On March 5, 2019 Iksuda Therapeutics (Iksuda), the next-generation Antibody Drug Conjugate (ADC) company, reported it has signed a licensing agreement with Femtogenix Limited (FGX), the next-generation ADC payload company (Press release, Iksuda Therapeutics, MAR 5, 2019, View Source [SID1234533978]). As part of this agreement, Iksuda will use FGX’s sequence-selective DNA-interactive payload molecules to progress its lead ADC towards the clinic, with the aim of targeting difficult-to-treat solid tumours.

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!

By harnessing FGX’s highly potent and broad-acting DNA mono-alkylating payloads in combination with its own PermaLink conjugation platform, Iksuda aims to significantly improve the therapeutic index of its ADCs and further advance the current standard of care for solid tumour types, which can be resistant to treatment. The agreement marks another key step in the build-out of Iksuda’s ADC technology-suite and drug pipeline, from which it aims to progress multiple candidates towards first clinical studies in 2020.

Dr Dave Simpson, Chief Executive Officer, Iksuda, said: "This agreement is an exciting progression of our ADC pipeline as it maximises potential for the greatest anti-cancer impact and enhanced therapeutic index, further underpinning our ambition to advance multiple ADCs to the clinic and treat the broadest patient population possible."

Dr Chris Keightley, Chief Executive Officer, Femtogenix, said: "We are pleased to be working with Iksuda to further validate the clinical potential of our payloads, which should provide improved efficacy and safety in comparison to those currently in the clinic. We have developed a wide range of easily conjugated payloads with novel mechanisms of action and potency levels, and these are available for licensing. In particular, we are developing payloads that can recognise and bind to transcription factor recognition site profiles within the genome. Such profiles are characteristic of specific tumour types, and this allows FGX to develop payloads with reduced toxicity and enhanced target specificity."

On March 5, 2019 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported its decision to initiate clinical developments of its lead myvacTM candidate, TG4050, and the finalization of its collaboration agreement with NEC (Press release, Transgene, MAR 5, 2019, View Source [SID1234533977]). This product is designed and manufactured by Transgene using its proprietary platform myvacTM (*1) and integrating neoantigens selected by NEC’s Neoantigen Prediction System (*2).

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!

TG4050 capitalizes on the tremendous progress in the field of artificial intelligence (AI) and on advances in genome sequencing to create an individualized immunotherapy, targeted to mutated antigens identified by sequencing and predicted to be relevant target by the NEC’s algorithm.

Transgene will be responsible for the clinical development and will sponsor two clinical studies starting in H2 2019:

A study in ovarian cancer patients after first line surgery and chemotherapy
A study in head and neck cancer patient after surgery and radiation therapy.
These studies, which will be co-financed by Transgene and NEC, will evaluate safety and immunogenicity of TG4050 and, pave the way for combination studies with different classes of therapies.

"Individualized vaccination is being increasingly perceived as a promising therapeutic modality to specifically activate the immune system to attack tumor cells. We are pleased, together with NEC, to be advancing in the clinic TG4050 in H2 2019. We are confident that this approach has the potential to transform the treatment of a broad range of solid tumors," said Éric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene.

"Individualized immunotherapy is a breakthrough science which holds great promises to achieve clinical benefits for cancer patients. We are honored to partner with Transgene in the initiation of these clinical trials this year. The success of this product would create immense impact that could improve the quality of life for many cancer patients", commented Osamu Fujikawa, Senior Vice President, Business Innovation Unit, of NEC Corporation.

***

Notes:

*1) myvac

myvacTM is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. The myvacTM-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities.

*2) NEC’s Neoantigen Prediction System

NEC’s neoantigen prediction utilizes its proprietary AI, such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house MHC-binding affinity prediction. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.

