On June 1, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that positive results from the second cohort in its Phase 1/2 study of NOX-A12 in combination with radiotherapy in patients with brain cancer (Glioblastoma Multiforme) (Press release, NOXXON, JUN 1, 2021, View Source [SID1234583331]). Data show that NOX-A12 at 400mg/week continues to be safe and well tolerated with apparent signals of reduction of tumor size.

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The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The six patients in the first two cohorts (3 patients receiving 200 mg/week and 3 patients receiving 400 mg/week) have now completed NOX-A12 therapy, with over 83% of these patients showing reductions in tumor size during or after NOX-A12 treatment with maximal reductions from baseline ranging from 2% to 62%1. These patients tolerated combined radiotherapy and NOX-A12 therapy well without any signs of dose-limiting toxicities.

Two patients, one in each of the first two cohorts, achieved objective responses with tumor reductions greater than 50%, one of which occurred after cessation of NOX-A12 therapy. In three of the six patients, smaller satellite lesions that were present before therapy around the primary tumor completely disappeared. In cohort 1 (200mg/week), two of three patients have survived past the expected average survival of 10 months. Further analysis of survival in each cohort is still pending follow-up.

"These exciting clinical data show a substantial impact on tumor size following treatment with NOX-A12, which continues to be safe and well tolerated in this challenging patient population. We are looking forward to continuing this study and generating further data on the potential of NOX-A12 to make a significant difference to patients in urgent need of effective and safe treatment. Enrolment of patients in the third cohort has been completed and we expect results from the last cohort in Q4 2021," commented Aram Mangasarian, CEO of NOXXON.

NOX-A12 targets CXCL12 (C-X-C Chemokine Ligand 12), a key chemokine protein that communicates between tumor cells and their environment, and is designed to 1) block repair of destroyed blood vessels and 2) break tumor protection against the immune system, enabling anti-cancer immune cells, such as killer T-cells, to enter tumor tissue and attack the cancer cells.

Advanced MRI imaging techniques showed that five of six patients in the first two cohorts achieved reduced blood flow to the tumor compared with baseline2, suggesting that NOX-A12 combined with radiotherapy was able to prevent blood vessel regrowth, a key mechanism of action predicted by preclinical data. The pharmacologic effect was further supported by comparison of pre-treatment to on-therapy tumor tissue from one patient in cohort 1, revealing a disappearance of CXCL12 from the barrier cells that separate the blood from the tissue, suggesting that NOX-A12 was able to effectively suppress its target3.

This tissue comparison also showed an extensive reduction in the number of actively dividing tumor cells, reaching almost zero in the on-therapy sample, and clusters of expanding cytotoxic immune cells throughout the under-treatment sample. This supports the notion that NOX-A12 can facilitate an entrance of immune cells into the tumor and an anti-tumoral immune response4, already at the lowest tested dose in the study.

On June 1, 2021 POINT Biopharma Inc. (POINT), a radiopharmaceutical company dedicated to bringing the many benefits of precision radioligand therapy to cancer patients, reported that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new production facility located in Indianapolis, Indiana (Press release, Point Biopharma, JUN 1, 2021, View Source [SID1234583348]).

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POINT is currently finishing renovations to its 80,000-square-foot radiopharmaceutical manufacturing center which, when complete, will make it one of the largest, state-of-the-art, Good Manufacturing Practices (GMP) radioligand manufacturing facilities in the world. The NRC Materials License authorizes the handling of nuclear material in chemical and/or physical form, enabling POINT to begin work with a wide variety of radioisotopes on-site and complete testing and qualification of its operations.

"The completion of our Indianapolis facility and scope of this Materials License will enable POINT to quickly bring its drug manufacturing operations online," said Todd Hockemeyer, EVP, US Manufacturing Operations at POINT Biopharma. "Our mission is to make radioligand therapy applicable to more cancers, available to more people, thereby improving the lives of cancer patients and their families everywhere. This Materials License is an important milestone in our journey to deliver on our mission. "

"I am proud of the many accomplishments Todd and his team in Indiana have achieved," added Joe McCann, CEO of POINT Biopharma. "Attaining the NRC Materials License means we can get to work using radioisotopes like Lutetium-177 and Actinium-225 at our facility, which is a key milestone in the path to manufacturing our products in Indianapolis."

