On September 8, 2022 GlyTherix Ltd reported that it has been jointly awarded a $4.8 million Australian Research Council (ARC) grant to establish a new Industrial Transformation Research Program (ITRP) Hub as part of a consortium of applicants led by The University of Queensland (Press release, Glytherix, SEP 8, 2022, View Source [SID1234619225]).

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The ARC Research Hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR) aims to establish a manufacturing platform for new medical technologies combining innovations in biotechnology and pharmaceutical science. The program addresses industry-led challenges for translation of biologics as molecular radiopharmaceuticals, building capacity in biomanufacturing, radiobiology and radiochemistry.

GlyTherix CEO Brad Walsh stated: "GlyTherix is delighted to be a key industry partner in this project. This project strengthens our long-standing collaboration with Professor Kris Thurecht’s group at The University of Queensland and the Australian Institute for Bioengineering and Nanotechnology (AIBN). The Hub will allow GlyTherix and UQ to accelerate the development of novel imaging and therapeutic versions of GlyTherix’s antibody Miltuximab for the diagnosis and treatment of a range of solid cancers, including prostate, pancreatic, glioblastoma, bladder and non-small cell lung cancer. This grant will further strengthen Australia’s capabilities in this exciting area of novel targeted radiopharmaceutical products and help bring new therapies to Australian patients."

AMTAR Research Hub Director, Professor Kristofer Thurecht from The University of Queensland added, "We are pleased to be working with GlyTherix and other industry and academic partners on this exciting and innovative research program. A key member of a high calibre project team, GlyTherix’s deep expertise in biologics as radiopharmaceuticals will help drive clinical and commercial translation, and advance the technologies required to ensure long-term production capability in Australia."

On September 8, 2022 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported top-line results from the Phase 3 study of its drug candidate rivoceranib combined with camrelizumab versus sorafenib as a first-line therapy for unresectable hepatocellular carcinoma (uHCC) (Press release, Elevar Therapeutics, SEP 8, 2022, View Source [SID1234619224]). Camrelizumab plus rivoceranib significantly prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate (ORR) versus sorafenib, a standard first-line treatment for uHCC. The findings will be presented Sept. 10 during the annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Paris.

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"Camrelizumab (C) plus rivoceranib (R) vs. sorafenib (S) as first-line therapy for unresectable hepatocellular carcinoma (uHCC): a randomized, Phase 3 trial," will be shared as a late-breaking proffered paper presentation at ESMO (Free ESMO Whitepaper) on Sept. 10, 8:40 a.m. – 8:50 a.m. CEST, location 7.1C – Cannes Auditorium. The session title is: Proffered Paper Session 1: GI, upper digestive.

The global, randomized, open-label trial (NCT03764293) included 543 patients (ITT population). The study began in June 2019, reaching its primary endpoint in April 2022. Top-line data included:

Median OS for camrelizumab+rivoceranib was 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5]; hazard ratio (HR) 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001,
Median PFS for camrelizumab+rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]); 1-sided p<0.0001, and
Confirmed ORR for camrelizumab+rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib.
"This study marks the first positive pivotal trial to show survival benefits with an anti-angiogenic TKI plus a PD-1 inhibitor for unresectable hepatocellular carcinoma," said Jan M. Van Tornout, M.D., MSc., chief medical officer of Elevar. "The efficacy results demonstrate that camrelizumab plus rivoceranib present as a new first-line treatment option for uHCC. We look forward to detailing additional findings, including results within Asian and non-Asian populations, shortly after our presentation at ESMO (Free ESMO Whitepaper)."

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer et. all) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for 8 indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.

About Rivoceranib

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) approved in gastric cancer in China (November 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is co-developed by Hengrui Pharmain China and by Elevar Therapeutics, Inc. globally (excluding China). It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Clinical studies are ongoing in multiple solid tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (HCC) (in combination with camrelizumab), adenoid cystic carcinoma (as monotherapy) and colorectal cancer (in combination with Lonsurf). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Hengrui Pharma, under the brand name Aitan.

