On October 22, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported updated preliminary results from a Phase 2 clinical trial of its lead product candidate, tipifarnib, in squamous cell carcinomas with HRAS mutations (Press release, Kura Oncology, OCT 22, 2018, View Source [SID1234530048]). The results are being presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich. A copy of the presentation is available online at www.kuraoncology.com.

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As of the September 7, 2018 clinical data cutoff date, 17 patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) were enrolled in the ongoing Phase 2 trial. Tumor size reductions were observed in nine of 11 evaluable patients, with five confirmed partial responses (PRs) as defined by standard RECIST criteria, including three patients with durable responses lasting more than 17 months. A sixth patient achieved a confirmed PR after the data cutoff. Four patients had stable disease, including two patients who experienced prolonged disease stabilization lasting more than six months. Only one patient experienced progressive disease as best response.

Another patient with HRAS mutant HNSCC, who is currently being treated off-protocol, has been reported as an unconfirmed PR with a 40% tumor size reduction.

In addition, the ongoing Phase 2 trial enrolled six patients in an additional cohort of other HRAS mutant squamous cell carcinomas (SCCs). One of the two evaluable patients in this cohort achieved a confirmed PR. Four patients were not evaluable as of the data cutoff date, including two patients who were pending initial efficacy assessments.

An analysis of available tumor biopsy samples (n=20) indicated a significant association between the allele frequency of HRAS mutations and a patient’s best response to tipifarnib. Patients with HRAS mutant allele frequencies as low as 1% were treated with tipifarnib. Of the 13 HNSCC/SCC patients with a tumor HRAS mutant allele frequency greater than 20%, six achieved PRs, one achieved an unconfirmed PR and is ongoing, and two experienced disease stabilization greater than six months. No meaningful clinical benefit was observed in the seven patients with an allele frequency less than 20%. Data from The Cancer Genome Atlas (TCGA HNSCC, provisional) indicate that patients with an HRAS mutant allele frequency greater than 20% represent approximately 5% of the overall HNSCC population.

"The results from this study indicate that tipifarnib is active in this difficult-to-treat population, with rapid and durable responses independent of prior therapy," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study. "These data are particularly encouraging when we consider the high unmet need for patients with recurrent, metastatic head and neck squamous cell carcinomas, despite the introduction of immunotherapy into the treatment paradigm."

Response rates for the three therapies approved for treatment of HNSCC in the second line, Keytruda (pembrolizumab), Opdivo (nivolumab) and Erbitux (cetuximab), range from 13-16%, with progression-free survival of approximately two months.

Patients in the Phase 2 trial of tipifarnib in HRAS mutant HNSCC had a median of two prior lines of therapy (range 1-5), with confirmed responses observed in patients who had progressed on cetuximab regimens, immunotherapy or both.

Dose-limiting, treatment-emergent adverse events in the trial included hematological events and gastrointestinal disturbances, which were managed by dose interruption and/or dose reduction. When dose interruption/delay is taken into account, the median dose received by trial patients across all three cohorts was determined to be 600 mg twice daily by Cycle 2. Four of the responses in the trial were achieved at the 600 mg dose, including one patient who started dosing at 600 mg due to frailty and experienced a PR, and three patients who were dose-reduced to 600 mg and experienced a confirmed PR. Two additional patients achieved disease stabilization greater than six months.

Based on the observations from this Phase 2 trial, Kura intends to introduce a minimum tumor HRAS mutant allele frequency, anticipated to be no lower than 20%, as an entry criterion and use 600 mg orally twice daily as the starting dose in its upcoming AIM-HN registration-directed study of tipifarnib in HRAS mutant HNSCC. Kura also intends to implement these modifications in its ongoing Phase 2 trial and anticipates being able to provide additional data in 2019.

"We are very encouraged by the progress reported today in the treatment of patients with HRAS mutant squamous cell carcinomas," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "These data provide

preliminary clinical evidence of successful targeting of RAS-driven tumors. Notably, we observed a significant association between HRAS mutant allele frequency and objective response. We believe this finding represents a meaningful advancement in the field of precision medicine that will help our efforts to deliver on the promise of tipifarnib as a therapy for the treatment of HNSCC. We are applying these learnings to our upcoming registration-directed trial, which remains on track to initiate by year end."

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 17:00 CET / 11:00 a.m. ET today, October 22, 2018, following the conclusion of Dr. Ho’s presentation at the ESMO (Free ESMO Whitepaper) 2018 Congress. The live call may be accessed by dialing (877) 516-3514 for domestic callers or (281) 973-6129 for international callers and using conference ID #6045389. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

About Tipifarnib

Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown compelling and durable anti-cancer activity in certain patient subsets. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, the company is seeking to identify those patients most likely to benefit from tipifarnib. In addition to its development program in solid tumors with HRAS mutations, Kura has identified the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of activity for tipifarnib in certain hematologic malignancies. The company expects to present biomarker-enriched data from peripheral T-cell lymphomas (PTCL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.

