On November 11, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that it has signed an exclusive licensing agreement with Gaeta Therapeutics Ltd., related to the use of locally delivered Interleukin-12 (IL-12) via oncolytic viral expression in combination with immune checkpoint inhibitors, including CTLA-4, PD-1 or PD-L1 checkpoint blockade (Press release, Oncorus, NOV 11, 2021, View Source [SID1234595266]). Gaeta Therapeutics was founded by the University of Zurich in 2017 as a vehicle for the commercialization of its immune-oncology patent estate relating to the use of IL-12 in combination with checkpoint inhibitors in the treatment of cancer.

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"Known to activate and expand CD8, CD4 TH1 and natural killer cells, IL-12 is a transgene of notable interest in the immune-oncology space. IL-12 in combination with immune checkpoint blockade has demonstrated the ability to augment treatment response in certain patients versus immune checkpoint inhibitor treatment alone," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. "IL-12 is one of five immunomodulatory payloads in our lead viral immunotherapy product candidate, ONCR-177. This agreement with Gaeta is a strategic addition to our IP portfolio as we continue to advance ONCR-177 as a potential new therapeutic option for cancer patients, including in combination with pembrolizumab and other immunotherapies."

Under the terms of the agreement, Gaeta will receive an upfront payment of $0.2M and is eligible to receive up to $7.5M in potential clinical and regulatory milestone payments on a product-by-product and indication-by-indication basis.

"We’re pleased to enter into this agreement with Gaeta, as it enhances our clinical development efforts for ONCR-177 and bolsters our future commercialization strategy and opportunities for this product candidate," said Stephanie Duncanson, Ph.D., Vice President, Corporate Strategy and Business Development. "We’ll continue to seek additional strategic opportunities to differentiate our pipeline programs as we work to drive innovation and advance our mission to realize the full promise of viral immunotherapy for cancer patients."

Being developed for multiple solid tumor indications, ONCR-177 is an intratumorally administered oncolytic Herpes Simplex Virus (HSV)-based viral immunotherapy engineered to induce immunogenic cancer cell death and ignite innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to IL1-12, ONCR-177’s complementary transgene payload also includes FLT3LG, CCL4, anti-PD-1 and anti-CLTA-4. Oncorus is currently enrolling patients in a Phase 1 open-label, dose escalation and expansion clinical trial designed to evaluate the safety and tolerability of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. Oncorus will present initial data from its ongoing Phase 1 clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually.

On November 11, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Grazia Ambrosini, PhD, an associate research scientist at Columbia University Vagelos College of Physicians and Surgeons, presented data regarding MN-166 (ibudilast) in a uveal melanoma (UM) model study at the 10th Annual CURE OM Global Science Meeting held online as a part of the Society for Melanoma Research International Congress on October 28, 2021 (Press release, MediciNova, NOV 11, 2021, View Source [SID1234595283]).

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This study was a collaborative effort between MediciNova and Dr. Ambrosini, Richard D. Carvajal, MD, associate professor of medicine at Columbia Vagelos College of Physicians and Surgeons and co-director of the Precision Oncology and Systems Biology research program at the Herbert Irving Comprehensive Cancer Center (HICCC), and Gary Schwartz, MD, professor of oncology at Vagelos College of Physicians and Surgeons, Division Chief of Hematology/Oncology at Columbia University Irving Medical Center, and Deputy Director at the HICCC.

The highlights of Dr. Ambrosini’s presentation are follows:

The role of UM exosomes in the crosstalk with hepatic cells was investigated in co-culture migration assays and in a mouse metastatic model.
UM exosomes induce activation of cell signaling pathways and the release of cytokines and growth factors from hepatocytes. The exosome-stimulated hepatocyte conditioned media (HCM) could in turn induce migration of UM cells.
Macrophage migration inhibitory factor (MIF) was the major player in these mechanisms and its blockade inhibited cell migration in co-cultures with exosome-stimulated hepatocytes and prevented the development of metastases in vivo.
MN-166 reduced migrated UM cell count in UM-exosome-stimulated HCM (p<0.001).
Quantified bioluminescence intensity for each animal in the abdominal region was significantly reduced by MN-166 treatment in the UM mouse model (p<0.05).
MN-166 prevented metastasis in a mouse UM metastasis model.
Dr. Carvajal commented, "We are excited about the preclinical data generated with the MIF inhibitor MN-166 in this uveal melanoma model study. Uveal melanoma is the most common primary intraocular malignancy and nearly half of patients ultimately will develop metastasis. Metastases are most frequently localized to the liver and associated with a poor prognosis. Currently there are no effective preventive treatments for uveal melanoma. Previously, our group identified MIF as a critical mediator of metastatic spread. In our new study, MN-166 treatment prevented remote metastasis in the orthotopic uveal melanoma model."

