On June 11, 2019 GT Biopharma, Inc. (GTBP) and (Euronext Paris: GTBP.PA) (the "Company"), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, reported preliminary clinical data taken from an interim review, or snapshot, of the OXS-1550 Phase 1/2 trial following a Bi-Specific Antibody Drug Conjugate (ADC) Advisory Board meeting and follow up discussions (Press release, GT Biopharma , JUN 11, 2019, View Source [SID1234539529]). OXS-1550 is a bi-specific scFv recombinant fusion protein-drug conjugate composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin, its cytotoxic drug payload. OXS-1550 targets cancer cells expressing the CD19 receptor, the CD22 receptor or both receptors.

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OXS-1550 is being evaluated in an open-label, two-stage, investigator-led, Phase 1/2 trial at the Masonic Cancer Center, University of Minnesota. The trial has two arms including patients diagnosed with relapsed/refractory B-cell lymphomas (NHL) and leukemias (ALL). Eighteen patients have been enrolled to date, including 12 NHL and six ALL patients. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients.

At the interim review more than 50% of patients (seven of 13) exhibited a clinical benefit, defined as stable disease plus partial response or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial response (PR) and five demonstrated stable disease (SD).

The efficacy signal was most prominent in ALL patients with 75% (three of four) exhibiting clinical benefit including one CR, one PR and one SD. In the NHL population, four of nine patients exhibited SD. Adverse events were mostly grade 1 and 2 and reversible. One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak.

GT Biopharma’s President and Chief Medical Officer (CMO) Dr. Raymond Urbanski said: "In light of these data and discussions with the Bi-Specific ADC Advisory Board, I am increasingly encouraged by OXS-1550 and its potential to have a significant role in an oncologist’s armamentarium. I also remain convinced that the bi-specific ADC platform has the potential to generate additional attractive product candidates. I look forward to continuing to work closely with the University of Minnesota team and other members of the Bi-Specific ADC Advisory Board with the goal of optimizing next steps for this program and the broader bi-specific ADC platform."

The Bi-Specific ADC Advisory Board has recommended that additional ALL patients be enrolled in the trial followed by another interim data review. The Company currently expects final data for this trial to be available in the fourth quarter of 2018 or the first quarter of 2019.

The Bi-Specific ADC Advisory Board is composed of distinguish clinicians, academics and researchers from several well-known institutions. Members include Dr. Jeffrey Miller, Deputy Director at the Masonic Cancer Center, University of Minnesota and Chair of GT Biopharma’s Scientific Advisory Board. Dr. Veronika Bachanova, hematologist/oncologist and the principal investigator of the Phase 1/2 study and Dr. Daniel Vallera, lead researcher for the bispecific ADC program, both at the Masonic Cancer Center. Also included are Drs. Mark Litzow and Arthur Frankel. Mark R. Litzow, M.D., is Professor of Medicine in the Division of Hematology at Mayo Clinic. Arthur E. Frankel, M.D., is the inaugural holder of the Arlene and Mayer Mitchell Endowed Chair in Medical Oncology, Chief of Medical Oncology at Mitchell Cancer Institute (USA-MCI), Interim Associate Director for Basic & Translational Sciences and Professor of Oncological Sciences.

On June 10, 2019 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and research reagents, reported that it has selected the clinical development candidate for first-time-in-human clinical trials of the Affimer platform (Press release, Avacta, JUN 10, 2019, View Source [SID1234536979]). This important milestone means that the Group remains on track to submit an IND/CTA application for an Affimer PD-L1 inhibitor by the end of 2020.

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The Group has generated a wide range of Affimer inhibitors of PD-L1, a well known cancer immunotherapy target. This target was chosen to demonstrate safety and tolerability of the Affimer platform in human and, importantly, to provide a proprietary basis for its novel tumour microenvironment activated drug conjugate (TMAC) and bispecific cancer immunotherapies.

Avacta has selected a specific Affimer molecule (AVA004) as its clinical candidate because of its excellent in vitro and in vivo pharmacological properties. This Affimer has been shown to have equivalent tumour growth inhibition to three approved monoclonal antibody inhibitors of PD-L1 (Tecentriq, Imfinzi and Bavencio) in several in vivo animal efficacy models.

