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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On August 26, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer" has been approved (Press release, Mabwell Biotech, AUG 26, 2024, View Source [SID1234646105]). The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. As of the announcement, 9MW2821 has been approved for three pivotal clinical trials.

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9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications. The results of existing clinical studies have demonstrated outstanding therapeutic efficacy and safety profile. The pivotal Phase III clinical study, "an open-label, randomized Phase 3 study to evaluate 9MW2821 vs investigator’s choice of chemotherapy in subjects with locally advanced or metastatic urothelial cancer who have previously received PD-(L)1 inhibitor and platinum-containing chemotherapy", is currently in the enrollment stage.

About Urothelial Carcinoma
Bladder cancer, a form of urothelial carcinoma, stands out among its various subtypes for its significant impact on public health. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) reports that bladder cancer is the ninth most common malignant tumor in incidence and ranks thirteenth in mortality among all malignant tumors. According to The Global Cancer Statistics published by the International Agency for Research on Cancer (IARC) in 2022, there were approximately 614,000 new cases and 220,000 deaths from bladder cancer worldwide. The Disease Burden of Malignant Tumors in China 2022, released by the National Cancer Center in February 2024, reported 92,900 new cases and 41,400 deaths from bladder cancer in China, placing it eleventh and thirteenth globally in terms of new incidences and mortality, respectively. As a prevalent cancer in China, urothelial carcinoma is characterized by a propensity for metastasis, a high recurrence rate, and a short survival time in its advanced stages. It represents a significant disease burden and poses a serious threat to the survival and quality of life of those affected.

About 9MW2821
9MW2821 is a site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. As the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data in cervical cancer (CC), esophageal cancer (EC) and breast cancer, 9MW2821 has been granted Fast Track Designation by FDA in 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has also been granted Orphan Drug Designation by FDA for the treatment of EC, and Breakthrough Therapy Designation by CDE of NMPA, for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.