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Mitazalimab synergizes with chemotherapy – Alligator Bioscience presents new preclinical data at AACR

On March 11, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that an abstract for a poster presentation at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2021, presenting new preclinical data for the clinical asset mitazalimab, is now released (Press release, Alligator Bioscience, MAR 11, 2021, View Source;alligator-bioscience-presents-new-preclinical-data-at-aacr-301245267.html [SID1234576547]). The AACR (Free AACR Whitepaper) Annual Meeting 2021 will be held in a virtual format over two one-week periods in April and May 2021. Alligator Bioscience’s abstract will be presented in an ePoster session during April 10-15.

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Alligator Bioscience has previously shown that mitazalimab synergizes effectively with immune checkpoint inhibitors and vaccines. The abstract, titled "Mitazalimab, a potent CD40 agonist with potential for combination with chemotherapy", demonstrates that mitazalimab synergizes with chemotherapy, notably FOLFIRINOX, leading to improved long-term survival in a preclinical tumor model.

"The new preclinical data are very encouraging. Together with the clinical data of mitazalimab from a previous Phase I study, where mitazalimab was well tolerated up to 1200 µg/kg, these data support the upcoming clinical Phase II study of mitazalimab in combination with chemotherapy in pancreatic cancer patients," says Per Norlén, CEO of Alligator Bioscience.

Mitazalimab is a human CD40 agonistic antibody developed for immunotherapy of cancer. The chemotherapy cocktail FOLFIRINOX kills tumor cells leading to increased release of tumor antigens. Activation of CD40 leads to improved presentation of tumor antigens, and the consequent T cell priming and initiation of T cell-dependent anti-tumor responses.

AVEO Oncology Announces Drawdown of $20 Million Tranche Under Hercules Debt Facility

On March 11, 2021 AVEO Oncology (Nasdaq: AVEO) reported that it has completed a drawdown of $20 million under its previously announced $45 million loan and security agreement with Hercules Capital, Inc. (NYSE: HTGC, "Hercules") and its affiliates (Press release, AVEO, MAR 11, 2021, View Source [SID1234576543]). This second tranche was made available in connection with the recent U.S. Food and Drug Administration (FDA) approval of FOTIVDA (tivozanib).

"With the additional $20 million now available to us from Hercules, AVEO is well positioned to support what we believe will be a successful launch of FOTIVDA in the U.S.," said Michael Bailey, president and chief executive officer of AVEO. "Our core infrastructure and core commercial organization is in place, and we now look forward to delivering on the promise of FOTIVDA. We also expect to see meaningful progress within our pipeline programs in the coming quarters, including our immunotherapy combination programs for tivozanib, our Phase 2 study of ficlatuzumab and our recently initiated Phase 1 study of AV-380."

With the closing of the second tranche, AVEO has drawn down a total of $35 million under its loan and security agreement with Hercules. The loan facility has a maturity date of September 1, 2023, extendable to September 1, 2024, and an interest-only period through September 30, 2021, extendable to September 30, 2022, in each case upon the achievement of certain performance milestones related to the commercialization of FOTIVDA. An additional $5 million tranche becomes available if net product revenues of FOTIVDA reach $20 million within a specified time frame, and the final $5 million tranche would be available after that time upon the lender’s consent.

As previously disclosed, AVEO believes that its $68.8 million in cash, cash equivalents and marketable securities as of September 30, 2020, along with proceeds from the $20 million loan facility drawdown, together with anticipated partnership cost sharing reimbursements, royalties from EUSA’s FOTIVDA sales and the resulting product revenues upon the commercial launch of FOTIVDA (tivozanib) in the U.S. and the potential additional $10 million in credit under the Hercules loan, would allow the Company to fund planned operations into 2022.

Spherical Nucleic Acid Technology Shows Promising Results in Phase 0 Trial in Patients With Glioblastoma at Northwestern University

On March 11, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology,reported to share that researchers at Northwestern University have utilized Exicure’s licensed first generation gold-nanoparticle SNA technology in an investigator-initiated trial for the treatment of glioblastoma (GBM), a deadly form of brain cancer (Press release, Exicure, MAR 11, 2021, View Source [SID1234576542]).

