On February 3, 2023 Celyad Oncology (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on the discovery and development of innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, reported a fourth quarter 2022 business update and an outlook for 2023 (Press release, Celyad, FEB 3, 2023, View Source [SID1234626795]).

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Michel Lussier, interim Chief Executive Officer of Celyad Oncology, said: "The second half of 2022 has been a pivotal time for the Company as we have engaged in a new Celyad 2.0 strategy to leverage our innovative technologies and R&D platforms and focus on IP partnering transactions. We’ve stretched our cash runway by divesting our manufacturing business unit, and discontinued our clinical programs to focus on selected, critical R&D efforts to mitigate the current limitations of CAR T-cell therapy. We believe we are now well-positioned to unleash the power of our IP estate and to help making the cell therapy approach a success."

Operational highlights

• The Company announced a strategic shift in October 2022 to prioritize discovery research in areas of expertise where it can leverage the differentiated nature of its platforms. The Company has implemented a differentiated and innovative strategy, which it believes has the potential to tackle the major current limitations of CAR T-cell therapies. This strategy includes a multiplexing approach of the short hairpin RNA (shRNA) platform, a dual CAR development of a next-generation NKG2D-based CAR, and the development of B7-H6-targeting immunotherapies.
• In October 2022, the Company decided to discontinue the development of CYAD-101, the allogeneic TIM-based, NKG2D-based CAR T-cell candidate for metastatic colorectal cancer (mCRC), based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program. There were no new safety concerns leading to this decision. The clinical hold announced in March 2022 on the CYAD-101-002 Phase 1b trial had been lifted in July 2022 by the FDA.
• Data collected in the IMMUNICY-1 trial of the clinical program CYAD-211, the allogeneic shRNA-based, anti-BCMA CAR T candidate for relapsed or refractory multiple myeloma (r/r MM), which was developed to validate shRNA technology in the clinic, have shown a favorable safety profile for CYAD-211 across all dose-levels and cohorts, with 19 patients treated in total. The lack of observed graft-versus-host disease (GvHD) despite engraftment of CYAD-211 provided proof-of-concept for the use of shRNA as a technology to control GvHD of allogeneic CAR T-cells.
• In December 2022, the Company decided to discontinue the development of its remaining clinical program CYAD-211 based on a strategic and financial review. There were no safety concerns leading to this decision and all patients previously treated with CYAD-211 still continue to receive their protocoldefined follow-up.

• In September 2022, the Company entered into a €6 million asset purchase agreement with Cellistic, the cell therapy development and manufacturing business of Ncardia BV, whereby Cellistic acquired Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell therapy manufacturing business unit.
• Since October 2022, the Company has implemented a strategic shift from an organization focused on clinical development to one prioritizing R&D discovery and leveraging its IP estate through partnerships, collaborations and license agreements. The Company has compiled a foundational and broad IP estate that controls key aspects of developing therapies in the allogeneic cell therapy space. The patents around allogeneic CAR T-cell therapies and NKG2D-based therapies provide an avenue to develop intellectual property programs and to partner with outside parties around the licensing of these patents.

Financial highlights As of December 31, 2022, the Company had cash and cash equivalents of €12.4 million ($13.3 million). Net cash burn during the fourth quarter of 2022 amounted to €1.0 million, in line with expectations. The Company projects that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023.

After due consideration of detailed budgets and estimated cash flow forecasts for the year 2023, which reflect the new strategy of the Company and include expenses and cash outflows estimations in relation to the development of its proprietary technology platforms and intellectual property, the Company continues to project that its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that this release is issued.

