On April 18, 2022 Amoy Diagnostics Co., Ltd (AmoyDx), a China based innovative molecular diagnostics company (SZSE: 300685), reported that it has entered into a Master Collaboration Agreement (Agreement) with AstraZeneca (LSE/STO/Nasdaq: AZN), a global, science-led biopharmaceutical company (Press release, Amoy Diagnostics, APR 18, 2022, View Source [SID1234612397]). The master collaboration agreement enables the Parties to collaborate in the development and commercialization of AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medicines globally.

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 first projects to be initiated under the Agreement include the co-development of a CDx to identify prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the EU and Japan, and a CDx to identify breast cancer patients with BRCA gene mutations in the EU for Lynparza (olaparib) monotherapy. HRR and BRCA mutations are well-documented targets for PARP inhibitor treatment and are important biomarkers that can inform potential treatment options including a PARP inhibitor. Lynparza (olaparib) is a first-in-class PARP inhibitor jointly developed by AstraZeneca and MSD and approved in a number of countries for the treatment of advanced ovarian, breast, prostate and pancreatic cancers. The AmoyDx decentralized CDx are based on the HANDLE system, a proprietary NGS library construction technology developed by AmoyDx, can enable the testing of HRR or BRCA gene mutations to be completed within three days.

Li-Mou Zheng, Ph.D., Founder and Chairman of AmoyDx, commented: "We are very pleased to announce today that we are further developing our partnership with AstraZeneca by entering into a master collaboration agreement. AmoyDx is a trustworthy CDx co-development partner with rich expertise in R&D, Regulatory Affairs and Commercialization globally. AmoyDx and AstraZeneca share the common core value of prioritizing patients, and we will work together to accelerate the contribution for the benefit of patients."

On April 18, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported the dosing of the first patient in the Phase 1 study evaluating BDTX-1535, a MasterKey inhibitor of epidermal growth factor receptor (EGFR) for the treatment of both non-small cell lung cancer (NSCLC) and glioblastoma (GBM)derived from Black Diamond’s MAP discovery engine (Press release, Black Diamond Therapeutics, APR 18, 2022, View Source [SID1234612396]).

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 dosing of the first patient in our Phase 1 study of BDTX-1535, a next generation brain-penetrant inhibitor of oncogenic EGFR MasterKey mutations is an important step as we believe this program is uniquely positioned to address the existing unmet needs of EGFR mutant NSCLC and GBM," said David M. Epstein, Ph.D., Chief Executive Officer of Black Diamond Therapeutics. "This is the second MasterKey inhibitor derived from our MAP drug discovery engine; we are incredibly excited about BDTX-1535’s advancement into the clinic and we look forward to providing a clinical update in the second half of 2023."

"Despite recent successes in targeting EGFR-mutated NSCLC, there is still a need for better therapeutics for patients with disease progression following first-line EGFR inhibitors," said Melissa Johnson, MD, Director of Lung Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology. "We hope to assess the ability of BDTX-1535 to inhibit tumors with primary TKI-resistant EGFR mutations or those with on-target acquired resistance mutations."

NSCLC accounts for approximately 85% of lung cancer cases worldwide. About 10-20% of all lung cancer patients in North American and Europe, and up to 50% of those in Asia harbor mutations in EGFR. Intrinsic resistance EGFR mutations, of which G719X, S768I, L861Q are among the most frequent, account for 10-20% of EGFR mutations in NSCLC. The classical Exon19del and L858R mutations, which account for 80-90% of EGFR mutations in NSCLC, are well treated but resistance invariably emerges to current generation EGFR inhibitors.

"GBM is an aggressive form of brain cancer with limited treatment options," said Patrick Y. Wen, MD, Director, Center for Neuro-Oncology at Dana-Farber Cancer Institute. "A majority of GBM tumors will co-express EGFR alterations, including mutations, splice variants and amplification, making EGFR an attractive target for new therapies with CNS penetration and potency against the spectrum of co-expressed EGFR alterations."

Up to 50% of GBM tumors express one or more co-occurring oncogenic EGFR mutations that affect the extracellular region of the receptor tyrosine kinase, and consequently promote oncogenic activation. There are no precision oncology medicines approved to treat these patients. Black Diamond believes that current targeted therapies have been unsuccessful in treating GBM due to insufficiencies in (i) drug selectivity for EGFR GBM alterations versus EGFR wildtype, (ii) drug potency against the full spectrum of co-expressed EGFR alterations, and (iii) brain penetration.

