Targovax ASA: Primary insider share purchase

On December 3, 2020 Victor Levitysky, Chief Scientific Officer of Targovax and primary insider, reported that purchased on 2 December 2020 10,000 shares in Targovax ASA ("the Company") at an average share price of NOK 10 per share (Press release, Targovax, DEC 3, 2020, View Source [SID1234572107]). Following this transaction, Victor Levitsky holds 10,000 shares and 250,000 share options in the Company.

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AstraZeneca demonstrates growing leadership in breast cancer at SABCS with data from its innovative medicines and robust pipeline

On December 3, 2020 AstraZeneca reported that it will unveil new developments across a range of stages and subtypes of breast cancer at the 2020 San Antonio Breast Cancer Symposium (SABCS), which will be held virtually from 8 to 11 December 2020 (Press release, AstraZeneca, DEC 3, 2020, View Source [SID1234572106]).

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Key abstracts include:

New data from the DESTINY-Breast01 Phase II trial, which reinforce the durable efficacy seen with Enhertu (trastuzumab deruxtecan) in HER2-positive metastatic breast cancer following two or more prior anti-HER2 based regimens
New results from the SERENA-1 Phase I trial, which demonstrate strong efficacy and safety for a next-generation oral selective oestrogen receptor degrader (SERD), AZD9833 as a monotherapy and in combination with the CDK4/6 inhibitor, palbociclib, in HR-positive, HER2-negative advanced breast cancer
José Baselga, Executive Vice President, Oncology R&D, said: "We are committed to transforming outcomes for women diagnosed or living with breast cancer by advancing a new generation of promising potential new medicines. The updates from the comprehensive DESTINY breast programme reflect the potential of Enhertu to help a wide range of breast cancer patients, while the encouraging data from the SERENA-1 Phase I trial paves the way for a clinical development programme to help patients with hormone receptor-positive disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Significant progress has been made to improve outcomes for those living with breast cancer but there is still much work to be done. At SABCS 2020, our dedication to transforming the lives of those living with breast cancer will be front and centre. With new updates from six different approved and potential new medicines, we are directly addressing patients’ greatest unmet needs and are potentially redefining treatment. Additionally, we are making an impact through collaborations with the scientific community to accelerate innovation."

New, longer-term data from DESTINY-Breast01 to be presented at SABCS will highlight the updated efficacy and safety profiles of Enhertu in patients with previously treated HER2-positive metastatic breast cancer with an additional 9.4 months of follow up.

Furthermore, AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) will showcase several TiP abstracts that highlight how the companies are building on the impressive results of Enhertu in patients with HER2-positive metastatic breast cancer. These include trials to explore the potential of Enhertu in earlier lines of treatment and stages of disease and in new breast cancer settings, including patients with low levels of HER2 expression. They also include combinations with other anti-cancer medicines such as paclitaxel, Faslodex, Imfinzi and the potential new medicine capivasertib, an AKT inhibitor.

AstraZeneca will present new efficacy and safety results from the dose escalation and expansion cohort of SERENA-1, a Phase I clinical trial of next-generation oral SERD AZD9833 as a monotherapy and in combination with the CDK4/6 inhibitor palbociclib in women with HR-positive breast cancer.

Building on the updated SERENA-1 findings, the Company will present two Phase II trial-in-progress (TiP) abstracts for the potential new medicine AZD9833, evaluating its efficacy and safety in previously treated post-menopausal women with advanced breast cancer and its biological effects in women with treatment-naïve early-stage breast cancer.

AstraZeneca is also presenting real-world evidence to understand outcomes for patients with germline BRCA mutations, and treatment patterns among patients with HER2-positive metastatic breast cancer. The Company will also showcase data on the potential role of artificial intelligence and digital pathology in measuring levels of HER2 expression in patients with breast cancer.

Additionally, AstraZeneca recognises the important role of externally sponsored scientific research (ESR) in expanding the medical and scientific understanding of the Company’s medicines, and in identifying associated areas of unmet need in breast cancer. More than half of the AstraZeneca abstracts at this year’s SABCS are ESR trials with AstraZeneca medicines across various subtypes of breast cancer.

Abstracts to be presented at 2020 SABCS featuring AstraZeneca medicines and potential new medicines include:*

Abstracts to be presented at 2020 SABCS
*Denotes ESR

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation SERD and potential new medicine AZD9833. PARP inhibitor, Lynparza (olaparib) was the first targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state. Building on the first approval of Enhertu, a HER2-directed antibody-drug conjugate, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy durvalumab in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan (DS-1062).

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

New Grant of Options

On December 2, 2020 Redx Pharma (AIM:REDX), the drug discovery and development company focused on cancer and fibrosis, reported new options awarded under the Redx All Employee Share Option Scheme (the "Scheme"), as adopted on 1 July 2020 (Press release, Redx Pharma, DEC 2, 2020, View Source [SID1234573529]).

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The Board has authorised the conditional grant of additional options to Lisa Anson (Chief Executive Officer) and Richard Armer (Chief Scientific Officer) on 2 December 2020, both of whom are classed as PDMRs, as set out further below. The options are being granted at 56p per ordinary share, being the price of the Placing and Open Offer announced earlier today, with the grant becoming unconditional once the Placing Shares and the Open Offer Shares have been admitted to trading on AIM, which is dependent, inter alia, on the passing by Shareholders of certain resolutions at the General Meeting of the Company being convened at 11.00 a.m. on 21 December 2020.

