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ImmunoPrecise Announces At-The-Market Facility of up to US$50 Million

On October 14, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA), a leader in full-service therapeutic antibody discovery and development, reported that it has entered into an At-The-Market Distribution Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC, as sole sales agent (the "Agent") (Press release, ImmunoPrecise Antibodies, OCT 14, 2021, View Source [SID1234591227]). Under the ATM Agreement, the Company will be entitled, at its discretion and from time-to-time during the term of the ATM Agreement, to sell, through the Agent common shares of the Company (the "Common Shares") having an aggregate gross sales price of up to US$50 million (the "Offering" or "ATM Facility"). Sales of the Common Shares will be made in transactions that are deemed to be "at-the-market offerings" as defined in Rule 415 of the United States Securities Act of 1933, as amended, and "at-the-market distributions" as defined in National Instrument 44-102 – Shelf Distributions, including, without limitation, sales made directly on the Nasdaq Global Market or any other existing trading market for the Common Shares in the United States. No offers or sales of Common Shares will be made in Canada on the TSX Venture Exchange (the "TSXV") or other trading markets in Canada.

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The Company will determine, at its sole discretion, the date, minimum price and maximum number of Common Shares to be sold under the ATM Facility. The Common Shares will be distributed from time to time in negotiated transactions, at market prices prevailing at the time of sale, at prices relating to such prevailing market prices, and/or in any other manner permitted by applicable law. As such, the prices may vary between purchasers over time. The Company is not required to sell any Common Shares at any time during the term of the ATM Facility.

The Company intends to use the net proceeds of the Offering, if any and at the discretion of the Company, to support the growth and development of the Company’s existing operations as well as working capital and general corporate purposes. The Company will pay the Agent a cash fee for Common Shares sold under the ATM Agreement and will reimburse certain expenses incurred by the Agent.

The TSXV has conditionally approved the listing of the Common Shares distributed in the Offering, and the Nasdaq Global Market has been notified of the Offering.

The Offering will be made by way of a prospectus supplement dated October 13, 2021 (the "Prospectus Supplement") to the Company’s existing Canadian short form base shelf prospectus dated December 11, 2020 (the "Base Shelf Prospectus") and U.S. registration statement on Form F-10, as amended (File No. 333-249957), dated January 5, 2021 (the "Registration Statement"). The Registration Statement was declared effective by the United States Securities and Exchange Commission (the "SEC") on January 11, 2021. The Prospectus Supplement has been filed with the British Columbia Securities Commission and the SEC. The ATM Agreement, the Prospectus Supplement and the related Base Shelf Prospectus are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Alternatively, the Agent will send the documents upon request by contacting the Agent: H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, telephone: (646) 975-6996, email: [email protected]. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Oncolytics Biotech® Partner Adlai Nortye Doses First Patient in Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer

On October 14, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that its partner Adlai Nortye has initiated dosing in a bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer (Press release, Oncolytics Biotech, OCT 14, 2021, View Source [SID1234591225]).

Results from the bridging trial are expected to allow Adlai Nortye to include data from Oncolytics’ North American metastatic breast cancer trials in a future submission to Chinese regulators. The first of Oncolytics’ randomized phase 2 trials, IND-213, showed that treatment with pelareorep and paclitaxel led to a statistically significant increase in overall survival compared to treatment with paclitaxel alone. Oncolytics’ second randomized phase 2 trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor.

"Adlai’s bridging trial is an important step forward for pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second-largest in the world," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "We are very pleased that dosing in the trial has commenced and congratulate our partner on this notable achievement. Looking ahead, we are eager to continue our partnership with Adlai as we work to advance pelareorep towards registration in major global markets."

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 2020.1 In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020.2
Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

Elevation Oncology’s Seribantumab Included as Part of a Case Series Presentation at the Australasian Gastro-Intestinal Trials Group 2021 Annual Scientific Meeting

On October 14, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported an investigator-presented case series from the Cancer Molecular Screening and Therapeutics (MoST) study at the Australasian Gastro-Intestinal Trials Group (AGITG) 2021 Annual Scientific Meeting, taking place virtually October 12-15, 2021 (Press release, Elevation Oncology, OCT 14, 2021, View Source;utm_medium=rss&utm_campaign=elevation-oncologys-seribantumab-included-as-part-of-a-case-series-presentation-at-the-australasian-gastro-intestinal-trials-group-2021-annual-scientific-meeting [SID1234591224]). The presentation was selected as one of four "Best of the Best" at the meeting and provides a select case series of patients treated on the MoST program, which uses genomic profiling to characterize molecular changes in tumors from patients with treatment-refractory advanced cancers and matches those patients with targeted oncology agents.

A patient with treatment-refractory metastatic pancreatic cancer had their tumor genomically profiled through the MoST program, was found to harbor an NRG1 fusion, and subsequently received treatment with seribantumab through a compassionate use program provided by Elevation Oncology. As of the data cut-off for the presentation, treatment with seribantumab resulted in durable clinical benefit for over 9 months, an approximately 90% reduction in the cancer biomarker CA19-9, and an ongoing 3 month confirmed partial response per RECIST criteria with a maximum tumor reduction of over 50%.

