On August 26, 2024 The South Korean biotech company GI Innovation reported that it has signed a clinical trial collaboration and supply agreement with MSD (a tradename of Merck& Co., Inc., Rahway, NJ, USA) to evaluate the combination of GI-102 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma (Press release, GI Innovation, AUG 26, 2024, View Source [SID1234646110]).

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This agreement marks GI Innovation’s second clinical trial collaboration with MSD, following a previous collaboration for GI-101A.

The Phase 2 clinical trial including GI-102 in combination with KEYTRUDA will enroll patients with resistance or non-response to immuno-oncology treatments, leaving them with no further treatment options. GI Innovation is focused on three indications with significant market potential and potential likelihood of success: metastatic liver cancer, melanoma, and renal cell carcinoma. The company has already demonstrated strong anti-cancer efficacy with a 42.9% overall response rate (ORR) in a monotherapy trial of GI-102 in melanoma patients who failed to respond to standard-of-care treatment (3 partial responses out of 7 patients). Complete tumor regression was previously observed in 60% of mice treated with GI-102 monotherapy in a preclinical liver cancer model.

Fourteen hospitals in South Korea and world-renowned sites in the U.S. have agreed to join the trial, including the Mayo Clinic (campuses in Rochester, Florida, and Arizona), Cleveland Clinic and Memorial Sloan Kettering Cancer Center. In South Korea, the trial will take place at leading hospitals including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital of Yonsei University, and St. Vincent’s Hospital.

"We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology. We aim to maximize the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy", said Dr Myung-Ho Jang, GI Innovation’s Chief Scientific Officer.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway NJ, USA.

On August 26, 2024 Diakonos Oncology Corp., a clinical-stage immuno-oncology company, reported the final closing of an oversubscribed seed financing of $11.4 million (Press release, Diakonos Oncology, AUG 26, 2024, View Source [SID1234646109]). The round was led by biotechnology investment firm Restem Group Inc., with participation from existing investors.

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To date, funds have enabled the company to establish manufacturing operations, add key leadership positions, and complete enrollment for the Phase 1 study of lead asset DOC1021 in the treatment of glioblastoma (GBM). The additional capital will fund operations into late 2025 and allow Diakonos to initiate the Phase 2 trial in GBM prior to closing a Series A round.

"We greatly appreciate the support of these investors in sharing our passion for improving the lives of patients suffering from deadly cancers such as glioblastoma," said Mike Wicks, Diakonos CEO. "The fact that this financing is nearly triple our initial target also shows they share our confidence in the effectiveness of our unique cancer therapy. This investment will fund operations through the final readout of key safety and efficacy data from our Phase 1 trial and will allow the company to ramp up preparations for pipeline expansion and the initiation of our Phase 2 GBM trial which is expected to begin in the fourth quarter of this year."

"We are thrilled to invest in this groundbreaking company that is at the forefront of cancer treatment innovation. As a firm deeply involved in the cell therapeutic field, we recognize the immense potential of their pioneering work with dendritic cell therapies and we are confident that this can become a new standard of care for cancer in the future," said Andres Isaias, Executive Chairman of Restem Group Inc.

About DOC1021

DOC1021 is a first-of-its-kind dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient’s cancer through our proprietary double loading technology. Enrollment in the two-year Phase 1 trial was completed in December 2023.

In addition to the lead GBM study, two other clinical trials of Diakonos’ DCV are ongoing for the treatment of pancreatic cancer and angiosarcoma. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program.

Diakonos’ DCVs activate robust cytotoxic TH1 cell signaling pathways that better harness a patient’s immune system to target and eliminate cancer cells. This is achieved without any genetic modification of the patient’s immune cells and without the need for toxic preconditioning.

On August 26, 2024 Opna Bio reported that it has dosed the first patient with OPN-6602, a potent and selective EP300/CBP bromodomain inhibitor, in a Phase 1 clinical study in multiple myeloma (Press release, Opna Bio, AUG 26, 2024, View Source [SID1234646108]). The trial is expected to enroll up to 130 total patients with relapsed or refractory multiple myeloma at sites in the U.S. Multiple myeloma is a type of blood cancer derived from malignant plasma cells in the bone marrow. There are approximately 180,000 people worldwide who are diagnosed with multiple myeloma and 117,000 deaths attributable to the disease annually.

