On July 25, 2023 Hanmi Financial Corporation reported its 2023 second quarter results (Press release, Hanmi, JUL 25, 2023, View Source [SID1234634870]).

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On July 25, 2023, Kiromic BioPharma, Inc. (the "Company") reported to have issued a 25% Senior Secured Convertible Promissory Note (the "Note") to an accredited investor (Press release, Kiromic, JUL 25, 2023, View Source [SID1234633458]). The Note has a principal amount of $2,400,000, bears interest at a rate of 25% per annum (the "Stated Rate") and matures on July 25, 2024 (the "Maturity Date"), on which the principal balance and accrued but unpaid interest under the Note shall be due and payable. The Stated Rate will increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws.

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The Note is convertible into shares (the "Conversion Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an initial conversion price of $6.50 per share (the "Conversion Price"), subject to a beneficial ownership limitation equivalent to 9.99% (the "Beneficial Ownership Limitation").

The unpaid principal of and interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all subordinated indebtedness and equity securities of the Company outstanding as of the Issuance Date; provided, however, that the Company may incur or guarantee additional indebtedness after the Issuance Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note, which are secured by all of the Company’s right, title and interest, in and to, (i) all fixtures (as defined in the Uniform Commercial Code, the "UCC") and equipment (as defined in the UCC), and (ii) all of the Company’s intellectual property as specified in the Note, subject to certain exclusions as described in the Note.

The foregoing description of the Note is qualified in its entirety by reference to the full text of such Note, a copy of which is attached hereto as exhibit 10.1 and incorporated herein by reference.

On July 25, 2023 NK:IO, a leader in natural killer (NK) cell biology applied to the development of exceptionally potent, off-the-shelf cell therapies targeting solid tumours, reported that it has raised £1.2M (Press release, NK:IO, JUL 25, 2023, View Source [SID1234633425]). This brings total equity financing to £3.2M and will enable the company to reach key milestones in progressing its differentiated NK cell therapy candidates into development. The £3.2M equity funding is in addition to £1.9M grants awarded comprising the recent Innovate UK New Cancer Therapeutics award of £1.6M and a previous Innovate UK Accelerator grant of £300,000. The current investment round was led by Cancer Research Horizons (through its Seed Fund) and included the Imperial College Enterprise Fund, Start Codon, UK Innovation & Science Seed Fund and Meltwind.

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NK:IO is based on pioneering discoveries in NK cell biology from Hugh J M Brady, Professor of Immunology and Matt Fuchter, Professor of Chemistry, at Imperial College. NK:IO is exploiting these in its unique platform which activates blood stem cell progenitors to yield industry-leading NK cell tumour-killing potency and very high yield cell production, which it believes will be transformative in cancer cell therapy. In addition, this platform enables efficient engineering of progenitor cells to enable the production of next-generation NK cells for further increases in potency or tumour targeting, which NK:IO is progressing for certain hard to treat tumour subtypes.

The company was founded in December 2020 by Hugh J M Brady, Matt Fuchter, and Mike Romanos, an experienced industry executive and entrepreneur. The Board is chaired by Keith Thompson CBE, former CEO of the UK’s Cell and Gene Therapy Catapult. The company’s first indication targeted will be ovarian cancer, in collaboration with Prof. Iain McNeish, Professor of Oncology at Imperial College, Director of the Ovarian Cancer Action Research Centre and a leading expert in the field.

The investment will be used to drive NK:IO’s cell therapy candidates through full pre-clinical testing. This includes development of a manufacturing process in collaboration with the Cell and Gene Therapy Catapult, whose mission is to support the UK’s cell and gene therapy industry.

Mike Romanos, Co-Founder and Interim CEO, said: "We are very excited by the potential of NK:IO’s platform to address unmet needs in cancer cell therapy, including solid tumours, and to revolutionise the field. We are delighted by the support of our investors, including Cancer Research Horizons, who have joined to lead the round. Our recent success in securing non-dilutive funding under Innovate UK’s ‘New Cancer Therapeutics’ program further endorses this vision."

Tony Hickson, Chief Business Officer at Cancer Research UK and Cancer Research Horizons, commented: "Cancer Research Horizons believes that NK:IO’s technology, based on pioneering research from Imperial College, has transformational potential for cancer patients. We are delighted to support the company’s progression and excited to work with the team as they progress to the clinic."

