On April 26, 2021 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S.-based SWOG Cancer Research Network has started patient enrollment for a Phase I/II study of OBI-3424, a first-in-class (small-molecule prodrug) DNA alkylating agent that targets cancers expressing the aldo-keto reductase 1C3 (AKR1C3) enzyme (Press release, OBI Pharma, APR 26, 2021, View Source [SID1234578513]).

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The study, S1905 (ClinicalTrials.gov Identifier: NCT04315324), is titled "A Phase 1/2 Study of AKR1C3-Activated Prodrug OBI-3424 in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)." SWOG is a member of the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN), America’s largest publicly funded cancer research network. In the NCTN, cancer trials are designed by some of the nation’s leading cancer experts, funded by tax dollars, and powered by patient volunteers.

OBI Pharma’s Chief Medical Officer, Tillman Pearce, M.D., noted, "This clinical trial intends to verify whether the potent efficacy that OBI-3424 demonstrated against T-ALL patient-derived xenografts in mice (Evans et al. Clin Ca Res 2019) can be observed in T-ALL and T-LBL patients. The initial xenograft experiments were conducted by the NCI Pediatric Preclinical Study Group, so it is very fitting that SWOG is the first to evaluate the concept in patients. This study in an unmet population of patients with T cell acute leukemias and lymphomas is complementary to OBI Pharma’s ongoing phase 1/2 study evaluating OBI-3424 in solid tumors (ClinicalTrials.gov Identifier: NCT03592264)."

Anjali S. Advani, MD, director of the Inpatient Leukemia Unit at Cleveland Clinic Taussig Cancer Institute and professor of medicine at Cleveland Clinic Lerner College of Medicine in Cleveland, OH is the lead investigator of the OBI-3424 T-ALL/T-LBL SWOG trial.

"Although the treatments in B-ALL have advanced significantly, we have lagged behind in T-ALL," said Dr. Advani. "We are hopeful that targeting AKR1C3 in T-ALL will represent a promising treatment strategy."

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

On April 26, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) and Boston Pharmaceuticals reported that the companies have entered into an exclusive product license agreement to develop PRS-342, a 4-1BB/GPC3 preclinical immuno-oncology Anticalin-antibody bispecific fusion protein (Press release, Pieris Pharmaceuticals, APR 26, 2021, View Source [SID1234578470]). Under the terms of the agreement, Boston Pharmaceuticals has exclusively licensed worldwide rights to PRS-342. Pieris will receive an upfront payment of $10 million and is further entitled to receive up to approximately $353 million in development, regulatory, and sales-based milestone payments, and tiered royalties on sales of PRS-342. Pieris will also contribute an undisclosed amount toward manufacturing activities.

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"Based on the encouraging preclinical data from PRS-342, as well as data demonstrative of the 4-1BB mechanism of action we have seen from Pieris’ other immuno-oncology programs, we are excited to have the opportunity on a global scale to progress this program into clinical development in areas of significant unmet need," said Robert Armstrong, Chief Executive Officer of Boston Pharmaceuticals. "We look forward to working with Pieris, benefiting from both their strong early-stage development expertise and their deep understanding of immuno-oncology bispecifics."

"Our recent presentations at AACR (Free AACR Whitepaper) for our HER2- and PD-L1-targeting 4-1BB bispecifics demonstrate the potency of our costimulatory approach, especially our bispecific antibodies’ ability to achieve clinical benefit, including in patients who have failed checkpoint therapy. It is therefore rewarding to see another one of our 4-1BB-based Anticalin bispecifics for immuno-oncology moving towards the clinic," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Boston Pharmaceuticals has a strong leadership team and proven track record of developing a broad range of assets, including in oncology, and we look forward to the advancement of this next-generation bispecific and to directly supporting some crucial next steps towards clinical initiation."