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The first patient was dosed at The START Center for Cancer Research in Grand Rapids, Michigan, with Dr. Andrew Sochacki, principal investigator, leading the study team. "OPN-6602 represents an exciting and novel therapeutic target that will provide a much-needed option for our relapsed and refractory myeloma patient population," stated Dr. Sochacki. "The innovative approach of this therapy has the potential to significantly improve outcomes for patients who have exhausted other treatment options. This collaboration with Opna underscores our commitment to advancing cutting-edge research and delivering new, effective therapies to patients who need them the most."

OPN-6602 is an oral, small molecule inhibitor of the E1A binding protein (EP300) and CREB-binding protein (CBP). Through EP300/CBP inhibition, OPN-6602 down regulates expression of IRF4 and MYC, two transcription factors that drive growth of multiple myeloma cells. Preclinical data presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2024 Annual Meeting showed that OPN-6602 significantly reduced tumor growth as a single agent (71% tumor growth inhibition) in the OPM-2 human multiple myeloma cell xenograft model as well as increased anti-tumor activity (>100% tumor growth inhibition) in combination studies.

"We are pleased to initiate clinical testing of OPN-6602, which has shown potent anti-tumor activity in multiple myeloma models as well as other cancers," said Reinaldo Diaz, MBA, chief executive officer.

The objectives of the open-label study are to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of OPN-6602 as monotherapy and in combination with dexamethasone in patients with relapsed or refractory multiple myeloma. The company expects to enroll up to 90 patients in the dose-escalation cohort, with an additional 40 patients in the dose-expansion cohort. The completion date is expected in the second half of 2026.

Company Appoints Industry Experts to Board of Directors

Additionally, Opna announced the appointments of Axel Bolte, MBA, MSc, to board director and Stephanie Oestreich, PhD, MPA, to board observer, following the Myeloma Investment Fund’s recent investment in Opna. The Myeloma Investment Fund is the philanthropic investment fund of the Multiple Myeloma Research Foundation.

Mr. Bolte most recently served as founder, president and CEO of Inozyme Pharma (INZY), a rare disease company where he continues as director and advisor. He also served as a board director of IVERIC Bio (ISEE) until its sale to Astellas. Mr. Bolte is managing partner for Healthcare Advisors GmbH and was previously venture partner and investment advisor for HBM Partners AG, while serving on multiple boards of private and public companies.

Dr. Oestreich, the managing director of the Myeloma Investment Fund, brings decades of experience, previously serving as chief business officer at Galecto, vice president at Mnemo Therapeutics, as well as venture partner at RA Capital. She was also executive vice president at Evotec where she built its North American investment arm and started an incubator with Samsara BioCapital, as well as worked in business development and commercial functions at Roche and Novartis.

"We welcome Axel Bolte and Dr. Stephanie Oestreich to our board, both of whom bring valuable hands-on experience in industry operations, disease areas, financing and business development," said Diaz.

On August 26, 2024 I-Mab (NASDAQ: IMAB), a US-based, global, clinical-stage biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported that management will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024 (Press release, I-Mab Biopharma, AUG 26, 2024, https://www.prnewswire.com/news-releases/i-mab-to-participate-at-the-hc-wainwright-26th-annual-global-investment-conference-302230144.html [SID1234646107]).

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H.C. Wainwright 26th Annual Global Investment Conference

Presentation Time

Tuesday, September 10 at 5:00 PM ET

Presenters

Sean Fu, PhD, Interim Chief Executive Officer (CEO)

Phillip Dennis, MD, PhD, Chief Medical Officer (CMO)

Webcast link

Here

Meetings

One-on-one and small group meetings: September 9 – 10, 2024

Management
Participants

Sean Fu, PhD, Interim CEO

Joe Skelton, Chief Financial Officer (CFO)

Phillip Dennis, MD, PhD, CMO

Tyler Ehler, Senior Director, Investor Relations

The webcast will also be available under "Event Calendar" on I-Mab’s IR website
at View Source

For more information, please contact your H.C. Wainwright representative.

On August 26, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference (Press release, Ideaya Biosciences, AUG 26, 2024, View Source [SID1234646106]).

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Morgan Stanley 22nd Annual Global Healthcare Conference
Wednesday, September 4th, 2024 at 5:35 PM ET

Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Judah Frommer, Executive Director, Senior Equity Research Analyst
A live audio webcast of the conference event, as permitted by the conference host, will be available at the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcast will be accessible for 30 days following the live event.