On September 7, 2022 Oncopeptides, a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that the company has received a research grant of 5 MSEK from Sweden´s Innovation Agency, to develop preclinical proof of concept (PoC) for a novel synthetic small polypeptide for the treatment of multiple myeloma (Press release, Oncopeptides, SEP 7, 2022, View Source [SID1234646789]). The compound is a Natural Killer (NK) cell engaging immunotherapy, with superior tissue penetration and immune cell activation. The NK ENGAGE project has been qualified as a Eurostars program and will be driven by a research consortium including the department of Cancer Immunology at Oslo University Hospital, Norway, Pharmatest Services Ltd in Turku, Finland, and Oncopeptides, together with its collaborator the Royal Institute of Technology in Stockholm, KTH, where the technology originally stems from.
"I am very proud and exhilarated that we have managed to attract world-leading expertise to our research consortium around NK-cell engagers," says Jakob Lindberg, CEO, Oncopeptides AB. "This grant makes it possible to further advance the NK Engage project, that is built on our proprietary technology platform for Small Polypeptide based Killer Engagers (SPiKE) and prepare this compound for clinical development."

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"We are very excited about joining this consortium and believe that the SPiKEs have a great potential to boost NK cell targeting of multiple myeloma," says Fredrik Schjesvold, Head of Oslo Myeloma Center, Norway.

The project is supported by a research grant from Sweden´s Innovation Agency. By project completion, the efficacy of the lead compound will be validated in a novel preclinical model. The data package generated in NK Engage, enables Oncopeptides to enter final preclinical studies including IND enabling studies, and subsequently start clinical development. Following a successful phase 1 trial, a strong data package will be generated to support further development of the candidate drug. The project is expected to start on October 1, 2022 and will continue for 36 months.

For further information, please contact:

Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
E-post: [email protected]
Mobil: + 46 70 262 96 28

On September 7, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported promising preliminary Phase 1/1b monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in BRAF-driven and RAS/MAPK-altered solid tumors (Press release, Erasca, SEP 7, 2022, View Source [SID1234639375]).

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A retrospective pooled analysis of all trials evaluating ERAS-007 or ERAS-601 in advanced solid tumors was performed that included Erasca’s ongoing HERKULES-1 and FLAGSHP-1 trials and Asana BioSciences’ previously completed ASN007-101 trial. The analysis was designed to identify responsive subsets that were particularly sensitive to ERAS-007 or ERAS-601 for prioritized combination development within indications of high unmet medical need where no approved targeted therapies are available. Patients with solid tumors with RAS/MAPK alterations were segmented into two groups based on differing levels of responsiveness to monotherapy inhibition and differences in RAS/MAPK pathway reactivation: (1) patients with colorectal cancer (CRC) and (2) patients with non-CRC.

"Worldwide, an estimated 5.5 million lives are at stake annually due to RAS/MAPK pathway alterations, with over 70% of unmet needs lacking approved targeted therapies. We believe the promising single agent responses and favorable safety and tolerability profiles for ERAS-007 and ERAS-601 in patient subsets are highly encouraging and further support our prioritized combination development strategy," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "These early data suggest combining ERAS-007 with the cell cycle inhibitor palbociclib may synergistically achieve tumor cell killing and overcome compensatory responses to RAS/MAPK inhibition in RAS mutant CRC, which represents half of all patients with CRC, and KRAS mutant pancreatic cancer, which accounts for over 90% of patients with pancreatic cancer. Moreover, these preliminary efficacy signals heighten our conviction regarding the therapeutic potential of our first MAPKlamp, combining ERAS-007 with ERAS-601 in specific patient populations with RAS/MAPK alterations such as certain BRAF-driven malignancies. We anticipate initiating a dose escalation trial for ERAS-007 in combination with ERAS-601 in the first half of 2023."

