On March 6, 2024 Blacksmith Medicines, Inc. (Blacksmith), a leading biopharma dedicated to discovering and developing medicines targeting metalloenzymes, reported the company will present data on its oncology program targeting flap endonuclease 1 (FEN1), a structure-specific metallonuclease that cleaves 5′ DNA flaps during replication and repair, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place April 5-10 at the San Diego Convention Center, San Diego CA (Press release, Blacksmith Medicines, MAR 6, 2024, View Source [SID1234640886]).

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Details of the poster presentation are as follows:

Abstract Number: 7148
Title: "Small molecule inhibitor of FEN1 nuclease utilizing a novel metal binding pharmacophore synergizes with inhibitors of USP1, PARP, PARG and ATR"
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 6
Session Date and Time: Wednesday April 10, 2024 9:00 AM – 12:30 PM
Location: Poster Section 23
Poster Board Number: 10

The abstract is now available on the conference website at AACR (Free AACR Whitepaper) Annual Meeting 2024.

About FEN1
Flap endonuclease 1 (FEN1) is a structure-specific di-magnesium metallonuclease that cleaves 5′ DNA flaps during replication and repair. FEN1 is an attractive target for development of anticancer therapeutics because it is overexpressed in many tumor types and has a large number of synthetic lethality partners including genes in Homologous Recombination (HR) pathway.

About metalloenzymes and the Blacksmith platform
Metalloenzymes utilize a metal ion cofactor in the enzyme active site to perform essential biological functions. This diverse class of targets has historically been difficult to drug due to small molecule chemistry limitations that have plagued the industry. The Blacksmith metalloenzyme platform has solved this problem by leveraging the following:

A large proprietary fragment library of metal-binding pharmacophores (MBPs);
A comprehensive database containing a full characterization of the metalloenzyme genome including functions, metal cofactors, and associations to disease;
A first-of-its-kind metallo-CRISPR library of custom single guide RNAs;
An industry-leading metalloenzyme computational toolkit for docking, modeling and structure-based drug design; and
A robust and blocking intellectual property estate covering bioinorganic, medicinal, and computational chemistry approaches for metalloenzyme-targeted medicines.

On March 6, 2024 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that on March 5, 2024 it has received formal confirmation of the fulfillment of the conditions necessary for the disbursement of the Tranche A of EUR 8 million venture debt from the European Investment Bank (EIB), under the financing agreement concluded on August 16, 2022 (Press release, Ryvu Therapeutics, MAR 6, 2024, View Source [SID1234640885]).[KS1] [JJ2] The offer of disbursement of Tranche A was issued by EIB, among other factors specified in the financing agreement, due to the successful transition of the RVU120 program from Phase I to Phase II of clinical development. The company is expecting to receive PLN 8 million payment on March 13, 2024.

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In August 2022, Ryvu announced that the EIB would provide up to a total of EUR 22 million, and this EUR 8 million represents the first tranche. The funds are being provided under the EIB’s venture debt instrument, which is tailored to the specific financing needs of high-growth innovative companies. The European Fund for Strategic Investments, part of the Investment Plan for Europe, is backing this funding with a guarantee.

"We are excited that the progress of RVU120 now allows us to access the funds to help accelerate the development of our lead program and the rest of Ryvu’s pipeline. Together with different sources, the financing secures Ryvu’s cash runway until Q1 2026.", said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu Therapeutics. "We expect that further progress on Phase II RVU120 clinical development will enable Ryvu to fulfill the requirements and obtain the remaining EUR 14 million from the EIB."

The EIB’s financial support will help Ryvu finance its development pipeline of new cancer treatments, from discovery to clinical trials. Ultimately, Ryvu aims to address the clinical limitations of current treatments in oncology and provide patients with access to innovative therapies for hematologic and solid tumors.

On March 6, 2024 Akeso Inc. ("Akeso", 9926. HK) reported the enrollment of the first patient in the registrational Phase III clinical study comparing Cadonilimab (PD-1/CTLA-4 bispecific antibody) combined with chemotherapy versus Tislelizumab (PD-1 antibody) combined with chemotherapy in the first-line treatment for patients with PD-L1 negative (PD-L1 TPS＜1%) non-small cell lung cancer (NSCLC) (NCT05990127) (Press release, Akeso Biopharma, MAR 6, 2024, View Source [SID1234640884]).

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Lung cancer is a prevalent malignancy with significant global incidence and mortality rates. Retrospective studies conducted both worldwide and in China have revealed that PD-L1 negative expression is observed in up to 48% of patients with driver gene-negative NSCLC. Immunotherapy combined with chemotherapy stands as the first-line standard treatment for these patients. However, current treatment approaches provide limited survival benefits for PD-L1 negative patients. Hence, there exists a pressing clinical imperative for novel treatment modalities to enhance patients’ clinical outcomes.

Compared to PD-1/PD-L1 monoclonal antibodies, PD-1 monoclonal antibody plus CTLA-4 monoclonal antibody combined with chemotherapy provides greater benefits for the PD-L1 negative population. Previous studies have demonstrated that Cadonilimab possesses a "high efficacy, low toxicity" profile and shows clinical efficacy in NSCLC patients with PD-L1 negative expression.

