On April 13, 2024 Ingenium Therapeutics reported the company had attracted ‘Pre-Series A’ investment worth 5.7 billion won (Press release, Ingenium Therapeutics, APR 13, 2022, View Source [SID1234643520]).

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Venture capital (VC) companies such as Capstone Partners, K-Ground, Kairos Investment, Maple, and Laplace participated in this investment.

Ingenium is developing an anti-cancer natural killer (NK) cell therapy. The patent was transferred from the Korea Research Institute of Bioscience and Biotechnology. It is explained that clinical results (data), management’s expertise, and potential as a next-generation anticancer drug led to this investment.

Ingenium plans to apply for phase 1 and 2 clinical trials to the Ministry of Food and Drug Safety at the end of this month. It is planned to be conducted on patients with refractory acute myeloid leukemia (refractory AML) at three domestic medical institutions, including Asan Medical Center, Samsung Medical Center, and Seoul St. Mary’s Hospital.

For lymphocytic leukemia, chimeric antigen receptor T cell (CAR-T) treatment is commercially available. On the other hand, there is currently no specific treatment for incurable acute myeloid leukemia. Even after receiving an allogeneic hematopoietic stem cell transplant, the recurrence rate within one year is 60-70%. Also, the 5-year survival rate is less than 10%.

Ingenium also reported that it succeeded in mass producing NK cells. The company’s NK cells are expected to have strong anti-cancer abilities due to their high expression of surface active receptors and high levels of ‘interferon gamma (IFN-r)’. It was said that cell viability was also high, overcoming the problem of ‘short survival period in the body’, which was known to be a limitation of existing NK cell treatments.

A company official said, "As a result of researchers’ clinical trials conducted by Korea Life Insurance Co., Ltd. on about 100 patients with incurable leukemia between 2009 and 2018, the survival rate increased more than three times compared to existing hematopoietic stem cell transplantation," adding, "The goal is to obtain conditional approval in 2024 when phase 2 is completed." "He said.

Ingenium is also preparing for global clinical trials with the goal of entering next year. We plan to pursue clinical trials not only for intractable leukemia, but also for lung cancer, liver cancer, and colon cancer, which have previously shown effectiveness in preclinical trials.

On April 13, 2022 Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or "the Company"), a biopharmaceutical company developing transformational vaccines to address significant global health challenges, reported that it has entered into definitive agreements with several institutional investors for the purchase of 1,180,812 shares of common stock (or common stock equivalents in lieu thereof) in a private placement priced at-the-market under Nasdaq rules (Press release, Onconetix, APR 13, 2022, View Source [SID1234641107]). The Company will also issue to the investors unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 1,180,812 shares of common stock. The purchase price for one share of common stock (or common stock equivalent) and one investment option to purchase one share of common stock is $6.775. The investment options have an exercise price of $6.65 per share, will be exercisable immediately upon issuance, and will have a term equal to four years following the issuance date.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the private placement are expected to be approximately $8.0 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the private placement for the research and development of its pipeline as well as for working capital and other general corporate purposes. The private placement is expected to close on or about April 18, 2022, subject to the satisfaction of customary closing conditions.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with investors, BWV has agreed to file a resale registration statement covering the securities described above within twenty days.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On 13 April 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, reported that Boehringer Ingelheim has exercised its option to receive exclusive rights to a third novel oncology target from an ongoing discovery collaboration (Press release, Oxford BioTherapeutics, APR 13, 2022, View Source [SID1234626469]). The target was discovered using OBTs proprietary OGAP drug discovery platform, which incorporates one of the world’s largest proteomic databases, integrating clinical, experimental and expression data. The option triggers another milestone payment from Boehringer Ingelheim to OBT.

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Under the terms of the agreement, Boehringer Ingelheim will be responsible for the future development and commercialization of antibody products to the target. OBT will receive development and regulatory milestone payments as well as royalties on any future product sales. This represents the third asset to be optioned under the longstanding partnership between OBT and Boehringer Ingelheim, with the first two programs already in clinical development.

"Boehringer Ingelheim’s decision to exercise its option on a third oncology drug target, developed under our collaboration, is further validation of our proprietary OGAP drug discovery platform," said OBT’s Chief Executive Officer, Dr. Christian Rohlff. "Selecting the right target is fundamental for the successful development of a first-in-class antibody drug product. OBT’s platforms are designed to discover and engineer antibody constructs to novel therapeutic targets – including bi-specific, Chimeric Antigen Receptor T Cell (CAR-T), other T- cell and NK cell-mediated cytotoxicity (ADCC) and ADC therapeutics – to best address difficult-to-treat cancers. We believe that the advancement of the first two Boehringer Ingelheim compounds, directed to oncology targets identified by us, into the clinic, further validates our approach."

