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Glytherix seeks AUD 7M Series A funding after securing grant – CEO

On July 21, 2020 Glytherix, an unlisted public Australian immuno-oncology company, reported that it is actively seeking AUD 7m (USD 5m) in a Series A equity round, after securing up to AUD 6m in non-dilutive funding, said CEO Brad Walsh (Press release, Glytherix, JUL 21, 2020, View Source [SID1234565156]).

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The Sydney-based company has secured AUD 3m in grant funding from Round 9 of the Federal Government’s Cooperative Research Centres Projects (CRC-P) program, as announced last week (16 July), with Sydney-based R&D Capital Partners agreeing to provide another AUD 3m once the AUD 7m is raised, Walsh said.

Glytherix, which is fielding interest from potential investors in Australia, the US, Hong Kong and China, including family offices and institutions, welcomes approaches from other interested investors, Walsh said. Its advisors are New York-and Melbournebased Biosynergy Partners and Sydney-based private placement firm Litmus Equity.

While the novel coronavirus (COVID-19) pandemic initially made it more difficult for the company to engage with potential investors, people are now used to the ‘new normal’ and it is proving easier to connect with people in their home offices, Walsh said.

Glytherix is confident of closing the raise in the next four to eight weeks with the credibility boost provided by the grant funding and on the back of advances made since the 2018 spin-off from its parent, Sydney-based non-invasive prostate cancer diagnostic developer Minomic, Walsh said.

It has completed a 12-patient first-in-human study for its Miltuximab antibody, which reached its primary endpoint of safety and tolerability, and its secondary endpoint of tumour targeting. The company now plans other pre-clinical work including a glioblastoma (brain cancer) study, he noted.

Equity capital raised will be used to support a Phase I trial in patients with prostate, pancreatic, bladder and glioblastoma cancers and will also be used to make more clinical-grade antibodies to prepare for a US Food and Drug Administration (FDA) Investigational New Drug (IND) application and a US Phase I trial, Walsh said.

The equity funding is expected to last two years, with financing options for a Phase II US trial including a NASDAQ listing, licensing deals or trade sales, he added. The company has some 200 shareholders comprising management and high net worth investors.

In collaboration with other Australian companies and research bodies, Glytherix will use grant funding to develop Miltuximab as a flagship molecule for radio-immunotherapies (RITs), which are combinations of radiation therapy and immunotherapy using antibodies to selectively deliver radiation to kill cancer cells, while limiting damage to healthy cells.

This is one of the most dynamic new areas in nuclear and radiochemistry with robust research and commercial interest globally, Walsh said, noting that Novartis [SWX:NOVN] paid some USD 6bn for both Advanced Accelerator Applications [NASDAQ:AAAP] and Endocyte [NASDAQ:ECYT] in 2018. Domestically, Telix [ASX:TLX] is also developing RITs, although for different disease indications to the ones Glytherix is targeting, he said.

Miltuximab is also being used for both imaging and immunotherapy applications, with this pairing of a precision diagnostic and a corresponding precision therapeutic having the potential to treat a wide range of cancers and position both Glytherix and Australia at the forefront of the theranostics industry, Walsh added.

by Louise Weihart in Sydney

Published by Acuris Mergermarket, an ION Group company

Singlera Genomics and Fudan University unveiled results demonstrating detection of five common cancers earlier than standard test

On July 21, 2020 Fudan University’s Taizhou Health Science Institute and Singlera Genomics, focused on non-invasive early cancer detection, reported the publication of a peer reviewed manuscript demonstrating the initial results from the Taizhou Longitudinal Study (TLS), showing Singlera’s PanSeer assay can detect five types of cancer up to four years before conventional diagnosis with a single blood draw (Press release, Fudan University, JUL 21, 2020, View Source [SID1234562261]). Some results from this study were also presented at the AACC 71st Annual Scientific Meeting held August 4-8 2019 in Anaheim, California, and selected as one of three finalists in the Disruptive Technology Award competition.

This collaborative study was a joint effort between Singlera Genomics with Professor Kun Zhang at the University of California San Diego, and Professor Li Jin at Fudan University.

The TLS study was launched by Professor Li Jin of Fudan University and began in 2007 collecting plasma samples from over 120,000 healthy individuals. Study participants were monitored for a 10-year period through linkages with local cancer registries and health insurance databases. Over 1.6 million specimens have been collected and archived to date.

"We really appreciate the reviewers and the editor for scrutinizing our study very carefully as this is one of the first retrospective longitudinal studies that demonstrates blood based non-invasive early detection of multiple cancer types four years before conventional diagnosis," said Yuan Gao, Ph.D., one of senior authors of the study and co-founder and Chairman of Singlera Genomics. Rui Liu, Ph.D., another senior author on the paper and co-founder/CTO of Singlera Genomics, added, "one unique aspect is that we use a longitudinal cohort with 10+ years of efforts to show detection of cancer before conventional diagnosis is possible, while previous work has mostly focused on a case-control design with symptomatic cancer patients that have already been diagnosed with the standard care. It is excited to see that cancer signatures can be detected so early in as little as 1ml plasma with Singlera’s PanSeer assay."

Professor Kun Zhang said: "I am very pleased to see that early developments of DNA methylation methods in my laboratory at UCSD were further improved and optimized at Singlera, leading to the PanSeer assay that is both robust and accurate in detecting cancers in blood early." Professor Li Jin said: "This study demonstrated that a large cohort such as TLS could offer a powerful tool for evaluating technologies for early and precision diagnoses."

