On June 7, 2022 Phost’in Therapeutics (Montpellier, France), a biotech company focused on the discovery and development of N-glycosylation inhibitors for the treatment of cancer and other serious diseases, reported the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Italian Medicines Agency (AIFA) have accepted an adaptive Phase I/II in patients with advanced solid tumors for the First-In-Class selective n-glycosylation inhibitor, PhOx430 (the PhAST trial) (Press release, Phost’in, JUN 7, 2022, View Source [SID1234615742]).

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PhOx430 targets a key glycosylation mechanism responsible for supporting cancer proliferation and suppressing the immune response. The program has demonstrated a significant antitumoral efficacy in several animal models, associated with a promising safety profile in regulatory preclinical studies.

The PhAST trial will begin enrolling two dozen of patients with non-selected tumour types in a dose escalation phase, followed by three expansion cohorts gathering patients with selected tumour types, including Glioblastoma multiforme (GBM), Triple-negative breast cancers (TNBC) and a selection of other solid tumour types, for which few therapeutic options exist.

The primary objective will be to determine the safety and tolerability of PhOx430 in patients. The secondary objectives will include a preliminary evaluation of efficacy, in addition with the identification of biomarkers.

In France, the CTA was submitted and accepted as part of ANSM’s Fast Track procedure designed to reduce processing times for clinical trial authorization requests for innovative medical products.

Karine Chorro, CEO of Phost’in Therapeutics, said: "The approval of this CTA marks an important regulatory milestone for PhOx430. We are grateful to the French and Italian Competent Authorities for their positive feedback on what we believe is a disruptive clinical innovation, and a formidable hope for patients with limited therapeutic options. We will continue our efforts to advance PhOx430 clinical development, and to bring it to patients and their families."

GBM, still a rare disease with a global incidence rate inferior to 10 per 100,000 in Europe and North America, remains one of the most aggressive malignant cancer types, difficult to treat and associated with high mortality. The life expectancy of GBM patients is typically less than 15 months after diagnosis. TNBCs represent 10-15% of all breast cancers, are typically associated with a high risk of early metastasis, including brain metastases, and bad 5-year prognostic. Therefore, there is a critical and unmet therapeutic need for both indications.

The clinical program received the scientific contribution of Gianni Bonadonna Foundation, which collaborated in the conception and design of the research protocol. "The approval of this trial represents the actualization of one of the main goals of the Gianni Bonadonna Foundation: to endorse therapeutic innovation from the earliest phases of research, to achieve the best results in favor of cancer patients" declared Dr. Luca Gianni, President of Gianni Bonadonna Foundation.

Dr. Diego Tosi, Gianni Bonadonna Foundation’s scientific coordinator and head of the Early Clinical Trial Unit-Medical Oncology Department of the Cancer Institute of Montpellier in France, has been entrusted with the international direction of this first-in-human clinical trial, conducted in French and Italian Oncological Centers. "This is the first drug with this type of mechanism of action", Diego Tosi explained. "The antitumor action seems mainly due to the effect on the membrane receptors, and the drug is highly effective in the preclinical setting; there are less data on how the immune response is modified, but our research will try to find answers".

Phost’in Therapeutics has also appointed contract research organization ("CRO") Michelangelo Tech Srl (Milan, Italy) to coordinate the PhAST trial. Owned by the Michelangelo Foundation with the aim of contributing to progress in cancer research and improving treatment options for tumors, Michelangelo Tech Srl provides extensive expertise in early phase clinical development, precisely to favor the rapid clinical application of new therapies.

About PhOx 430 treatment
The aberrant, complex and hypersialylated glycosylation of tumor cells is now recognized as a novel immune checkpoint, affecting key membrane receptors and masking tumor cells from the immune system, via the formation of complex abnormal glycan patterns operating as a shield. PhOx430 targets this aberrant glycosylation directly to the source through selective inhibition of a specific enzyme for a double antitumor effect, inducing simultaneously an anti-cancer immune response and the down regulation of the main receptors implicated in cancer. PhOx430 is the first program from the Phost’ScreenTM platform that combines unique and patented chemical libraries with cutting-edge screening tools to produce selective n-glycosylation inhibitors.