POINT expects the Indianapolis facility will begin to provide supply for its Phase 3 clinical trial targeting metastatic castration resistant prostate cancer later this year. More information about POINT’s Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH) is available at View Source

POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol "PNT". A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.

On June 1, 2021 Ajax Therapeutics, Inc., a biotechnology company applying computational chemistry and structure-based technologies to develop novel small molecules for hematologic malignancies, reported the completion of a $40 million financing (Press release, Ajax Therapeutics, JUN 1, 2021, View Source [SID1234583362]). The round was led by EcoR1 Capital LLC with participation from additional new investor, Boxer Capital, as well as co-founding investors Inning One Ventures and Schrödinger, Inc. (Nasdaq: SDGR). Existing research collaboration partners, Memorial Sloan Kettering Cancer Center (MSK) and NYU Langone Health, also participated in the financing. Concurrent with the financing, Scott Platshon, Partner of EcoR1 Capital, will join the Ajax Board of Directors.

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"We’re excited to be joining the Ajax team through this financing and supporting the company as it advances its drug development programs toward the clinic," said Scott Platshon, Partner, EcoR1 Capital. "Ajax’s world class scientific founders have proprietary insights into treating hematologic malignancies and we have been impressed by the company’s ability to translate these insights into a promising pipeline of treatments for significant unmet needs for patients."

"We are pleased to welcome EcoR1 and Boxer Capital to our investor syndicate," said Martin Vogelbaum, Ajax co-founder, interim CEO and Managing Partner at Inning One Ventures. "We’ve made significant progress at Ajax since founding the company in 2019 and look forward to continuing the momentum we’ve built with our unique approaches to selectively targeting key cytokine signaling pathways that drive hematologic malignancies."

Proceeds from the financing will support the advancement of Ajax’ lead drug development programs targeting hematologic malignancies. The financing will also support the company’s drug discovery pipeline, including the potential expansion of research efforts beyond hematologic malignancies, in addition to building out the company’s scientific and technical leadership team.

"Ajax began as an academic consortium among the scientific founders who recognized the need for new approaches to treating hematologic malignancies," said Ross Levine, MD, Chair of the Ajax Scientific Advisory Board, a member of the company’s board of directors and a physician-scientist at MSK. "We are extremely pleased with the progress that has been made since converting our consortium into Ajax Therapeutics and look forward, with this financing, to continuing to pursue our selectively targeted approaches to treating hematologic malignancies."

Ajax’s pipeline of novel small molecules is based on disease and structural biology insights from the company’s scientific founders combined with computational drug discovery capabilities through its unique partnership with Schrödinger, the industry leader in molecular simulation software for drug discovery. Through this ongoing collaboration, Ajax and Schrödinger scientists work as an integrated team to precisely design compounds with the desired functional activity, selectivity and drug-like properties.

"When the Ajax team approached us about helping launch the company, we recognized that several of the drug targets under consideration were structurally enabled and highly amenable to our industry-leading computational drug discovery platform to develop novel selectively targeted therapeutics," said Ramy Farid, PhD, President and CEO and of Schrödinger, Inc. and a member of the board of directors of Ajax. "We are very pleased with the rapid progress made from the discovery to the advancement of Ajax’s lead programs toward the clinic."

On June 1, 2021 GlaxoSmithKline (GSK) plc reported that it will present new data from key focus areas within its oncology portfolio at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (4-8 June) and the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress (9-17 June) (Press release, GlaxoSmithKline, JUN 1, 2021, View Source [SID1234583299]).

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GSK will showcase innovative approaches to oncology R&D and cutting-edge science at the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings. The company will present new data on its approved therapies, BLENREP (belantamab mafodotin), JEMPERLI (dostarlimab) and ZEJULA (niraparib), as well as its investigational T-cell receptor therapy (TCR-T) letetresgene autoleucel (lete-cel; GSK3377794) for solid tumours.