The next logic phase would be a prospective cohort study and clinical trial. However, the difficulty for prospective study is the length of time and the amount of resource involved. Singlera Genomics is in the process of raising additional funds for this purpose. Furthermore Singlera Genomics has also met with FDA twice for its blood-based colorectal cancer colonES assay and is expected to launch the trial in the near future. The research team is in the process of extending this early detection approach to additional cancer types, and Singlera is currently looking for collaboration partners in the United States.

CASI Pharmaceuticals Announces Proposed Public Offering Of Common Stock

On June 21, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock (Press release, CASI Pharmaceuticals, JUL 21, 2020, View Source [SID1234562243]). In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

Oppenheimer & Co. Inc. is acting as the sole bookrunning manager, and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager, for the offering.

CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing our product portfolio, acquiring the rights to new product candidates and general and administrative expenses.

The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on December 13, 2017 and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 22, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales 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.

Cellectar Announces Poster Presentation of Clinical Data at the American Association of Cancer Research (AACR) Annual Meeting

On July 21, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported a poster presentation at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting being held virtually on August 17-19, 2020 (Press release, Cellectar Biosciences, JUL 21, 2020, View Source [SID1234562221]).

Poster presentation details:

Poster Title CLR 131 Demonstrates 100% Overall Response Rate in Relapsed or Refractory Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom’s Macroglobulinemia (WM): Initial Results from Ongoing Phase 2 trial, CLOVER-1 Study

A copy of the presentation materials can be accessed on the Events and Presentations section of the Cellectar website once the presentation has concluded.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in r/r multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

About the Phase 2 CLOVER-1 Study

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma/ Waldenstrom’s macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study can enroll up to 80 patients with its primary endpoint being clinical benefit response (CBR), which is defined as the proportion of MM patients following infusion of CLR 131 with stringent complete response, complete response, very good partial response, partial response and stable disease per International Myeloma Working Group criteria, or the proportion of lymphomas patients (CLL/SLL, LPL, MZL, MCL, and DLBCL) following infusion of CLR 131 with CR, PR and SD per the Lugano classification CT-based response criteria or International Waldenstrom’s Macroglobulinemia Society criteria or the International Chronic Lymphocytic Leukemia criteria. Additional endpoints include overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy. Patients were treated with three different doses (<60mCi single cycle, >60mCi single cycle and >60 mCi multi-cycle total body dose).

The CLOVER-1 Phase 2 study completed the Part A dose-exploration portion conducted in relapsed/refractory (r/r) B-cell malignancies and is now enrolling in the Part B expansion cohorts in relapsed/refractory (r/r) multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM). Part B is evaluating the two cycle dosing of CLR 131 in additional patients. Each cycle is defined as two doses provided 14 days apart (+/- 1 day). Cycle 2 shall be given 8-weeks post the initial infusion. Additional cycles can be considered following an additional 8-week period. The Part A portion of the study met its primary and secondary endpoints with detailed data being announced on February 19, 2020.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the study. More information about the study, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

Dragonfly Therapeutics Initiates Phase 1/2 Study of its IL12 Immunotherapy in Patients with Advanced Solid Tumors

On July 21, 2020 Dragonfly Therapeutics, Inc. ("Dragonfly" or the "Company"), a clinical stage biotechnology company developing novel immunotherapies, reported it has dosed its first patient in a Phase 1/2 study of the Company’s proprietary IL12 investigational immunotherapy, DF6002 (Press release, Dragonfly Therapeutics, JUL 21, 2020, View Source [SID1234562206]). Dragonfly’s DF6002 clinical trial is currently recruiting patients with advanced solid tumors at Lifespan Cancer Institute at Rhode Island Hospital, the principal teaching hospital of Brown University, with additional sites scheduled to open shortly. DF6002 will be Dragonfly’s second drug in the clinic, with its NK cell engager therapy DF1001 having started clinical testing in the fall of 2019.

"DF6002’s therapeutic potential is particularly exciting," said Dr. Mario Sznol, Dragonfly Clinical Advisory Board member and Professor of Medicine & Co-Leader, Cancer Immunology, Yale Cancer Center. "Dragonfly’s extended half-life IL12 with retained potency and remarkable in vivo anti-tumor data may help fulfill the long-awaited potential of this cytokine in a broad population of cancer patients."

"Dragonfly’s pre-clinical data package on IL12 is extraordinary, and we are eager to demonstrate its effects in cancer patients"," said said Dr. Tyler Jacks, Director of the Koch Institute at MIT and Chairman of the Company’s Scientific Advisory Board. "DF6002 is Dragonfly’s first cytokine and has demonstrated preclinically superior efficacy to native IL12 combined with a compelling preclinical safety profile and wide therapeutic window."

Dragonfly Therapeutics received investigational new drug approval for DF6002 from the U.S. Food and Drug Administration (FDA) in late May. The company’s Phase 1/2 clinical trial is a first-in-human, multi-part, open-label, non-randomized, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF6002 alone and in combination with PD-1 inhibition in patients with locally advanced or metastatic solid tumors, followed by expansion in selected indications.

Initiating clinical trials with our first cytokine underscores both the breadth of Dragonfly’s portfolio of innovative therapeutics, and the pace with which our team is bringing important new treatment options to patients with cancer and autoimmune disease," said Bill Haney, CEO and Dragonfly co-founder. "In addition to DF6002, our productive collaborations building drugs for BMS, Merck, and Abbvie, and our DF1001 TriNKET presently advancing in the clinic, we’re already racing to bring our second TriNKET to IND in 2021."

Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04423029).

About DF6002
DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.