On April 26, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell discovery engine platform to discover and develop first-in-class antibody therapeutics, reported it has entered into a definitive securities purchase agreement for the sale of its equity securities in a private placement with certain accredited investors for gross proceeds to Immunome of approximately $27 million, before deducting placement agent commissions and other offering expenses (Press release, Immunome, APR 26, 2021, View Source [SID1234578497]).

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The agreement provides for the sale of an aggregate of 1,000,000 units at a price of $27.00 per unit. Each unit consists of one share of Immunome’s common stock and a warrant to purchase one half of a share of common stock at an exercise price of $45.00.

Ladenburg Thalmann & Co. Inc. acted as Immunome’s placement agent in the transaction.

Immunome intends to use the net proceeds to accelerate the development of its oncology and infectious disease portfolio, including COVID-19, and for other general corporate purposes.

The private placement is expected to close on or about April 28, 2021, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Immunome with the Securities and Exchange Commission ("SEC").

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Immunome has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On April 26, 2021 STORM Therapeutics, the biotechnology company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it has published a scientific paper in the internationally recognised scientific journal Nature (Press release, STORM Therapeutics, APR 26, 2021, View Source [SID1234583250]).

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The paper entitled ‘Small molecule inhibition of METTL3 as a strategy against myeloid leukaemia’ reveals findings that further establish and validate STORM’s ground-breaking work on targeting RNA modifying enzymes for the development of new anti-cancer therapeutics and describes recent progress made with the METTL3 inhibitor programme.

STORM has identified novel, potent and selective first-in-class inhibitors of METTL3 that are orally bioavailable and show pronounced anti-tumour efficacy in physiologically relevant, proof of concept animal models of Acute Myeloid Leukaemia (AML), as well as solid tumours. The paper demonstrates that METTL3 small molecule inhibition is effective as a new therapeutic strategy against AML, prolonging survival in a variety of AML models, by specifically targeting key stem cell subpopulations of AML. Additionally, it confirms anti-tumour activity against different AML driver mutations demonstrating that targeting METTL3 is not limited by specific mutations (in contrast to other approaches such as FLT3 or IDH inhibition) and so may have a broad range of patients who might respond to this therapy.

Professor Tony Kouzarides, Founder of STORM Therapeutics and Director of the Milner Therapeutics Institute, University of Cambridge, said: "At STORM we are proud to be leading the field in development of drugs targeting RNA epigenetics and are making rapid progress. This paper has provided comprehensive proof of concept that targeting RNA modifying enzymes represents a promising new avenue for anti-cancer therapy and confirms the findings in our 2017 Nature paper made using genetic approaches."

In October 2020, STORM announced that STC-15, its first-in-class drug candidate targeting METTL3, had been selected for development towards first in human clinical studies in 2022. STC-15 is an orally bioavailable, small molecule METTL3 inhibitor targeting an entirely new mechanism of action (modulation of RNA epigenetics) to treat AML and other solid and haematological cancers. This publication utilises STM2457, an earlier compound than STC-15.

Keith Blundy, CEO of STORM Therapeutics, said: "I am delighted to see the publication of our ground-breaking research on STM2457 in a world leading journal. We are excited to be leading the field having selected STC-15, STORM’s first-in-class clinical candidate targeting METTL3 for development towards first in human clinical studies in 2022, addressing AML patients refractory to chemotherapy treatment with limited other options in addition to exploring combinations with standard of care."

STORM’s work was carried out in collaboration with the University of Cambridge (Gurdon and Milner Institutes) and Wellcome Sanger Institute, and was supported by grants from Cancer Research UK.

On April 26, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it will release financial results for the first quarter ended March 31, 2021 after the close of trading on Tuesday, May 11 (Press release, Biodesix, APR 26, 2021, View Source [SID1234578498]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day. Dial-in and call details are as follows:

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Tuesday, May 11th at 4:30 p.m. Eastern Time
Domestic: 833-665-0678
International: 929-517-0173
Conference ID: 4089648
Webcast: View Source