On December 21, 2022 Anocca, a fully integrated cell therapy biotechnology company, reported that it has secured EUR 25 million Venture Debt financing from the European Investment Bank (EIB) (Press release, Anocca, DEC 21, 2022, View Source [SID1234625469]). This significant investment recognises the strength and high potential of Anocca and its transformational approach to developing T-cell therapies for cancer.

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Anocca’s CEO and co-founder Reagan Jarvis said, "We’re delighted that the EIB has chosen to support us as we build a critical piece of advanced biotechnology capability and infrastructure in Sweden. Anocca’s mission is to expand the clinical and commercial reach of cell therapies by leveraging our proprietary analytical and manufacturing platforms. This financing supports us in moving our first generation of T-cell immunotherapies towards clinical trials in a solid tumour indication during 2024."

Anocca’s Board Chairman, Hans Stråberg added, "This financing further validates Anocca’s cutting-edge and novel approach to immunotherapy. It supports our ambitious plan to create an extensive clinical pipeline of game changing cancer therapies. We welcome the EIB to our committed group of investors as we continue building a leading European biotechnology company with the potential to transform the treatment of serious diseases."

Paolo Gentiloni, European Commissioner for Economy, said: "This agreement is one of the first InvestEU investment in Sweden in life science. It is also an important contribution to the development of cutting-edge technologies which can help us fight cancer, in line with Europe’s Beating Cancer Plan. Research and development endeavours need significant and sustained investment to make sure they deliver on the promises they hold for our future. InvestEU is helping build this bright future by giving innovative companies access to the finance they need to grow and continue to innovate."

Thomas Östros, Vice-President at EIB, said: "Impressed by the team and their pioneering approach to engineering T-Cell therapies for cancer, I am delighted to announce this EUR 25 million EIB venture debt support to Swedish biotechnology company Anocca. Ultimately, our financing will help to accelerate clinical development to provide patients with access to innovative therapies in areas of high unmet medical need. This support confirms EIB’s role as a leading investor in innovation and life sciences and boosts Europe’s competitiveness and role as a research powerhouse."

On December 20, 2022 iOnctura BV, a clinical-stage biotech developing novel cancer therapies, reported that it has been granted EUR17.5 million funding from the European Investment Council’s (EIC) Accelerator Program to develop IOA-289 for pancreatic cancer (Press release, iOnctura, DEC 20, 2022, View Source [SID1234640234]). The EIC’s funding consists of a grant of EUR2.5 million, and EUR15 million of equity investment.

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On 8 December 2022 iOnctura announced the first patient was dosed in a Phase Ib clinical trial of IOA-289 in metastatic pancreatic cancer.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "We are delighted to announce this funding from the EIC to support the clinical development of IOA-289 for the treatment of pancreatic cancer. Pancreatic cancer is the only cancer with mortality on the rise in both sexes and is currently the 3rd largest cause of death by cancer in the US, and the 4th in Europe."

"There’s an urgent need to develop new therapies for pancreatic cancer and preclinical data demonstrate that IOA-289 offers a new approach, through a multi-pronged mechanism that addresses three hallmarks of cancer: fibrosis, immune suppression and tumor cell proliferation."

iOnctura was granted the maximum allowed funding in appreciation of the significant potential of IOA-289, a highly-selective, first-in-class autotaxin inhibitor, to transform the treatment of pancreatic cancer. The judging panel recognized its unique ability to simultaneously target independent tumor survival pathways associated with tumor proliferation, fibrosis and immune suppression.

Funding came as part of the most recent tranche of grants from the EIC Accelerator program under Horizon Europe, that aims to accelerate deep tech start-ups through grants and equity investments. For this second wave of grants, the European Commission selected 78 innovative start-ups for funding during a highly competitive process. In all, 240 companies were interviewed by juries of experienced investors and entrepreneurs out of a total of more than 1,000 applications. The selected companies will together receive up to EUR470 million of funding in a combination of grants and equity investments.

The Phase Ib AION-02 study (NCT05586516) is a dose-escalation study of IOA-289 in combination with standard-of-care gemcitabine/nab-paclitaxel chemotherapy in first-line metastatic pancreatic cancer.

