On December 2nd, 2021 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") reported that the first patient with Primary immunologic thrombocytopenic purpura (ITP) had been dosed in the Phase II Clinical trial of self-developed Zuberitamab (development code: HS006) (Press release, Zhejiang Hisun Pharmaceutical, DEC 2, 2021, View Source;a=index&classid=43&id=3 [SID1234634620]). The study aims to evaluate the safety and efficacy of Zuberitamab (HS006) in subjects with primary persistent or chronic ITP who failed from prior therapy(ies). The leading entity of the clinical trial is Tongji Medical College, Union Hospital, Huazhong University of Science and Technology and the principal investigator is Prof.Yu Hu.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Zuberitamab (HS006) is a human-mouse chimeric monoclonal antibody that specifically binds to B-lymphocyte antigen CD20 and can kill B cells via ADCC and CDC action. Zuberitamab (HS006) has demonstrated a favorable safety and efficacy profile in B-cell lymphoma in clinical trials. As B cells play an important role in the pathogenesis of autoimmune diseases such as primary immunologic thrombocytopenic purpura (ITP), rheumatoid arthritis (RA), and multiple sclerosis (MS), Zuberitamab (HS006) has the potential to be used in the treatment of autoimmune diseases.

Primary immunologic thrombocytopenic purpura (ITP) is an acquired autoimmune disease characterized by thrombocytopenia. The pathogenesis of ITP is mainly due to the loss of immune tolerance to the patient’s platelet membrane antigens. The patient’s B cells produce antibodies against different platelet antigens, leading to the formation of antigen-antibody complexes, and resulting in excessive destruction of platelets in the spleen or liver. Meanwhile, thrombopoiesis is impaired. Zuberitamab (HS006) specifically clears B-lymphocytes, thereby reducing autoantibody production and platelet destruction. Zuberitamab (HS006) is expected to bring an alternative treatment optionfor ITP patients and improve their quality of life.

"Zuberitamab (HS006) is a self-developed monoclonal antibody that targets the CD20 protein on the surface of B cells. It can rapidly, thoroughly and durably remove CD20+ B cells, and this effect is reversible after drug withdrawal, " said by Dr. Haibin Wang, the Chief Medical Officer (CEO) of BioRay, "The Phase III Clinical trial of Zuberitamab (HS006) for primary treatment of diffuse large B-cell lymphoma has completed the observation of the primary endpoint, and the study results confirmed its good safety, tolerability and efficacy, which provides strong support for the subsequent clinical development of ITP. Based on the existing achievements, BioRay will make every effort to promote its clinical research in ITP and other diseases and promote the early launch of this product in China to benefit more patients."

On December 2, 2021, Delcath Systems, Inc. Presented the Corporate Presentation (Presentation, Delcath Systems, DEC 2, 2021, View Source [SID1234596394]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On December 2, 2021 InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, reported it received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Phase I clinical trial evaluating lead miRNA candidate, INT-1B3, in patients with advanced solid tumors (Press release, InteRNA Technologies, DEC 2, 2021, View Source [SID1234596412]). INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified mimic of the endogenous tumor suppressor, miR-193a-3p, and represents a promising novel therapeutic approach that is designed to simultaneously address multiple hallmarks of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The IND approval enables InteRNA to expand the number of clinical sites and to facilitate the enrollment of patients for the dose expansion (Phase Ib) part of the trial in the United States. The first part of the Phase I trial was initiated in Europe at the beginning of 2021, with the dosing of the first patient in the dose escalation (Phase Ia) part in February. The treatment of the first patient in the Phase Ib cohort is planned for the second half of 2022.

"Receiving such a positive outcome from the FDA shortly after submitting a full IND application is a major achievement for us," commented Laurens van Pinxteren, Chief Operating Officer of InteRNA. "It underlines the high potential of our novel miRNA-based approach that enables us to address the multi-facetted disease cancer from different angles with one drug providing a novel therapeutic entity to patients with hard-to-treat solid tumors, such as advanced breast cancer or hepatocellular carcinoma."