About BDTX-1535
BDTX-1535 is designed as an irreversible, mutant selective, brain-penetrant MasterKey inhibitor of oncogenic mutations of epidermal growth factor receptor (EGFR) expressed in glioblastoma multiforme (GBM) and intrinsic and acquired resistance EGFR mutations in non-small cell lung cancer (NSCLC). In pre-clinical studies, Black Diamond has demonstrated that oncogenic alterations of EGFR, particularly those associated with GBM, result in distinct conformations which impart unique pharmacology and drug resistance. It is estimated that approximately 50% of GBM patients harbor an oncogenic EGFR alteration that has the potential to be addressed by BDTX-1535, representing a potential patient population of greater than 60,000 patients annually across the US, EU, Japan and China. It is estimated that across the US, EU, Japan and China there are approximately 20,000 patients who are diagnosed annually with non-small cell lung cancer (NSCLC) harboring an EGFR intrinsic or acquired resistance mutation.

April 12, 2022, Affimed N.V. ("Affimed" or the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, SVB Securities LLC, Truist Securities, Inc. and Wells Fargo Securities, LLC, as representatives of the several underwriters named therein (collectively, the "Underwriters"), relating to the issuance and sale (the "Offering") of 22,500,000 of the Company’s common shares (the "Underwritten Shares"), as well as an additional 3,375,000 common shares to be sold pursuant to the full exercise of the option to purchase over-allotment shares granted to the Underwriters (the "Over-Allotment Shares") (Filing, 6-K, Affimed, APR 12, 2022, View Source [SID1234612395]). The price to the public in the Offering is $4.00 per share, and the Underwriters have agreed to purchase the common shares from the Company pursuant to the Underwriting Agreement at a price of $3.76 per share. The net proceeds to the Company from the Offering of the Underwritten Shares and the Over-Allotment Shares are expected to be approximately $97.0 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company. All of the common shares in the Offering are being sold by the Company.

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 Offering is being made pursuant to the Company’s effective registration statement on Form F-3 (Registration Statement No. 333-260946) previously filed with the Securities and Exchange Commission and a prospectus supplement thereunder.

The Underwriting Agreement contains customary representations, warranties and covenants by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

The Underwriting Agreement is filed as Exhibit 1.1 to this report, and the description of the terms of the Underwriting Agreement is qualified in its entirety by reference to such exhibit. Copies of the opinions of De Brauw Blackstone Westbroek N.V. relating to the validity of the Underwritten Shares and the Over-Allotment Shares issued and sold in the Offering are attached as Exhibit 5.1 hereto and Exhibit 5.2 hereto, respectively.

On April 18, 2022 Ankyra Therapeutics reported that it has established a formal Cooperative Research and Development Agreement with the National Cancer Institute (NCI) to pursue basic, translational and clinical research using Ankyra Therapeutics’ emerging anchored immunotherapy pipeline in collaboration with NCI’s Center for Cancer Research (CCR) (Press release, Ankyra Therapeutics, APR 18, 2022, View Source [SID1234612394]). CCR is located within the National Institutes of Health (NIH) in Bethesda, Maryland, and it has made many contributions to cancer therapy. CCR includes intramural investigators focused on understanding cancer biology and developing new therapeutic strategies for the treatment of cancer. The primary NCI investigators include Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology in CCR, NCI, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, Director of the Medical Oncology Service, and Deputy Director of the CCR, NCI.

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!

"Ankyra is excited to partner with both the basic scientists and clinical investigators at NCI to more rapidly understand how our drugs promote anti-tumor immunity and to quickly get our drugs into clinical trials for patients with cancer," stated Dr. Howard L. Kaufman, Chief Executive Officer of Ankyra Therapeutics. Dr. Michael Schmidt, Chief Scientific Officer of Ankyra, added "We are especially excited to collaborate with NCI researchers to expand the pre-clinical and clinical development of our lead cytokine therapeutic ANK-101 and look forward to combining our expertise to demonstrate the ability of our anchored immunotherapy platform to enhance the safety and efficacy of powerful immune agonist drugs."

On April 18, 2022 Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") and NEC Corporation (Head Office: Tokyo, Japan; President & CEO: Takayuki Morita; hereafter "NEC"), reported the execution of a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine (Press release, NEC, APR 18, 2022, View Source [SID1234612393]). NEC OncoImmunity (Head Office: Oslo, Norway, CEO: Richard Stratford Ph.D.), an NEC subsidiary that specializes in artificial intelligence-driven biotechnology, is also participating in this research collaboration.

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!

Hepatitis B is a potentially life-threatening liver disease caused by the hepatitis B virus (HBV). Chronic infection with HBV results in a high risk of death from cirrhosis and liver cancer. About 300 million people are living with chronic hepatitis B infection worldwide, and hepatitis B resulted in an estimated 820,000 deaths in 20191. Although the widespread use of hepatitis B vaccines in infants has considerably reduced the incidence of new chronic HBV infections under the age of 5, the number of new infections by other routes continues to increase2.

Interferon (IFN) and nucleotide analog therapy are currently used in the treatment of hepatitis B. However, treatment with IFN has a high frequency of side effects, and nucleotide analog therapy has a high recurrence rate if treatment is interrupted, so it is necessary to take drugs for a lifetime3. Therefore, the unmet medical need for safe and highly effective drugs that can finally achieve a complete cure for hepatitis B is high.