The previous clinical studies have demonstrated that the combination therapy of cadonilimab as a first-line treatment for advanced gastric cancer and advanced cervical cancer provides significant survival benefits for the all-comer patients, irrespective of their PD-L1 expression levels. Furthermore, it exhibits robust anti-tumor effects even in patients with low PD-L1 expression or negative status. This therapeutic approach effectively addresses the limitations of current PD-1/PD-L1 monoclonal antibody immunotherapy and has the potential to reshape the landscape of cancer treatment. Akeso anticipates that Cadonilimab, in the treatment of PD-L1 negative NSCLC population, will continue its unique advantages observed in gastric and cervical cancers, becoming a new generation of efficient immunotherapy regimen for first-line treatment of advanced PD-L1 negative NSCLC patients.

On March 6, 2024 Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of personalized therapeutic cancer vaccines (PTCV), reported the upcoming presentation of two posters sharing new clinical data from its Phase 1b/2a GT-30 study of GNOS-PV02, a personalized neoantigen DNA vaccine, in patients with advanced hepatocellular carcinoma, at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The AACR (Free AACR Whitepaper) Annual Meeting will be held in San Diego from April 5-10 (Press release, Geneos Therapeutics, MAR 6, 2024, View Source [SID1234640883]).

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Details of the poster presentations are as follows:

Title: Personalized neoantigen DNA vaccine GNOS-PV02 and pembrolizumab as second-line treatment for advanced hepatocellular carcinoma
Presenting Author: Mark Yarchoan, MD
Abstract Number: 1191
Poster Board Number: 25
Session Title: Tumor Immune Response 1
Session Date and Time: Sunday, Apr 7, 2024, 1:30 pm – 5:00 pm PT
Location: San Diego Convention Center, Poster Section 47

Title: Detection of circulating tumor DNA predicts survival in advanced HCC patients treated with personalized therapeutic DNA cancer vaccine in combination with immune checkpoint blockade
Presenting Author: Jian Yan, PhD
Abstract Number: 976
Poster Board Number: 17
Session Title: Circulating Nucleic Acids 1
Session Date and Time: Sunday, April 7, 2024, 1:30 pm – 5:00 pm PT
Location: San Diego Convention Center, Poster Section 40

On March 6, 2024 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox platform, reported the completion of a $119 million Series E preferred stock financing, including $45 million in new capital and the conversion of $74 million of convertible promissory notes with accrued interest (Press release, Rakuten Medical, MAR 6, 2024, View Source [SID1234640882]).

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Rakuten Medical intends to further develop its proprietary Alluminox platform and contribute to the future of patients and healthcare around the world by allocating the funds raised for the following business priorities:

Continuing efforts to accelerate its global Phase 3 clinical trial (ASP-1929-301 study, ClinicalTrials.gov Identifier: NCT03769506) of Alluminox treatment (photoimmunotherapy) using ASP-1929, with the goal of achieving approval of ASP-1929 in the United States and several other countries and regions as soon as possible
Supporting ongoing clinical trials and initiating new studies for Alluminox treatment using its three key assets (ASP-1929, RM-1995, and RM-0256), including combination therapy with anti-PD-1, which has shown promising early data that Rakuten Medical believes warrant additional clinical studies
In-house discovery of new drug conjugates under its drug discovery program, Alluminox Palette
Development of new medical devices to improve treatment in the clinic and trials
Leveraging learnings and experience from Alluminox treatment in the commercial setting in Japan in an effort to improve patient outcomes and for further understanding and development of this treatment technology
Mickey Mikitani, Co-CEO of Rakuten Medical, commented, "We are very proud to have raised $119 million in Series E financing despite the challenging market environment for biotechnology companies in 2023, when we started this financing round. I would like to thank our many investors for having valued our achievements and great potential. The Alluminox platform will continue to evolve, and together with our trusted business partners and the healthcare professionals who believe in our technology, we will expand this innovative therapy both geographically and clinically, and pave the way for a brighter future."

One of the major investors in this Series E Financing is Hikma Pharmaceuticals PLC ("Hikma"), a global pharmaceutical company headquartered in the UK, with a local presence across the MENA region, North America and Europe. Other major investors include existing investors such as Rakuten Group, Inc., a global internet services company and its Chairman and CEO, Mickey Mikitani, and SBI Group, a leading venture capital firm in Japan, as well as new investors Mizuho Bank, Ltd. and the Dai-ichi Life Insurance Company, Limited, leading Japanese financial institutions.

Rakuten Medical also welcomed Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA region, to its Board of Directors. Darwazah is an experienced executive with more than 38 years of pharmaceutical industry experience gained through serving in various positions within the Hikma Group. With his strong operational direction and experience in driving strategic business decisions that grow healthcare businesses in the MENA region and globally, Darwazah will add value as a solid guide for Rakuten Medical as it moves to a new stage of uncovering more potential as a global biotechnology company.

In making this investment and appointment to the Board of Directors, Darwazah commented, "I am honoured to join Rakuten Medical’s board. Through this appointment, I am looking forward to driving synergies and facilitating a closer working relationship with an important partner that shares Hikma’s vision of shaping a healthier world."