On December 20, 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 dosing of the first patient in the HERKULES-1 Phase 1b trial evaluating ERK1/2 inhibitor ERAS-007 in combination with SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in patients with RAS/MAPK pathway-altered solid tumors (Press release, Erasca, DEC 20, 2022, View Source [SID1234639362]).

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"We are pleased with our team’s efficient execution that resulted in dosing the first patient in our MAPKlamp trial in 2022 ahead of schedule," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "ERK and SHP2 inhibition with ERAS-007 and ERAS-601 targets critical downstream and upstream nodes in the RAS/MAPK pathway, offering a rational approach that is supported by early clinical data that we presented at our R&D Day in September. Notably, we reported four responses in nine patients with BRAF-driven tumors to either monotherapy ERAS-007 or ERAS-601. Three of these responses were in tumors with BRAF Class 2 or 3 alterations, including a confirmed response to monotherapy SHP2 inhibition in a patient with a BRAF Class 3 alteration, which is dependent on upstream receptor tyrosine kinase (RTK) activation. We look forward to exploring the potential to address the high unmet need in these BRAF subtypes, which have no approved targeted therapies and represent up to 25% of all BRAF-driven tumors."

The MAPKlamp portion of HERKULES-1 will initially examine the safety, tolerability, and preliminary efficacy of ERAS-007 in combination with ERAS-601 in patients with RAS/MAPK pathway-altered solid tumors. After a recommended dose is determined, the Phase 2 expansion portion will further evaluate the safety and efficacy of the combination in patients with different mutational subtypes, including BRAF Class 2 and 3 patients. ERAS-007 and ERAS-601 had favorable monotherapy safety and tolerability profiles with largely non-overlapping treatment-related adverse events that support combination development. Forty-four percent (4/9) of patients with BRAF-driven tumors responded (one confirmed and three unconfirmed PRs) to single agent ERAS-007 or ERAS-601, including three (one confirmed and two unconfirmed PRs) in tumors with BRAF Class 2 and 3 alterations.

The clinical data referred to above was presented at Erasca’s September 7, 2022 R&D Day, and consisted of a retrospective pooled interim analysis of monotherapy ERAS-007 and ERAS-601 data, with data cutoff dates of 11/6/20, 7/11/22, and 5/16/22 for the ASN007-101, FLAGSHP-1, and HERKULES-1 trials, respectively.

About ERAS-007
ERAS-007 is a potential best-in-class 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 the series of HERKULES clinical trials that span multiple tumor types and includes both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in 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 clinical trial 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 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal (GI) 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 receptor tyrosine kinase (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 includes evaluation of ERAS-601 in combination with ERAS-007 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol clinical trial that includes evaluation of ERAS-601 in combination with various agents in patients with non-small cell lung cancer (NSCLC).

On December 20, 2022 Thyas Co. Ltd. ("Thyas"; Kyoto, Japan; Representative Directors, Yasumichi Hitoshi and Ryosuke Gonotsubo) has reported it concluded a joint research agreement and a license agreement for an exclusive use of data and patents of clinical manufacturing methods of iPSC-derived CAR-transduced natural killer cells ("iCAR-NK") with the Center for iPS Cell Research and Application, Kyoto University ("CiRA"; Kyoto, Japan; Director: Jun Takahashi),
The CiRA Foundation ("CiRA_F"; Kyoto, Japan; Representative Director: Shinya Yamanaka), Kirin Holdings Company, Limited ("Kirin Holdings"; Tokyo, Japan; President and CEO: Yoshinori Isozaki) (Press release, Thyas , DEC 20, 2022, View Source [SID1234629216]).