Key findings from the retrospective pooled interim analysis of ERAS-007 and ERAS-601 include*:

23% (6/26) of patients with RAS/MAPK-altered non-CRC solid tumors responded (2 confirmed and 4 unconfirmed PRs) to single agent ERAS-007 or ERAS-601
44% (4/9) with a subset of BRAF-driven non-CRC solid tumors responded (1 confirmed and 3 unconfirmed PRs) to single agent ERAS-007 or ERAS-601
ERAS-007 and ERAS-601 had favorable safety and tolerability monotherapy profiles with largely non-overlapping treatment-related adverse events that are expected to be monitorable and manageable at the likely recommended combination doses
Wei Lin, M.D., Erasca’s chief medical officer, added, "What we have learned from other targeted therapies is that combinations are the best approach to provide durable treatment responses in patients with RAS/MAPK alterations. These early data demonstrating monotherapy activity with ERAS-007 or ERAS-601 and favorable safety profiles are highly encouraging and support the potential of ERAS-007 and ERAS-601 to be foundational combination agents for the treatment of solid tumors with RAS/MAPK alterations. We look forward to further exploring the therapeutic potential of combinations involving ERAS-007 and ERAS-601, including with each other as part of Erasca’s first MAPKlamp combination, across different patient types."

* Data cutoff dates of 11/6/20, 7/11/22, and 5/16/22 for ASN007-101, FLAGSHP-1, and HERKULES-1 trials, respectively.

About ERAS-007
ERAS-007 is a potential best-in-class oral, selective ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the RAS/MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of HERKULES clinical trials that span multiple tumor types and includes both monotherapy and combinations with approved and investigational agents, such as receptor tyrosine kinase (RTK), RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and will include a combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol for ERAS-007 in combination with various agents in patients with non-small cell lung cancer (NSCLC). HERKULES-3 is a Phase 1b/2 master protocol for ERAS-007 in combination with various agents in patients with gastrointestinal cancers.

About ERAS-601
ERAS-601 is a potential best-in-class oral, selective SHP2 inhibitor being investigated alone or in combination. SHP2 acts as a convergent node for RTK signaling, relaying growth and survival signals from RTKs to intracellular signaling pathways. ERAS-601 combined with the ERK1/2 inhibitor ERAS-007 makes up Erasca’s first innovative MAPKlamp strategy. ERAS-601 is being investigated across a series of clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents. FLAGSHP-1 is a Phase 1/1b clinical trial evaluating ERAS-601 as a monotherapy in advanced solid tumors and in combination in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC and human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). HERKULES-1 is a Phase 1b/2 clinical trial that will include evaluation of ERAS-601 in combination with ERAS-007 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol that includes evaluation of ERAS-601 in combination with various agents in patients with NSCLC.

On September 7, 2022 Integral Molecular, the leader in antibody discovery against membrane proteins, reported that it has been accepted into the U.S. Food & Drug Administration (FDA)’s ISTAND pilot program (Press release, Integral Molecular, SEP 7, 2022, View Source [SID1234623249]). This program supports Innovative Science and Technology Approaches for New Drugs and was created to expand the drug development tool types listed in the 21st Century Cures legislation. A major goal of the pilot program is to qualify these tools, thus facilitating regulatory review by allowing them to be used in regulatory (IND, NDA or BLA) applications without needing the FDA to reconsider and reconfirm their suitability.

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Despite their reputation for ‘exquisite specificity’, antibodies and antibody-based therapies, such as CAR-T cells, frequently demonstrate unexpected off-target binding. Integral Molecular’s Membrane Proteome Array (MPA) for antibody specificity and safety profiling intends to address ICH-FDA’s in vitro testing recommendations to assess unintended binding of monoclonal antibodies that can result in safety and toxicity issues.

The MPA is one of the largest collections of membrane proteins used for specificity profiling of antibody-based therapeutics, with over 6,000 native-conformation membrane proteins encompassing nearly the entire human membrane proteome. This technology is intended to be compatible with numerous biotherapeutic modalities, including monoclonal antibodies, bispecifics, and CAR-T therapeutics.

"We are thrilled to be working with the FDA’s ISTAND program," said Benjamin Doranz, CEO of Integral Molecular. "We share the FDA’s interest in developing in vitro technologies to better assess the safety of antibody drugs at an earlier and less costly stage of development."