On April 9, 2020 Rexahn Pharmaceuticals terminated a nearly two-year-old agreement with Merck that paired the company’s experimental phosphorylated-p68 inhibitor with Keytruda as a potential treatment for metastatic triple-negative breast cancer (Press release, Merck & Co, APR 9, 2020, View Source [SID1234556249]).

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Rexahn disclosed the decision in a filing with the U.S. Securities and Exchange Commission this week, Seeking Alpha first reported. Rexahn said it notified Merck on April 7 of its decision to discontinue the development of RX-5902 for the treatment of metastatic triple-negative breast cancer. The two companies initially struck the agreement in 2018. At the time the deal was struck, Rexahn’s RX-5902 was already being studied as a monotherapy for triple-negative breast cancer. The companies intended to pair Keytruda with RX-5902 to treat patients with metastatic TNBC who have progressed following at least one prior treatment. Rexahn was intended to be the sponsor of the Phase II study.

In preclinical studies, RX-5902 had been shown to inhibit the growth and proliferation of multiple human cancer cell lines, including triple-negative breast cancer, decrease tumor growth in patient-derived xenograft models and potentiate the activity of immune checkpoint inhibitors and other anti-tumor agents, Rexahn said at the time of the deal.

In its disclosure this week, Rexahn provided little reason for the discontinuation of the Phase II program. The company said it had previously disclosed that it was evaluating the development strategy for RX-5902, including whether to proceed with the trial. In September, Rexahn announced it was exploring strategic alternatives to enhance shareholder value. Those options included the potential sale or licensing of assets. In that announcement, Rexahn said it would not disclose any developments of its strategy until "the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required."

While Rexahn has been somewhat silent on the state of its exploration of strategic alternatives, the company has continued to conduct business. In an SEC filing last month, the company said it amended its 2019 license agreement for its oncology asset RX-3117 with BioSense Global to use in Singapore, China, Hong Kong, Macau and Taiwan. BioSense initially aimed at developing the cancer treatment for China.

In February, Rexahn entered into a licensing agreement with China-based Zhejiang HaiChang Biotechnology for RX-0201, an asset that is a "nano-liposomal formulation of RX-0201 known as RX-0301, and RX-0047, a proprietary compound currently in preclinical development." HaiChang intends to develop one product comprising RX-0301 and one product comprising RX-0047, Rexahn said in the filing. Under terms of the deal, Rexahn could earn nearly $100 million if certain developmental and regulatory milestones are met.

On April 9, 2020 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX in North America, reported that the Board of Directors has appointed Joseph Truitt as interim Chief Executive Officer (Press release, BioSpecifics Technologies, APR 9, 2020, View Source [SID1234556234]). He will also serve on the Company’s Board of Directors. Mr. Truitt succeeds J. Kevin Buchi, who served as CEO since October 2019, and has departed the company.

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"We are delighted to have Joe on board and believe he will play a major role in helping to shape the future of BioSpecifics. Joe is a highly experienced biopharma executive with a strong track record of clinical, commercial, and operational leadership. The Board of Directors remains strongly focused on its corporate strategy of fully maximizing near- and long-term sustainable value creation, including full exploration of opportunities within the CCH portfolio of commercial and pipeline assets, as well as identifying external strategic opportunities. We believe BioSpecifics is poised for a new leg of growth bolstered by strong fundamentals," said Jennifer Chao, Chairman of the Board of Directors. "As we continue on this path, we would like to thank Kevin for what he accomplished during his tenure with the company and wish him well in his future endeavors."

Prior to joining BioSpecifics, Mr. Truitt was most recently Chief Executive Officer of Achillion Pharmaceuticals, Inc. since May 2018. He joined the company in 2009 and had previous roles of Chief Operations Officer and Chief Commercial Officer. Under his leadership, the company was acquired by Alexion Pharmaceuticals, Inc. for $1.2 billion. Mr. Truitt joined Achillion from Viropharma, Inc. following its acquisition of Lev Pharmaceuticals. At Lev, Mr. Truitt was most recently Vice President of Business Development and Product Strategy and led the build out of the commercial team and infrastructure in preparation for product launch. Mr. Truitt joined Lev from Johnson & Johnson, where he was Vice President of Sales and Operations and directed commercial operations and had P&L responsibility for sales, operations and national accounts at the company’s OraPharma subsidiary. Mr. Truitt holds a BS degree in Marketing from LaSalle University, Philadelphia, and an MBA degree from St. Joseph’s University, Philadelphia.

"I am excited to take on the role of interim CEO of BioSpecifics. There are very significant value creation opportunities and I look forward to working closely with the Board of Directors and team to fully execute on the Company’s clearly defined corporate objectives," said Joseph Truitt, interim Chief Executive Officer.

On April 9, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported it has entered into a clinical collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate the combination of NeoImmuneTech’s NT-I7 (also known as Hyleukin-7), a long-acting IL-7, and Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody (Press release, NeoImmuneTech, APR 9, 2020, View Source [SID1234556235]).

