On February 18, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the fourth quarter and full year ended December 31, 2020 after the market closes on Thursday, February 25, 2021 (Press release, MacroGenics, FEB 18, 2021, View Source [SID1234575272]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, February 25, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 6094343.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On February 18, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI), reported the treatment of the first patient in the Phase I TENDU trial, representing the start of clinical evaluation for the Company’s Tetanus-Epitope Targeting (TET)-platform (Press release, Ultimovacs, FEB 18, 2021, View Source [SID1234575289]). The platform allows for the production of multiple therapeutic cancer vaccines that can be used to strengthen and increase T cell responses to cancer cells by targeting antigens that are specific to one type of cancer or common to many tumor types. By combining cancer antigens and the vaccine adjuvant in the same molecule, this unique platform can generate vaccine candidates with a beneficial safety and administration profile, presenting an opportunity to treat patients at an early stage of their disease. The TENDU clinical trial, conducted at the Oslo University Hospital, is a first-in-human, dose-escalation study designed to generate initial safety and immune activation data for a prostate cancer-specific therapeutic TET-based vaccine in relapsed prostate cancer patients. The Company expects to provide the first interim, preliminary safety readout from the trial by the end of this year.

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"By offering Ultimovacs’ new therapeutic prostate cancer vaccine to patients that have relapsed after radical prostatectomy but prior to their standard radiation and antihormone therapy, we hope to further reduce the risk of recurrence and to take the next step towards a better outcome for these patients," commented Dr. Wolfgang Lilleby, principal investigator at the Oslo University Hospital. "The design of the study allows us to obtain a range of important insights regarding the activation of the immune system, including following the patients to identify novel biomarkers. I am convinced that the TET-technology has great potential to aid us in our battle against prostate cancer and it is a great pleasure to participate in this trial."

"Conducting the TENDU study is an important step for us to gain initial data on the novel platform, while continuing to optimize the core TET-molecule and production process. The TET-technology will enable us to expand our pipeline and bring us closer to fulfilling our ultimate ambition of establishing Ultimovacs as a leader in the cancer vaccine field," added Sara Mangsbo, Chief Innovation Officer at Ultimovacs.

About the TENDU trial

The TENDU clinical trial is a first-in-human, Phase I study and the first clinical trial resulting from Ultimovacs’ Tetanus-Epitope Targeting (TET)-platform. The trial is being conducted at the Oslo University Hospital, Norway, and evaluates the safety of the vaccine in prostate cancer patients who have relapsed after radical prostatectomy. The primary objective of the study is to evaluate the safety and tolerability of three different doses of the vaccine. Patients will receive the vaccine prior to obtaining standard-of-care treatment consisting of radiation and antihormone therapy and will be followed for 6 months after the last dose of the vaccine to assess immunological responses such as the activation of T cells and anti-tumor activity. Patient enrollment is expected to be completed in the first half of 2022. Further details on the study can be found on clinicaltrials.gov identifier NCT04701021.

About the TET-Technology

In addition to its universal vaccine, UV1, Ultimovacs is developing novel vaccine products based on the patent-protected Tetanus-Epitope Targeting (TET)-platform. The TET-platform offers a promising approach to strengthen and increase T cell responses against cancer-specific peptides by combining antigens and the vaccine adjuvant in the same molecule, allowing for a beneficial safety profile and simplifying administration. The platform generates new, first-in-class cancer vaccine candidates that harness the pre-existing antibody response against tetanus resulting from standard tetanus vaccination. These vaccine candidates can be tailored to many types of cancer as well as infectious diseases.

On February 18, 2021 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that Philip Astley-Sparke, Chief Executive Officer of Replimune, will present at the SVB Leerink 10th Annual Global Healthcare Conference being held virtually on Wednesday, February 24, 2021 at 8:40 AM ET (Press release, Replimune, FEB 18, 2021, View Source [SID1234575257]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for approximately 90 days following the conference.

