On August 17, 2020, Aduro Biotech, Inc. ("Aduro" or the "Company"), Aspire Merger Sub, Inc. ("Merger Sub") and Chinook Therapeutics U.S., Inc. ("Chinook") reported that it entered into Amendment No. 1 (the "Amendment") to the Agreement and Plan of Merger and Reorganization (the "Merger Agreement"), dated June 1, 2020, by and among the Company, Merger Sub and Chinook (Filing, 8-K, Aduro Biotech, AUG 18, 2020, View Source [SID1234563776]). The Amendment revises the Merger Agreement to, among other things, reflect Chinook’s contemplated private placement financing, which is expected to occur immediately prior to the closing of the merger of Merger Sub with and into Chinook (the "Merger"). The Amendment revises the Exchange Ratio to be used for purposes of determining the number of shares of Aduro common stock to be received by Chinook stockholders in the Merger to exclude the shares of common stock issued by Chinook in its proposed private placement financing from the shares of Chinook capital stock treated as outstanding for purposes of the Exchange Ratio.

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Other than as expressly modified pursuant to the Amendment, the Merger Agreement remains in full force and effect as originally executed on June 1, 2020. The foregoing summary of the terms of the Amendment is subject to, and qualified in its entirety by, the copy of the Amendment filed as Exhibit 2.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

On August 18, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported it will participate in two presentations at the World Orphan Drug Congress USA 2020 being held virtually August 24-27, 2020 (Press release, Aeglea BioTherapeutics, AUG 18, 2020, View Source [SID1234563775]).

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Presentation Details

Panel Title: Stronger Together: Continuing industry and patient partnerships to ensure inclusion of patient voice along the full continuum of development, from pre-clinical through commercialization
Date/Time: August 24 at 9:10 a.m. EDT
Moderator: Michael C. Hanley, Aeglea’s chief commercial officer

Presentation Title: Next generation human enzymes: Innovative solutions for patients with rare diseases
Date/Time: August 25 at 12:50 p.m. EDT
Presenter: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer

The company presentation will be available for download on the Presentations & Events section of the Company’s website.

On August 18, 2020 MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) reported that Monjuvi (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in Oncology for B-cell Lymphomas (Press release, Incyte, AUG 18, 2020, View Source [SID1234563774]). Specifically, the NCCN Guidelines in the United States now include Monjuvi in combination with lenalidomide with a Category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant (ASCT).

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This press release features multimedia. View the full release here: View Source

"We are very gratified the NCCN acted quickly to include Monjuvi in combination with lenalidomide with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a treatment for patients with relapsed or refractory DLBCL who are not candidates for transplant. This targeted therapeutic option helps address an immediate medical need for patients who previously had limited treatment options," said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. "There is no other FDA-approved second line treatment for these patients with a 2A designation within the NCCN guidelines."

The U.S. Food and Drug Administration (FDA) approved Monjuvi in combination with lenalidomide under accelerated approval on July 31, 2020, for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DBLCL arising from low grade lymphoma, and who are not eligible for ASCT. The approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter single arm trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research and education. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care – including physicians, nurses, pharmacists, payers, patients and their families – with the ultimate goal of improving patient care and outcomes.

"The inclusion of Monjuvi in the NCCN Guidelines will help further inform healthcare providers of this advancement for patients," said Peg Squier, M.D., Group Vice President, U.S. Medical Affairs, Incyte. "We believe Monjuvi has the potential to address an urgent medical need for patients with relapsed or refractory DLBCL and are pleased that the NCCN has acknowledged the clinical benefit of this targeted therapeutic option."

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide,2 characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year, approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.4,5,6

The updated NCCN Guidelines are available at www.nccn.org.

NCCN and the NCCN Guidelines are registered trademarks of National Comprehensive Cancer Network.

About Monjuvi (tafasitamab-cxix)
Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab-cxix is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.
XmAb is a registered trademark of Xencor, Inc.

Important Safety Information
What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

On August 18, 2020 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 62,716 shares as a consequence of the exercise of employee warrants (Press release, Genmab, AUG 18, 2020, View Source [SID1234563772]).

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The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

400 shares at DKK 31.75,
6,500 shares at DKK 40.41,
1,500 shares at DKK 67.50,
47,438 shares at DKK 225.90,
50 shares at DKK 231.50,
850 shares at DKK 337.40,
2,000 shares at DKK 466.20,
275 shares at DKK 623.50,
250 shares at DKK 636.50,
1,175 shares at DKK 815.50,
1,150 shares at DKK 939.50, and
1,128 shares at DKK 1,145.00.

Proceeds to the company are approximately DKK 16 million. The increase corresponds to approximately 0.1% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription, i.e. inter alia full rights to dividends for the financial year 2020. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No. 377 of April 2, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,409,296 which is made up of 65,409,296 shares of a nominal value of DKK 1 each, corresponding to 65,409,296 votes.

On August 18, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company") reported that it has entered into definitive agreements with investors providing for the sale and issuance of up to 19,587 shares of its Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share in a private placement offering priced at-the-market under the rules of the Nasdaq Stock Market. The Preferred Stock is convertible into shares of DelMar common stock at a conversion price of $1.16 per share (Press release, DelMar Pharmaceuticals, AUG 18, 2020, View Source [SID1234563757]). The offering is expected to result in gross proceeds to DelMar of up to approximately $19.6 million.

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The private placement is expected to close concurrently with DelMar’s previously announced proposed merger with Adgero Biopharmaceuticals Holdings, Inc. ("Adgero") on or about August 19, 2020, subject to the satisfaction of customary closing conditions. Upon closing of the transactions, DelMar will change its name to "Kintara Therapeutics, Inc." and it is anticipated that the shares of common stock will commence trading on the Nasdaq Capital Market under the ticker symbol "KTRA."

The Company intends to use the net proceeds from the offering for the previously announced registration study for VAL-083 in newly diagnosed and recurrent glioblastoma multiforme (GBM), the 15-patient REM-001 confirmatory lead-in study intended to continue seamlessly into a full Phase 3 pivotal study for Cutaneous Metastatic Breast Cancer (CMBC), and for working capital. Also, as previously disclosed, the GBM trial will be executed through the Company’s partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in GBM.

The Preferred Stock accrues dividends payable in shares of DelMar common stock on the first four anniversaries of the closing of the private placement as long as the Preferred Stock has not been converted with percentages ranging from 10% in year one to 25% in year four.

The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.