On September 24, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that the Safety Review Committees overseeing the Phase 1/2 clinical study of Seclidemstat in Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors (AST) have approved the advancement of each study to the fourth level dosing cohort (Press release, Flex Pharma, SEP 24, 2019, View Source [SID1234539734]).

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The Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma and Phase 1 AST clinical trial are designed as open-label dose-finding studies to determine the maximum tolerated dose (MTD) and initial safety profile of Seclidemstat. Seclidemstat is administered daily as an oral tablet, with each cohort receiving an increased dose of study medication. This MTD, as determined by the Safety Review Committee, will then be used to treat a larger group of patients to confirm the safety profile for Seclidemstat and capture additional information regarding pharmacokinetics and potential preliminary efficacy.

David Arthur, President and Chief Executive Officer of Salarius, stated, "Clearance from the Safety Review Committees to proceed to the higher dosing cohort is an important milestone in the ongoing clinical trials. Ultimately, our goal with these studies is to pinpoint the optimal dose of Seclidemstat, which, in addition to determining the safety parameters of the drug, will enable us to obtain key pharmacokinetic information and, potentially, initial efficacy data. Based on current projections we are on track to reach maximum tolerated dose early next year and report early patient data from both studies in 2020."

The Ewing sarcoma study opened patient enrollment in Q3 2018 and is currently enrolling patients of 12 years of age or older at leading cancer centers in the U.S., including Johns Hopkins All Children’s Hospital, Children’s Hospital of Los Angeles, Moffitt Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. Most recently, the Sarcoma Oncology Center in California was added, bringing the total number of active clinical trial sites to six. The Safety Review Committee recently cleared the third dose level (300 mg Seclidemstat twice-daily), and the fourth dose level is currently enrolling (600 mg Seclidemstat twice-daily). Based on the first 3 dose levels, the pharmacokinetic profile (i.e., how the drug is distributed in the body following administration) appears to be dose proportional.

In June 2019, the Advanced Solid Tumor study began enrolling patients with advanced or recurrent solid tumors including, but not limited to, breast, ovarian and prostate cancer. All study patients had received standard of care therapies but continued to experience progression of their disease. Similar to the Ewing sarcoma study, the Safety Review Committee has cleared the 300 mg dose twice-daily and the 600 mg twice-daily dosing group is currently enrolling patients across the two active sites, HonorHealth in Arizona and the Sarcoma Oncology Center in California.

On September 24, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycles) product platform, reported that updated data from the Phase I dose escalation portion of the Phase I/IIa trial evaluating the Company’s lead asset BT1718 in patients with advanced solid tumors will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, September 27 – October 1 in Barcelona, Spain (Press release, Bicycle Therapeutics, SEP 24, 2019, View Source [SID1234539750]).

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Details for the poster presentation are as follows:

Session Title: Poster Session 2
Location: Poster Area (Hall 4)
Poster Presentation Title: Pharmacokinetic (PK) assessment of BT1718: A phase 1/2a study of BT1718, a first in class Bicycle Toxin Conjugate (BTC), in patients (pts) with advanced solid tumors
Abstract #: 5764
Date & Time: September 28, 2019, 12:00 p.m. – 1:00 p.m. CET

On September 24, 2019 Foundation Medicine, Inc. and Natera, Inc. (NASDAQ: NTRA) reported a partnership to develop and commercialize personalized circulating tumor DNA (ctDNA) monitoring assays, for use by biopharmaceutical and clinical customers who order FoundationOneCDx (Press release, Foundation Medicine, SEP 24, 2019, View Source [SID1234539735]). The initial focus of the partnership will be to enable ctDNA monitoring in biopharmaceutical trials in 2020 to establish the clinical utility for these novel assays. Following these studies, a monitoring product will be made available to clinical customers.

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"We are excited to develop monitoring products based on Foundation Medicine’s genomic insights, and we believe that partnering with Natera, a leader in personalized ctDNA monitoring, offers the potential to significantly advance personalized medicine," said Cindy Perettie, Chief Executive Officer of Foundation Medicine. "Cancer monitoring is an important part of patient care and developing innovative and more efficient diagnostics for physicians to identify disease progression and therapy resistance earlier is critical."

The companies will leverage Foundation Medicine’s FoundationOne CDx as the baseline test to define a set of unique variants that will subsequently be monitored utilizing a co-developed assay that includes components of Natera’s Signatera platform. While the initial focus is to develop personalized cancer monitoring assays that are compatible with FoundationOne CDx as the baseline test, Foundation Medicine may also elect to expand the scope of the partnership to develop monitoring assays that utilize genomic data generated from Foundation Medicine’s FoundationOneLiquid test for solid tumors utilizing ctDNA and/or FoundationOneHeme test for hematologic malignancies and sarcomas.

Foundation Medicine has the exclusive right to commercialize the co-developed monitoring assays. Natera will continue to exclusively offer Signatera testing based on whole exome sequencing of tumor and matched normal DNA.