Roel Schaapveld, CEO of InteRNA, added: "The IND approval enables us to enroll an international, diversified patient population, marking significant progress in the clinical evaluation of our novel therapeutic modality. The rapid, positive feedback by the FDA is highly encouraging and we look forward to start patient recruitment in the United States next year."

The multicentric, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) will investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors. The study is expected to enroll a total of up to 80 patients at up to 15 clinical centers in the United States and Europe. The Phase Ia part of the trial is currently ongoing in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. In the second part (Phase Ib) of the trial, approximately 50 patients with hepatocellular carcinoma or triple negative breast cancer will be enrolled in the United States and Europe. Topline results from the Phase Ia part of the study are expected in the first half of 2022.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment.

On December 2, 2021 EOM Pharmaceuticals, Inc. ("EOM"), a privately held, clinical-stage pharmaceutical company, and ImmunoCellular Therapeutics, Ltd. (OTC: IMUC) ("ImmunoCellular") reported that the companies have entered into and closed on a merger agreement pursuant to which the shareholders of EOM are now the majority shareholders of the combined company (Press release, EOM Pharmaceuticals, DEC 2, 2021, View Source [SID1234618848]). The merger will create a public company that will continue EOM’s focus on advancing novel immunomodulatory and retinal disease drug agents to address a range of inflammatory, viral, retinal, and other diseases. ImmunoCellular will be renamed EOM Pharmaceuticals Holdings, Inc. Pending the assignment of a new ticker symbol, EOM Pharmaceuticals’ Common Stock will continue to be quoted on the OTC Markets under the ticker symbol "IMUC." EOM may consider in the future changing the principal listing of the Company Common Stock to a national exchange, assuming it will then meet the relevant listing requirements.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The combined company’s two pipeline assets are EOM613 and EOM147.

• EOM613 is an investigational peptide-nucleic acid solution believed to have both antiinflammatory and pro-inflammatory broad-spectrum cytokine effects. Patients are currently enrolled in R 1 : RESCUE, a Phase 1/2a open-label clinical study in Brazil evaluating EOM613 treatment in severe hospitalized COVID-19 patients with "cytokine storm" immune responses. EOM expects to announce data from this trial in first quarter 2022. Further clinical development of EOM613 includes planning a Phase 2a multi-center trial for cancer cachexia in the U.S. and initiating exploratory trials for rheumatoid arthritis.

• EOM147 is an investigational, reformulated broad-spectrum aminosterol with a unique intracellular mechanism for the treatment of retinal diseases. EOM147 affects multiple angiogenic growth factors such as VEGF, PdGF, and bFGF. This mechanism of action is uniquely differentiated from other retinal therapies that are only anti-VEGF and administered as an intraocular injection. The novel formulation, administered as an eye drop, represents a potential breakthrough that does not require intraocular injection. Planning is underway for Phase 2 ophthalmic trials for macular edema in patients with diabetic retinopathy and wet age-related macular degeneration (wet-AMD).

EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger said, "EOM’s merger with ImmunoCellular provides the resources necessary to advance our lead program, EOM613, as a potential treatment for COVID-19, as well as support the development of both EOM613 and EOM147. We look 2 forward to advancing our pipeline assets and delivering value to all our stakeholders, including patients, the scientific and medical community, and our stockholders."

"COVID-19 continues to pose a grave threat to millions of people worldwide and to challenge the medical and scientific community as it seeks to understand and treat the underlying causes and symptoms of this devastating disease," said EOM Chief Executive Officer and Director Irach Taraporewala, Ph.D. "We are grateful to the investigators and patients in Brazil who are currently participating in our EOM613 clinical trial and look forward to reporting initial results in early 2022."

"After an extensive review of strategic options for ImmunoCellular, we are pleased to announce the merger with EOM," said Gary S. Titus, ImmunoCellular’s Chairman of the Board. "We believe EOM’s focus on advancing novel immunomodulatory and retinal disease agents addressing unmet medical needs, as well as its experienced management team and board of directors, represent a potentially meaningful opportunity for stockholders in the newly combined company to realize long-term value."