On February 18, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies to deliver oxygen to areas of the body where it is needed most, reported that the underwriter of its previously announced underwritten public offering has exercised in full its option to purchase an additional 4,390,244 shares of its common stock at a price to the public of $1.025 per share, less underwriting discounts and commissions (Press release, Diffusion Pharmaceuticals, FEB 18, 2021, View Source [SID1234575273]). After giving effect to the option closing, the aggregate gross proceeds to Diffusion from the offering were approximately $34.5 million, before deducting underwriting discounts and commissions and offering expenses payable by Diffusion.

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

Diffusion intends to use the net proceeds of the offering to fund research and development of its lead product candidate, trans sodium crocetinate, including the TCOM Study, the DLCO Study, and other clinical trial activities, and for general corporate purposes.

The shares of common stock described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-249057) filed with the Securities and Exchange Commission (SEC) and declared effective on October 2, 2020 and the accompanying prospectus contained therein. The offering of the shares of common stock was being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling 646-975-6996.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation or sale is unlawful. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

On February 18, 2021 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, reported that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK for a phase I study of its lead pre|CISION pro-drug, AVA6000 pro-doxorubicin (Press release, Avacta, FEB 18, 2021, View Source [SID1234575290]).

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In AVA6000, doxorubicin has been modified with Avacta’s pre|CISION chemistry, which renders the modified drug inactive in the circulation until it enters the tumour micro-environment. Here it is activated by an enzyme called FAP (fibroblast activation protein), which is in high abundance in most solid tumours but not in healthy tissue such as the heart.

In animal models AVA6000 has been shown to significantly increase the amount of active drug in a tumour compared with the heart and has significant potential to improve tolerability and achieve better clinical outcomes for patients.

The MHRA CTA approval is for a phase I clinical study and is a first-in-human, open-label, multi-centre study to be carried out in the UK in patients with locally advanced or metastatic solid tumours, which are known to be FAP positive including pancreatic, colorectal, breast, ovarian, bladder and non-small cell lung cancers, squamous cell carcinoma of the head and neck and soft-tissue sarcoma.

The timing of dosing the first patient in the study may be affected by the ongoing COVID-19 pandemic and its effect on hospital resources. However, it is anticipated that the study will start around mid-year.

Alastair Smith, Chief Executive Officer of Avacta Group, commented: "I am delighted to receive this approval for the AVA6000 Pro-doxorubicin phase I study from the MHRA. This is a significant milestone for Avacta and opens the path to a potentially transformational clinical proof-of-concept study for AVA6000 and the pre|CISION platform.

If the AVA6000 study shows that the pre|CISION chemistry is effective in reducing systemic toxicity of doxorubicin in humans, then it can be applied to a range of other established chemotherapies to improve their safety and efficacy. This would open up a pipeline of next generation chemotherapies for the Group with significant clinical and commercial value in a chemotherapy market that is expected to grow to $56 billion by 2024.1.

I look forward to updating the market on the timing of the dosing of the first patient and on the clinical data in due course."

Professor Chris Twelves, AVA6000 Study Chief Investigator, Leeds Teaching Hospitals Trust and the University of Leeds, commented: "This is tremendous news. When I see patients with cancer, I want to offer them more effective treatments with fewer side effects. My team are excited to be part of the AVA6000 Phase I first into human study and we look forward to enrolling patients into the clinical trial."

Neil Bell, Chief Development Officer of Avacta Group, commented: "The AVA6000 clincial trial authorisation approval represents another important milestone for the pre|CISION platform and AVA6000 programme. Working in partnership with the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), Avacta has obtained approval to initate our first Phase I open-label clinical study to evaluate AVA6000, a novel FAP-activated doxorubicin prodrug.

By utilizing FAP activation as a selective drug delivery system the pre|CISION platform provides the capability to deliver chemotherapies to the tumour microenvironment whilst limiting severe and life-threatening toxicities in non-target tissues. pre|CISION has the potential to change future treatment paradigms for many chemotherapies which have not yet optimised their clinical utility.

The next key milestone for the AVA6000 programme is to dose our first patient, planned for mid-year 2021 in the UK. Notwithstanding Covid-19 restrictions, the team are energetically working towards achieving this milestone, which will see Avacta transform into a clinical stage company."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

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