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The details of the agreements are as shown below:
Contracts Contents Contract Parties Joint
Research
Agreements Thyas to support clinical manufacturing of iCARNK CiRA, CiRA_F, Thyas Patent
License Agreement CiRA and Kirin Holdings to license Thyas an
Exclusive use of patents and data related to the clinical manufacturing methods of iCAR-NK CiRA, Thyas Research
Data
License Agreement CiRA, Kirin Holdings, Thyas
Under the agreements, Thyas participates in the manufacturing of iCAR-NK for the Phase I clinical trial (the "Clinical Trial"; investigator-initiated clinical trial) of the product. Thyas obtains an exclusive license of the patents related to the manufacturing methods of iCARNK from Kyoto University and the manufacturing data and documents from Kyoto University and Kirin Holdings.

About The Clinical Trial and AMED’s "Innovative Cancer Research Project
Funded by the Japan Agency for Medical Research and Development ("AMED") (The project is called "Innovative Cancer Therapy Research Project for Practical Use"), the Clinical Trial is being conducted by Professor Shin Kaneko’s group at CiRA and the National Cancer Center Hospital East. In the Clinical Trial, patients with inoperable advanced recurrent ovarian clear cell carcinoma that expresses glypican-3 (GPC3; a protein only certain tumors specifically express) are treated with GPC3-specific iCAR-NK. The endpoints of the Clinical Trial is to evaluate the safety, tolerability, and preliminary efficacy of the iCARNK. The first patient is dosed in Fall 2021.

About iCAR-NK
Professor Kaneko’s group at CiRA developed iCAR-NK by introducing a chimeric antigen receptor (CAR) gene that recognizes GPC3 into iPS cells and differentiated them into natural killer cells. In recent years, clinical development of cancer immune-cell therapy is growing rapidly all over the world. However, at present, only a few clinical trials have been

conducted with iPSC-derived immune cells. The iCAR-NK, developed by Professor Kaneko’s group, is the world’s first iPSC-derived immune cell product for a clinical trial involving patients with a solid tumor.

On December 20, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, reported that it just completed a pre-clinical study using its intranasal formulation of AccuTOXTM in the context of animals with pre-established lung cancer (Press release, Defence Therapeutics, DEC 20, 2022, View Source [SID1234626259]). The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals. This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination.

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AccuTOXTM as a pleiotropic anti-cancer treatment.

The AccuTOXTM molecule was originally designed to exhibit enhanced anti-tumoral properties compared to the original AccumTM molecule. In fact, the IC50 of AccuTOXTM is 30-fold lower than that of AccumTM clearly demonstrating improved therapeutic potency as shown using a large set of murine and human tumors. This is also exemplified by the enhanced therapeutic potency of the compound when directly injected in solid tumors in combination with various immune-checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47).

The sum of these results paved the path to test the compound in another animal model of preestablished lung cancer delivered via the intranasal route. For that purpose, a series of maximum tolerated dose (MTD) studies was conducted to identify the volume, dosage and tolerance of mice to repetitive administration of AccuTOXTM. These studies show that AccuTOXTM is well tolerated up to 3 mg/kg (5-6 times lower than the injectable dose) with a regimen of 6 administrations over 2 weeks. When tested using this schedule on animals with lung tumors, AccuTOXTM decreased by over 50% the number of cancer nodules especially in the group combined with the anti-PD1 immune-checkpoint inhibitor.

"We are very pleased with the versatile use of AccuTOXTM as a cancer therapeutic. The compound has not only shown a great potential in treating solid tumors, but we have now data demonstrating that it can be further adapted and delivered via the intranasal route to treat lungs with metastatic tumors which is a new hope for lung cancer patients", says Mr. Plouffe, the CEO of Defence Therapeutics. "And this will open-up a completely new horizon for AccuTOXTM as an anti-cancer treatment", he adds. The global lung cancer therapeutics market size was estimated at USD 27.57 billion in 2021 and it is expected to surpass around USD 55.6 billion by 2030 with a registered CAGR of 8.11% from 2022 to 2030 according to Precedence Research.

The AccuTOXTM program is one of Defence’s most advanced immune-oncology programs. The Company is currently preparing for its FDA meeting to obtain approval for initiating a Phase I trial against solid tumors in 2023. By demonstrating great safety and tolerability profiles in patients, AccuTOXTM can become the next generation anti-cancer treatment for a wide range of indications.