About the Merger Pursuant to the merger agreement, EOM shareholders have exchanged all of their EOM common stock for newly issued shares of ImmunoCellular common and Series C convertible preferred stock. Postmerger, ImmunoCellular’s then-current equity holders will own approximately 3.5% and the former EOM equity holders will own approximately 96.5% percent of ImmunoCellular’s common stock, calculated on a fully diluted basis. Effective with the merger, all existing officers and directors of EOM have assumed their same positions in the new company and all existing officers and directors of ImmunoCellular have resigned. The transaction has been unanimously approved by the board of directors of both companies. EOM Pharmaceuticals Holdings, Inc. will be headquartered in Montvale, NJ. Bridgeway Capital Partners and its affiliates served as exclusive financial advisor to EOM on the transaction.

Management and Organization

The new senior leadership team at EOM Pharmaceuticals Holdings, Inc. includes Chief Executive Officer Irach Taraporewala, Ph.D.; EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger; EOM Co-founder, Chief Scientific Officer and Medical Director Shalom Z. Hirschman, M.D; Wayne I. Danson, Chief Financial Officer and Treasurer; and Scientific Advisor and Chair of the Scientific Advisory Board, Frank L. Douglas, Ph.D., M.D.

On December 2, 2021 Integra Therapeutics, a biotechnology company that is creating next-generation gene writing tools to boost the efficiency and safety of advanced therapies, reported the company has completed its first round of funding for €4.5 million with Advent France Biotechnology (France), Invivo Capital (Spain) and Takeda Ventures (USA) (Press release, Integra Therapeutics, DEC 2, 2021, View Source [SID1234654526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Integra Tx was founded in late 2020 as a spin-off of Pompeu Fabra University (UPF) based on technology developed in the Translational Synthetic Biology Lab led by Dr Marc Güell (EMBO Young Investigator, National Research Award for Young Talent and co-founder of two biotech firms).

The great potential of this novel gene writing technology lies in the fact that it resolves some of the main technical limitations of gene therapy: it can be used to paste DNA sequences of any size gene with high precision. Advanced therapies are one of the pillars of the medicine of the future and are aimed at both preventing and treating genetic and oncological diseases that, for now, are incurable.

The funds raised in this round will allow Integra Tx to complete the prototype of the new gene writing technology platform, carry out preclinical validation using in vivo and ex vivo models, and manage its patent portfolio in 2022 and 2023. After that, the company plans to open a Series A round to seek regulatory approval and carry out clinical trials with patients.

"We’re very proud to be transferring our scientific knowledge and technological skills in gene editing from the lab to society. We thank all our investors for their commitment to Integra Tx and to making advanced therapies safer and more effective, and getting them to patients that urgently need them," says Dr Avencia Sánchez-Mejías, co-founder and CEO of Integra Tx. Sánchez-Mejías joined the UPF Translational Synthetic Biology Lab in 2018 after doing research at the Institute of Biomedicine of Seville, the National University of Singapore and the University of Miami Miller School of Medicine.

Dr Marc Güell, co-founder and CSO of Integra Tx, explains, "the Integra Tx technology platform is very promising because it is an evolution of the CRISPR-Cas techniques. We’ve found a way to merge them with transposase and integrase proteins that have a great capacity for gene transfer and to not depend on viral vectors for transporting the components into the cell, which is a step forward in making these therapies safer." Plus, it has applications both in vivo (directly in patients) and ex vivo (outside of patients).

Matthieu Coutet, Managing Partner at Advent France Biotechnology, adds: "We decided to invest in Integra Tx because we believe in its seasoned scientific and management team. Its founders have shown a strong passion and ambition to move Integra Tx’s technology forward, combined with a proven expertise in gene editing and advanced therapies."

Dr Luis Pareras, Managing Partner at Invivo Capital, says: "We’re thrilled with the possibilities Integra Tx’s plataform can develop to solve the problem of cargo size in gene therapy. We’re also very pleased with the international syndicate supporting this seed round, in yet another example of technology transfer opportunity and the competitiveness of the biotech ecosystem in Spain."

Miles Gerson, Takeda Ventures Partner and Senior Investment Director, says: "Takeda Ventures is very excited to support Integra Tx and their next generation gene writing platform with many potential applications to benefit patients."