On June 7, 2022 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, reported that it has entered into a committed equity purchase agreement (the "Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), for the issuance and sale, from time to time, of up to $40 million of its American Depositary Shares (the "ADSs"), each of which represents one ordinary share, DKK 1 nominal value, of the Company (the "Ordinary Shares") (Press release, Evaxion Biotech, JUN 7, 2022, View Source [SID1234615741]).

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Under the terms of the Agreement, Evaxion has the right, at its sole discretion, but not the obligation, to sell to LPC up to $40 million of its ADSs over the 36-month term of the Agreement, subject to certain conditions.

Lars Wegner, CEO of Evaxion, said: "We are pleased to conclude this Agreement with Lincoln Park Capital, securing access to $40 million from a widely respected investor in the biotech industry and further strengthening Evaxion’s financial position during a period of market uncertainty. This equity facility will contribute to the progression of our exciting portfolio of assets, including personalized cancer medicines, developed in programs EVX-01 and EVX-02, both of which are currently in Phase 2 clinical development, according to plan. This gives us momentum to reach our value-creating, upcoming clinical milestones. Importantly, it also maintains Evaxion’s flexibility in deciding if and when to exercise the option to sell, so we can continue to choose the optimum development path for the Company."

Evaxion had cash and cash equivalents of $31.4 million at the end of the first quarter of 2022 and expects its cash position, without proceeds from the Agreement, to be sufficient to fund operating expenses and capital expenditure requirements through at least the next 12 months.

There are no upper limits to the price LPC may pay to purchase the ADSs, and the purchase price will be based on the prevailing market prices of the ADSs at the time of each sale to LPC. Evaxion controls the timing and amount of any future sales of its ADSs to LPC. The Company may terminate the Agreement at any time, in its sole discretion, without any additional cost or penalty. In consideration for entering into the Agreement, LPC received 428,572 Ordinary Shares represented by ADSs from the Company.

On June 7, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Kevin Farr, will be presenting at Oppenheimer’s 22nd Annual Consumer Growth and E-Commerce Conference (Press release, ChromaDex, JUN 7, 2022, View Source [SID1234615739]).

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The ChromaDex management team is scheduled to present virtually on Wednesday, June 15th at 3:45 p.m. Eastern Time (12:45 p.m. Pacific Time).

ChromaDex management will also attend virtual one-on-one meetings with institutional investors throughout the day.

Webcast link: ChromaDex Investor Presentation – Oppenheimer Consumer Conference

On June 7, 2022 Chordia Therapeutics Inc. ("Chordia"), a biotech company engaged in the research and development of novel therapies for cancers, reported that it has presented the interim results from the Phase 1 clinical trial of CTX-712, a selective pan-CDC-like kinase ("CLK") inhibitor discovered by Chordia, at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which was held from June 3 to June 7 (Press release, Chordia Therapeutics, JUN 7, 2022, View Source [SID1234615737]).

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A Phase 1 clinical trial of CTX-712 in solid tumors and hematological malignancies demonstrated a clinically acceptable safety profile. As for antitumor efficacy, it was observed in multiple subjects, establishing an initial Proof of Concept (POC). Dose limiting toxicities (DLTs) observed included dehydration, decreased platelet count, and hypokalemia, and the maximum tolerated dose (MTD) for twice-weekly dosing was determined to be 140 mg. Additionally, two partial responses (PRs) and two complete responses (CRs) were observed in patients with ovarian cancer and acute myeloid leukemia, respectively. A dose-dependent increase in systemic exposure was observed in pharmacokinetics (PK) analysis, and a dose-dependent increase in exon skipping of RNAs set as pharmacodynamics (PD) markers confirmed mRNA splicing modification by CTX-712. Further studies are currently underway to determine the recommended Phase 2 dosing.

"It is a great honor to be involved in the first-in-human clinical trial of a new anticancer drug candidate with a novel mechanism of action," said Dr. Noboru Yamamoto, Director of the Department of Experimental Therapeutics at the National Cancer Center Hospital and Principal Investigator of the study. "Although it is still in the early stages of clinical trials, we hope that CTX-712 will become an effective treatment for patients with advanced, relapsed, or refractory malignancies in the future."

ASCO abstract number: 3080
Title: A First-in-Human Phase 1 Study of CTX-712 in Patients with Advanced, Relapsed or Refractory Malignant Tumors

About CTX-712

CTX-712 is a first-in-class, orally available and selective small molecule inhibitor of CDC-like kinase (CLK), a key regulator of the RNA splicing process that plays an important role in cell growth. CTX-712 inhibits the growth of various human tumor cell lines in vitro, and in addition, exhibits antitumor activity in multiple xenograft mouse models in vivo.

Details of Phase 1 Clinical Trial

The Phase 1 clinical trial in Japan is investigating the tolerability, safety, and pharmacokinetics (PK) of CTX-712 in patients with advanced, relapsed, or refractory malignancies. For details of the study, please refer to JapicCTI-184188.

About RNA Splicing

The RNA immediately after transcription is called precursor messenger RNA which contains noncoding sequences (introns) as well as coding sequences (exons) that are needed to make proteins. RNA splicing is a process to remove the introns and connect the exons to form mature mRNA, which is then translated into protein.

About CDC-like Kinases (CLKs)

Kinase is a general term for enzymes that catalyze the transfer of phosphate groups in biological substances, such as ATP, over to target substances that are called substrates. Over 500 protein kinases are known in humans, of which the CLK family consists of four members – CLK1, CLK2, CLK3, and CLK4, and phosphorylates serine/arginine-rich (SR) proteins as substrates.

About Serine/Arginine-rich Proteins (SR Proteins)

SR protein is a general term for a group of proteins with serine (S) and arginine (R)-rich SR domains, of which about 10 types have been reported in humans. The serine in the SR domain is phosphorylated by CLK kinase. The phosphorylated SR proteins bind to the exon region of the precursor mRNA and facilitate the incorporation of the bound exon into the mature mRNA during splicing.

About Exon Skipping

When CTX-712 inhibits CLK kinases and the SR protein dephosphorylates, a splicing change called exon skipping occurs, in which the exons fail to be incorporated into the mature mRNA.

Important Notice

In this press release, the definition of "press release" covers any oral presentation, question and answer session, and written and/or oral materials discussed or distributed by Chordia Therapeutics in connection with this press release. This press release (including the oral description and related questions and answers) is not intended to constitute, represent, or form part of any offer, invitation, or solicitation to purchase and/or acquire anything, including securities.

Disclaimer

Any announcements by Chordia Therapeutics, including this press release, may contain information on products derived from pharmaceutical developments, but are intended to inform the latest information related to Chordia’s business, and not intended as promotions, solicitations, advertisements, or to provide medical advice.

On June 7, 2022 Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported a collaboration with Novo Nordisk, a leading global healthcare company, to create novel expression hosts for pharmaceutical products (Press release, Ginkgo Bioworks, JUN 7, 2022, View Source [SID1234615736]).

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Today, hundreds of millions of people are living with diabetes, obesity, and other serious chronic diseases, putting a strain on individuals, families, and healthcare systems. More effective medicines could improve treatment options for these people. Using synthetic biology, Ginkgo and Novo Nordisk will collaborate to unlock the potential of expression systems, which may accelerate and enhance the discovery and development of Novo Nordisk’s biological medicines.

"Novo Nordisk is constantly pushing the boundaries for innovative tools to bring new treatments to people living with diabetes and other serious chronic diseases," said Brian Vandahl, Senior Vice President, Global Research Technologies, Novo Nordisk. "Using synthetic biology and the reprogramming of expression system genomes, we have the potential to engineer biological systems that will expand the chemical space of biological medicines."

"It’s an honor to work with partners like Novo Nordisk that not only have an incredible range of critically important products, but that also provide us with the opportunity to do meaningful work that could help so many patients," said Jason Kelly, CEO and cofounder of Ginkgo Bioworks. "At Ginkgo, we are always on the lookout for projects that will have an outsized impact on people’s lives and well-being. We’re excited to be working with Novo Nordisk in our efforts to use biology to create better medicines for patients with chronic diseases."

Under the terms of the partnership, Ginkgo and Novo Nordisk will launch a multi-year collaboration. Ginkgo will receive an upfront R&D fee and is eligible to receive milestone payments as the parties advance in the collaboration.