On October 22, 2018 BerGenBio ASA (OSE:BGBIO) reported that the company and its collaborators have presented interim clinical and biomarker data from BerGenBio’s Phase II clinical programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich (19 – 23 October 2018). Additionally, a pre-clinical study in myelodysplastic syndrome (MDS) was presented (Press release, BerGenBio, OCT 22, 2018, View Source [SID1234530046]).

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The posters are available at www.bergenbio.com in the Investors / Presentations section and a summary of results is given below.

(1) Poster Discussion: Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical Trials
Bob Holt et al

The poster discussed the broad biomarker programme run in parallel to the phase II clinical trial programme with bemcentinib and detailed some of the key findings to date:

Tumour AXL expression predicts patient benefit: 7 out of 10 second line NSCLC patients show clinical benefit (70% CBR) including 4 responses (40% ORR) on KEYTRUDA/bemcentinib combination therapy (determined by BerGenBio’s proprietary immunohistochemistry method).
Blood based biomarkers, including soluble AXL, have been found predictive of patient benefit in relapsed/refractory AML/MDS & NSCLC
(2) Poster Presentation: Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma
Cornelia Schuster et al

The poster gave an update on the randomised trial in first line metastatic melanoma, combining bemcentinib with standard of care therapies:

Confirmed recommended phase II dose of bemcentinib in combination with MEKINIST/TAFINLAR and KEYTRUDA.
All combinations continue to be well tolerated.
Efficacy is seen across all arms with 18 out of 23 radiographically evaluated patients reporting clinical benefit including complete responses.
(3) Poster Discussion: The identification of the AXL/Gas6 signalling axis as a key player of myelodysplastic syndrome (MDS) and the potential of the oral selective AXL inhibitor bemcentinib in the treatment of MDS
Hind Medyouf et al

The poster discussed the relationship between AXL and myelodysplastic syndrome using both patient samples and animal model studies. The data show that AXL is upregulated in MDS patients and that inhibiting AXL with bemcentinib shows efficacy in pre-clinical models of the disease.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "The ability to predict which patients are most likely to derive benefit from treatment is an important competitive advantage as it is key to improving patient outcomes and regulatory success. The data presented at ESMO (Free ESMO Whitepaper) increases our confidence in the predictive nature of our proprietary biomarkers and diagnostics. What is more, 7 out of 10 AXL positive NSCLC patients showed clinical benefit in our phase II trial combining bemcentinib with KEYTRUDA, this is a remarkable observation and gives us confidence in bemcentinib’s proposed mechanism of action. Additionally, data presented at ESMO (Free ESMO Whitepaper) continue to show that bemcentinib is well tolerated and effective across our broad phase II combination program. We are looking forward to provide further updates on the development of our AXL inhibitor pipeline over the coming months."

– END –

About the ESMO (Free ESMO Whitepaper) Congress
The ESMO (Free ESMO Whitepaper) Congress is the leading European meeting for medical oncology convening over 26,000 international delegates from the field. ESMO (Free ESMO Whitepaper) 2018 will be held in Munich, Germany 19 – 23 October 2018.

About BerGenBio’s Companion Diagnostics programme
In parallel with its phase II clinical trial programme, BerGenBio explores predictive biomarker candidates with the aim to develop a companion diagnostic to identify patients most likely to benefit from bemcentinib treatment.

Thus far, the company reported strong correlation with response of both plasma soluble AXL levels and the presence of tissue AXL in relapsed/refractory AML or MDS and advanced NSCLC, respectively.

About the BGBC008 trial
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy na’fve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

About the BGBIL006 trial
The BGBIL006 trial is a randomised Phase 1b/2 clinical study of bemcentinib (BGB324) in combination with either the MAPK inhibitors MEKINIST (trametinib) plus TAFINLAR (dabrafenib) or the immune checkpoint inhibitor KEYTRUDA (pembrolizumab) in patients with advanced melanoma.

On October 22, 2018 AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma reported the presentation of updated interim results from the Phase 2 portion of the TiNivo study, a Phase 1b/2 multicenter trial of oral (PO) tivozanib (FOTIVDA) in combination with intravenous (IV) nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced or metastatic renal cell carcinoma (Press release, AVEO, OCT 22, 2018, View Source [SID1234530044]). The results were presented today at European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Annual Congress, in a poster presentation titled "TiNivo: Tivozanib Combined with Nivolumab: Safety and Efficacy in Patients with Metastatic Renal Cell Carcinoma (mRCC)" (Presentation 878P). A copy of the presentation is available at www.aveooncology.com or further information can be obtained via EUSA Pharma Medical Information.

