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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On October 16, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported a collaboration with the Netherlands Cancer Institute (Stichting Het Nederlands Kanker Instituut (NKI) – Antoni van Leeuwenhoek Ziekenhuis) in Amsterdam to evaluate domatinostat in combination with checkpoint blockade in a "Multicenter Phase 1b Study testing the Neoadjuvant Combination of Domatinostat, Nivolumab, and Ipilimumab, in RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma – DONIMI" (Press release, 4SC, OCT 16, 2019, View Source [SID1234542306]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Immunotherapy, and particularly checkpoint inhibitors like anti-PD-1 (e.g. Nivolumab) and anti-CTLA4 (Ipilimumab), are increasingly investigated not only in the advanced unresectable or metastatic setting but also in earlier stages of disease. The rationale for such treatment is to activate the immune system before resection of the tumor to generate an immune memory and prevent recurrence of the disease. On the basis of some encouraging data published by the International Neoadjuvant Melanoma Consortium (INMC; View Source), innovative combination approaches will now be tested to optimize the treatment in a more personalized manner where domatinostat is a promising combination partner.

Jason Loveridge, Ph.D., CEO of 4SC: "It is getting clearer and clearer that immunotherapy for cancer is most effective when used early in disease progression and we believe the neoadjuvant setting offers a great potential for protecting patients from recurrence of their malignancy after resection, potentially leading to a much higher number of cured patients with resectable, high-risk melanoma. Prof. Blank and his collaborators within the INMC have already made remarkable progress in this highly innovative field in melanoma and the NKI is a worldwide leading cancer center in the treatment of melanoma and other indications in the neoadjuvant setting. We are grateful entering such collaboration with the NKI and looking forward to the initiation of the DONIMI study in the near future."

Prof. Dr. Christian Blank, NKI: "It is exciting to see what we have achieved with neoadjuvant immunotherapy in melanoma within the INMC during the last few years. However there´s still a way to go to implement a standard neoadjuvant treatment in melanoma. Additional combination approaches to modulate the tumor microenvironment and the patients´ immune system remains a priority so as to optimize and personalize treatment for patients with melanoma, and potentially impact the treatment of patients with other cancers. For example, we do not know yet which patients require double neoadjuvant checkpoint inhibition and who can be treated with neoadjuvant PD-1 blockade alone. Based on preclinical and early clinical data, epigenetic modulation with domatinostat in combination with checkpoint blockade might be a promising approach in the neoadjuvant setting. In the DONIMI study, Domatinostat will be one of the first compounds tested in a personalized neoadjuvant combination trial implemented by INMC researchers from Sydney and Amsterdam. We are much looking forward to enroll the first patients later this year."

On Octobber 16, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO) reported that the company will present at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held Oct. 26-30, 2019, in Boston (Press release, Sutro Biopharma, OCT 16, 2019, View Source [SID1234542305]). The presentation will include both new preclinical efficacy data and initial dose escalation safety data from the company’s ongoing Phase I study of STRO-002 in patients with ovarian cancer. STRO-002 is a novel antibody-drug conjugate (ADC) targeting the clinically validated folate receptor-α (FRα), an antigen known to be overexpressed in ovarian cancer. Sutro discovered and manufactures STRO-002 using its proprietary XpressCF+ cell-free protein synthesis technology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Presentation Details:

Antitumor activity of STRO-002, a novel folate receptor-α (FRα) antibody drug conjugate (ADC), in patient-derived xenograft (PDX) models and preliminary phase I dose escalation safety outcomes in patients with ovarian carcinoma (OC)

Date: Tuesday, Oct. 29, 2019

Time: 12:30 p.m. – 4:00 p.m. EDT

Location: Hall D, Hynes Convention Center, Boston, MA, United States

Poster Session: Tubulin-interacting Agents

Abstract Number: C095

The abstract was published today on the AACR (Free AACR Whitepaper) website. The poster will be accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company’s website at www.sutrobio.com on the day of the poster presentation.