This molecule will therefore now be taken forwards into clinical manufacturing and IND/CTA enabling studies, allowing the Group to remain on track for an IND/CTA application in late 2020 and dosing of first patients shortly afterwards.

The planned phase I study will be in patients with advanced PD-L1 positive solid tumours. This study will explore both intra-venous and sub-cutaneous routes of administration to provide proof-of-concept with primary endpoints of safety, tolerability and appropriate pharmacokinetics/pharmacodynamics, and with a secondary efficacy endpoint. The study will include 20-30 patients in at least two sites in North America and Europe.

The cancer immunotherapy market is currently worth $60bn and is predicted to double by 20251. Avacta’s combinatorial approach to treatment through its TMAC and bispecific cancer immunotherapies, which build upon inhibition of PD-L1, are designed not only to compete strongly in this market through improved clinical benefit to patients, but also to expand the market to patients who do not respond to single checkpoint inhibitors.

Avacta will provide an on-line analyst briefing on the AVA004 in vitro and in vivo pharmacology data at 16:00 BST on Wednesday, 12 June 2019. To register for this analyst briefing please contact [email protected].

Dr Alastair Smith, Chief Executive Officer, Avacta Group plc, commented:

"Selection of the Affimer PD-L1 inhibitor candidate for clinical development is an important milestone in our development of the Affimer therapeutic platform. The Group remains firmly on track to submit an application to the regulators for a first-time-in-human clinical study late in 2020.

Demonstration of appropriate safety and tolerability in humans is key to de-risking the platform overall for partners and therefore key to the number and value of licensing deals in the future.

Not only will the PD-L1 programme be used to demonstrate the safety of the Affimer platform in humans, but it will provide us with a proprietary inhibitor of the PD-1/PD-L1 checkpoint pathway which will be central to our ground-breaking TMAC drug conjugates and bispecifics. These novel programmes will allow us to build a clinically differentiated pipeline to address the lack of a durable response to single immune checkpoint therapies for most patients.

It is a hugely exciting period for Avacta and I look forward to keeping the market updated on our progress."

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On June 10, 2019 Oncternal Therapeutics, Inc., (Nasdaq: ONCT) a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical need, reported that the reverse merger with GTx, Inc., closed on June 7, 2019 (Press release, GTx, JUN 10, 2019, View Source [SID1234536962]). The combined company will operate under the name Oncternal Therapeutics, Inc., and its shares will commence trading on the Nasdaq stock exchange on June 10, 2019, under the ticker symbol "ONCT."

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"We believe that the closing of the merger signifies a transformative event that will provide Oncternal with the opportunity to achieve its next level of corporate growth as we continue to advance our promising oncology drug candidates through development," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We recently presented updated interim data from an ongoing clinical study of our investigational monoclonal antibody, cirmtuzumab, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and we look forward to achieving a number of exciting milestones in our development programs in the future."

Pursuant to the merger, all of Oncternal’s outstanding shares of common stock and securities convertible into or exercisable for Oncternal’s common stock were converted into GTx common stock and securities convertible into or exercisable for GTx common stock. Immediately following the completion of the merger, the former stockholders of Oncternal held approximately 77.5% of the outstanding shares of common stock of the combined company. In addition to retaining an ownership interest representing approximately 22.5% of the outstanding shares of common stock of the combined company, the GTx stockholders of record as of immediately prior to the effective time of the merger received contingent value rights (CVR) entitling the holders to receive, in the aggregate, 75% of any net proceeds derived from the grant, sale or transfer of rights to GTx’s selective androgen receptor degrader (SARD) and selective androgen receptor modulator (SARM) technology during the term of the CVR and, if applicable, to receive royalties on the sale of any SARD products by the combined company during the term of the CVR.

Oncternal’s development pipeline consists of the following programs:

Oncternal’s lead program, cirmtuzumab, is an investigational, potential first-in-class anti-receptor tyrosine kinase-like orphan receptor 1 (ROR1) monoclonal antibody. Cirmtuzumab is currently in a Phase 1/ 2 clinical trial in combination with ibrutinib for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Last week, the company presented interim data from the study at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women

with metastatic breast cancer is being conducted at the University of California San Diego (UC San Diego) School of Medicine. The California Institute for Regenerative Medicine (CIRM) has provided funding to support the cirmtuzumab development program.