"The MoST program is focused on exploring the importance of matching therapeutics to patients based upon genomic evaluation of their individual tumors," said Dr Subotheni Thavaneswaran, Medical Oncologist at The Kinghorn Cancer Centre and a research fellow and principal investigator of the MoST program, Garvan Institute of Medical Research and NHMRC Clinical Trials Centre. "We are pleased to have been able to gain access to an investigational treatment option for this patient, following identification of an NRG1 fusion. Compassionate early access to seribantumab following three prior lines of therapy resulted in a clinical benefit for this individual patient, and is an important reminder of the potential for matching specific therapeutics to genomic tumor profiling results."

The full presentation from AGITG can be accessed here.

The details for the AGITG 2021 poster presentation are as follows:

Title: Comprehensive genomic profiling reveals novel opportunities for treatment-refractory gastrointestinal cancers
Authors: Wei Yen Chan1, Subotheni Thavaneswaran1,2,3, Frank Lin2,3, Lucille Sebastian3, Mandy Ballinger2, John Grady2, Maya Kansara2, Anthony Joshua1,2, Rasha Cosman1, John Simes3, David Thomas1,2
1 The Kinghorn Cancer Centre St Vincent’s Hospital Sydney; 2 Garvan Institute of Medical Research, Faculty of Medicine, UNSW; 3 NHMRC Clinical Trials Centre, University of Sydney
Presenter: Wei Yen Chan, The Kinghorn Cancer Centre, St. Vincent’s Hospital, Sydney
Session: Best of the Best
Date and time: Thursday, October 14, 2021; 11:15 to 12:15 AEDT

Distinct from the compassionate use program through which this patient was treated, seribantumab is currently being investigated by Elevation Oncology in the company-sponsored Phase 2 CRESTONE study, a tumor-agnostic "basket trial" in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The CRESTONE study is currently enrolling across the U.S. at over 26 active clinical sites and is anticipated to expand to other global regions. Elevation Oncology expects to report clinical data from an interim analysis of the CRESTONE study in mid-2022.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins." The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States. For more information visit www.NRG1fusion.com.

Pegsitacianine Demonstrates Tumor-Agnostic Real-Time Surgical Imaging in Phase 2 Study

On October 14, 2021 OncoNano Medicine, Inc. reported that results from a Phase 2 study of its lead clinical development candidate, pegsitacianine, presented as a late- breaking oral presentation at the 2021 World Molecular Imaging Congress (WMIC) (Press release, OncoNano Medicine, OCT 14, 2021, View Source [SID1234591223]). This late- breaking oral presentation by Dr. Jason Newman of the University of Pennsylvania Health System revealed the fluorescent nanoprobe, pegsitacianine, provided real-time surgical imaging in a tumor-agnostic manner for the accurate identification of malignant tissue in the operating room.

Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing removal of their solid tumor. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARDTM platform, pegsitacianine exists in a fluorescently dark ( "Off") state at physiological pH but transitions rapidly to a fluorescently "On" state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential to function as a tumor agnostic imaging agent compatible with most clinical cameras designed for ICG imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in a Phase 1 clinical trial where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.

"The Phase 2 study results for pegsitacianine presented at the recent World Molecular Imaging Congress indicate this fluorescent nanoprobe has the potential to change the current surgical paradigm," said Dr. Newman. "With the real-time feedback that pegsitacianine provides, we could now have a tool that offers real-time surgical imaging on margin status and provides a greater degree of confidence in achieving complete tumor resection. Given the unique activation mechanism of targeting a universally dysregulated tumor metabolic signature, pegsitacianine could be beneficial in aiding surgical oncologists across multiple tumor disciplines."

The recently completed Phase 2 study (NCT03735680) was a non-randomized, open-label, multi-center study being conducted at three U.S. sites. This exploratory study further confirmed the selected dose-schedule, expanded upon the drug’s safety profile and increased the number of tumor types in which pegsitacianine imaging was shown to be feasible. Together, the results demonstrated that pegsitacianine is well-tolerated in patients and provides the surgeon with accurate, real-time feedback in the operating room. Intraoperative imaging observations demonstrated a high correlation with the pathological assessments of collected tissues, and imaging can be reliably performed using multiple FDA-cleared NIR imaging devices. Results from evaluable patients demonstrated favorable sensitivity (100%) and specificity (92%) values, as well as a strong negative predictive value (100%) for detecting histologically normal tissue that was collected as part of standard of care surgery.

"The high sensitivity and specificity valuesfrom the Phase 2 trial not only corroborated our Phase 1 observations to further support the use of OncoNano’s ON-BOARDTM platform in surgical imaging, but also highlight the potential benefit of this pH-activatable platform for tumor-targeted delivery of therapeutic payloads with an increased therapeutic window," commented Jinming Gao, PhD, OncoNano’s Chief Scientific Officer.

Settlement Agreement

On October 14, 2021 Purple Biotech Ltd. (the "Registrant" or the "Company") reported that the Company entered into a settlement agreement with Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc. (collectively, "Lupin"), resolving the Company’s patent litigation against Lupin (Press release, Purple Biotech, OCT 14, 2021, View Source [SID1234591220]). The litigation concerned Lupin’s filing of an Abbreviated New Drug Application (ANDA) seeking approval from the U.S. Food and Drug Administration (FDA) to market a generic version of the Company’s commercial drug CONSENSI. This agreement with Lupin allows Lupin to enter the market on March 1, 2030 and earlier, under certain circumstances.