Once the option grant becomes unconditional, any subsequent vesting will be subject to certain time and performance criteria having been met.

In addition, options over a further 1,350,000 Ordinary Shares of 1p each will be granted on 2 December 2020 to certain new staff of the company under the Scheme on an unconditional basis. These options will also be granted at 56p, and are not subject to performance conditions.

Following the grants referred to above, and assuming the associated conditions are met in relation to the conditional grant, the Company will have granted options over a total of 28,057,964 Ordinary Shares representing 10.2 per cent. of the share capital in issue following completion of the Placing and the associated issue of 32,806,159 Ordinary shares to Redmile and Sofinnova in aggregate pursuant to their conversion of £5,084,954.65 of the principal amount of the convertible loan notes issued to them

on 4 August 2020 (but ignoring any Ordinary Shares issued in the Open Offer, the take-up of which is currently uncertain). In addition, certain ex-employees continue to hold options, totalling 2,340,800 shares, representing 0.9 per cent. of the share capital that will be in issue following completion of the Placing and aforementioned conversion (but not the Open Offer). The number of options that may be awarded under the Scheme, and all prior share incentive plans, remains limited such that the aggregate number of Ordinary Shares of 1p each under option will be less than 15 per cent. of the total issued share capital of the Company.

Pascal Biosciences and S?RSE Technology Optimize Cannabinoid Formulation for Clinical Development of Cancer Treatment

On December 2, 2020 Pascal Biosciences Inc. (TSX.V:PAS) (OTC:BIMUF) ("Pascal" or the "Company") and SōRSE Technology Corporation ("SōRSE") reported that have validated and optimized a formula for oral cannabinoid delivery (Press release, Pascal Biosciences, DEC 2, 2020, View Source [SID1234572398]). Their shared efforts are advancing the cannabinoid PAS-393 towards clinical testing against cancer.

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"This progress is very promising because this step is critical for testing in human volunteers," said Patrick Gray, CEO. "We will next identify a drug product manufacturer to prepare our product for testing in cancer patients treated with checkpoint inhibitors."

This will be the first pharmaceutical use of the novel formulation technology developed by SōRSE and the first clinical trial for Pascal and SōRSE. The collaboration utilizes propriety discoveries by both companies, including Pascal’s intellectual property, which covers the use of cannabinoids in cancer patients treated with checkpoint inhibitors, and SōRSE’s proprietary formulation expertise.

"It’s great to see such rapid progress with the invitro studies using our formulation technology," said SōRSE CEO Howard Lee. "We are on track to enter our first clinical trial with Pascal within a year."

Following characterization of safety and pharmacology in a Phase 1a clinical trial, Pascal and SōRSE may elect to continue clinical development as equal partners in a Phase 1b cancer trial in combination with a checkpoint inhibitor.

Entry into a Material Definitive Agreement

On December 2, 2020, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with Geneva Roth Remark Holdings, Inc. ("Geneva"), pursuant to which Geneva purchased a convertible promissory note (the "December 2020 Geneva Note") from the Company in the aggregate principal amount of $78,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Geneva (Filing, 8-K, Propanc, DEC 2, 2020, View Source [SID1234572318]). The transaction contemplated by the Purchase Agreement closed on or about December 4, 2020. The Company intends to use the net proceeds ($75,000) from the December 2020 Geneva Note for general working capital purposes.

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The maturity date of the December 2020 Geneva Note is December 2, 2021 (the "Maturity Date"). The December 2020 Geneva Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Geneva in shares of common stock, but shall not be payable until the December 2020 Geneva Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Geneva has the option to convert all or any amount of the principal face amount of the December 2020 Geneva Note, starting on May 30, 2021 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 December 2020 Geneva 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 ("Reporting Service") designated by Geneva (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, Geneva shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Geneva and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The December 2020 Geneva Note may be prepaid until 180 days from the issuance date. If the December 2020 Geneva 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 61 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 91 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 121 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 151 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 December 2020 Geneva Note is outstanding, the Company covenants not to, without prior written consent from Geneva, 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 Geneva’s fees and expenses in the aggregate amount of $3,000.

Other than as described above, the December 2020 Geneva 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 December 2020 Geneva 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 December 2020 Geneva 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 Geneva 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 Geneva shares of common stock issuable upon conversion of principal or interest under the December 2020 Geneva Note within three business days of a notice of conversion by Geneva, the Company shall incur a penalty of $1,000, 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 December 2020 Geneva Note will become immediately due and payable and the Company will pay Geneva, in full satisfaction of its obligations in the December 2020 Geneva Note an amount equal to 150% of an amount equal to the then outstanding principal amount of the December 2020 Geneva Note plus any interest accrued upon such event of default or prior events of default (the "Default Amount").

The December 2020 Geneva Note was issued, and any shares to be issued pursuant to any conversion of the December 2020 Geneva 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.

The foregoing description of the Purchase Agreement and the December 2020 Geneva Note does not purport to be complete and is qualified in their entirety by reference to the full text of the Purchase Agreement and the December 2020 Geneva Note, which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.