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.

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 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue-targeted therapeutics for the treatment of cancer, chronic viral infections and other serious diseases, reported that it will present preclinical data on its second product candidate, SBT6290, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Conference, taking place virtually April 10-15 (Press release, Silverback Therapeutics, APR 8, 2021, View Source [SID1234577749]). The data highlight the ability of SBT6290, a systemically administered Nectin4-directed TLR8 ImmunoTAC product candidate, to selectively activate myeloid cells in the tumor microenvironment, a promising approach to overcome resistance mechanisms associated with most current immunotherapies.

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"SBT6290 showcases the versatility of our ImmunoTAC platform and along with our lead program SBT6050, exemplifies our goal to target difficult-to-treat solid tumors subset by subset. We are building on learnings from SBT6050, leveraging the same TLR8 linker-payload, which is highly transferrable across different targeting antibodies," said Valerie Odegard, Ph.D., president & chief scientific officer of Silverback Therapeutics. "These preclinical data show that SBT6290 activates human myeloid cells in a Nectin4-dependent manner and that a SBT6290 mouse surrogate confers single agent anti-tumor activity in preclinical studies. We will continue to evaluate SBT6290 in GLP toxicology studies and anticipate submitting an IND for this program in the fourth quarter of 2021."

SBT6290 comprises a selective TLR8 agonist conjugated to a Nectin4-specific monoclonal antibody. Nectin4 is a cell surface adhesion molecule that is overexpressed in multiple solid tumor types including urothelial, triple negative breast, squamous cell head and neck, and non-small cell lung cancers, with limited expression in normal tissues.

The abstract is now available on the AACR (Free AACR Whitepaper) Annual Meeting website. Details of the poster presentation are as follows:

Title: SBT6290, a Systemically Administered Nectin4-Directed TLR8 ImmunoTAC Product Candidate, is Designed for Tumor-localized Activation of Myeloid Cells

Abstract Number: 1858

Session Category: Immunology

Session Title: Therapeutic Antibodies, Including Engineered Antibodies

Virtual Poster Session Date and Time: The poster will be made available on the AACR (Free AACR Whitepaper) website and Silverback website on April 10, 2021 at 8:30 a.m. ET

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 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.