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The goal of the Phase 2 study is to establish safety and tolerability, and to evaluate preliminary anti-tumor activity of the combination in subjects with advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma (EAC). The results of this study will be used to further clinical development of this combination in these tumor types.

"According to the American Cancer Society1, approximately 46,000 Americans will be diagnosed with gastric and/or esophageal cancers in 2020, and 27,200 will die from these devastating diseases," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech (NIT). "This Phase 2 trial is based on the scientific rationale and results of preclinical studies demonstrating that NT-I7, our unique T-cell amplifier, worked synergistically with checkpoint inhibitors such as Opdivo to broaden and deepen the anti-tumor response."

Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT, added: "The clinical collaboration between NeoImmuneTech and Bristol Myers Squibb is based on our shared commitment to developing new therapeutic options that could improve outcomes for patients living with serious diseases such as gastric, GEJ or esophageal cancers. Further, it strengthens NIT’s position as pioneers of T cell-centered immuno-oncology therapeutics by focusing on enhanced clinical outcomes through a novel mechanism of action."

Under the terms of the agreement, NeoImmuneTech will be the sponsor of the trial and Bristol Myers Squibb will supply nivolumab for use in the study. While the first study will focus on gastric/GEJ/EAC cancers, under the terms of this Master Clinical Trial Collaboration Agreement, the two companies may conduct additional combination trials in the future.

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7

NT-I7 (also known as Hyleukin-7) is the only clinical-stage long-acting human IL-7 and is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer). NT-I7’s exhibits a favorable PK/PD and safety profiles, making it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. NT-I7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On April 9, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported the publication of preclinical data on the potent anti-tumor activity of FS120, a first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 and OX40, in leading peer-reviewed journal Cancer Immunology Research (Press release, F-star, APR 9, 2020, View Source [SID1234556236]).

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Preclinical data from the article show that FS120 delays tumor growth by improving the activation and proliferation of peripheral T cells. These data also reinforce the superiority of dual agonist targeting over alternative TNFR-targeting agonists and support the clinical development of FS120 to treat patients with cancer.

FS120 is a first-in-class dual agonist bispecific antibody that has the potential to address ‘cold’ tumors and overcome cancer resistance by simultaneously targeting CD137 (4-1BB) and OX40 (CD134, TNFRSF4), two receptors which are part of the Tumor Necrosis Factor Receptor family (TNFRSF) of receptors and broadly expressed on activated T-cells and NK cells. Most (TNFRSF) -targeting antibodies require cross-linking via Fcγ receptors (FcγRs), which can limit their clinical activity and lead to undesirable toxicity effects. Preclinical data from this study show that FS120 can activate both CD4+ and CD8+ T-cells in an FcγR-independent mechanism, therefore promoting focused immune stimulation. FS120 is currently a clinical stage program, with the investigational new drug application being accepted by the Food and Drug Administration (FDA) earlier this year.

In this study, FS120 showed greater anti-tumor activity than a combination of CD137 and OX40 agonists, which was associated with activation and proliferation of CD4+ and CD8+ T-cells independently of FcγR interaction. Furthermore, FS120 induced lower levels of liver T-cell infiltration when compared to a crosslink-independent CD137 agonist monoclonal antibody.

A link to the full study can be found here.

Neil Brewis, CSO of F-star, said: "Driven by the open IND filed earlier this year, these data are a great validation of F-star’s tetravalent bispecific technology and a further endorsement for the clinical development of FS120. FS120 exhibits disruptive activity in cold tumors and has been shown to successfully induce T-cell activation in an FcγR‑independent manner, which can potentially display broader clinical activity, likely to be used in a combination drug therapy, compared to already existing compounds. This is an exciting time for us as we continue to develop our pipeline and progress our research towards improving treatment outcomes for patients with difficult-to-treat cancers."

On April 9, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the United States Patent Office (USPTO) issued U.S. Patent No. 10,597,443 with an expiry of May 2034 (Press release, Scholar Rock, APR 9, 2020, View Source [SID1234556237]). This patent broadly covers methods for making activation modulators of TGFβ that utilize Scholar Rock’s proprietary platform approach of targeting the precursor form of growth factors.

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"We are pleased with this important addition to our patent portfolio as it further differentiates our leadership position in the development of antibodies that modulate signaling of TGFβ isoforms," said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. "TGFβ is a key driver of a number of disease-relevant processes, including fibrosis and immune system evasion by cancer cells, for which we have discovered highly potent and selective inhibitors of TGFβ1 activation. Notably, this patent covers SRK-181, our product candidate being developed for the treatment of cancers resistant to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies."

The issued claims are directed to manufacture methods that include selection of modulators that specifically bind a large latent complex antigen of TGFβ isoforms. This broadly relates to TGFβ activation inhibitors that are specific to the context of presenting molecules, such as GARP and LTBP, as well as activation inhibitors that are not dependent on a specific presenting molecule. The latter class of antibodies includes our cancer immunotherapy clinical product candidate, SRK-181, being developed to expand the number of patients who could benefit from checkpoint inhibitor therapies.