On September 7, 2022 Qli5 Therapeutics GmbH (QLi5), a German-Korean joint venturedeveloping a new class of proteasome inhibitors, reported the company has closed a EUR 10 million series A financing round with an international consortium of investors including SV Investment (Korea), KHAN Technology Transfer Fund I (Germany), Atinum Investment (Korea) and DAOL Investment (former KTB, Korea) (Press release, QLi5 Therapeutics, SEP 7, 2022, View Source [SID1234654540]).

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QLi5 will use the proceeds to advance its pipeline of highly-differentiated proteasome inhibitors to the start of clinical trials addressing various indications. The proteasome functions as cellular ‘garbage processing facility’ eliminating misfolded, damaged or expired proteins. It is therefore critical to cell survival and presents a compelling target for the treatment of multiple conditions that involve an overproduction of non-functional proteins, including cancer, inflammation and autoimmune diseases.

Based on the leading proteasome expertise of Nobel laureate and company co-founder Prof. Robert Huber and a multi-year collaboration between his lab at the Max Planck Institute for Biochemistry and the Lead Discovery Center (LDC), QLi5 has established a versatile platform for the design of proteasome inhibitors with outstanding selectivity, unique non-covalent binding characteristics and favourable pharmacodynamic properties.

"This new class of proteasome inhibitors has significant advantages over first-generation approaches and opens a wide field of therapeutic applications. We are very much impressed with both, the platform and the progress made so far", Representative of SV Investment says.

"QLi5 demonstrates what can be achieved when excellent science meets with professional drug discovery and development expertise", adds Kiyean Nam, CEO and CSO of Qurient, co-founder of QLi5 and long-term strategic partner of the Max-Planck-Society and the LDC.

"We are glad to see the program advance so rapidly and efficiently. With the financing and added management expertise it is well on track to deliver on its promise for many patients who currently lack sufficient treatment options", says Bert Klebl, CEO of the LDC.

"The commitment of this renowned group of investors highlights the exceptional potential of QLi5’s proteasome programs. I am looking forward to being part of this team of brilliant scientists and drug developers. Together, we are perfectly set to bringing the approach full fruition, medically and commercially", says Martin Huber, CEO of QLi5.

"The current financing round is straightforwardly enabling new opportunities for treating patients with cancer, inflammation and autoimmune diseases. We are perfectly satisfied, that the groundbreaking work from the Max Planck Institute for Biochemistry, put into experienced hands in industry, lays the foundation for this promising endeavour", explains Dieter Link, licensing and patent manager at Max Planck Innovation.

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."

On September 7, 2022 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the selection of an abstract for a poster presentation at the 34th EORTC/NCI/AACR Symposium on Molecular Targets and Cancer Therapeutics (Press release, Merus, SEP 7, 2022, View Source [SID1234619268]).

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Presentation Details:

Title: MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors: an ongoing phase 1/2 study
Session: New Therapies in Immuno Oncology
Date: Friday, October 28, 2022
Time: 10:00-15:00 CET
Abstract #: 341
Poster #: PB121

The abstract will be available starting Wednesday, October 12, 2022 at 9:00 a.m. CET and the poster available at the start of the conference on October 26, 2022 and on-demand throughout the conference, both on the conference website. The poster will also be available on the Merus website contemporaneously.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant non-small cell lung cancer (NSCLC) in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.