On April 9, 2021 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported the presentation of data from the company’s HPK1 inhibitor program in a poster at the AACR (Free AACR Whitepaper) Annual Meeting held virtually April 10-15, 2021 (Press release, Nimbus Therapeutics, APR 9, 2021, View Source [SID1234577755]).

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Newly disclosed data show that Nimbus’ small-molecule HPK1 inhibitor, NMBS-2, demonstrates significant tumor growth inhibition as a single agent and in combination with anti-PD1 in multiple mouse syngeneic tumor models. In combination with anti-PD1, NMBS-2 restored cytokine secretion from exhausted human T cells and induced robust tumor growth inhibition in the CT-26 model. Furthermore, animals treated with NMBS-2 and anti-PD1 showed complete rejection of subsequently reintroduced CT-26 tumor cells, suggesting the establishment of a robust and durable immune memory.

"Building on our promising findings to date demonstrating the anti-tumor immune activity of NMBS-2, these latest data provide a compelling picture of its potential clinical utility in a range of tumor types — both as a single agent and as a combination therapy with anti-PD1 treatment," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "We’re rapidly progressing IND-enabling studies of NMBS-2 now with plans to initiate first-in-human studies in the second half of 2021."

On April 8, 2021 Organon Finance 1 LLC, a subsidiary of Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Organon Finance 1 LLC has priced its previously announced offering of €1,250,000,000 aggregate principal amount of 2.875% senior secured notes due 2028 (the "euro secured notes"), $2,100,000,000 aggregate principal amount of 4.125% senior secured notes due 2028 (the "U.S. dollar secured notes") and $2,000,000,000 aggregate principal amount of 5.125% senior unsecured notes due 2031 (the "unsecured notes" and together with the euro secured notes and U.S. dollar secured notes, the "notes"), in connection with the previously announced spinoff of Organon & Co. ("Organon") from Merck (Press release, Merck & Co, APR 8, 2021, View Source [SID1234577733]). As part of the spinoff, the notes will be assumed by Organon, and a Dutch private limited company and wholly owned subsidiary of Organon which will act as co-issuer of the notes.

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Organon intends to use the net proceeds from the notes offering, together with available cash on its balance sheet and borrowings under senior secured credit facilities which Organon anticipates entering into, to repay one or more intercompany loans or notes owed by Organon to a Merck affiliate and to pay fees and expenses related to the spinoff. The proceeds of the notes offering will be held in escrow until satisfaction of the conditions precedent to the spinoff and certain other escrow release conditions (the "Effective Date").

Each series of notes will be issued at an issue price of 100%. From and after the Effective Date, the euro secured notes and the U.S. dollar secured notes will be guaranteed on a senior secured basis, and the unsecured notes will be guaranteed on a senior unsecured basis, jointly and severally, by all of Organon’s existing or future subsidiaries that guarantee its proposed senior secured credit facilities. Prior to the Effective Date, each series of notes will be senior secured obligations solely of the Organon Finance 1 LLC, and will not be guaranteed by Organon or any of its subsidiaries.

The notes offering is expected to close on April 22, 2021, subject to customary closing conditions.

The notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation").

In member states of the European Economic Area, this announcement is directed only at persons who are "qualified investors" within the meaning of the Prospectus Regulation. In the United Kingdom, this announcement is directed only at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation.

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK.

In the United Kingdom, this announcement is directed only at persons (i) that have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"); (ii) falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc.") of the Order; or (iii) at whom this announcement may otherwise be directed without contravention of Section 21 of the Financial Services and Markets Act 2000, as amended (all such persons together being referred to as "relevant persons"). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On April 8, 2021 Luoqi Biotechnology reported the completion of Series A+ financing of tens of millions of yuan (Press release, Novamab, APR 8, 2021, View Source [SID1234637753]). This round of financing was led by Hongyun Fund, a partnership between Huatai Zijin and Alibaba Health, and was followed by Daoyuan Capital. , Haoyue Capital continues to serve as the exclusive financial advisor.

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This round of financing will continue to be used for IND filing and clinical development of two inhaled nanobody asthma treatments, as well as preclinical development of other respiratory and autoimmune disease pipelines. In addition, Luoqi is also about to build a 500L GMP Pichia pastoris production plant that can meet clinical phase II sample preparation. In the next 1-2 years, three products will enter the clinical research stage.

Dr. Wan Yakun, founder and general manager of Luoqi Biotech, said "Luoqi Biotechnology is a nanobody biopharmaceutical R&D company focusing on the entire industry chain. It is committed to the industrialization of innovative biopharmaceutical achievements and the research and development of targeted new drugs. It has established a complete nanobody new drug development system, integrating early screening and research and development of nanobodies. The late-stage process development of candidate drugs is effectively combined to form a systematic and complete R&D system, which is at the leading level in the industry domestically and even internationally. Thank you very much to investors for their high recognition of our team and projects! The success of this round of financing provides a strong guarantee for the rapid advancement of the company’s new drug projects. We will continue to delve into the field of respiratory and autoimmune diseases and accelerate the development of corresponding products."

