On June 10, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (OTCQB: GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate (MTBDC) platform, reported an update of the company’s drug development programs (Press release, GT Biopharma , JUN 10, 2019, View Source [SID1234539512]).

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!

GT Biopharma continues to move forward with its development of the HIV TriKE. On April 24th GT Biopharma announced the elimination of HIV infected cells using its Tri:Specific Killer Engagers (TriKEs) in Preclinical Testing at the University of Minnesota. Which could represent a possible cure to HIV which now has over 35 million infected people worldwide.

About the HIV TriKE

In preclinical testing led by Dr. Jeffrey Miller, M.D., Deputy Director Masonic Cancer Center and Dr. Timothy Schacker, M.D., Medical School and Director, Program in HIV Medicine, the research team designed a series of Bispecific and Trispecific Natural Killer Cell Engagers (BiKE and TriKE) constructs to direct Natural Killer cell mediated cytotoxicity against an HIV infected target. The data demonstrate that a BiKE construct can eliminate HIV infected targets expressing the HIV envelope on their surface. Based on the success of the BiKE data, GT Biopharma is planning to develop a TriKE version by incorporating IL-15 into the BiKE scFv construct to increase the level of NK cell killing of targeted HIV infected cells.

Additional TriKEs (Trispecific NK cell engagers) which target hematological malignancies (liquid tumors), and solid tumor cancers, are also progressing under the TriKE platform. The TriKE platform’s ability to expand into solid tumors (80% of the cancer market) allows for a much more economical and wider approach then CAR-T. Most recently KITE Pharma was bought by Gilead Sciences, Inc. for $12 Billion (NASDAQ: GILD) and Juno Therpeautics was accuried ($9 Billion) by Celegene Corporation (NASDAQ: CELG). These highly expensive cell therapies are limited to only liquid tumors (20% of the cancer market). The TriKE off the shelf technology is a protein (drug) version of CAR-T using the TriKE’s ability to employ NK (Natural Killer) cells from the immune system as the catalyst to target, attack and kill specific cancers.

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE) product candidate being initially developed for the treatment AML. GTB-3550 (OXS-3550) is being readied to begin enrolling patients with advanced Acute Myeloid Leukemia (AML) in a Phase I/II expansion clinical trial starting mid- July 2019.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

GTB-1550 (DT2219) top-line Phase I/II expansion clinical trial results have been promising; two patients exhibited a complete remission (CR) with one patient currently disease-free at 50 months post completion of the study. A Phase 2 study is being planned.

About GTB-1550 Multi-Target Directed Bispecific Drug Conjugate

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented, "­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­We are pleased with the progress of our clinical development programs." The HIV TriKE’s possibility to kill the HIV virus would solve a massive economic burden as well as stop infected patients from spreading the disease. Mr. Cataldo also noted that the Company has two key platform technologies to attack cancer: the TriKE platform, and the Multi-Targeted Directed Bispecific Cytotoxic Payload platform. Mr. Cataldo stated, "We believe that these Platform technologies present first-in-class therapeutic opportunities for the Company, and will be the main focus going forward."

On June 10, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson have reported the latest research to be presented at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress taking place in Amsterdam, The Netherlands, from 13–16 June 2019 (Press release, Johnson & Johnson, JUN 10, 2019, View Source [SID1234536978]). Janssen will present 28 company-sponsored abstracts from its leading haematological malignancy portfolio at the congress, including the latest results for DARZALEX (daratumumab) and IMBRUVICA (ibrutinib).

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!

"With more than 11,000 attendees, EHA (Free EHA Whitepaper) is the premier congress for the latest innovations in haematology in Europe and Janssen is proud to be presenting important data from our clinical development programmes," said Dr Patrick Laroche, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen-Cilag France. "We are committed to changing outcomes and improving options for patients diagnosed with cancer. Therefore, we are pleased to present results from the daratumumab CASSIOPEIA study, which has been selected for inclusion in the Presidential Symposium. We are also encouraged by the five-year ibrutinib RESONATETM-2 follow-up findings, which provide longer-term evidence supporting the efficacy and safety of this BTK inhibitor in the treatment of chronic lymphocytic leukaemia."

