On May 15, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that new translational research for second-generation Bicycle Toxin Conjugate (BTC) BT5528 and preclinical data for novel, fully synthetic tumor-targeted immune cell agonists (TICAs) BT7480 and BT7455 will be presented during poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II on June 22-24, 2020 (Press release, Bicycle Therapeutics, MAY 15, 2020, View Source [SID1234558113]). All e-posters will be made available for browsing on AACR (Free AACR Whitepaper)’s e-poster website starting June 22.

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!

BT5528 is a second-generation BTC, which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload, that targets EphA2, a tumor antigen that is overexpressed in a wide range of solid tumor types and is associated with poor outcomes. BT7480 is a TICA targeting tumor antigen Nectin-4 and agonizing CD137 (4-1BB). BT7455 is a TICA targeting EphA2 and agonizing CD137.

Details on Bicycle’s poster presentations at AACR (Free AACR Whitepaper) are as follows:

Session Title: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes 2
Session Category: Experimental and Molecular Therapeutics
Poster Title: A survey of EphA2 expression by immunohistochemistry (IHC) in tumor tissue microarrays (TMAs) to support BT5528 indication selection
Abstract #: 3302

Session Title: Immunomodulatory Agents and Interventions 2
Session Category: Immunology
Poster Title: BT7480, a novel fully synthetic tumor-targeted immune cell agonist (TICA) induces tumor localized 4-1BB agonism
Abstract #: 5241

Session Title: Immunomodulatory Agents and Interventions 3
Session Category: Immunology
Poster Title: A fully synthetic EphA2/4-1BB tumor-targeted immune cell agonist (TICA) induces tumor localized 4-1BB agonism
Abstract #: 4613

The posters will be available on the Publications section of bicycletherapeutics.com following presentation.

On May 15, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that new pre-clinical data evaluating the potential of the lead candidate melflufen (melphalan flufenamide) have been selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Oncopeptides, MAY 15, 2020, View Source [SID1234558112]). The poster presentations are now available online.

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!

Melflufen is a first-in-class anticancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is in late stage clinical development as a potential treatment of patients with relapsed refractory multiple myeloma (RRMM).

"The annual AACR (Free AACR Whitepaper) meeting is an important forum to present and discuss early-stage data, and we are very pleased that three posters highlighting new data and important insights from our pre-clinical program have been accepted," said Fredrik Lehmann, EVP and CMC at Oncopeptides. "As we continue to evaluate melflufen as a potential treatment for multiple myeloma, and broaden our research to evaluate its potential, we are pleased to highlight data that further evaluate the therapeutic peptide-drug conjugate platform."

Below is a brief description of the three abstracts accepted for poster presentations at this year’s AACR (Free AACR Whitepaper) Annual Meeting including highlights from the presentations. The full AACR (Free AACR Whitepaper) Annual Meeting 2020 abstracts can be found here. View Source!/9045

Title: Prognostic significance of esterase gene expression in multiple myeloma
Presenter: Romika Kumari, MD, Institute for Molecular Medicine Finland (FIMM), Helsinki Institute of Life Science, University of Helsinki, Helsinki, Finland

Esterases may play a role in multiple myeloma biology. Their expression levels are dysregulated during disease progression from NDMM to RRMM and several esterases are identified as prognostic markers in myeloma patients.

Title: Melflufen efficacy in multiple myeloma cell lines with TP53 aberrations
Presenter: Ana Slipicevic, Oncopeptides AB, Stockholm, Sweden

Melflufen can trigger myeloma cell death regardless of cells TP53 status and overcome the p53-deficiency-mediated melphalan resistance. Melflufen response rate in the del 17p patient subpopulation from the phase 2-study HORIZON is comparable to the general RRMM population suggesting that melflufen might be a therapeutic option for these difficult-to-treat patients.

Title: Melflufen, a peptide-conjugated alkylator, shows efficacy in breast cancer cell lines
Presenter: Alexander Schepsky, MD, University of Iceland

Melflufen shows high efficacy and selectivity in breast cancer cells compared to their normal derived isogenic counterparts. Efficacy is facilitated by multiple aminopeptidases including CD13, LAP3 and DPP7. This model indicates that melflufen, a peptide drug-conjugate, has an impact on malignantly transformed cells, which cannot be seen in their non-malignant, physiological normal counterpart.

For more information, please contact:
Fredrik Lehmann, EVP Research and CMC at Oncopeptides
E-mail: [email protected]
Phone: +46 8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 12.00 CET May 15, 2020.

About melflufen
Melflufen (melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On May 15, 2020 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT and network technologies, reported that they will present data demonstrating that the prediction algorithm used to customize TG4050 for each patient is accurate at identifying immunogenic cancer mutations even among a large set of candidate mutations (Press release, NEC, MAY 15, 2020, View Source [SID1234558111]). These data were jointly generated by the Transgene, NEC and NEC Laboratories Europe GmbH teams and will be presented at the upcoming meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2020 (AACR Virtual Annual Meeting II).