In addition to the programs in the partnership with Boehringer Ingelheim, OBT’s own clinical assets have also been enabled through the OGAP discovery platform. A major differentiator between OBT’s discovery platform and other approaches is the retention of the link between individual patient samples through to the design of therapeutic antibodies and diagnostic patient selection tools, which increases the overall success rate of these novel compounds transitioning into clinical development.

On April 13, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that new preclinical findings of ALLO-316, an AlloCAR T therapy targeting CD70 for the treatment of renal cell carcinoma (RCC), were presented in a poster session of the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Allogene, APR 13, 2022, View Source [SID1234616272]). The findings were also published in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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ALLO-316 targets CD70, which is expressed in a number of malignancies ranging from solid tumors such as RCC, lung cancer and glioblastoma to hematologic cancers including acute myeloid leukemia (AML), diffuse large B-cell lymphoma, T-cell lymphomas, and multiple myeloma.

CD70 has previously been shown to be highly expressed in RCC and several hematological cancers with limited normal tissue expression. The current work illustrates that CAR T cells targeting CD70 could be generated in which expression of CD70 CARs was found to mask the cells own CD70 receptors in cis, providing protection from CAR T-mediated fratricide. Multiple CAR T cell constructs were evaluated for anti-tumor activity against RCC cell line and patient-derived mouse tumor models. Lead candidates were evaluated in preclinical safety studies which indicated limited potential for off-target binding. Lastly, highly functional CD70 allogeneic CAR T cells that were gene-edited with TALEN to eliminate TCR expression were produced at large scale. These preclinical data provide support for the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing hematological cancers and solid tumors.

"These results add to our strong interest in evaluating the potential of ALLO-316 to treat patients with CD70 expressing malignancies, including RCC and other cancers," said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "Coupled with previously published preclinical data on ALLO-316 in a variety of tumors, these findings reinforce our belief that CD70 is an important target across a broad spectrum of cancers."

In March, Allogene announced that the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. RCC is a disease in need of innovation as current therapies are limited to a few mechanistic targets and complete response rates are low. The five-year survival rate for patients with metastatic kidney cancer is less than 15%. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC.

On April 13, 2022 Juniper Biologics, a science-led healthcare company focused on researching, developing and commercializing novel therapies reported that it has gained the licensing rights to develop and commercialize TG-C LD (TissueGene-C low dose) for the treatment of knee osteoarthritis (Press release, Juniper Biologics, APR 13, 2022, View Source [SID1234615016]).

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The $600 million USD licensing deal which covers Asia Pacific, Middle East and Africa was signed withKolon Life Science, and is Juniper Biologics’ second acquisition in as many months. Under the terms of the partnership, Juniper Biologics will be responsible for developing and commercializing TG-C LD to medical professionals and hospitals within these regions. Kolon Life Science will be responsible for supporting the development as well as supplying TG-C LD.

TG-C LD is a non-surgical investigational treatment that has been hailed as the world’s first cell-mediated gene therapy for osteoarthritis of the knee,[i] which is the most common form of arthritis.[ii] According to research, osteoarthritis is estimated to be the eleventh[1] leading cause of disability worldwide with an estimated 300 million patients in Asia Pacific and Middle East and Africa alone, suffering from the debilitating effects of the degenerative joint disease. It is one of the biggest unmet medical needs among musculoskeletal conditions with the risk demonstrated to increase with age[iii] .

A first-in-class cell-mediated gene therapy, TG-C LD targets knee osteoarthritis through a single intra-articular injection. Kolon TissueGene, the license holder for TG-C in the United States (not TG-C LD), has already completed a phase 2 clinical trial in the United States, with initial data demonstrating sustained pain relief and mobility improvement following a single injection in the knee joint, for possibly up to 2 years. Phase 3 clinical trials in the United States comprising 1,020 patients are currently ongoing to confirm the safety and efficacy of TG-C. In addition to confirm the statistically significant pain reduction and function improvements observed from the US Phase 2 clinical trial, the trials are designed to show the delay of disease progression to achieve a DMOAD (Disease Modifying Osteoarthritis Drug) designation.

Juniper Biologics CEO, Raman Singh, said: "We are always looking to identify areas in which we can make the most difference and TG-C LD offers substantial relief for knee osteoarthritis patients who would otherwise be in need of surgery or other treatment options. We are committed to providing innovative treatments to treat osteoarthritis of the knee through the regeneration of cartilage and we believe this innovative investigational treatment will bring relief to millions of patients across the region."

"We are excited to work with Juniper Biologics to establish new avenues for patients to access this innovative investigational cell therapy. This would be a validation of our technology and its market value." said Woosok Lee President and CEO, Kolon Life Science. "We believe patients in Asia Pacific, Middle East and Africa will be able to benefit from TG-C LD as we go through the rigor of establishing it as a global standard treatment option."