On December 16, 2022 Humanetics Corporation, a clinical-stage pharmaceutical company focused on novel products to improve outcomes for patients with cancer, reported that it presented at the MedInvest Oncology Investor Conference in New York City on December 15, 2022 (Press release, Humanetics, DEC 16, 2022, View Source [SID1234625363]).

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At the conference, Ronald Zenk, President and Chief Executive Officer at Humanetics, delivered a corporate overview and details on the company’s lead drug candidate, BIO 300. BIO 300 is a new class of drug focused on improving outcomes in cancer patients who receive first-line radiotherapy with or without concurrent chemotherapy. These patients suffer from myriad unintended side effects, which can reduce the efficacy of treatment and/or result in serious toxicities. BIO 300 acts to protect normal tissues, improving therapeutic outcomes.

BIO 300 is currently being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce lung damage in COVID-19 long haul patients. It is self-administered by patients in these trials as an oral liquid nanosuspension. BIO 300 also shows potential to minimize radiation damage in normal tissues without impacting the effectiveness of the radiation therapy against the tumor. BIO 300 was the recent subject of an early stage trial in non-small cell lung cancer patients undergoing chemoradiotherapy and was found to be safe, with results pointing to positive clinical outcomes.

Humanetics licensed BIO 300 from the United States Department of Defense (DOD), where it was discovered as a potent radioprotectant for warfighters on the battlefield. Its use in cancer patients is highly aligned with its military use, as it serves in both cases to protect normal tissues from radiation damage.

On December 16, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the use of CYTALUX in lung cancer (Press release, On Target Laboratories, DEC 16, 2022, View Source [SID1234625361]). CYTALUX is the first and only targeted molecular imaging agent that illuminates lung and ovarian cancer intraoperatively, enabling the detection of more cancer for removal. The new indication will provide surgeons the ability to integrate CYTALUX into their treatment plan for adult patients with known or suspected lung cancer, where it previously was only approved for adults with ovarian cancer.

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The label expansion is based on safety and efficacy evidence demonstrated in the ELUCIDATE Trial, a Phase 3, multi-center, single dose, open-label trial that investigated the use of CYTALUX in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.

Lung cancer is the leading cause of cancer deaths, with over 130,000 deaths from the disease in the U.S.1 and nearly 1.8 million globally2 each year. While surgery is a gold-standard treatment, up to 55% of people with lung cancer who undergo surgery with curative intent have a recurrence3. During surgery for lung cancer, some lesions can be difficult for surgeons to visualize, particularly if they are small, beneath the surface of the lung, or a type of lesion called a ground glass opacity, which is becoming increasingly common as the rates of lung cancer screenings rise.

"Today’s approval of an expanded indication for CYTALUX marks an important step forward in the treatment landscape for lung cancer and for the more than 220,000 people in the U.S. who receive a lung cancer diagnosis each year," said Chris Barys, President and Chief Executive Officer of On Target Laboratories, Inc. "We are proud to continue pioneering development of targeted intraoperative molecular imaging agents that illuminate cancers intraoperatively to enhance surgeons’ ability to see cancer in real time as they operate."

"During the ELUCIDATE Trial, CYTALUX proved to be a valuable surgical tool with its ability to localize lung lesions that may have otherwise been missed," said Dr. Linda Martin, Chief of Thoracic Surgery, University of Virginia School of Medicine. "CYTALUX has potential to become standard of care in thoracic surgery because of the safety and efficacy demonstrated in the trial. It is an important tool for surgeons to consider for patients."

CYTALUX was approved in November 2021 for use in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian and lung cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in certain cancers4,5 and illuminates intraoperatively under near-infrared light.

About the ELUCIDATE Trial
The ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) trial was a Phase 3, multi-center, single dose, open label trial led by Principal Investigator, Sunil Singhal, MD, the William Maul Measey Professor in Surgical Research and director of the Center for Precision Surgery at Penn Medicine and included 12 sites across the United States. The study (NCT04241315) investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.

About Intraoperative Molecular Imaging
To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

On December 16, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Committee for Medicinal Products for Human use ("CHMP") has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe (Press release, Y-mAbs Therapeutics, DEC 16, 2022, View Source [SID1234625360]).

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"This recommendation by the CHMP is disappointing given the significant unmet medical need, which exists for patients with CNS/LM neuroblastoma who have no approved therapies available. CHMP considered that it was not possible to conclude on the effectiveness of omburtamab as the main study did not have a randomized comparator. The company does not believe it is feasible to conduct a randomized study in a life-threatening disease where no other approved therapy is available to these children," said Thomas Gad, founder, President and Interim Chief Executive Officer. "Our focus is now on assessing the implications of the negative opinion and our plans for the omburtamab program."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.

On December 16, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that the Company has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), for the supply of KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, to be used in the combination arm of Redx’s ongoing PORCUPINE2 Phase 2 clinical study evaluating RXC004 as a potential treatment for patients with biliary cancer (Press release, Redx Pharma, DEC 16, 2022, View Source [SID1234625359]). RXC004, Redx’s lead oncology asset, is being developed as a targeted treatment for Wnt-ligand dependent tumours. It is a potent, selective, oral, small-molecule inhibitor of the Porcupine enzyme, a key activator of Wntligands in the Wnt signalling pathway.

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RXC004 is being investigated both as a monotherapy treatment and in combination, where RXC004 will be combined with immune checkpoint inhibitors (ICIs).