On March 5, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Sanjiv K. Patel, M.A., M.D., MBA, president and chief executive officer, will present a company overview at the Cowen 39th Annual Health Care Conference on Monday, March 11, 2019 at 11:30 a.m. ET. The conference is being held March 11-13, 2019 in Boston (Press release, Relay Therapeutics, MAR 5, 2019, View Source [SID1234533976]).

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!

On March 5, 2019 Pfizer Inc. reported investors and the general public to view and listen to a webcast of a presentation by Andy Schmeltz, Global President, Oncology, and Chris Boshoff, Chief Development Officer, Oncology, at the Cowen and Company 39th Annual Healthcare Conference on Tuesday, March 12, 2019 at 9:20 a.m. Eastern Daylight Time (Press release, Pfizer, MAR 5, 2019, View Source [SID1234533975]).

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!

To view and listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today.

Visitors will be able to view and listen to an archived copy of the webcast at www.pfizer.com/investors.

On March 5, 2019 Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, reported that they have enrolled the first patient in the expansion stage of a Phase 1/2 clinical trial of tinostamustine, an investigational treatment, in patients with relapsed refractory (R/R) hematologic malignancies in the U.S. and Europe (Press release, Imbrium Therapeutics, MAR 5, 2019, View Source [SID1234533974]).

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!

Following a dose escalation trial to establish tolerability, this expansion phase seeks to investigate the overall response rate, duration of response and safety of five cohorts of patients with R/R cancers, including: multiple myeloma, Hodgkin lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma and T-cell prolymphocytic leukemia. Each study arm will run separately, with results to be submitted for upcoming medical meetings.

"The initiation of the expansion arms of this Phase 1/2 trial is a significant step for our work in oncology as we pursue important treatment options for people living with these types of devastating cancers," said Paul Medeiros, president of Imbrium Therapeutics. "We look forward to continue building on the foundation of safety data generated in the dose-escalation portion of the trial as we advance the development of tinostamustine as a potential therapy for people with limited treatment options."

Craig Landau, MD, president and CEO, Purdue Pharma L.P., added, "This milestone underscores our continued commitment to improving the lives of patients with cancer and leveraging our capabilities in science and medicine to develop more effective therapies. We are creating a strong pipeline of potential medicines to help us achieve this mission."

In addition to tinostamustine, Imbrium’s clinical stage oncology portfolio includes etoposide toniribate, a novel prodrug with a target cell-activated topoisomerase inhibitor. Imbrium is currently collaborating in research for four drug candidates across 14 different cancer types. Research on these compounds is being advanced on behalf of Imbrium by Mundipharma EDO.

"We are excited to see the first patient enrolled in the tinostamustine expansion study in patients with hematologic malignancies, a group of difficult-to-treat cancers," said John Renger, PhD, vice president, Head of Research & Development and Regulatory Affairs, Imbrium Therapeutics. "Preclinical data suggest tinostamustine’s dual mechanisms of action may improve access to the DNA strands within cancer cells, both through breaking the strands and also counteracting the cancer cells’ attempt to repair the DNA damage."

Imbrium Therapeutics, in collaboration with Mundipharma EDO GmbH, expects to continue enrollment in the Phase 1/2 trial. To learn more about the trial, please visit clinicaltrials.gov.

About Hematologic Malignancies

Hematologic malignancies are forms of cancer in the cells of blood-forming tissue or in the cells of the immune system. Examples of hematologic cancer are acute and chronic leukemias, lymphomas, multiple myeloma and myelodysplastic syndromes. In most blood cancers, the normal blood cell development process is interrupted by uncontrolled growth of an abnormal type of blood cell. These cancerous cells prevent the blood from performing many of its functions.1

About Tinostamustine

Tinostamustine is an alkylating deacetylase inhibiting molecule (AK-DACi) in development for a range of rare or difficult-to-treat blood cancers and solid tumors. It is a multi-action therapy and is currently in Phase 1 clinical trials. Pre-clinical studies with tinostamustine as monotherapy have shown response, in myeloid and lymphoid malignancies and solid tumors.