Outlook for 2023
• Celyad Oncology is increasing its R&D efforts on areas of expertise where it believes it can leverage the differentiated nature of its platform technology and continue to bolster its IP estate. The Company will continue to leverage the dynamic potential of the shRNA platform, and to explore options to tackle the major current limitations of CAR T-cell therapies through its dual targeting CARs with NKG2D capabilities and B7-H6 targeting cell therapies.
• The Company will provide updates on the potential proof-of-concept of the dual CAR and multiplexing research programs and on business development in the course of 2023 and will take part in several conferences to share these data. Financial Calendar 2023
• March 23rd, 2023 Full Year 2022 Financial Results
• May 5th, 2023 First Quarter 2023 Business Update
• May 5th, 2023 Annual shareholders meeting
• August 3rd, 2023 First Half 2023 Interim Results
• November 9th, 2023 Third Quarter 2023 Business Update The financial calendar is communicated on an indicative basis and may be subject to change.

On February 2, 2023 HLB Life Science, which holds the domestic rights to the targeted anticancer drug ‘Riboceranib’ and some of the profit rights in Europe and Japan, reported the company has applied for conditional product approval for adenoid cystic carcinoma (adenoid carcinoma) for the first time in Korea (Press release, HLB Life Science, FEB 2, 2023, View Source;word=&page=1&v=380 [SID1234649275]).

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HLB Life Science announced on the 2nd through a public notice that it has applied for conditional product approval of riboceranib for ‘patients with recurrent or metastatic adenoid cystic carcinoma’ to the Ministry of Food and Drug Safety.

Adenoid cystic carcinoma, commonly called salivary gland cancer, is a rare disease and an intractable cancer with no proper treatment other than repeated surgery or radiation therapy. It is a very difficult to differentiate in advance because it is histologically very diverse and complex, and it occurs multiple times throughout the salivary glands. It is a very difficult type of cancer to treat as it frequently relapses locally along the nerves or metastasizes remotely to the lungs, bones, intestines, and brain.

HLB’s US subsidiary Elevar Therapeutics and HLB Life Science have conducted a phase 2 clinical trial of riboceranib on 80 patients with adenoid cystic carcinoma in the US and Korea. According to the clinical results announced at the American Society of Cancer (ASCO) (Free ASCO Whitepaper) in June last year, the primary endpoint, objective response rate (ORR), showed 15.1% by the Response Evaluation Criteria (RECIST v1.1) based on the change in tumor size, and 51.7% by the CHOI evaluation criteria that measures the density along with the change in tumor size, confirming its high potential as a treatment for adenomatous polyposis.

The disease control rate (DCR) was 64.4%, and the duration of response (DOR) was 14.9 months. While many anticancer drugs showed low response rates of 0-10% in investigator-directed clinical results for adenomatous polyposis, riboceranib is evaluated to have confirmed high efficacy and safety in a strictly controlled large patient group.

If HLB Life Science receives conditional product approval from the MFDS, it plans to quickly supply riboceranib to major domestic hospitals for the treatment of adenomatous polyposis patients. At the same time, as it is a conditional approval, we plan to immediately begin preparing for phase 3 clinical trials to further prove the efficacy and safety of the new drug.

Rivoceranib was designated as an orphan drug and an orphan drug in development stage for adenoma of the thyroid gland in the United States (February 2021) and Korea (November 2022), respectively.

According to the MFDS guidelines, orphan drugs are subject to accelerated review, so they can be approved and launched with only phase 2 clinical trials, and can enjoy benefits such as clinical trial subsidies, market exclusivity, and conditional sales approval.

Separately, in the United States, Elevar is also finalizing a trial plan for phase 3 clinical trials after conditional approval, and HLB Life Sciences, which holds the Korean rights, has applied for product approval to the Korean MFDS first.

Han Yong-hae, CEO of HLB Life Science, said, "In the case of adenomatoid carcinoma, there is no standard treatment, so it is a representative cancer with high unmet medical needs among patients, and the rapid launch of a new drug is very important." He continued, "HLB Life Science and Elevar have been working together to apply for approval from the MFDS and the FDA, respectively, but HLB Life Science completed its preparations one step ahead and has now applied for approval of the new drug. We will do our best to receive conditional product approval from the MFDS, and we will establish a systematic system to ensure a fast and stable supply of riboceranib in the future."

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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