On July 25, 2023 Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating the development of promising treatments to market reported the FDA authorization of a Phase II clinical trial to re-assess a targeted treatment in light of newly discovered pharmacogenomic predictor data in patients with newly diagnosed high-grade glioma (HGG) (Press release, Denovo Biopharma, JUL 25, 2023, View Source [SID1234633424]).

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Anova reported the FDA authorization of an IND for a Phase II clinical trial under it’s management to re-assess a targeted treatment in light of newly discovered pharmacogenomic predictor data in patients with newly diagnosed high-grade glioma.

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Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, acquired Toca 511 and Toca FC (now collectively known as DB107) from Tocagen in 2020, with the aim of identifying one or more pharmacogenomic predictors for DB107 efficacy using its proprietary biomarker discovery platform.

In December 2021 Denovo Biopharma announced discovery of a novel genetic biomarker, Denovo Genomic Marker 7 (DGM7TM), by leveraging Tocagen’s randomized 403-patient Phase 3 study in recurrent HGG that had negative results overall, but that had subsets of patients who received clear benefit. DGM7 has been shown to be associated with increased overall survival with treatment of recurrent HGG, via retrospective analysis.

This year, Anova Enterprises, Inc. assembled a team of key opinion leaders from the University of California at San Diego (UCSD), University of California at San Francisco (UCSF), the University of Southern California (USC) and Denovo Biopharma to explore the best way to confirm the efficacy of DB107 in patients with HGG who have the DGM7 biomarker. The resulting Phase 2 study design has been authorized to proceed by the U.S. FDA, literally bringing a treatment "back from the dead" to help patients in need.

The Phase 2 study of DB107 will investigate the impact of giving multiple doses of DB107 both directly at time of surgery and intravenously (IV). The study also stratifies patients to more easily identify those individuals who benefit from treatment from those who do not. "FDA authorization of the study of DB107 is another important milestone for Denovo as we work to bring this retroviral replicating vector (RVV) back into clinical development" said Matthew A. Spear, M.D., Chief Medical Officer & Chief Development Officer, Denovo Biopharma. "Our dedicated team worked diligently to identify the biomarker which predicts response to DB107 and it will be exciting to potentially confirm our work in this prospective clinical trial."

Anova Enterprises, Inc. (Anova) will manage the study using its transformative AnovaOS technology. AnovaOS is the industry’s first collaborative ‘learning system’. "This is exactly the sort of opportunity Anova wants to deliver in the marketplace" said Martin Walsh, President at Anova. "We regularly see patients responding to treatments in studies that fail in large randomized patient populations. Identifying predictive biomarkers such as DGM7 and confirming results in smaller, targeted patient populations is the way toward better and more cost effective treatments."

The Phase 2 clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107 when added to standard-of-care (SOC) provides clinical benefit to newly diagnosed HGG when compared to historical performance documented in well controlled clinical trials published in the peer reviewed literature. The trial is expected to enroll approximately 70 adult patients with newly diagnosed HGG, and the primary endpoint of the trial will be progression free survival (PFS).

"I am excited to see DB107 heading back into the clinic" said Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF). "Outcomes in patients newly diagnosed with HGG are essentially unchanged for 40 years and confirming DB107 works in patients with the DGM7 biomarker may change outcomes in those patients for the better"

"Our partnership with Denovo Biopharma, UCSD, UCSF and USC is another example of Anova’s commitment to improving access to promising new treatments for patients in need, in diseases where patients are often left with limited treatment options" said Chris Beardmore, CEO at Anova. "By fixing what is broken in clinical research we can conduct better studies and deliver the right treatments to the right patients."

On July 25, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Company has received approval to conduct clinical trial of its second generation pan-TRK inhibitor zurletrectinib (ICP-723) to treat pediatric patients (2 to 12 years old) in China (Press release, InnoCare Pharma, JUL 25, 2023, View Source [SID1234633423]). This is following the clinical trial of zurletrectinib for adolescent patients (12 to 18 years old) after showing good safety and efficacy in adult patients.

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Zurletrectinib was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma, etc., and for patients resistant to the first generation of TRK inhibitors.

Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, "NTRK gene fusion is more common among pediatric patients. By now, our clinical study with zurletrectinib has covered NTRK fusion patients at all ages. We will continue to accelerate the clinical trials of zurletrectinib, looking forward to providing better treatment options for patients early."