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."

On April 8, 2021 Stockholm-based Sprint Bioscience, which conducts early preclinical drug development primarily targeting cancer, reported that it had raised 20.7 MSEK in a share issue directed at a group of existing and external investors (Press release, Sprint Bioscience, APR 8, 2021, View Source [SID1234577884]). BioStock has contacted the company’s CEO Erik Kinnman to find out more about what it means for the company.

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The biotechnology company Sprint Bioscience specialises in early preclinical development of drug candidates, primarily aimed at treating cancer. Today, the company’s portfolio consists of five development projects, where the goal is to reach early outlicensing to partners who can advance them to clinical testing and onwards.

So far, two projects from the company’s existing portfolio have been outlicensed; oncology project PETRA01, where the company collaborates with the cancer drug developer HiberCell, and a NASH project that is being developed together with South Korean biotech company LG Chem.

Strengthened cash position with directed issue
On Thursday, Sprint Bioscience announced that it had completed a directed issue of 20.7 MSEK. This corresponds to a discount of approximately 12 per cent compared to the closing price on April 7. For shareholders who did not participate in the issue, the issue will mean a dilution of approximately 16 per cent in total. In connection with the issue, the company pays back an outstanding loan of 10 MSEK.

You have now strengthened the cash position by 20.7 MSEK. Why did you choose to strengthen the company’s financial situation through a directed issue?

– With this issue, we have been able to increase the company’s shareholding among qualified investors, both existing and new. The interest is a sign of an understanding of the potential of our portfolio of innovative drug candidates and our business model.

What does this latest capital injection mean for the company?

– The strengthened cash position allows us to accelerate activities in our various projects as well as in business development. All to build shareholder value and continue to deliver drug candidates that are attractive to potential licensees and that could eventually become new unique drugs for cancer patients with medical needs who need alternative treatments.

How would you describe the financial situation in the company in relation to the capital requirement going forward?

– The capital requirements are now met for the near future. This enables continued value-building development of our portfolio and strengthens opportunities for deliveries in terms of our licensing activities.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

On April 8, 2021 Galapagos (Euronext & Nasdaq; GLPG) reported that Gilead and Galapagos signed an amendment to the share subscription agreement closed in 2019, extending the full lock-up of Gilead’s current shareholding in Galapagos to 2024 (Press release, Galapagos, APR 8, 2021, View Source [SID1234577774]).

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In August 2019, Gilead and Galapagos entered into a 10-year global transformative research and development collaboration, giving Gilead access to Galapagos’ innovative portfolio of compounds and drug discovery platform. As part of the transaction, Gilead made a $1.1B equity investment, increasing Gilead’s stake in Galapagos from approximately 12.3% to 22% of the issued and outstanding shares in Galapagos. In addition, Galapagos issued two warrants, allowing Gilead to further increase its ownership of Galapagos to up to 29.9% of the company’s issued and outstanding shares. Through the exercise of a first warrant, Gilead’s shareholding further increased to 25.1%. The most recent transparency notice received by Galapagos from Gilead indicates a 25.5% ownership position.

The amendment announced today stipulates that the full lock-up is extended: Gilead is now committed to a full lock-up of 5 years, retaining all of its 16,707,477 shares (currently 25.5%) until 22 August 2024. Previously, there was a full lock-up of 2 years, followed by a 3-year period during which the company would have held a minimum of 20% of outstanding shares. The lock-up restrictions are subject to certain exceptions as provided in the share subscription agreement.

Commenting on the amendment, Gilead CFO Andrew Dickinson said, "We remain strongly committed to our long-term collaboration. We continue to see significant value in Galapagos’ unique target discovery approach, and we support Galapagos, as the company works to deliver on this potential."

Bart Filius, COO and President of Galapagos, added, "The amendment announced today highlights Gilead’s commitment and support for our 10-year collaboration. We greatly benefit from Gilead’s scientific, developmental, and commercial know-how, and we look forward to continuing to work together as we push novel modes of action drugs forward, with the shared goal to help patients worldwide."

About the Gilead-Galapagos collaborations

In August 2019, Galapagos and Gilead entered into a 10-year global transformative research and development collaboration. Through this agreement, Gilead gained access to an innovative portfolio of compounds and a proven drug discovery platform. Gilead received an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe.

Gilead and Galapagos also have a collaboration for the development and commercialization of filgotinib, originally signed in 2015, with a new agreement announced in December 2020. Through a phased transition including the transfer of filgotinib’s marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead retains commercial rights and remains marketing authorization holder for filgotinib outside of Europe, including in Japan.

Gilead and Galapagos continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease (IBD). Gilead will retain operational responsibility for the current trials in Crohn’s disease while Galapagos will assume operational responsibility for ongoing trials in ulcerative colitis (UC). Filgotinib in UC has been filed in Europe and a global Phase 3 program is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov.