Puma Biotechnology to Participate in Breast Cancer Panel at Cowen’s Annual Health Care Conference

On March 7, 2022 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will participate in a panel discussion on breast cancer at Cowen’s 42nd Annual Health Care Conference, which will be held virtually (Press release, Puma Biotechnology, MAR 7, 2022, View Source [SID1234609609]). The Breast Cancer Panel will take place on Wednesday, March 9, at 2:10 p.m. ET.

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A live webcast of the presentation will be available on the Company’s website at View Source The presentation will be archived on the website and available for 30 days.

Entry into a Material Definitive Agreement

On March 7, 2022, Syros Pharmaceuticals, Inc. (the "Company") reported that it entered into a Master Collaboration Agreement and a project schedule (collectively, the "Agreement"), with QIAGEN Manchester Limited ("QIAGEN") (Filing, 8-K, Syros Pharmaceuticals, MAR 7, 2022, View Source [SID1234609627]). Pursuant to the Agreement, QIAGEN has agreed to develop and commercialize an assay as a companion diagnostic test to determine the expression level of the Company’s proprietary RARA biomarker for use with tamibarotene, a selective retinoic acid receptor alpha, or RARα, agonist, in newly diagnosed higher-risk MDS patients.

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Under the Agreement, QIAGEN is responsible for developing, and obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States and, at the request of Syros and subject to the negotiation of mutually agreed payments, in the following additional markets: Canada, the United Kingdom, the member states of the European Economic Area, Switzerland, Mexico, Australia, Russia, Israel and Brazil (the "Additional Markets"). In addition, QIAGEN has agreed to use commercially reasonable efforts to manufacture the companion diagnostic test and, upon negotiation of mutually agreed terms, to make the companion diagnostic test commercially available in the United States, the Additional Markets and such other countries as the parties may mutually agree. QIAGEN has agreed to undertake specified actions to minimize the risk of an inability of supply occurring for the manufacture of the companion diagnostic test.

Subject to the terms of the Agreement and upon achievement of specified technical and development milestones, the Company is obligated to pay QIAGEN an amount up to a high single-digit million-dollar payment over the term of the initial project schedule in connection with developing and obtaining and maintaining regulatory approval for the companion diagnostic in the United States. In addition, the Company will reimburse QIAGEN for certain pass-through costs. These amounts are subject to adjustment if the parties determine that changes in the scope of the development program are required. In addition, QIAGEN will retain all proceeds from the commercialization of the companion diagnostic test. Syros has no financial obligations to QIAGEN under the Agreement on the commercialization of tamibarotene.

The initial term of the Agreement expires on the later to occur of (i) the fifth anniversary of the Agreement and (ii) the expiration or termination of all project schedules executed under the Agreement. Thereafter, the Agreement automatically renews for additional periods of one year. The Company may terminate the Agreement or a project schedule executed under the Agreement for convenience upon 90 day’s prior written notice to QIAGEN. Either party may terminate the Agreement or any project schedule executed under the Agreement, as applicable, upon a material breach of the other party that is not cured within 30 days after written notice of such breach, immediately upon the bankruptcy or insolvency of the other party, or in certain other circumstances described in the Agreement. In the event of a termination of the Agreement by the Company for reasons other than QIAGEN’s material breach or bankruptcy, the Company will be obligated to pay QIAGEN wind-down and other costs and other final payments.

The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022.

Oasmia to present at Aktiedagen Stockholm on March 14

On March 7, 2022 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at Aktiespararna’s Aktiedagen Stockholm on March 14, 2022 (Press release, Vivesto, MAR 7, 2022, View Source [SID1234611839]). The presentation starts at 11:00 CET and will be broadcast live as a webcast at: www.aktiespararna.se/tv/live.

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The presentation will be available online the following day on www.aktiespararna.se/tv/evenemang and on Oasmia Pharmaceutical’s website www.oasmia.com.

Independent Researchers Reaffirm REQORSA’s Potential in Cancer, Suggest REQORSA May Benefit Other Diseases and Infections

On March 7, 2022 Genprex reported A new study publishedin Cancer Gene Therapy by independent researchers outlines REQORSA as a promising therapeutic candidate for combinational therapy in cancer (Press release, Genprex, MAR 7, 2022, View Source [SID1234609574])

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Independent researchers at Meharry Medical College and Vanderbilt University recently published a study in Cancer Gene Therapy titled, "Mitochondrial Fus1/Tusc2 and cellular Ca2+ homeostasis: tumor suppressor, anti-inflammatory and anti-aging implications."

The study provides an overview of TUSC2 (sometimes referred to as FUS1), which is the tumor suppressor gene used in Genprex’s REQORSA Immunogene Therapy. The study highlights TUSC2’s mechanism of action, the preclinical and clinical data of REQORSA in non-small cell lung cancer, and REQORSA’s ability to be combined with targeted therapies and immunotherapies; thus serving as an outside, unbiased affirmation to REQORSA and its potential as a therapeutic candidate in cancer.

Some of the study’s key highlights and supporting evidence of TUSC2 and Genprex’s clinical strategies include:

The deletion of TUSC2 in lung cancer – "FUS1/TUSC2 is a tumor suppressor gene that is frequently deleted in lung cancer." In fact, approximately 80% of all lung cancers lack or have low levels of the TUSC2 tumor suppressor protein.
TUSC2’s Mechanisms of Action – "FUS1/TUSC2 induces cancer cell death, increases apoptosis and inhibits cell proliferation."
Drug Resistance – "Conventional therapy for metastatic NSCLC currently uses epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors such as osimertinib. Beside toxicity, this type of therapy often leads to treatment-resistant cancer as a result of selecting tumor cell clones carrying mutations, thus leading to drug resistance." In addition to targeted therapies, "effectiveness of immunotherapeutics is limited due to evasion of tumor cells from immunosurveillance mechanisms eventually leading to tumor resistance similar to chemotherapy."
TUSC2 as a Combination Therapy – On targeted therapies: "Ability of FUS1/TUSC1 to suppress receptor and non-receptor kinases as well as sensitize NSCLC cells to chemotherapeutics makes this tumor suppressor a promising therapeutic candidate for combinational therapy." On immunotherapies: "REQORSA and anti-PD-1 combined therapy demonstrated significantly stronger immune response than individual therapies." On chemotherapy: "FUS1/TUSC2 is a promising adjuvant for successful anti-tumor chemotherapy."
TUSC2 May Benefit Many Types of Cancer – "The localization of tumor suppressor genes in the 3p21 region was reinforced by detection of deletions in this area in other solid (breast, cervix, and renal carcinoma) and hematopoietic (chronic myeloid leukemia) tumors."
TUSC2 May Benefit Other Diseases and Infections – "FUS1-dependent mechanisms are relevant in etiologies of diseases beyond cancer, such as chronic inflammation, bacterial and viral infections, premature aging, and geriatric diseases."
To read the article in its entirety, click here. For more information and additional studies supporting TUSC2, please refer to our Bibliography Page.

This research paper was not sponsored Genprex and the Company has no affiliation with the researchers or the research paper.

Evaxion Biotech Completes Recruitment for Phase 1/2a Clinical Trial for EVX-02

On March 7, 2022 Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported that now finalized recruitment for Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma patients (Press release, Evaxion Biotech, MAR 7, 2022, View Source [SID1234609592]).

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The Company already conducts the successful EVX-01 program with clinical testing in Australia, Europe and the US, where app. 100 patients suffering from malignant melanoma (metastasized skin cancer) will be treated with EVX-01 therapy in combination with Keytrudaâ from Merck. In the EVX-02 program, Evaxion treats patients with adjuvant melanoma, meaning that their tumors have been successfully removed (surgically), and in the study the focus of the therapy is to avoid relapse.

In the EVX-02 study encouraging preliminary findings around its potential clinical benefit now allows Evaxion to accelerate the development program. Following the finalization of recruitment, Evaxion will advance into a dedicated Phase 2b clinical trial using its patented DNA-based immunotherapy.

For the patients enrolled in the Phase 1/2a clinical trial, Evaxion’s proprietary PIONEERTM AI technology identified a sufficient number of mutations to design a personalized treatment and so far, no serious side effects have been reported.

Lars Wegner, CEO of Evaxion, said:

"Completion of recruitment for the Phase 1/2a clinical trial of EVX-02 is an important milestone, which supports our belief that the Evaxion approach is feasible. EVX-02 appears to be well tolerated and shows encouraging signs as a treatment for adjuvant melanoma patients. The T-cell activation is promising, which allows us to take data and insights from this clinical trial and move into a dedicated Phase 2 clinical trial."

About the EVX-02 Program:

1.Evaxion Biotech has completed recruitment of 16 patients and will now move directly into a dedicated phase 2b clinical trial in adjuvant melanoma.

2.Final data from the current phase 1/2a clinical trial are expected to be announced and reported second quarter of 2023, which is earlier than previously communicated.

3.Expected milestones for the EVX-02 phase 2b study are: Regulatory filing in H1 2022, First patient first visit in H2 2022 and an interim readout in 2023.