On February 2, 2023 RefleXion Medical, a therapeutic oncology company, reported the U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers (Press release, RefleXion, FEB 2, 2023, View Source [SID1234638894]). The company will host a live-stream event featuring both its co-founder and CEO discussing the breakthrough significance of SCINTIX therapy for cancer treatment.

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SCINTIX is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine where and how much radiation to deliver, second-by-second, during actual treatment delivery. This expands the RefleXion X1 into the only dual-treatment modality platform that can treat patients with indicated solid tumors of any stage. The SCINTIX biologic modality tracks tumor motion from all types of movement, including expected motion from internal processes such as breathing and digestion or unexpected movement by a patient. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.

SCINTIX ushers in a new era of external-beam radiotherapy by harnessing data produced from the biologic process of cancer cells, which until now has been untapped. We are excited to be among the early adopters of SCINTIX and to help develop this therapy for all cancer patients, especially those with stage 4 disease, where treatment options often remain very limited.

Terence Williams, M.D., Ph.D.
Chair of City of Hope’s Department of Radiation Oncology

"SCINTIX ushers in a new era of external-beam radiotherapy by harnessing data produced from the biologic process of cancer cells, which until now has been untapped," said Terence Williams, M.D., Ph.D., chair of City of Hope’s Department of Radiation Oncology. "We are excited to be among the early adopters of SCINTIX and to help develop this therapy for all cancer patients, especially those with stage 4 disease, where treatment options often remain very limited.

"With SCINTIX, the X1 machine and the tumor communicate continuously via a live data stream produced during patient treatment," continued Dr. Williams. "This precision should enable us to treat less surrounding tissue and may enable the treatment of more tumors in the same course of therapy."

The FDA cleared SCINTIX biology-guided radiotherapy to treat patients with lung and bone tumors. These tumors may arise from primary cancers or from metastatic lesions spread from other cancers in the body. Previously granted Breakthrough Device designation by the FDA for treating lung tumors, the breakthrough nature of SCINTIX technology lies in its ability to detect and then treat multiple moving tumors. Initially cleared for use with the radiopharmaceutical fludeoxyglucose F18—commonly known as FDG—the company plans to adapt SCINTIX therapy to work with the full array of novel radiopharmaceuticals under development for different cancer types.

"From its inception, the novel nature of SCINTIX therapy demanded that we fundamentally rethink how to design a machine capable of delivering cancer treatment to patients that were not considered candidates for radiotherapy because of the extent of their disease," said Todd Powell, CEO and president of RefleXion. "Likewise, our regulatory pathway encompassed unprecedented hurdles as medical device and pharmaceutical teams within the FDA worked together to create a new classification regulation for this breakthrough device and therapy.

"With initial clearance for SCINTIX therapy behind us, we will begin full commercialization and patient treatments in the coming weeks."

SCINTIX therapy (formerly referred to as BgRT) is delivered through the RefleXion X1 machine, which combines positron emission tomography (PET) with a linear accelerator (LINAC) to deliver a radiation dose that tracks the cancer’s motion. Immediately prior to treatment, the patient is injected with a radiopharmaceutical that interacts with cancer cells to produce signals or emissions. The X1 continuously constructs a map from the detected emissions data that determines where to aim beamlets of radiation. This crosstalk between the tumor and the X1 requires the system to rotate at 60 rpm—making it the first and only radiotherapy machine to spin at this speed.

Autonomous radiotherapy was just a concept over a decade ago, but now for the first time in the history of cancer treatment, the individual biology of the cancer itself guides its own destruction. Today, I want to acknowledge and thank the many talented people who have contributed over the years to translate SCINTIX therapy to the clinic.

Sam Mazin, Ph.D.
Founder and CTO of RefleXion

"Autonomous radiotherapy was just a concept over a decade ago, but now for the first time in the history of cancer treatment, the individual biology of the cancer itself guides its own destruction," said Sam Mazin, Ph.D., founder and CTO of RefleXion. "Today, I want to acknowledge and thank the many talented people who have contributed over the years to translate SCINTIX therapy to the clinic."

Combined, tumors in the lung or bone, including those that metastasize from other primary cancers, arise in approximately 430,000 patients.[1] In metastatic cancer, where patients can present with both lung and bone tumors, radiotherapy is often not considered as a treatment option due to the cumbersome clinical workflow and toxicity of treating more than one tumor in a treatment session.

RefleXion is hosting a brief live stream event from its headquarters in Hayward, Calif., about the SCINTIX therapy clearance. The live stream can be accessed on RefleXion’s YouTube channel today at 10:30 AM PST.