Ms. Cao Qun, Chairman of Huatai Zijin said the founding team of Luoqi Biotech has rich R&D experience and international vision in the field of nanobodies. Based on the in-depth understanding of the advantages of nanobody drugs, the team develops innovative drug delivery methods for large market space indications, improves the accessibility and medication compliance of antibody drugs, and benefits patients at home and abroad. We are firmly optimistic about the future development of the nanobody industry and the company’s unique potential to become a domestic leader in this field. Huatai Zijin will adhere to the investment philosophy of "grow together with entrepreneurs" and rely on its own resources to continue to support the company’s development.

Mr. Zhang Dafeng, Chairman of Daoyuan Capital, said Luoqi Biotech has a leading position in the field of domestic nanobodies. It has systematically established the core competitive Pichia pastoris CMC platform and nanobody rapid screening platform. In order to give full play to the compliance of nanobody delivery methods, the production of low Characteristics such as cost and ease of engineering transformation have laid a good foundation. We are full of expectations for the innovative drug projects currently developed by Luoqi Biotech and hope to be approved for marketing as soon as possible to meet the clinical needs of patients and reduce the cost burden of patients.

On April 8, 2021 Portage Biotech reported that began the first human study of its invariant natural killer T-cell agonist, PORT-3, in patients with advanced or metastatic solid tumors that express NY-ESO-1 (Press release, Portage Biotech, APR 8, 2021, View Source [SID1234579565]).

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The drug is a coformulation of the invariant natural killer T-cell agonist and a tumor-specific antigen targeting NY-ESO-1. The Phase I dose escalation study, called PRECIOUS-01, will evaluate PORT-3 at three dose levels in about 15 participants. Study participants are being screened for NY-ESO-1 expression using immunohistochemistry.

Researchers will use an IHC assay to measure participants’ immune responses and determine the composition of immune cell subsets before and after treatment with PORT-3 to establish the recommended Phase II dose. They will also measure the immunological responses in blood to determine the functional response of invariant natural killer T cells and T cells.

Portage is currently developing two invariant natural killer T-cell agonists, PORT-2 and PORT-3. "Preclinical studies of both compounds have shown that treatment can lead to a broad reprogramming of the immune system," Portage CEO Ian Walters said in a statement. "We are excited to begin first-in-human trials of PORT-3 to test the proof-of-concept of this approach. If the trial is successful with NY-ESO-1, it will open the door to a multitude of opportunities to design more formulations with other tumor-specific antigens."

The PRECIOUS-01 trial is funded by the EU Horizon 2020 program and recruitment has begun at Radboud University in the Netherlands.

On April 8, 2021 Morphogenesis, Inc. ("Morphogenesis"), a clinical stage biotechnology company specializing in the development of cell and gene therapy products to treat chronic diseases such as cancer, reported that the United States Food and Drug Administration (FDA) has granted the Company’s lead clinical stage candidate, IFx-Hu2.0, Fast Track drug designation for the treatment of patients with advanced skin cancer (Press release, Morphogenesis, APR 8, 2021, View Source [SID1234578994]). Specifically, these are patients with unresectable or metastatic cutaneous melanoma who have not responded to, or have stopped responding to, FDA-approved immune checkpoint inhibitors. Most advanced skin cancer patients who receive immune checkpoint inhibitors do not respond to these therapies. Based on the data amassed to date and its mechanism of action, IFx-Hu2.0 has the potential to change that. The FDA previously granted Orphan Drug Designation to IFx-Hu2.0 for the same indication.

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Fast Track is a designation issued by the FDA for products that have the potential to treat patients with a serious disease and who have an unmet medical need. Morphogenesis provided the FDA with epidemiologic data as well as pre-clinical and clinical evidence to support IFx-Hu2.0’s mechanism of action. IFx-Hu2.0 is an immunomodulator that as well as initiating a significant anti-tumor response in previously untreated patients, also has the potential to re-sensitize patients to immune checkpoint inhibitors. More people have skin cancer than all the other primary cancers in the United States combined. Advanced melanoma’s aggressiveness and high mortality rate make it the deadliest type of skin cancer.

"We believe that being able to initiate a broad anti-tumor response in late-stage melanoma patients with a 30-second intralesional injection of IFx-Hu2.0 fulfills an unmet medical need of these patients," said Patricia D. Lawman, PhD, Chief Executive Officer of Morphogenesis.

"Fast Track designation for IFx-Hu2.0 signifies the FDA’s recognition that patients suffering from this life-threatening disease remain in dire need of effective treatment options even with all the therapies that are being developed for melanoma. IFx-Hu2.0 holds promise to effectively treat these patients," said Michael J.P. Lawman, PhD, President of Morphogenesis.

The FDA is committed to facilitating the development and to expediting the review of IFx-Hu2.0 to treat patients with advanced skin cancer, thereby potentially addressing a significant unmet medical need. Morphogenesis is advancing the clinical development of IFx-Hu2.0, a highly differentiated cancer immunotherapy drug candidate, especially since IFx-Hu2.0 is now eligible for accelerated approval and priority review if relevant criteria are met.

"With IFx-Hu2.0’s Fast Track designation, we look forward to having expert guidance and frequent communication with the FDA throughout the entire drug development and review process," said Christopher Konig, PharmD, Regulatory Affairs Manager at Morphogenesis. "In the past, this quality and frequency of communication with the FDA has led to earlier drug approval and access by patients."