On January 4, 2022 Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") reported that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, for the treatment of radioiodine refractory differentiated thyroid cancer (RR-DTC) and unresectable hepatocellular carcinoma (u-HCC) (Press release, Knight Therapeutics, JAN 4, 2022, View Source [SID1234598111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lenvima (lenvatinib) demonstrated a statistically significant progression-free survival prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine therapy1. In a separate study in patients with previously untreated unresectable HCC2, Lenvima (lenvatinib) was proven to be non inferior to sorafenib for overall survival. In addition, Lenvima (lenvatinib) was statistically significantly superior to sorafenib for progression-free survival and objective response rate. In 2020, there were approximately 5,3043 new patients with thyroid cancer and 2,2893 new patients with liver cancer in Colombia.

"We’re pleased to announce the approval of Lenvima (lenvatinib) in Colombia as it provides a new treatment option for radioiodine refractory differentiated thyroid cancer and unresectable hepatocellular carcinoma," said Samira Sakhia, President & Chief Executive Officer. "We look forward to working with payors to ensure access to the product for all patients who can benefit from Lenvima (lenvatinib)."

Knight has an exclusive license from Eisai to commercialize Lenvima (lenvatinib), Halaven (eribulin mesylate), Fycompa (perampanel) and Inovelon (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven (eribulin mesylate) and Lenvima (lenvatinib).

About LENVIMA (lenvatinib); available as 10mg and 4mg capsules

LENVIMA (lenvatinib), discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA (lenvatinib) inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.

Currently, LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It has also been approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA (lenvatinib) has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States. LENVIMA (lenvatinib) has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

On January 4, 2022 NaNotics LLC, a nanomedical company focused on developing and commercializing NaNots, a novel subtractive nanoparticle that treats disease by capturing and clearing pathogenic molecules from blood, reported a research collaboration with Mayo Clinic to develop a NaNot that targets the soluble form of PD-L1, a tumor-generated immune inhibitor (Press release, Mayo Clinic, JAN 4, 2022, View Source [SID1234598131]). The goal is to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) and commence human trials within two years .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cancer cells with high levels of PD-L1 are able to "trick" the immune system into not attacking, allowing tumors to become more advanced. Approved drugs against PD-L1 do exist today but are limited in their capabilities. Specifically, they are unable to distinguish pathogenic soluble PD-L1 from membrane PD-L1 – which also has a vital immune regulatory role – leading to dose-limiting toxicity. Soluble PD-L1 – also known as "sPD-L1" – is elevated in many cancer patients and correlates very negatively with survival.

NaNots are distinct from drug therapies in that they deplete soluble targets without engaging membrane forms of the same target, something that drugs generally cannot do. Furthermore, NaNots offer ultra-low toxicity in comparison to drug therapies. Multiple animal studies to date have shown no measurable NaNot toxicity – even at 25-100 times the planned dose in humans.

Sean Park, MD, PhD, oncologist at Mayo Clinic, stated, "Our team has been studying sPD-L1 for several years. We believe it’s a key driver of immune evasion for many tumor types. The ability to deplete sPD-L1 without incurring the toxicity of drugs against PD-L1 is potentially significant. We’re excited to collaborate with NaNotics and test NaNots against sPD-L1 in humans for the first time."

"Collaborating with Dr. Park and his team at Mayo Clinic is a dream come true for us. Not only are they world-class scientists with extensive human trial experience, but they also possess deep knowledge of sPD-L1 specifically," said Lou Hawthorne, CEO of NaNotics and the inventor of NaNots – the subject of 12 granted patents to date. "Dr. Park’s team includes Haidong Dong, MD, PhD, co-discoverer of PD-L1. All they need is a way to deplete the target, which we’re happy to provide with our platform. Together, we have an opportunity to explore a fundamentally new kind of treatment that could contribute to improved outcomes for millions of cancer patients."

As part of the collaboration, NaNotics will provide its core nano-depletion platform and Mayo Clinic will provide an antibody of its own design against PD-L1, which will be specific to sPD-L1 once incorporated into a NaNot. Mayo Clinic will also provide a transgenic mouse model that secretes human sPD-L1, as well as a broad range of know-how.