On February 2, 2023 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations, used to safely and effectively destroy various cancers, bacteria and viruses, reported that its Phase II Bacillus Calmette Guerin ("BCG") Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") clinical study ("Study II") (Interim) data has been accepted by the American Urology Association ("AUA") for a moderated poster presentation at it’s annual meeting (Press release, Theralase, FEB 2, 2023, View Source [SID1234627414]).

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The AUA annual meeting will take placebetweenApril 28th to May 1st, 2023 in Chicago, Illinois with the poster presented for general viewing and discussion within one of the moderated poster sessions, during the AUA annual meeting.

The poster titled: "A Phase II Clinical Study of Intravesical Photo Dynamic Therapy ("PDT") in Patients with BCG-Unresponsive NMIBC (interim analysis)"will be presented by the lead author, Girish Kulkarni M.D., Ph.D., FRCSC, Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, Professor, University of Toronto, (Toronto, Ontario, Canada).

The poster will include interim clinical data and analysis collected through the enrollment and treatment of patients at all Canadian and US clinical study site by their respective principal investigators for Study II.

Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase stated, "I am delighted that Theralase will have the opportunity to showcase its latest reported interim clinical data and analysis for Study II at the AUA annual meeting to leading uro-oncologists from around the world. The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in 53% of patients evaluated at 90 days and 28 % of patients evaluated at 450 days. Based on the clinical data collected to date, PDT could represent a viable treatment option with an acceptable safety profile."

About AUA

Founded in 1902, with more than 20,000 members worldwide, the AUA is a premier urologic association, providing invaluable support to the urologic community with the mission is to promote the highest standards of urological clinical care through education, research and the formulation of health care policy.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the United States.

About TLD-1433

TLD-1433 is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.

On February 2, 2023 Takeda reported its financial report for the Quarter Ended December 31, 2022 (Presentation, Takeda, FEB 2, 2023, View Source [SID1234626983]).

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On February 2, 2023 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported updated clinical data from Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI) (Press release, 4d Pharma, FEB 2, 2023, View Source [SID1234626952]).

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The primary efficacy endpoint for Part B of the study is more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months. In March 2022, it was announced that 4 patients in the RCC cohort had experienced durable stable disease.

At the time 4D pharma plc was placed into administration it was agreed that patient recruitment into the study would be placed on temporary pause but patients who had already started treatment would be allowed to continue. There were 2 Part B RCC patients on treatment at the time of administration.

Today, 4D pharma is pleased to announce that one of these patients is experiencing a partial response. Part B of the study has to date enrolled 22 patients with RCC, of which 5 out of 20 evaluable patients have achieved clinical benefit. To date, Part B of the study has enrolled 51 patients of up to a total of 120 patients with RCC, non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma. MRx0518 continues to be safe and well tolerated and 5 patients are continuing on treatment.

The study is being conducted in heavily pre-treated metastatic patients with solid tumors who have previously experienced clinical benefit on prior ICI therapy and subsequently developed progressive disease. The study is being conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA).

"Despite recent setbacks in the microbiome field experienced by other companies and the limitations on patient recruitment as a result of the administration, we are delighted that patients continue to benefit from the trial treatment. We continue to build on the body of evidence for the future development of MRx0518 and 4D’s approach to Live Biotherapeutics" commented Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. "Together with the clinical, safety and biomarker data we have generated in the wider MRx018 programme, it is clear that there is an opportunity to take MRx0518 into earlier lines of treatment to improve outcomes with immunotherapy. While the safety and tolerability of MRx0518 lends itself to multiple combinations and indications, the data we have generated in RCC suggests that this provides our most viable route to market."

4D pharma is in discussion regarding next steps for this study and future pivotal studies with partners and Key Opinion Leaders.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On 24 June 2022, David Pike and James Clark of Interpath Advisory were appointed as administrators of 4D Pharma plc. The administrators make no statement or representation in respect of the announcement.

On February 2, 2023 Roivant Sciences (Nasdaq: ROIV) reported the pricing of an upsized underwritten public offering of 26,666,666 of its common shares at a price to the public of $7.50 per share (Press release, Roivant Sciences, FEB 2, 2023, View Source [SID1234626929]). All of the common shares to be sold in the offering are to be sold by Roivant. The gross proceeds to Roivant from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be $200 million. In addition, Roivant has granted the underwriters a 30-day option to purchase up to an additional 3,999,999 common shares on the same terms and conditions. The offering is expected to close on February 7, 2023, subject to customary closing conditions.

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Goldman Sachs & Co. LLC, SVB Securities LLC, Cowen and Company, LLC and Cantor Fitzgerald & Co. are acting as bookrunning managers for the offering.

The common shares are being offered pursuant to a registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on October 3, 2022. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement related to the offering will be filed with the SEC and will be available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov.

When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by telephone at (833) 297-2926, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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 registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.