On June 24, 2021 Gliknik Inc., an immunology company dedicated to patients with cancer and autoimmune disorders, reported that it has successfully completed an $11.5 million Series C Preferred Stock financing (Press release, Gliknik, JUN 24, 2021, View Source [SID1234584333]). First In Ventures (FIV) led the Series C with SAISO Partners and affiliates of RDA Ventures and Garden Street Holdings also participating. The proceeds are targeted to progress the growing pipeline of Gliknik product candidates. Gliknik has secured $81 million to date to advance its programs.

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"We believe that Gliknik has created several potential best-in-class mid-stage assets," said Scott Roth, managing partner of FIV. "This capital will help unlock the potential of these compounds and uniquely positions Gliknik to make a difference for patients with cancer or autoimmune disorders."

Funding will help advance Gliknik clinical and pre-clinical programs, including:

A randomized double-blind, placebo-controlled phase 2 study of Gliknik immuno-oncology compound biropepimut-S, which is nearing completion. Clinicians are assessing two-year endpoints in the prevention-of-recurrence of high-risk squamous cell oral cavity cancer.
Gliknik immune modulating compound GL-2045, a recombinant mimetic of pooled human IVIG, which is a potent clinical candidate under active development by Gliknik licensee Pfizer for autoimmune diseases. Gliknik believes that based on potency, purity and anticipated convenience, GL-2045 has the potential to be a disruptive advance for autoimmune diseases that could help address the current critical shortage of IVIG.
GL-0719 is a new type of complement modulator, which is designed to control diseases while leaving critical host defense systems intact. GL-0719 is poised to enter a phase 1 trial in 2021.
Other compounds in preclinical development
Kyle Rusconi, a founder of FIV, is joining the Gliknik Board. "During the last several years, Gliknik has created a significant pipeline of important compounds," said Mr. Rusconi. "This scientific development was done in a capital-efficient manner that preserved shareholder equity."

"We are humbled by the depth of support from our investor base and welcome the addition of discerning investors with a long-term view," said Gliknik CEO David Block.

On June 24, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported that HBI-8000 will be marketed under the brand name Hiyasta in Japan (Press release, HUYA Bioscience, JUN 24, 2021, View Source [SID1234584367]). Hiyasta was recently approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adult T-cell leukemia/lymphoma (ATLL) as monotherapy.

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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "Today’s approval of Hiyasta for ATLL came in just 9 months. Our commercial partnership with Meiji will now bring Hiyasta to patients and provide much needed public health benefit for this devastating, life threatening disease."

Hiyasta was also submitted to the PMDA in March for approval as monotherapy to treat peripheral T-cell lymphoma (PTCL). In addition, the ODD designation for Hiyasta in Japan has been formally approved for both ATLL and PTCL.

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development

On June 24, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients,reported that it will present its oropharyngeal cancer (OPC) patient population analysis of the Phase 2 Validive (clonidine HCl MBT) trial for the prevention of chemoradiotherapy-induced severe oral mucositis in head and neck cancer at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2021 annual meeting (Press release, Monopar Therapeutics, JUN 24, 2021, View Source [SID1234584318]). This analysis provided the rationale for the design of Monopar’s Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US.

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"We are excited to share the data from our analysis at this pre-eminent multidisciplinary conference dedicated to supportive care in cancer and for the opportunity to continue working towards providing a treatment for this debilitating condition," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

Session Title: Mucositis – New Dimensions in Research and Clinical Practice, Oral Proffered Paper 2

Presentation Title: Subgroup Analysis of Head and Neck Cancer Patients Treated with Clonidine Mucobuccal Tablet in a Randomized, Double-Blind Phase 2 Trial (Study BA2009-28-01) Supports Further Clinical Development in Patients with Oropharyngeal Cancer

Author: Andrew Mazar, PhD, Chief Scientific Officer of Monopar Therapeutics

Date and Time: The Company’s presentation will be available on demand for registered attendees starting Friday, June 25, 2021 at 8:00am EDT. For information on registration, visit: View Source

About Validive

Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation. The mucobuccal tablet provides for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient’s home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages’ expression of the destructive cytokines that are released in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence compared to placebo (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg, a safety profile similar to placebo, and a high rate of treatment compliance (over 90%).

On June 24, 2021 Personal Genome Diagnostics Inc. (PGDx) reported a strategic collaboration with Massachusetts General Hospital (MGH) (Press release, Personal Genome Diagnostics, JUN 24, 2021, View Source [SID1234584334]). The two organizations will work closely on the development of innovative solutions aimed at enabling seamless introduction of next-generation sequencing and genomic-based tumor profiling capabilities across a diverse set of clinical operations and laboratory settings.

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"PGDx is thrilled to collaborate with MGH, one of the nation’s most highly regarded research hospitals and a leader in advancing the field of genomic testing into clinical cancer care for the benefit of patients," said Megan Bailey, Chief Executive Officer of PGDx. "Our elio tissue complete platform enables comprehensive tumor profiling and assessment of tumor mutation burden, which can be used to inform treatment strategies that employ targeted immunotherapies and other advanced precision medicines. This collaboration will aid in our goal of ensuring this powerful technology is broadly accessible to patients across all types of healthcare settings."

Cancer care in the 21st century requires comprehensive genetic information. The field of oncology has firmly embraced genetic tumor testing into patient care. One of the biggest challenges, however, is having access to all diagnostic information at the right time to make the best treatment decisions possible. The increased demand for testing has resulted in increased pressures on laboratories to implement high-throughput sequencing services.

"Despite dramatic advances in the number of targeted therapies and biomarkers identified in non-small cell lung cancer, several studies have shown that fewer than 50% of patients diagnosed with this disease receive comprehensive genomic profiling," said Lauren Ritterhouse, MD, PhD, Associate Director of MGH’s Center for Integrated Diagnostics. "Many of these instances are associated with a lack of access to multigene next-generation sequencing panels."

The collaboration between PGDx and the MGH recognizes the critical importance of empowering local laboratories. The groups will initially focus on a Precision Diagnostics solution that comes with a playbook and enables seamless introduction of next-generation sequencing testing across many laboratories. The groups are also committed to creating an on-site training program with a special emphasis on laboratory and clinical operations to accomplish broad-scale patient access.

"Next-generation sequencing is complex, and overcoming the various constraints puts many laboratories in a tough position," said Ritterhouse. "MGH is known for bringing discoveries to patients. And we believe it is important to focus our attention on facilitating a solution that will enable broader patient access to precision diagnostics."

On June 24, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported the closing of its previously announced registered direct offering to Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering (Press release, Anavex Life Sciences, JUN 24, 2021, View Source [SID1234584350]).

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The gross proceeds from the offering were approximately $50 million before deducting placement agent fees and other offering expenses. Anavex intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above were offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock have been offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.