The researchers that led the study, Drs. Priya Kumthekar and Alexander Stegh, conducted a single-arm, open-label phase 0 first-in-human clinical trial (NCT03020017) to determine safety, pharmacokinetics, intratumoral accumulation and gene-suppressive activity of systemically administered SNAs comprised of siRNA specific for the GBM oncogene Bcl2L12. Patients with recurrent GBM were treated with intravenous administration of siBcl2L12-SNAs (NU-0129).

The paper reports first-in-human evidence that siRNA-based SNAs can be administered intravenously, cross the blood-brain-barrier in glioblastoma patients, accumulate in GBM tumor cells, and engage with their target gene.

"We congratulate Drs. Kumthekar and Stegh on these results," said Dr. David Giljohann, the CEO of Exicure. He added, "We are excited about the impact to patients and its implications in treating other diseases, as Exicure continues to build and grow our pipeline in neurological disorders."

Exicure anticipates filing an IND for its lead program in Friedreich’s ataxia by the end of 2021.

About Glioblastoma

Glioblastoma (GBM) is the most common and most aggressive type of primary malignant tumor of the central nervous system. The global incidence of glioblastoma is less than 10 per 100,000 people. Standard treatment for patients with newly diagnosed glioblastoma can include surgery followed by radiation and chemotherapy, but treatment options are limited. The last investigational medicine to improve survival for patients with newly diagnosed glioblastoma was approved by the U.S. Food and Drug Administration in 2005. The five-year survival rate of patients with GBM is less than five percent.

About Friedreich’s Ataxia

Friedreich’s ataxia (FA) is the most commonly inherited ataxia, a degenerative neuromuscular disease leading to progressive loss of coordination, causing severe childhood disability and early mortality, in most cases before age 40. It is a monogenic disorder caused by mutations in the FXN gene resulting in reduced levels of frataxin protein. FA affects about 13,500 people in the US, Europe, Canada and Australia combined. There are currently no approved therapies for Friedreich’s ataxia patients.

InnoCare to Host 2020 Full Year Earnings Call on March 29, 2021

On March 11, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that it will host a conference call to discuss the 2020 full year financial results and provide a corporate update at 9:00 a.m. Beijing time on March 29, 2021 (Press release, InnoCare Pharma, MAR 11, 2021, View Source [SID1234576541]). Before the call, the Company will announce the financial results for the full year ended December 31, 2020.

Conference Call Information

InnoCare will host a conference call on March 29, 2021 at 9:00 a.m. Beijing time. Participants must register in advance of the conference call. Details are as follows:

Registration Link: View Source

Conference ID: 4956225

The call will be conducted in English.

Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

A replay will be available on the Company’s website at Investor Relations page.

IDT Acquires Swift Biosciences, a Pioneer in the Development of Next-Generation Sequencing (NGS) Library Preparation Genomics Kits for Academic, Translational, and Clinical Research

On March 11, 2021 Integrated DNA Technologies (IDT), a leading comprehensive genomics solutions provider, reported the acquisition of Swift Biosciences, a pioneer in the development of Next-Generation Sequencing (NGS) library preparation genomics kits for academic, translational, and clinical research (Press release, Integrated DNA Technologies, MAR 11, 2021, View Source [SID1234576540]). IDT is a leader in developing and manufacturing nucleic acid products for academic and commercial research, agriculture, medical diagnostics, pharmaceutical development, and synthetic biology. Swift develops and commercializes NGS Library Prep Kits that maximize data output, provide comprehensive coverage, and reduce sequencing costs.

"We have been impressed with the Swift products and organizational talent," said IDT President Trey Martin. "Swift’s research tools are being used for cancer, inherited disease and other health applications, as well as research in agrigenomics, metagenomics, and the biotech/pharmaceutical industry. Their broad portfolio of library preparation and enrichment products are highly complementary to IDT’s existing NGS product line, giving us an increased ability to provide gold standard offerings to researchers and to be well positioned for future growth."

"The synergies between IDT and Swift make this acquisition an excellent fit," commented Nathan Wood, President and CEO of Swift. "Since entering the NGS market in 2013, Swift’s mission has been to provide research tools for long term improvements in the health of individuals and their communities all around the world. IDT has the commercial engine, operational tools, and resources to catalyze these efforts."

Swift associates and products will transition into IDT while continuing to operate from its existing facilities in Ann Arbor, Michigan. Financial terms of the transaction were not disclosed.