TK216, an investigational, potential first-in-class small molecule designed to inhibit the biological activity of E26 transformation-specific (ETS) oncoproteins, is being evaluated alone and in combination with vincristine in a Phase 1 clinical trial in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer. Oncternal is also planning a Phase 1 clinical trial in patients with relapsed acute myeloid leukemia (AML).

A ROR-1 targeted chimeric antigen receptor T-cell (CAR-T) program is in preclinical development in collaboration with UC San Diego for hematologic cancers and solid tumors.

On June 10, 2019 F-star, a clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy, reported the appointment of Louis Kayitalire, MD, as Chief Medical Officer (CMO), which will be effective on 17 June 2019 (Press release, f-star, JUN 10, 2019, View Source [SID1234536980]).

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F-star believes this newly created management position will be crucial to F-star’s transition to a wholly-owned portfolio strategy as it expands its clinical operation capabilities and accelerates progression of its proprietary pipeline.

Dr Kayitalire will oversee the clinical development of F-star’s lead product candidate, FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody currently in a Phase 1 clinical trial, recruiting the expansion cohorts of the two highest dose levels. He will also lead the clinical strategy and operations for F-star’s pipeline of potential first- and best-in-class immuno-oncology bispecific antibody therapeutics, including FS120 and FS222, two proprietary product candidates currently in cGMP production and on track for investigational new drug application submissions this year.

Louis Kayitalire said: "This is an exciting time for me to join F-star as the company pivots to a wholly-owned portfolio strategy and accelerates the clinical development of its pipeline. As we saw at the recent ASCO (Free ASCO Whitepaper) meeting, bispecific antibodies are leading a paradigm shift in cancer care and the potential to improve the outcome for cancer patients has never been greater. I believe F-star is ideally positioned to become the next leader in this field."

Dr Kayitalire will bring over 20 years’ experience in oncology and immuno-oncology, having previously held positions at major pharmaceutical companies including Bristol-Myers Squibb, Celgene and Eli Lilly. Dr Kayitalire has strong commercial acumen to complement his extensive clinical expertise with a proven track record of developing and delivering clinical research programmes and ensuring alignment with overall medical and commercial strategies. Dr Kayitalire completed his medical training at Butare University, Rwanda and later held a position as Assistant Professor in Oncology at the Paris XI University of France. He is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Eliot Forster, CEO of F-star, said: "We are delighted to welcome Louis to the F-star team. His oncology expertise and extensive experience advancing clinical research programmes will be invaluable at this stage in F-star’s evolution as we accelerate development of our lead product candidate, FS118, and work to rapidly progress more assets into the clinic."

On June 10, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Chief Executive Officer, Kenneth L. Waggoner, and his team are now in Bangkok, Thailand (Press release, PharmaCyte Biotech, JUN 10, 2019, View Source [SID1234536964]). They have been attending meetings on site at Austrianova’s GMP manufacturing facility. Production of PharmaCyte’s clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is already underway.

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On Tuesday, June 11, Mr. Waggoner and PharmaCyte’s consultant cellular biologist, David A. Judd, will observe and assist the team from Austrianova, if needed, as they continue their work to produce the necessary clinical trial material for PharmaCyte’s planned clinical trial for LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the necessity to be on the ground at the GMP production facility, "We are at a very crucial point on our path to a clinical trial. The production of our clinical trial material is vital to our success in the clinic, and it is vital to advancing our clinical development timeline. We need the testing of the finished cancer product to get underway. The data from those tests should enable us to complete our Investigational New Drug application (IND). After the changes Austrianova made to the manufacturing process, about which we have already reported, we are back on track. We’ll be here in Thailand overseeing the production runs that will produce the clinical trial material PharmaCyte needs to continue its journey to the clinic."

Also, a film crew will be on hand to document the company’s manufacturing process for the production of a video that will tell PharmaCyte’s pancreatic cancer therapy story in its entirety.

As a reminder, Mr. Judd has a broad array of experience in development of cell culture media for many primary cells and cell lines and is particularly knowledgeable in the growth of HEK-293 cells. He has developed manufacturing processes, cell assays, biochemical analysis, cell culture processes and downstream recovery strategies for over 35 years, 30 of which have been with a major biotechnology company in the United States.