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The Phase 1b/2 study has enrolled a total of 28 patients. The Phase 2 portion of the study (n=22) was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib (1.5 mg/QD for 21 days followed by a 7-day rest period), as established in the Phase 1b portion of the study (n=6), in combination with IV nivolumab (240 mg every 2 weeks). The combination was generally well tolerated. Treatment-related Grade 3/4 adverse events occurred in 60% of patients, the most common of which was hypertension.

Interim efficacy was assessed in all 25 patients treated with the full dose and schedule of PO tivozanib in combination with IV nivolumab and enrolled at least 4 months prior to the data cutoff date. Of these, 13 (52%) had received at least one prior systemic therapy. An objective response rate was observed in 56% of patients (complete responses + partial responses), including 4% of patients (n=1) achieving a complete response, and a disease control rate (complete response + partial response + stable disease) was observed in 96% of patients. At the time of data collection 52% (n=13), of patients remained on study. To date, a total of 72% of patients (n=18) had tumor shrinkage of ≥25%, with a majority of patients having disease control for ≥48 weeks.

"With high and durable tumor shrinkage rates for the combination of tivozanib and nivolumab, including a complete response, coupled with a favorable tolerability profile and nearly all patients having disease control, the TiNivo study continues to underscore a compelling rationale for using a high-specificity VEGF inhibitor as the TKI of choice in immuno-oncology combinations," Doctor Bernard Escudier, MD, ex-Chairman of the Genitourinary Oncology Committee, Gustave Roussy, and lead investigator of the study. "The ability to give a VEGF inhibitor and immuno-oncology agent both at full dose and strength could serve to deliver both improved outcomes and an improved patient experience. I look forward to better understanding tivozanib’s potential in immunotherapy combinations through a larger randomized study, which is currently being planned."

"There are multiple cancers where IO-TKI combinations have demonstrated potential, and the favorable tolerability and efficacy outcomes seen in the TiNivo study make further exploration of these indications a priority for AVEO," said Michael Bailey, president and chief executive officer of AVEO. "We continue to build out a clinical strategy for studying such combinations, and look forward to outlining our plans following reporting of topline data from our Phase 3 TIVO-3 study, which is expected in the mid-fourth quarter."

"The data arising from combination studies with checkpoint inhibitors demonstrate the considerable potential for tivozanib in metastatic RCC," said Lee Morley, Chief Executive Officer of EUSA Pharma. "EUSA continues to launch tivozanib across the EU in line with its EMA approval as monotherapy in the first line setting where its efficacy and favorable tolerability profile continue to provide benefits to patients, and we are excited by the prospect of further development of tivozanib as part of a future IO-TKI treatment option."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy.3 As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

On October 22, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported positive interim data from the fully enrolled epithelioid sarcoma cohort of its ongoing Phase 2 study of its lead candidate tazemetostat, a potent, selective, orally available EZH2 inhibitor (Press release, Epizyme, OCT 22, 2018, View Source [SID1234530043]). The data were presented by the study’s lead investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Services, Memorial Sloan Kettering Cancer Center, during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany.

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Interim data as of August 21, 2018 from the 62 patients enrolled show that tazemetostat treatment demonstrated clinically meaningful activity for patients with epithelioid sarcoma (ES). Oral, twice daily administration of tazemetostat resulted in durable objective responses and encouraging overall survival in both treatment-naive patients and patients who had been previously treated with an anticancer therapy. In addition, tazemetostat was generally well-tolerated.

"Epithelioid sarcoma is a rare and aggressive form of soft tissue sarcoma, with limited effective treatment options available. We often see patients diagnosed with advanced disease who have a very poor prognosis," said Dr. Gounder. "It is highly encouraging to see these updated efficacy and tolerability data with tazemetostat, and I believe this agent has the potential to be an important treatment option for patients with epithelioid sarcoma and their treating physicians."

"We are very pleased with the interim data from this cohort, which represents the largest prospective study of epithelioid sarcoma with any approved or investigational anticancer treatment to date. The data presented today further demonstrate the potential treatment opportunity we see with tazemetostat," said Rob Bazemore, president and chief executive officer of Epizyme. "We are one step closer to achieving our mission of bringing epigenetic treatments to people with cancer and other serious diseases. We look forward to working with investigators and regulators in an effort to bring to market the potential first therapy indicated for patients with epithelioid sarcoma."