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 is an individualized therapeutic vaccine based on Transgene’s myvac technology. It is powered by NEC’s cutting-edge AI capabilities. Two Phase 1 trials with TG4050 are ongoing in Europe and in the USA.
TG4050 has been designed to target up to 30 patient-specific neoantigens (cancer cell mutations) which are selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary immune data, allowing it to accurately prioritize and select the most immunogenic sequences.

To evaluate the accuracy of the prediction, samples from cancer patients were collected. Healthy and tumor tissue were sequenced, and mutations were identified and ranked using the algorithm. These were then evaluated by measuring the frequency of T cells against the predicted antigens. Although preliminary, the results generated to-date suggest that the system can identify rare immunogenic mutation among a large list of candidates identified in the patients.

Transgene uses its expertise in viral vectorization to incorporate the selected neoantigen sequences in the genome of the Modified Vaccinia virus Ankara (MVA) viral vector. The Company has set up a unique in-house good manufacturing practice (GMP) unit dedicated to manufacturing the individualized batches of TG4050 needed for the clinical development of this novel individualized therapeutic vaccine.

Title of the poster: « Performance of neoantigen prediction for the design of TG4050, a patient specific neoantigen cancer vaccine »
Authors: Brandon Malone, Caroline Tosch, Benoit Grellier, Kousuke Onoue, Timo Sztyler, Karola Rittner, Yoshiko Yamashita, Eric Quéméneur, Kaïdre Bendjama
Session Date and Time: June 22-24, 2020
Abstract/Poster Number: 4566
The abstract can be downloaded on the AACR (Free AACR Whitepaper) website.

About TG4050
TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.
TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed for each patient and can be produced in a very short time frame.
This best-in-class candidate is being evaluated in two Phase 1 clinical trials for patients with ovarian cancers (new windowNCT03839524) and HPV-negative head and neck cancers (new windowNCT04183166).

About myvac
myvac is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system to recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network to support the development of myvac individualized immunotherapies that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded an "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050, the first myvac-derived product, is currently being evaluated in two solid tumor clinical trials.

About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (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 major histocompatibility complex (MHC) binding affinity prediction trained on public and proprietary datasets. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.

On May 15, 2020 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported the identification of an HPK1 inhibitor with highly potent and selective anti-tumor activity in preclinical models (Press release, Nimbus Therapeutics, MAY 15, 2020, View Source [SID1234558110]). The data will be presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II, June 22-24, 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!

HPK1 (hematopoietic progenitor kinase 1) is a highly valued target in immuno-oncology due to its role as a regulator of both T cell and dendritic cell activity. However, a key challenge for development of small molecules acting on HPK1 has been to achieve selectivity against other T cell kinases and MAP4K family members. Nimbus utilized its unique structure-based drug discovery engine to identify multiple potent and selective small molecule inhibitors of HPK1. One of these molecules, advanced to in vivo testing, has high selectivity against T cell-specific kinases and kinases in the MAP4K family and exhibits promising activation of human T cells and B cells. In a mouse syngeneic tumor model, oral administration of the HPK1 inhibitor completely eliminated HPK1’s phosphorylation of the T cell receptor, enhanced inflammatory cytokine production, and demonstrated robust tumor growth inhibition.

"We’re excited to pull back the curtain on Nimbus’ HPK1 program and share some of the progress we’ve made against a target that has evaded so many others’ efforts," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Nimbus’ unparalleled expertise in structure-based drug discovery allowed us to chart an entirely new approach to inhibiting HPK1. In addition, we have recently leveraged this approach to generate small molecules against a range of promising new targets, and we look forward to sharing details on these programs in the coming weeks."

"These data support the potential of our HPK1 inhibitor to alter the tumor microenvironment to halt cancer’s immune evasion, which we think could be a powerful tool in today’s immuno-oncology arsenal," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "We are advancing this program into IND-enabling studies, with the goal of entering the clinic next year, and ultimately providing a new therapeutic approach to address the large unmet need among patients with cancer."

On May 14, 2020 Isofol Medical AB’s (publ) (Nasdaq First North Premier Growth Market: ISOFOL) ("Isofol" or the "Company") Board of Directors reported that resolved on May 7, 2020, on a fully guaranteed new share issue of a maximum of 42,739,736 shares with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Isofol Medical, MAY 14, 2020, View Source [SID1234561553]). Through the Rights Issue, the Company will receive approximately SEK 150 million before transaction costs related to the Rights Issue. In connection with the Rights Issue, the Company publishes a prospectus which today has been approved and registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen).

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!