On October 16, 2019 Cleveland Diagnostics, Inc., a clinical-stage company focused on developing next-generation diagnostic tests for the early detection of cancers, reported that it has received FDA Breakthrough Device Designation for the IsoPSA Assay, a novel prostate cancer diagnostic test (Press release, Cleveland Diagnostics, OCT 16, 2019, View Source [SID1234542311]). Published studies from multicenter prospective clinical trials suggest that the non-invasive, blood-based IsoPSA assay has significant superior diagnostic accuracy when compared to traditional prostate-specific antigen (PSA) tests in detecting high-grade prostate cancer.

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FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Through the Breakthrough Device Program, Cleveland Diagnostics will work more closely and frequently with FDA to expedite its review of IsoPSA.

"We are very grateful that FDA recognizes the potential of IsoPSA, the first test in our pipeline of simple, affordable, and highly accurate cancer tests that focus on cancer-relevant changes to protein biomarkers in blood," said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. "We look forward to working closely with FDA to expedite the appropriate approvals and get this important new test into the hands of physicians."

Cleveland Diagnostics has concluded two multicenter clinical trials in top U.S. and international hospitals and clinics, led by Cleveland Clinic, in which the diagnostic accuracy of IsoPSA was compared to that of PSA, the current standard of care in prostate cancer, in men scheduled for prostate biopsy. The results from those studies demonstrated that IsoPSA has superior diagnostic performance to traditional PSA in identifying which patients have high-grade disease.

"The clinical utility of PSA is limited by the relatively poor diagnostic accuracy and predictive value of the test," said Mark Stovsky, M.D., CMO at Cleveland Diagnostics and urologist at Cleveland Clinic. "Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer. We believe that IsoPSA has the potential to fill a major void in this space."

It is estimated that 1 in 9 men will develop prostate cancer in their lifetime. The results of previous studies have shown that IsoPSA could reduce unnecessary biopsies by at least 45 percent, saving men from unneeded invasive, potentially risky and expensive procedures that can sometimes lead to serious and lasting side effects.

On October 16, 2019 Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, reported dosing of the first patient in a Phase 1 clinical trial in solid tumors evaluating AMV564, a CD33/CD3 T cell engager that selectively eliminates myeloid derived suppressor cells (MDSC), sparing normal neutrophils and monocytes (Press release, Amphivena Therapeutics, OCT 16, 2019, View Source [SID1234542310]).

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"Our lead candidate, AMV564, originating from our platform technology, is a bivalent T cell engager that binds with high avidity and specificity to CD33. AMV564 has been shown to eliminate subsets of activated myeloid cells, including granulocytic, monocytic and immature MDSC, in acute myeloid leukemia patients," said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President. "This creates a unique opportunity for Amphivena to evaluate the effect of AMV564 on these immune suppressive cells and the potential therapeutic benefit of relieving this important source of T cell suppression in patients with solid tumors."

The multi-center Phase 1 study is currently open for enrollment at NEXT Oncology (PI: Raghad Karim) in San Antonio, TX, MD Anderson Cancer Center (PI: Sarina Piha-Paul) and Peninsula Cancer Institute (PI: Alexander Starodub) in Newport News, VA. The study will be a multicenter, all-comers solid tumor dose-finding trial with expansion cohorts planned in 2020. AMV564 is being administered to solid tumor patients by subcutaneous injection.

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 October 16, 2019 GammaDelta Therapeutics, a company focussed on harnessing the unique properties of gamma delta (γδ) T-cells to develop transformational immunotherapies, reported the formation of a spin-out company: Adaptate Biotherapeutics. While GammaDelta Therapeutics’ primary goal is to develop γδ T-cell based cell therapy products, the new spin-out will build on GammaDelta’s knowledge to modulate γδ T-cell activity using therapeutic antibodies, with the potential to trigger an immune response against cancer (Press release, GammaDelta Therapeutics, OCT 16, 2019, View Source [SID1234542309]).

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γδ T-cells are a distinct T-cell sub-type that respond to molecular patterns of distress and have been shown to have tremendous potential in treating cancer and other immunological disorders. GammaDelta Therapeutics was formed in 2016 to harness these properties, and since then has gained extensive knowledge of γδ T-cell biology developing a portfolio of investigational cell therapies poised to enter clinical development. In addition to gaining insight into cell growth and isolation, the company’s scientists have also discovered a number of potential drug targets and antibodies that have potential to modulate the activity of γδ T-cells in situ.

