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.

On April 8, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution with a new class of precision genetic medicines, reported that it will host a virtual R&D day for investors and analysts on Tuesday, June 8, 2021, from 12:30 p.m. to 2:30 p.m. EDT (Press release, NeuBase Therapeutics, APR 8, 2021, View Source [SID1234577768]).

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During the event, NeuBase will present new data, along with an in-depth review of the Company’s pipeline of drug candidates – including in Huntington’s disease, myotonic dystrophy type 1, and a new oncology program for a target that has previously been thought of as undruggable – as well as an introduction to the expanded management team.

Additional details will be made available prior to the event. The event will be webcast live on NeuBase’s website at View Source Following the live webcast, a replay will be available on the Company’s website and archived for approximately 90 days.

On April 8, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that it has completed enrollment, with 101 patients, into the PRIMO study, which is evaluating COPIKTRA for the treatment of patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) (Press release, Secura Bio, APR 8, 2021, https://www.prnewswire.com/news-releases/secura-bio-announces-enrollment-completion-of-the-copiktra-duvelisib-study-primo-in-peripheral-t-cell-lymphoma-301264723.html [SID1234577765]). The completion of study enrollment is an important milestone in the continued development of COPIKTRA to treat T-cell lymphomas, a disease category for which it is not currently indicated.

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The PRIMO study is a global, multi-center, open-label, parallel cohort registration-directed Phase 2 study. In the dose optimization portion of the study, patients were randomized to receive COPIKTRA 25mg twice daily (cohort 1) or COPIKTRA 75mg twice daily continuously (cohort 2) until disease progression or unacceptable toxicity. Based on the dose optimization results, an expansion group was added in which COPIKTRA was dosed at 75mg twice daily for two cycles, followed by 25mg twice daily, until disease progression or unacceptable toxicity. The primary endpoint in the expansion phase of the study is independent review committee assessed overall response rate (ORR). Secondary endpoints include duration of response (DOR) and safety.

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells.

"Secura Bio will continue to aggressively support the development of COPIKTRA in the treatment of T-cell malignancies, because these patients often have limited therapeutic options and generally poor outcomes, and because PI3K inhibition appears to be a relevant, safe and promising mechanism of action" said Dr. David Cohan, Chief Medical Officer of Secura Bio.

For the treatment of PTCL, COPIKTRA monotherapy has received Fast Track status and Orphan Drug Designation, and investigations are imminently planned in combination with other proven anti-cancer agents.

"Secura Bio now has two meaningful oncology drugs with novel modes of action that offer the potential to build a broad portfolio of indications in hematologic and solid malignancies. We will also fully explore the combination of COPIKTRA with FARYDAK (panobinostat), Secura Bio’s pan-HDAC inhibitor" said Joseph M. Limber, President and CEO of Secura Bio.

Interim results of the PRIMO study are expected to be published later in 2021.