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "The data we will share at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) demonstrate the continued strengthening of our oncology R&D pipeline in our focus areas of immuno-oncology, cell therapy and synthetic lethality. We are committed to ensuring our three approved medicines – niraparib, belantamab mafodotin and dostarlimab – help as many patients as possible while exploring novel approaches to expand treatment options for the millions of lives impacted by cancer each year."

Continuing GSK’s momentum in immuno-oncology

Dostarlimab, a programmed death receptor-1 (PD-1) blocking antibody, received accelerated approval in the US in April 2021 for certain women with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test who have progressed on or following prior treatment with a platinum-containing regimen. In addition, in April dostarlimab also received a conditional approval in the EU for the treatment of women with dMMR/microsatellite instability-high (MSI-H) endometrial cancer. Data from the registrational GARNET trial of dostarlimab in multiple tumour types will be presented at ASCO (Free ASCO Whitepaper), including an interim combined efficacy and safety analysis of the endometrial and pan-tumour cohorts (ASCO abstract #2564).

Additionally, GSK will present new data regarding the management of adverse events associated with belantamab mafodotin in relapsed/refractory multiple myeloma (ASCO abstract #8033; EHA (Free EHA Whitepaper) abstracts #EP1026 and #PB1698). Belantamab mafodotin is an anti-BCMA (B-cell maturation antigen) treatment that received accelerated and conditional approvals in the US and EU, respectively, for adult patients with relapsed/refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 antibody, a proteasome inhibitor and an immunomodulatory agent.

Updates from GSK’s efforts in synthetic lethality

GSK will share data from combined analysis of three phase III studies in patients with BRCA mutated ovarian cancer, examining the efficacy of niraparib, as well as its safety profile (ASCO abstract #5518). This research adds to the understanding of the use of this poly (ADP-ribose) polymerase (PARP) inhibitor for maintenance treatment in ovarian cancer. GSK remains committed to fully exploring the potential of niraparib, with clinical trials underway evaluating it in ovarian cancer in combination with other therapies and in other solid tumours.

GSK’s latest research in oncology cell therapy

Lete-cel, GSK’s leading cell therapy asset, is a potential first-in-class TCR-T consisting of modified T cells designed to recognise the NY-ESO-1 antigen, which is present across multiple solid tumours, including synovial sarcoma and myxoid/round cell liposarcoma.[1] A presentation of note will include findings from an interim analysis on the safety and efficacy of lete-cel in myxoid/round cell liposarcoma (ASCO abstract #11521). With three programmes currently in clinical development and an emerging pipeline of enhancement technologies and targets, cell therapy in solid tumours is a key pillar of GSK’s broader oncology strategy to help address unmet patient needs.

The complete list of GSK sponsored abstracts accepted by ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) for presentation/ publication from the company’s areas of cancer research is below.

ASCO

Immuno-oncology

Abstract Name

Presenter

Abstract Number

Antitumor activity of dostarlimab in patients with mismatch mutation repair-deficient/microsatellite instability-high tumours: A combined analysis of 2 cohorts in the GARNET study

Berton, D.

#2564

Inducible T-cell co-stimulatory (ICOS) receptor agonist, feladilimab (fela), alone and in combination (combo) with pembrolizumab (P): Results from INDUCE-1 urothelial carcinoma (UC) expansion cohorts (ECs)

Balar, A.

#4519

Evaluation of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in cervical cancer: Data from phase 1 and phase 2 studies

Strauss, J.

#5509

Long-term follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck (SCCHN)

Chul Cho, B.

#6020

Relationship between corneal exam findings, best-corrected visual acuity (BCVA), and ocular symptoms in patients with relapsed or refractory multiple myeloma (RRMM) receiving belantamab mafodotin (belamaf)

Terpos, E.

#8033

Evolution of standard of care therapies used for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A real-world analysis of patient health records from 2016 to 2019

Saba, N.F.

#e18728

Landscape review of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in oncology: Adoption and recent learnings

Regnault, A.

# e18587

Real-world treatment patterns and outcomes of triple-exposed multiple myeloma patients treated in community oncology practices in the United States

Smith, R.

#e18727

Treatment patterns among patients with advanced/recurrent endometrial

cancer in the United States

Maiese, E.M.

#e18693

Synthetic Lethality

Abstract Name

Presenter

Presentation Details

Niraparib efficacy and safety in patients with BRCA mutated (BRCAm) ovarian cancer: Results from three phase 3 niraparib trials

Gonzalez-Martin, A.

#5518

Real-world patterns and predictors of first-line maintenance use among newly diagnosed advanced ovarian cancer: Is there an opportunity for change?

Liu, J.

#e18710

Real-world progression free survival among newly diagnosed advanced ovarian cancer: Does maintenance therapy work?

Liu, J.

#e18707

Tissue distribution and brain penetration of niraparib in tumour bearing mouse models and its clinical relevance

Gada, K.

#e15066

Oncology Cell Therapy

Abstract Name

Presenter

Presentation Details

IGNYTE-ESO: A master protocol to assess safety and activity of letetresgene autoleucel (lete-cel; GSK3377794) in HLA-A*02+ patients with synovial sarcoma or myxoid/round cell liposarcoma (Substudies 1 and 2)

D’Angelo, S.

#TPS11582

Master protocol to assess safety and recommended phase 2 dose of next generation NY-ESO-1–specific TCR T-cells in HLA-A*02 patients with synovial sarcoma or non-small cell lung cancer (Substudies 1 and 2)

Schoenfeld, A.

#TPS2661

Safety and efficacy of letetresgene autoleucel (lete-cel; GSK3377794) in advanced myxoid/round cell liposarcoma (MRCLS) following high lymphodepletion (Cohort 2): Interim analysis

D’Angelo, S.

#11521

Cancer Epigenetics

Abstract Name

Presenter

Presentation Details

Real-world treatment patterns among advanced HR+/HER2- breast cancer patients in the post-CDK4/6 inhibitor era: An analysis of administrative claims data

Boyle, T. A.

#e18695

EHA

Immuno-oncology

Abstract Name

Presenter

Presentation Details

Characterization of ocular adverse events in patients receiving belantamab mafadotin for ≥12 months: post-hoc analysis of DREAMM-2 study in relapsed/refractory multiple myeloma

Lonial, S.

#EP1026

Relationship between corneal exam findings, best-corrected visual acuity (BCVA), and ocular symptoms in patients with relapsed or refractory multiple myeloma (RRMM) receiving belantamab mafodotin (belamaf)

Terpos, E.

#EP1001

DREAMM-5 platform trial: Belantamab mafodotin (belamaf) in combination with five different novel agents in patients with relapsed/refractory multiple myeloma (RRMM)

Richardson, P.

#PB1698

Landscape review of the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Oncology: Adoption and recent learnings

Regnault, A.

#EP1171

Important information for BLENREP in the EU

Indication

BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Refer to the BLENREP Prescribing Information for a full list of adverse events and the complete important safety information.

About Dostarlimab

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[2] In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab (GSK4057190), a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these Products under the Agreement.

Important Information for JEMPERLI in the EU

Indication

JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum‑containing regimen.

Refer to the JEMPERLI Prescribing Information for a full list of adverse events and the complete important safety information in the EU.

About Niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.

Important Information for ZEJULA

Indication

ZEJULA is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Refer to the ZEJULA Prescribing Information for a full list of adverse events and the complete important safety information.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

On June 1, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following virtual conferences in June (Press release, Iovance Biotherapeutics, JUN 1, 2021, View Source [SID1234583316]):

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Jefferies Virtual Healthcare Conference
Fireside Chat: Tuesday, June 1 at 3:30 p.m. ET
Goldman Sachs 42nd Annual Global Healthcare Conference
Fireside Chat: Wednesday, June 9 at 5:30 p.m. ET
JMP Securities Life Sciences Conference
Fireside Chat: Thursday, June 17 at 2:00 p.m. ET
The live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at View Source