Epithelioid Sarcoma Interim Efficacy Data
Epithelioid sarcoma is an ultra-rare and aggressive soft tissue sarcoma, characterized by a loss of the INI1 protein. It is most commonly diagnosed in young adults (18-40 years old) and is often fatal, with a median survival of less than one year in treatment-naive patients. Today, there is no treatment indicated specifically for epithelioid sarcoma.

The ES cohort completed enrollment in July of 2017 with 24 treatment-naive patients and 38 relapsed and/or refractory patients for a total of 62 epithelioid sarcoma patients. The primary endpoint of the study is objective response rate (ORR), comprised of complete and partial responses as measured by RECIST 1.1. Key secondary endpoints include duration of response, overall survival, disease control rate (DCR; comprised of confirmed objective responses for any duration or disease stabilization of 32 weeks or more) and safety.

Interim findings are summarized below, based on an August 21, 2018 data cut-off date.

Notably, since the data cut-off, one patient in the treatment-naive group who had stable disease subsequently achieved an objective response. This additional patient brings the total to six responders (~25%) in this treatment-naive group and nine responders (15%) in the overall population, to date, with several patients with stable disease remaining on treatment.

Tazemetostat Interim Safety Data
Tazemetostat has been generally well-tolerated and continues to demonstrate favorable safety in the Phase 2 study, with no discontinuations or deaths due to treatment-related adverse events (AEs) observed. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2. Only 13 percent of patients experienced a grade 3 or higher treatment-related AE. Treatment-related AEs with an incidence of 10 percent or greater were fatigue (26%), nausea (26%), decreased appetite (16%), vomiting (16%), diarrhea and weight decrease (13%) and anemia (10%).

"We are pleased with the clinically meaningful and durable objective responses observed in this study, with a number of stable disease patients who are still on treatment and have the potential to achieve an objective response in the future," stated Dr. Shefali Agarwal, medical oncologist and chief medical officer of Epizyme. "These updated efficacy and safety data from the completed ES cohort suggest that tazemetostat may play an important role for patients in the future, particularly when considering the known limitations and challenges with current treatment options, and further bolster our confidence in our first planned NDA submission for tazemetostat. I’d like to thank the study investigators, medical staffs, and most importantly, the patients and caregivers, who have participated in this trial and supported the ongoing development of tazemetostat."

Conference Call Information
Epizyme management will host a conference call today at 8:30 am E.T. To participate in the conference call, please dial 877-844-6886 (domestic) or 970-315-0315 (international) and refer to conference ID 8780088. The webcast can be accessed in the Investor Relations section of the company’s website at www.epizyme.com. The replay of the webcast will be available in the investor section of the company’s website for 60 days.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).

On October 22, 2018 amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, presented clinical trial data from its lead oncology drug candidate, AMC303, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich (Press release, amcure, OCT 22, 2018, View Source [SID1234530042]). The data presented on Sunday, 21 October in a proffered oral presentation demonstrated the favorable safety profile of AMC303. The company is currently conducting a Phase 1b expansion cohort and expects to publish updates from the study in 2019.

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AMC303 is a cyclic peptide targeting CD44v6, a key cell membrane protein in pathways of several receptor-tyrosine kinases, such as c-MET, VEGFR-2 and RON. This approach provides a potential novel mechanism for the treatment of patients with advanced and solid tumors that have already begun to spread throughout the body. Trial results presented at ESMO (Free ESMO Whitepaper) 2018 have shown the compound to be well-tolerated in 27 patients with a total of 11 different cancer types, with a favorable PK profile. No related serious adverse events (SAEs) were reported, and most frequently reported related events were infusion related reactions and hypersensitivity (grade 1-2, in 22% of patients), followed by nausea, diarrhea and fatigue.

"AMC303 was well tolerated in a heavily pretreated and diverse cancer patient population. The most related adverse events were transient and manageable. AMC303 has thus the potential of being a safe therapeutic option with a unique and additive mechanism of action," said Dr. Emiliano Calvo, MD, Lead Investigator of the trial at the Hospital Madrid Norte Sanchinarro and Director at the START Madrid-CIOCC Early Phase Clinical Drug Development program.

"These encouraging data support the continuation of the trial into its second part, targeting patients with a moderate to high expression of the target molecule CD44v6 and selected cancer types with a confirmed squamous cell histology. We look forward to updating the community on the progress of this trial and publish additional data sets as they emerge," added Klaus Dembowsky, CEO of amcure GmbH.

The trial, conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin. In addition, the study includes a comprehensive biomarker program. The study was designed to include a broad variety of tumor types in the first part of the study irrespective of the target expression and a tumor type-specific expansion cohort at the recommended dose for a subsequent Phase 2 study. With the expansion cohort, amcure focuses its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors: head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumors.

For more information on the trial please visit View Source

About AMC303
amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.