Highlights of the data to be presented by Janssen include:

First-Time Daratumumab Data in the Treatment of Newly Diagnosed Patients with Relapsed/Refractory Multiple Myeloma, and its Investigational Subcutaneous Formulation1,2
Fourteen daratumumab abstracts have been selected for presentation at the EHA (Free EHA Whitepaper) Annual Congress this year, four of which will be featured in oral sessions. Notably, results from the Phase 3 CASSIOPEIA study evaluating daratumumab in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant eligible have been selected for presentation as part of the Presidential Symposium (Abstract #S145).1 The Presidential Symposium includes the six best abstracts of the Congress, reflecting ground-breaking research as chosen by the Scientific Program Committee. These data recently supported regulatory filings in both the European Union and the U.S., seeking to expand the current indication for daratumumab in the frontline setting.

Findings from the Phase 3 COLUMBA study will be presented (Abstract #S823) evaluating a daratumumab subcutaneous formulation in the treatment of patients with relapsed or refractory multiple myeloma.2

Ibrutinib Long-Term Data in Chronic Lymphocytic Leukaemia3
Results from the final analysis of the Phase 3 RESONATETM-2 study (PCYC-1115/1116) study evaluating ibrutinib monotherapy in previously untreated patients with chronic lymphocytic leukaemia (CLL) will be presented in an oral session (Abstract #S107).3 Ibrutinib, a once daily oral BTK inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.3

Select company-sponsored abstracts follow below. Abstracts for additional Janssen therapies will also be presented and can be found through the EHA (Free EHA Whitepaper) abstract database here.

Abstract No. Title Date/Time
Daratumumab
Oral Presentations
Abstract #S1451

Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results Presidential Symposium,
Friday, June 14 3:45 – 4:00 PM CEST

Abstract #S8744

Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA Saturday, June 15
4:45 – 5:00 PM CEST

Abstract #S8232

Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA Saturday, June 15
11:30 – 11:45 AM CEST

Abstract #S8755

Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA Saturday, June 15
5:00 – 5:15 PM CEST

Poster Presentations
Abstract #PF5986

Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF5927

Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF6038

Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF5919

Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF59610

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF64111

Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF64312

Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PS137713

Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA Saturday, June 15
5:30 – 7:00 PM CEST

Abstract #PS142514

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma Saturday, June 15
5:30 – 7:00 PM CEST

Abstract #PS139515

Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible Saturday, June 15
5:30 – 7:00 PM CEST

Ibrutinib
Oral Presentation
Abstract #S1073

Five Year Follow-Up of Patients Receiving Ibrutinib For First-Line Treatment of Chronic Lymphocytic Leukemia Friday, June 14
12:00 – 12:15 PM CEST

Poster Presentations
Abstract #PF38416

Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice: Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38717

French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Chronic Lymphocytic Leukemia (CLL) in France Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38318

Prognostic Testing and Treatment Approaches Based on Real-World Clinical Experience from An Interim Analysis of the INFORMCLL Registry of Patients With Chronic Lymphocytic Leukemia [ASH encore] Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF49419

Clinical Outcomes with Single-Agent Ibrutinib for Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38920

Progression-Free Survival Predicts Overall Survival in Frontline CLL Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PS126421

French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Mantle Cell Lymphoma (MCL) in France Saturday, June 15
5:30 – 7:00 PM CEST

#ENDS#

About daratumumab
Daratumumab is a first-in-class22 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.23 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.24 A subset of myeloid-derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.26 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.25,26,27,28,29,30,31,32 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.33,34 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.35

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.36 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying the progression of the cancer.37

Ibrutinib is currently approved in Europe for:38

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell lymphoma.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.
Ibrutinib is approved in more than 90 countries, and, to date, has been used to treat more than 140,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g. bruising), musculoskeletal pain, nausea, rash, and pyrexia.38

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

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.

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 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."

1. View Source

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."

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!

"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]).

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!

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."