SCK CEN and Quirem Medical announce the first production of Ho-166 microspheres for patient use at the BR2 reactor in Mol, Belgium.

On June 15, 2021 Quirem Medical reported that A first clinical QuiremSpheres patient procedure took place with radioactive holmium-166 microspheres that were activated at the BR2 reactor in Mol, Belgium (Press release, Quirem Medical, JUN 15, 2021, View Source [SID1234584001]). QuiremSpheres is an innovative product for treating liver cancer patients. In 2020, primary liver cancer was the 7th most common cancer worldwide, responsible for 905,677 new cases. This equates to 4.7% of all cancers diagnosed in 2020. Primary liver cancer became fatal that year for 830,180 patients worldwide, making liver cancer the third most deadly cancer of 2020, accounting for 8.3% of all cancer-related deaths.

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"We are very pleased that after a period of extensive testing and validation, we can now use the BR2 reactor for clinical productions." says Jan Sigger, CEO of Quirem Medical. "SCK CEN has proven to be a strong partner and we value their commitment during the development process leading up to this first clinical case. With the high reliability of the BR2 reactor, we are confident we can meet the strongly increasing demand for our products throughout Europe and beyond."

"The Belgian Nuclear Research Centre (SCK CEN) is a global leader in the field of nuclear research, services and education. SCK CEN is operating the BR2 reactor and has a long-standing tradition of partnering with healthcare companies to secure the global supply of medical radioisotopes. We are excited that we are now also able to support the production of holmium-166 microspheres for the treatment of liver cancer." says Bernard Ponsard, Stakeholder Manager of the BR2 reactor for radioisotope production and silicon doping.

QuiremScout is a unique product that allows for screening of patients that are candidates for Selective Internal Radiation Therapy (SIRT). QuiremScout is unique, as it is the only CE-marked product on the market for that purpose. It is more predictive than the current standard, Tech-99m-MAA.

QuiremSpheres, the next generation of radio-embolization microspheres, is the only commercially available SIRT product that contains holmium-166 microspheres. Unlike the widely adopted yttrium-90 microspheres, holmium-166 microspheres can be visualized in low concentrations by means of Single Photon Emission Computed Tomography (SPECT) and Magnetic Resonance Imaging (MRI). This allows clinicians to quantitatively assess the distribution of microspheres in the liver, enabling accurate evaluation of treatment directly after the radio-embolization procedure.

eFFECTOR Therapeutics to Present at JMP Securities 2021 Life Sciences Conference

On June 15, 2021 eFFECTOR Therapeutics, Inc. ("eFFECTOR"), a biopharmaceutical company focused on pioneering the development of selective translation regulation inhibitors ("STRIs") for the treatment of cancer, reported that Steve Worland, Ph.D., president and chief executive officer of eFFECTOR, and Chris Ehrlich, chief executive officer and director of Locust Walk Acquisition Corp. (NASDAQ: LWAC), a special purpose acquisition company, will present a company overview at the JMP Securities 2021 Life Sciences Conference on Thursday, June 17 at 2:00 p.m. ET (Press release, eFFECTOR Therapeutics, JUN 15, 2021, View Source [SID1234583983]).

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A live webcast will be accessible from the "Events and Presentation" page of the "News" section of the eFFECTOR’s website (www.effector.com).

As previously announced on May 27, 2021, eFFECTOR entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with LWAC and Locust Walk Merger Sub, Inc., a wholly owned subsidiary of LWAC ("Merger Sub"). Upon the closing of the transaction, anticipated to occur in the third quarter of 2021, subject to approval of LWAC stockholders and the satisfaction or waiver of certain other customary closing conditions, the combined company will be named eFFECTOR Therapeutics, Inc. and is expected to be listed on the Nasdaq Capital Market under the ticker symbol "EFTR".

Cue Biopharma to Present at the Upcoming JMP Securities Life Sciences Conference

On June 14, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will take part in a fireside chat at the JMP Securities Life Sciences Conference being held June 16-17, 2021 (Press release, Cue Biopharma, JUN 14, 2021, View Source [SID1234608276]).

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During the fireside chat, Cue Biopharma will provide an update highlighting the ongoing Phase 1a/1b monotherapy dose escalation clinical trial of CUE-101, as second-line treatment for patients with HPV+ recurrent/metastatic head and neck cancer. The discussion will include details pertaining to cohort 6 of the dose escalation Part A and the recently announced initiation of the patient expansion Part B at the recommended Phase 2 dose (RP2D) of 4 mg/kg. The Phase 1B portion of the trial is expected to enroll up to 20 patients. The encouraging early data for CUE-101, demonstrating six confirmed stable disease and one confirmed partial response as a monotherapy in the dose escalation Part A of the Phase 1 trial, underscores the clinical potential of CUE-101 and by implication, the entire IL-2-based CUE-100 series. Management will also provide an update on the Company’s additional platform developments and pipeline progress, including CUE-102, targeting the Wilms’ tumor 1 (WT1) antigen, as well as CUE-401, the lead autoimmune drug product candidate from the CUE-400 series.