Mayo Clinic and Drs. Sean Park and Haidong Dong have a financial interest in NaNots targeting sPD-L1. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

On January 4, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022, at 11:15 a.m. ET (Press release, Nuvalent, JAN 4, 2022, View Source [SID1234598157]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast will be available in the investor section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On January 4, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported that Clive Richardson, Chief Executive Officer, will present a Company overview at the H.C. Wainwright BioConnect Conference being held virtually January 10-13, 2022 (Press release, Akari Therapeutics, JAN 4, 2022, View Source [SID1234598319]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The pre-recorded presentation will be available on-demand beginning January 10, 2022 at 7:00 a.m. ET by visiting ‘Events’ in the Investor Relations section of the Company’s website at www.akaritx.com. A webcast replay will be accessible for 90 days following the event.

On January 4, 2022, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with Sixth Street Lending, LLC ("Sixth Street"), pursuant to which Sixth Street purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $63,750, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Sixth Street (Filing, 8-K, Propanc, JAN 4, 2022, View Source [SID1234598499]). The transaction contemplated by the Purchase Agreement closed on January 6, 2022. The Company intends to use the net proceeds ($60,000) from the Note for general working capital purposes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The maturity date of the Note is October 21, 2022 (the "Maturity Date"). The Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Sixth Street in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Sixth Street has the option to convert all or any amount of the principal face amount of the Note, starting on July 3, 2022, and ending on the later of the Maturity Date and the date of payment of the Default Amount (as defined below) is paid if an event of default occurs, for shares of the Company’s common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Variable Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Variable Conversion Price" shall mean 65% multiplied by the Market Price (as defined herein) (representing a discount rate of 35%). "Market Price" means the average of the lowest three (3) Trading Prices (as defined below) for the Common Stock during the ten (10) Trading Day period ending on the latest complete Trading Day prior to the Conversion Date. "Trading Price" means, for any security as of any date, the closing bid price on the OTCQB, OTCQX, Pink Sheets electronic quotation system or applicable trading market (the "OTC") as reported by a reliable reporting service designated by Sixth Street (i.e. Bloomberg) or, if the OTC is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the "pink sheets". Notwithstanding the foregoing, Sixth Street shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Sixth Street and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 90 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, but less than 151 days from the issuance date, then the prepayment premium shall be 125% of the face amount plus any accrued interest, and if prepaid after 150 days from the issuance date, but less than 181 days from the issuance date, then the prepayment premium shall be 129% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from Sixth Street, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144. Pursuant to the terms of the Purchase Agreement, the Company paid Sixth Street’s fees and expenses in the aggregate amount of $3,750.

Other than as described above, the Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the Note. Additional events of default shall include, among others: (i) failure to reserve at least five times the number of shares issuable upon full conversion of the Note; (ii) bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted by or against the Company or any subsidiary of the Company; provided, that in the event such event is triggered without the Company’s consent, the Company shall have sixty (60) days after such event is triggered to discharge such event, (iii) the Company’s failure to maintain the listing of the common stock on at least one of the OTC markets (which specifically includes the quotation platforms maintained by the OTC Markets Group) or an equivalent replacement exchange, the Nasdaq National Market, the Nasdaq Small Cap Market, the New York Stock Exchange, or the American Stock Exchange, (iv) The restatement of any financial statements filed by the Company with the SEC at any time after 180 days after the issuance date for any date or period until this note is no longer outstanding, if the result of such restatement would, by comparison to the un-restated financial statement, have reasonably constituted a material adverse effect on the rights of Sixth Street with respect to this note or the Purchase Agreement, and (v) the Company’s failure to comply with its reporting requirements of the Securities and Exchange Act of 1934 (the "Exchange Act"), and/or the Company ceases to be subject to the reporting requirements of the Exchange Act.

In the event that the Company fails to deliver to Sixth Street shares of common stock issuable upon conversion of principal or interest under the Note within three business days of a notice of conversion by Sixth Street, the Company shall incur a penalty of $1,000 per day, provided, however, that such fee shall not be due if the failure to deliver the shares is a result of a third party such as the transfer agent.

Upon the occurrence and during the continuation of certain events of default, the Note will become immediately due and payable and the Company will pay Sixth Street, in full satisfaction of its obligations in the Note an amount equal to 150% or 200% of an amount equal to the then outstanding principal amount of the Note, dependent on the nature of the default, plus any interest accrued upon such event of default or prior events of default.

The Note was issued, and any shares to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.