On October 23, 2022 Mevion Medical Systems, the leading provider of compact proton therapy systems for use in radiation treatment for cancer patients, reported that it is developing the MEVION S250-FIT Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) (Press release, Mevion Medical Systems, OCT 23, 2022, View Source [SID1234622279]). Stanford Health Care has been selected as the first site where the system will be developed and installed.

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Proton therapy is a precise form of radiation therapy that reduces the amount of unnecessary radiation exposure to healthy tissue, which has the potential to decrease or eliminate the treatment side effects and lessen the risk of secondary malignancies.

Historically, the size, cost, and inherent complexity of proton technologies have limited the adoption of proton therapy. Mevion believes that the MEVION S250-FIT system has the potential to overcome the practical challenges of other technologies because the system is designed to be a more compact, affordable solution that can fit into an existing LINAC vault. Today, new proton therapy centers in the U.S. are almost exclusively compact single-room systems. Mevion’s compact system would continue to advance the design and accessibility of proton therapy. The MEVION S250-FIT system is currently in development and has not received regulatory clearance for clinical use.

"Mevion is dedicated to making proton therapy deployment similar to conventional radiation by simplifying room renovation requirements, enabling faster installation, and facilitating integration with other radiation therapy modalities," said Tina Yu, Ph.D., CEO and President of Mevion Medical Systems. "Through our arrangement with Stanford Health Care, Mevion is aiming to demonstrate that proton therapy can fit in an existing vault of a radiation oncology department and in turn become more accessible."

*The MEVION S250-FIT Proton Therapy System has not received regulatory clearance.

On October 22, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, is pleased to reported the start of a pre-clinical program using its novel patent pending technology AccuTOXTM (Press release, Defence Therapeutics, OCT 22, 2022, View Source [SID1234626253]). The novel AccuTOXTM formulation is designed for the treatment of lung cancer including various types of malignancy of the upper or lower respiratory tracks. The AccuTOXTM will be delivered intranasal to effectively deliver the AccuTOXTM into the transmucosal and will target the lungs. Future programs may expand into targeting various malignancy of the upper and lower respiratory.

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The AccuTOXTM technology is an AccumTM variant developed by Defence Therapeutics to specifically halt tumor growth when administered intratumorally. The use of this compound in combination with various immune-checkpoints results in a substantial cure rate. At the molecular level, AccuTOXTM impairs several crucial cellular pathways exploited by tumors such as: DNA replication, cell division, nuclear integrity, and various modifications affecting the genome. The net outcome culminates in limited cell repair as well as accumulation of misfolded proteins and generation of free radicals capable of eliciting irreversible DNA damage. AccuTOXTM causes the overall cellular equilibrium to collapse consequently resulting in effective diseased cell death.

Small cell lung cancer, lung carcinoid tumor and non-small cell lung cancer are three different types of lung cancer. Global lung cancer therapeutics market was valued at USD 24,667.82 million in 2021 and is expected to reach USD 54,475.11 million by 2029, registering a CAGR of 10.41% during the forecast period of 2022-2029.

"AccuTOXTM represents a key player in Defence’s research and development programs. This molecule is not only suitable for combinatory therapies with immune-checkpoints or in the design of a novel antibody-drug conjugate, but it can be also exploited as a treatment for "hard-to-reach" tumors such as lung cancer. With the AccumTM technology in hand, Defence Therapeutics intends to become a word leader by providing a new line of products capable of accumulating in target cells while exhibiting unheralded pharmacological properties", says Mr. Plouffe, the CEO of Defence Therapeutics.

On October 21, 2022 Jubilant Life Sciences reported its Financial Results Quarter Ended September 30, 202 (Presentation, Jubilant Life Sciences, OCT 21, 2022, View Source [SID1234624657]).

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On October 21, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it has entered into definitive agreements with several institutional investors (the "Investors") for the purchase of 3,275,153 shares of the company’s common stock at $2.085 per share in a registered direct offering and warrants to purchase up to an aggregate of 3,275,153 shares of common stock in a concurrent private placement priced at-the-market under Nasdaq rules (Press release, Cellectar Biosciences, OCT 21, 2022, View Source [SID1234622345]).

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In a separate concurrent private placement transaction, Cellectar has agreed to sell pre-funded warrants to purchase up to an aggregate of 1,875,945 shares of common stock and warrants to purchase up to an aggregate of 1,875,945 shares of common stock.

The warrants will be immediately exercisable at an exercise price of $1.96 per share and will expire on the fifth anniversary of the closing date. The purchase price of each pre-funded warrant will be $2.08499 and the pre-funded warrants will be immediately exercisable at an exercise price of $0.00001 per share and will not expire until exercised in full.

The registered direct offering and private placements are expected to result in total gross proceeds of approximately $10.7 million before deducting estimated offering expenses. The company intends to use the net proceeds from the registered direct offering and the private placements for funding clinical studies, research and development, working capital and general corporate purposes.

Oppenheimer & Co. Inc. served as sole placement agent for the transaction. The registered direct offering and private placements are expected to close on October 25, 2022, subject to customary closing conditions.

The registered direct offering described above is being made pursuant to a Registration Statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). Copies of the prospectus supplement, when available, and the accompanying base prospectus relating to the registered direct offering may be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected], or by accessing the SEC’s website, www.sec.gov.

The pre-funded warrants, warrants and shares of common stock issuable upon the exercise of warrants or pre-funded warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2) under the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder. Such warrants, pre-funded warrants, and shares of common stock issuable upon exercise of the warrants and the pre-funded warrants have not been registered under the Act or applicable state securities laws, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement registering for resale the shares of common stock issuable upon exercise of the warrants and the pre-funded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On October 21, 2022 Prelude Corporation (PreludeDxä), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that its prospective data of 926 patients demonstrating the clinical utility of DCISionRT and its Residual Risk Subtype (RRt) was selected for a scientific session oral presentation at the 64th Annual American Society for Radiation Oncology (ASTRO) Meeting, to be held on October 23 – 26, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, TX (Press release, PreludeDx, OCT 21, 2022, View Source [SID1234622277]).

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"We are pleased to have our recent clinical utility and validation data on DCISionRT selected for oral presentation, at the prestigious ASTRO Annual Meeting," said Dan Forche, President and CEO of PreludeDx. "This new data is paradigm-changing and further enhances treatment decision making for radiation oncologists and their DCIS patients regarding personal radiation benefit."

Oral Presentation
Title: Number 176: Re-Thinking Clinicopathologic Risk Assessment in DCIS: Pooled Data from Validation Studies Comparing a 7-gene DCIS Assay to Clinicopathologic Features Alone
Presenter: Chirag S. Shah, MD, Director of Breast Radiation Oncology, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH
Date: Monday, October 24, 5:40 PM CT

Additional PreludeDx ASTRO Poster Will Be Presented
Title: Number 2028: The PREDICT Registry Australia: A Prospective Registry to Evaluate the Clinical Utility of a Biomarker Assay on Treatment Decisions in Patients with DCIS Following Breast Conserving Surgery
Presenter: Yvonne Zissiadis Jr, MBBS, Radiation Oncologist, GenesisCare, Perth, Australia
Date: Monday, October 24, 3:00 PM CT

About DCISionRT for Breast DCIS
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.