Presentation Details:
JMP Securities Life Sciences Conference
Date and Time: Wednesday, June 16, 2021 10:00 a.m. – 10:25 a.m. EDT
Webcast link: View Source
A live and archived webcast of the presentation will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

RAPT Therapeutics Announces Proposed Public Offering of Common Stock

On June 14, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported that it has commenced an underwritten public offering of $125 million of its common stock (Press release, RAPT Therapeutics, JUN 14, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-proposed-public-offering-common [SID1234585134]). In addition, RAPT expects the underwriters to be granted a 30-day option to purchase up to an additional $18.75 million of its common stock on the same terms and conditions. All of the shares of common stock are being offered by RAPT. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

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J.P. Morgan, SVB Leerink and Piper Sandler are acting as joint lead book-running managers for the proposed offering. Cantor is acting as book-running manager for the proposed offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (SEC), which was declared effective by the SEC on November 16, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by email at [email protected] or by telephone at (800) 808-7525, ext. 6105; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by email at [email protected] or by telephone at (800) 747-3924.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Vaccitech Reports First Quarter 2021 Financial Results and Recent Corporate Developments

On June 14, 2021 Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, reported financial results for the quarter ended March 31, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, JUN 14, 2021, View Source [SID1234584933]).

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"The first quarter of 2021 was transformational for Vaccitech as we closed a Series B financing round and initiated patient dosing in our two lead therapeutic programs, HBV and HPV," said Bill Enright, CEO of Vaccitech. "We drove on to successfully complete our IPO early in the second quarter and are now capitalized to advance multiple pipeline candidates into Phase 3 trials."

First Quarter and Recent Corporate Developments

Closed an initial public offering of American Depository Shares for total gross proceeds of $110.5 million
Initiated patient dosing in HPV001, a Phase 1/2 clinical trial of VTP-200, an immunotherapeutic in development for the treatment of high-risk and persistent HPV infection
Completed a $168 million Series B financing. This includes $43 million of proceeds from previously issued convertible loan notes that converted into Series B shares
Appointed three independent members to its Board of Directors
Initiated patient dosing in HBV002, a Phase 1b/2a clinical trial of VTP-300, an immunotherapeutic candidate in development for the treatment of chronic HBV infection
Upcoming Milestones

Third quarter of 2021: VTP-300 topline safety and immunogenicity results of the Phase 1 trial, HBV001, in healthy volunteers and patients with chronic HBV infection
Third quarter of 2021: VTP-600 dosing initiation in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy
Fourth quarter of 2021: VTP-300 interim efficacy review, including surface antigen loss, of HBV002, the Phase 1/2a clinical trial in patients with chronic HBV infection
First quarter of 2022: VTP-200 interim efficacy review of HPV100, the Phase 1/2a clinical trial in patients with high-risk and persistent HPV infection
First Quarter 2021 Financial Highlights:

Cash position: As of March 31, 2021, cash and cash equivalents were $155.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing. Subsequent to the end of the first quarter, the Company closed an initial public offering that raised a gross amount of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into 2024.
Research and development (R&D) expenses: Research and development expenses were $4.6 million for the first quarter of 2021 compared to $4.2 million for the comparable period of the prior year. The increase in R&D expense was primarily due to increased spending on progressing VTP-300 and VTP-850 development.
General and administrative expenses: General and administrative expenses were $1.8 million for the first quarter of 2021 compared to $1.1 million for the comparable period of the prior year. The increase was primarily attributable to higher personnel costs driven by an increase in the Company’s headcount between the quarters and higher professional fees.
Other expenses: Other expenses, net were $9.3 million for the first quarter of 2021 compared to $0.7 million of income for the comparable period of the prior year. The increase in other expenses was primarily attributable to loss on extinguishment of convertible loan notes of $13.8 million and interest on loan notes of $2.7 million in the period, net of gain in fair value of derivatives of $6.0 million.
Net loss: The company generated a net loss of $15.3 million, or $1.90 per basic and diluted share, for the first quarter of 2021 compared to a net loss of $3.8 million, or $0.49 per basic and diluted share, for the comparable period of the prior year.