Adaptate Biotherapeutics has been formed to further develop these targets and antibodies for therapeutic purposes and advance them into clinical studies. Dr. Natalie Mount, currently Chief Scientific Officer of GammaDelta will move to Adaptate Biotherapeutics as Chief Executive Officer. The two companies will continue sharing their insights into γδ T-cell biology as they work towards developing different therapeutic modalities.

The founding of Adaptate Biotherapeutics has been made possible by investment from Abingworth and Takeda Pharmaceutical Company Limited. Takeda has a time-limited option to acquire Adaptate Biotherapeutics in the future. Both Adaptate Biotherapeutics and GammaDelta Therapeutics have also benefited from the support of King’s College London, the Francis Crick Institute and Cancer Research Technology.

Dr. Paolo Paoletti, CEO of GammaDelta Therapeutics, said: "γδ T-cells have tremendous therapeutic potential that is yet to be fully realised, and our fascinating journey has afforded additional opportunities beyond our main focus on cell therapy. Spinning out these activities to create Adaptate Biotherapeutics now enables the deployment of a focussed effort on non-cell therapy. Natalie has managed this effort as part of her role at GammaDelta Therapeutics, and she is the natural CEO to lead the efforts of Adaptate. I’m extremely pleased for this opportunity for Natalie and want to thank Raj Mehta, Director of BD, IP and Alliance Management at GammaDelta Therapeutics, for his work on the spin-out and Abingworth and Takeda for their continued support."

Dr. Natalie Mount, CEO of Adaptate Biotherapeutics, said: "I’m proud to be leading this new company, and excited by the potential we have to expand the therapeutic opportunities of γδ T-cells. Both companies continue to share the same ultimate goal of harnessing the power of these cells to improve the lives of patients and I look forward to driving Adaptate Biotherapeutics to achieve this goal."

On October 16, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions in skin cancers and uveal melanoma, reported the presentation of a multicenter, prospective study demonstrating that DecisionDx-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (Press release, Castle Biosciences, OCT 16, 2019, View Source [SID1234542308]). The study was presented at the American Academy of Ophthalmology 2019 Annual Meeting held October 12-15, 2019, in San Francisco.

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The CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate metastatic surveillance regimens for patients with uveal melanoma who were tested with the DecisionDx-UM gene expression profile (GEP) test as part of their diagnostic work-up.

"Treatment planning in uveal melanoma is critical since 30% of patients who are diagnosed with uveal melanoma will experience life-threatening metastasis within five years despite successful control of the primary tumor," commented study co-author and presenter Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center at Houston, and Retina Consultants of Houston. "The results from the CLEAR II study demonstrate that the DecisionDx-UM test has a significant impact on treatment planning, helping to ensure that patients receive imaging, follow-up and referrals that are appropriate for their individual risk."

Study Highlights:

138 patients from eight centers were enrolled between March 2018 and February 2019.
93 patients (67%) had a low-risk Class 1 test result; 45 patients (33%) had a high-risk Class 2 test result.
Results showed that patients with a Class 2 DecisionDx-UM result were significantly more often followed by medical oncology for surveillance compared to ocular oncology or primary care physicians (p=0.002).
95% (42 of 44) of the Class 2 patients who received a referral were referred to medical oncology.
Patients with a Class 2 result were significantly more likely to receive recommendations for frequent (three or four times a year) abdominal imaging, chest imaging, and liver function testing compared to Class 1 patients (p<0.0001).
These findings show that treatment plan recommendations are aligned with metastatic risk and consistent with results from previously published studies documenting the impact of DecisionDx-UM on patient management.

On October 16, 2019 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized chimeric antigen receptor T cell ("CAR T") platform technology engineered to target patient-specific tumor neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at BIO Investor Forum on Wednesday, October 23, 2019 at 2:45 PM PT in San Francisco, CA (Press release, Xenetic Biosciences, OCT 16, 2019, View Source [SID1234542307]).

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As part of his presentation, Mr. Eisenberg will provide a Company overview and discuss the Company’s novel CAR T platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. Xenetic is currently advancing the development program for XCART to confirm the positive preclinical results shown to date and to demonstrate a more attractive safety profile than existing therapies.

In addition to the presentation, management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live audio webcast of the presentation will be available on the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com) or by accessing the conference website here. Within three days of the event, a webcast replay will be made available on the Company’s website.

About BIO Investor Forum

Now in its 17th year, the BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables, therapeutic workshops, company presentations, and BIO One-on-One Partnering meetings. For more information, please visit the conference website here.