Biliary cancer is known to be heavily reliant upon Wnt signalling, with over 70% [1] of biliary cancer patients showing high Wnt-ligand expression, potentially making this indication highly sensitive to the benefits of Porcupine inhibition. Tumour-derived Wnt-ligand signalling is implicated in reduced intrinsic and adaptive resistance to ICI therapy in multiple cancers [2][3][4]. Inhibition of Wnt-ligand signalling can enhance ICI efficacy by reversing dendritic cell tolerisation, decreasing Treg cells, and reducing the recruitment of myeloid-derived suppressor cells [5]. It has been shown that RXC004 can reverse immune evasion in mouse tumour models and therefore there may be an additive benefit when given in combination with ICI therapies[6] such as pembrolizumab.

Professor Juan Valle, Professor and Honorary Consultant in Medical Oncology, University of Manchester & The Christie NHS Foundation Trust and RXC004 PORCUPINE2 Chief Investigator commented: "Currently, advanced biliary cancer has only a 2% 5-year survival rate, with a critical unmet need for additional treatment options. It is important to study agents such as the Porcupine inhibitor RXC004, which may sensitise some types of tumours to ICI therapies, in an effort to find effective treatment combinations that may improve outcomes for these patients, who have a particularly poor prognosis.

" Dr Jane Robertson, Chief Medical Officer, Redx Pharma commented: "We are delighted to enter into a collaboration agreement with MSD for our ongoing PORCUPINE2 study to evaluate RXC004 in combination with their anti-PD-1 therapy, pembrolizumab. Biliary cancer is a devastating disease that is heavily reliant on Wnt signalling, so we are keen to explore the potential of combining RXC004 with ICIs. Our hypothesis, based on the preclinical data we have generated, is that when combined, there may be a greater chance of the patients showing an immune response, which we hope will lead to improved outcomes.

" About the RXC004 Phase 2 Clinical Trial Programme RXC004 entered Phase 2 clinical trials in November 2021. The first study in the Phase 2 programme, PORCUPINE, (clinicaltrials.gov NCT04907539) is focused on patients with advanced microsatellite stable metastatic colorectal cancer (MSS mCRC) who have progressed following treatment with standard of care and is evaluating preliminary efficacy and safety of RXC004 in genetically selected 16/12/2022, 09:28 View Source

com/public/redx/news/rns/story/rm3jnvx View Sourcecom/public/redx/news/rns/story/rm3jnvx 2/3 patients with Ring finger protein 43 (RNF43) or R-spondin (RSPO) aberrated, advanced MSS mCRC. A second Phase 2 study of RXC004, PORCUPINE2, (clinicaltrials.gov NCT04907851), as a monotherapy for genetically selected pancreatic cancer and biliary cancer, a highly Wnt-ligand dependent cancer, commenced in January 2022.

Given the dual mechanism of action of RXC004, which preclinically was shown to inhibit tumour growth and immune evasion, there is a strong rationale for immune therapy combination. In November 2022, Phase 1 clinical data evaluating the safety and tolerability of RXC004 in combination with nivolumab, in patients with advanced malignancies was presented as a poster at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference. The data was suggestive of an anti-tumour immune response, which is reported to correlate with an improved response to PD-1 immune checkpoint inhibitors. The results of the study supported a dose selection of 1.5mg once daily to be used in combination modules of both PORCUPINE and PORCUPINE2.

The combination module of the PORCUPINE trial will evaluate RXC004 in combination with nivolumab, (OPDIVO-Bristol Myers Squibb, a PD-1 inhibitor) and this module is now approved by the FDA, which will allow patient recruitment to commence in US trial centres. The second module of the PORCUPINE2 study, (clinicaltrials.gov NCT04907851), will evaluate RXC004 in combination with pembrolizumab (KEYTRUDA-MSD’s anti-PD-1 therapy) in biliary cancer. Redx expects to report topline data readouts from the Phase 2 programme starting in the first half of 2023.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, U.S.A.

On December 16, 2022 IMV Inc. ("IMV" or the "Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage biopharmaceutical company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX, to potentially treat solid and hematologic cancers, reported that it has entered into definitive agreements for the sale of an aggregate of 3,448,276 common shares (or common share equivalents) (each, a "Share" and, collectively, the "Shares") and warrants to purchase up to an aggregate of 3,448,276 common shares (each, a "Warrant" and, collectively, the "Warrants") at a purchase price of US$2.61 per common share (or common share equivalent) and accompanying Warrant in a registered direct offering (the "Offering") priced at-the-market under the Nasdaq Capital Market (the "Nasdaq") rules (Press release, IMV, DEC 16, 2022, View Source [SID1234625354]). The Warrants have an exercise price of US$2.50 per share, are exercisable immediately, and will expire five years following their date of issuance.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the Offering.

The gross proceeds from the Offering to IMV, before deducting placement agent commissions and other offering expenses and excluding any proceeds that may be received upon exercise of the Warrants, are expected to be approximately US$9 million. IMV intends to use the net proceeds from the Offering to continue the clinical development of its lead product candidate, maveropepimut-S, in diffuse large B cell lymphoma (DLBCL), ovarian cancer, the completion of its ongoing basket trial and to continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes. The Offering is expected to close on or about December 20, 2022, subject to the satisfaction of customary closing conditions.

The Offering will be made pursuant to a registration statement on Form F-10 (File No. 333-266082), effective upon filing with the United States Securities and Exchange Commission (the "SEC") on July 25, 2022 (the "Registration Statement"), and the Company’s Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated July 22, 2022. IMV will offer and sell the securities in the United States only. No securities will be offered or sold to Canadian purchasers.

A prospectus supplement and accompanying Base Shelf Prospectus relating to the Offering and describing the terms thereof will be filed with the applicable securities commissions in Canada and with the SEC in the United States and will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Electronic copies of the prospectus supplement and accompanying Base Shelf Prospectus may be obtained, when available, upon request by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (212) 856-5711 or by emailing [email protected].

For the purpose of Toronto Stock Exchange ("TSX") approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ, provided that the transaction is being completed in compliance with the requirements of such other recognized exchange