIENT-4 is the first clinical study of PD-1 antibody from China that was orally presented at ASCO (Free ASCO Whitepaper).

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As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient," 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session by Professor Jianyong Li, Director of Department of Hematology of Jiangsu Province Hospital.

ORIENT-4, the first data released globally for prospective phase II clinical study of PD-1 monoclonal antibody for the treatment of r/r ENKTL, evaluates the efficacy and safety of sintilimab as monotherapy in the treatment of patients with r/r ENKTL.

Patients receive 200 mg sintilimab every 3 weeks until disease progression. Treatment beyond disease progression is allowed. This study includes 28 patients with r/r ENKTL who have progressed after receiving an average of 3 conventional treatments. The primary endpoint is objective response rate (ORR) per LUGANO2014 criteria.

According to the predefined analysis, 19 patients achieved objective response for an ORR of 67.9%, disease control rate (DCR) of 85.7% and 1-year overall survival (OS) rate was 82.1%. (The data cutoff was February 2, 2019 with the median follow-up time of 15.4 months; at which time, 19 patients were still on treatment.)

Extranodal NK/T cell lymphoma is an aggressive malignancy and accounts for more than 20% of the peripheral T-cell lymphoma in Asia. Currently, patients with relapse or refractory disease have few treatment options and poor prognosis. According to historical data, the overall survival is about 6 months, reflecting high unmet medical needs.

Biomedtracker and Datamonitor HealthCare, the two major clinical assessments companies certified by ASCO (Free ASCO Whitepaper), have commented on the results of ORIENT-4, "With 82.1% of patients still alive at one year, these are impressive results for an anti-PD1 antibody in a setting, relapsed/refractory extranodal NK/T cell lymphoma (ENKTL), with few options and where the historical median overall survival is approximately six months."

The results of the ORIENT-4 study suggests that sintilimab, one of 17 major drugs presented at ASCO (Free ASCO Whitepaper) Annual Meeting and also the only drug developed outside U.S. and commented by Biomedtracker and Datamonitor Healthcare, may provide efficacy with an acceptable safety profile for the treatment of r/r ENKTL.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

On June 7, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, will present at the Raymond James Life Sciences and MedTech Conference at 1:50 p.m. ET on Tuesday, June 18, 2019 in New York, NY (Press release, AngioDynamics, JUN 4, 2019, View Source [SID1234536885]).

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A live webcast of the presentation and Q&A breakout session will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On June 4, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that Ilia Tikhomirov, CEO of Forbius, will be presenting a company overview at the Jefferies 2019 Healthcare Conference in New York City held June 4-7, 2019 (Press release, Forbius, JUN 4, 2019, View Source [SID1234536884]).

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Details of the presentation are as follows:

Date: June 7, 2019
Time: 11:30 AM (Eastern Time)
Location: Ballroom 5

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer

Forbius is a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer. We are focused on the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Forbius’ team of TGF-beta biology experts designed a proprietary platform of TGF-beta inhibitors with best-in-class potency and selectivity against the principal disease-driving isoforms 1 & 3. This novel class of TGF-beta inhibitors has proven highly active in preclinical models of fibrosis and cancer and was well-tolerated in long-term toxicology studies. Forbius’ lead TGF-beta 1 & 3 inhibitor, AVID200, is undergoing Phase 1 clinical trials in two fibrotic indications as well as in solid tumors.

Forbius’ lead program targeting EGFR is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate (ADC) with a novel tumor-selective mode of action. This program is undergoing Phase 2a clinical trials in EGFR-overexpressing solid tumors.

For more information, please visit www.forbius.com.