Kazuko Matsuda, M.D. Ph.D, MPH., Chief Medical Officer, MediciNova, Inc., commented, "In clinical practice, cancer metastasis is often the major driver of cancer-related death rather than the primary cancer. We are very excited about MN-166’s potential to prevent metastasis in uveal melanoma. We previously reported that MN-166 reduced levels of immune suppressive myeloid-derived suppressor cells (MDSCs) and enhanced CD8 T cell activity in the tumor microenvironment. The new data from this UM model study suggested that treatment with MN-166 can potentially address significant unmet medical needs for novel and effective therapies for patients with UM at risk of metastasis. We are looking forward to moving to a clinical trial and we are optimistic that this project could help patients with uveal melanoma and other malignancies."

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases including ALS, progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) is being evaluated in patients at risk for developing acute respiratory distress syndrome (ARDS).

On November 11, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present in a fireside chat at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum being held virtually November 18, 2021 (Press release, Biodesix, NOV 11, 2021, View Source [SID1234595299]).

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Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum
Date: Thursday, November 18, 2021
Time: 4:30 PM ET

The fireside chat will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

On November 11, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will participate in the following investor conferences (Press release, ORIC Pharmaceuticals, NOV 11, 2021, View Source [SID1234595343]):

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Jefferies London Health Conference – Participating in a virtual fireside chat on Thursday, November 18, 2021, at 8:00 a.m. GMT.

Evercore ISI 4th Annual HealthconX Conference – Participating in a virtual fireside chat on Thursday, December 2, 2021, at 3:55 p.m. ET.
Webcasts of the fireside chats will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the events.

On November 11, 2021 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") reported financial results for the third quarter ended September 30, 2021 (Press release, IntelGenx, NOV 11, 2021, View Source,in%20the%202020%20third%20quarter. [SID1234595436]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise .

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2021 Third Quarter Financial Summary:

Revenue was $593,000, compared to $510,000 in the 2020 third quarter.
Net comprehensive loss was $2.2 million, compared to $1.6 million in Q3-2020.
Adjusted EBITDA loss was $1.4 million, compared to $1.2 million in the 2020 third quarter.
Third Quarter and Recent Developments:

Resumed patient screening in the ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease ("AD") following Health Canada’s issuance of a No Objection Letter in response to the Company’s amended Clinical Trial Application.
Graduated to the Toronto Stock Exchange.
Announced that its co-development and commercialization partner for Tadalafil oral films for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH), Aquestive Therapeutics, Inc. (NASDAQ:AQST), entered into a definitive license and supply agreement with an undisclosed leading men’s health company.
Announced that atai Life Sciences AG ("atai") committed $6.0 million in future financial support to IntelGenx via amendments to the loan facility between the parties.
Announced that Exeltis Healthcare S.L., the Company’s commercialization partner in the European Union for RIZAPORT, a unique treatment for acute migraines, launched the product in Spain.
Completed an initial shipment of CBD Filmstrips in support of Heritage Cannabis Holdings Corp.’s (CSE:CANN) Canadian market launch of its "CB4 Control" branded product.
Closed a $2.1 million private placement of 8% convertible notes due July 31, 2025, which the Company intends to use to finance its BUENA trial of Montelukast in AD.
Increased the size of the Board of Directors from six to eight with the appointments of Srinivas (Srini) G. Rao, M.D., Ph.D. and Frank Stegert.
"The past few months have been a very productive and exciting period for IntelGenx, marked by the achievement of five major milestones," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "Our graduation to the TSX, Canada’s most senior exchange, came on the heels of our successful transition from a development-stage to a commercial-stage leader in pharmaceutical films as well as our transformational partnership with atai. We were also pleased to resume patient screening in our ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate AD. Having executed on many elements of our growth strategy this quarter, we look forward to continuing to advance our portfolio of innovative film products and product candidates."

Financial Results:

Total revenues for the three-month period ended September 30, 2021 amounted to $593,000, an increase of $83,000, or 16%, compared to $510,000 for the three-month period ended September 30, 2020. The change is mainly attributable to increases in sales milestone revenues of $320,000, product revenues of $70,000, partially offset by a $308,000 decrease in revenues from licensing agreements.

Operating costs and expenses were $2.2 million for the third quarter of 2021, versus $1.9 million for the corresponding three-month period of 2020. The increase for the three-month period ended September 30, 2021 is mainly attributable to increases of $26,000 in R&D expense, $255,000 in manufacturing expenses, $37,000 in selling, general and administrative expenses, $17,000 in depreciation of tangible assets.

For the third quarter of 2021, the Company had an operating loss of $1.6 million, compared to an operating loss of $1.4 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended September 30, 2021 was $2.2 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $1.6 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

As at September 30, 2021, the Company’s cash and short-term investments totalled $12.0 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these third quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) and (973) 528-0135 (International), access code 995615. The call will also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.