"We are thrilled to partner with Foundation Medicine on this landmark opportunity," said Steve Chapman, Natera’s Chief Executive Officer. "This partnership accelerates Natera’s progress towards making personalized ctDNA monitoring the global standard of care for evaluating patient response to cancer therapy."

Foundation Medicine’s tests are ordered by physicians for more than 100,000 patients per year, and the company has more than 50 active biopharma partnerships.

On September 24, 2019 Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, reported the closing of a $62 million Series C financing (Press release, Amphivena Therapeutics, SEP 24, 2019, View Source [SID1234539751]). The round was co-led by NanoDimension and Qiming Venture Partners USA, and included new investors Clough Capital, Aju IB, Korys Merieux, Kaitai Capital, Industrial Investors, Nawton Limited and insiders MPM Capital, funds managed by Tekla Capital Management LLC and Franklin Berger.

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"AMV564 is a T cell engager that selectively eliminates myeloid-derived suppressor cells (MDSC) in cancer patients while sparing normal neutrophils and monocytes. Its unique activity and excellent safety profile positions AMV564 well, as monotherapy or in combination with other agents, for the treatment of hematologic malignancies and solid tumors," said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President.

"The Series C financing is an endorsement by new and existing investors of our leadership in the evolving T cell engagement space," said Peter Van Vlasselaer, Ph.D., Executive Chairman. "This funding enables us to study the therapeutic impact of selective MDSC removal in both hematologic and solid cancers and to advance AMV564 and our novel T cell engagement portfolio to the forefront of immuno-oncology."

About AMV564

AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3. To date, over 50 patients have received AMV564 in two Phase 1 clinical trials for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is currently being evaluated in a First-in-Human Phase 1 trial in patients with relapsed/refractory AML at Washington University School of Medicine, MD Anderson Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

The safety, efficacy and selectivity of AMV564 was highlighted most recently at both the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) and at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA last December. Amphivena believes that AMV564 has demonstrated novel clinical activity by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes.

AMV564 is also being evaluated in a Phase 1 solid tumor study which is currently open to enrollment.

On September 24, 2019 AIM ImmunoTech (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported the U.S. Department of Defense (DoD) has granted $8.32 million in funding in another "Breakthrough Award (Press release, AIM ImmunoTech, SEP 24, 2019, View Source [SID1234539736])". This award is to Moffitt Cancer Center for a Phase 2 clinical study of a combination of therapies, including the Company’s drug Ampligen, in patients with brain-metastatic breast cancer (BMBC).

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The funding is through the DoD’s Breast Cancer Research Program, which started the Breakthrough Awards to support research that has the potential for a major impact and to accelerate progress toward ending breast cancer. As recently announced, Roswell Park Comprehensive Cancer Center (Roswell Park) reported receipt of its own DoD-funded Breakthrough Award of $6.42 million to study Ampligen in the treatment of BMBC. Together, these separate but parallel proposed clinical trials are receiving approximately $15 million in DoD funding to study Ampligen as a tumor microenvironment modulating agent component of a dendritic cell vaccine approach in the treatment of brain-metastatic breast cancer, which include both brain parenchyma and leptomeningeal sites of metastasis.

The grant to Moffitt Cancer Center was made possible by the unique complementary preclinical and clinical expertise of the teams of Dr. Brian Czerniecki of Moffitt Cancer Center and Dr. Pawel Kalinski of Roswell Park. The researchers hypothesize that vaccination with HER2/HER3-loaded dendritic cells (alpha-DC1s) combined with tumor-selective chemokine modulation (CKM) will be clinically effective and may enhance antitumor efficacy of PD-1 blockade when treating BMBC. Ampligen is a component of CKM therapy.

"Treatment of brain metastasis to the central nervous system is a large need for women with metastatic breast cancer and this novel immunotherapy offers promise to this group of patients," said Dr. Czerniecki, chair of the Department of Breast Oncology at Moffitt Cancer Center.

The researchers’ submitted impact statement highlights this need: "The current treatments, such as surgery or radiotherapy (whole-brain radiation or stereotactic radio-surgery), or intrathecal (I.T.) chemotherapy, constitute a significant burden for patients and do not prevent recurrence and death. The proposed immune therapy will provide new treatment options for these patients who currently face a very grim prognosis."

"These combination therapies are designed to convert ‘cold’ tumors that don’t respond well to existing immune therapies into ‘hot’ tumors that are more susceptible to targeting by immune therapies," said Equels. "We are honored to have Ampligen evaluated as part of a combination therapy in brain-metastatic breast cancer in this DoD-funded comprehensive clinical trial at Central Florida-based Moffitt Cancer Center, one of the world’s premier breast cancer research centers. Brain-metastatic breast cancer is a devastating illness with very poor prognosis, and we are hopeful that Ampligen will play a major role in providing hope to these patients."