On November 16, 2020 Mateon Therapeutics, Inc. ("Mateon" or the "Company") (OTCQB: MATN) reported financial results for the third quarter ended September 30, 2020 ("Q3 2020"), as well as an update on its therapeutic development initiatives, including those related to COVID-19 (Press release, Mateon Therapeutics, NOV 16, 2020, View Source [SID1234571145]).

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Recent Operational Highlights

●ArtiShield (outside of India)/ARTIVeda (India)

oSigned an agreement with Windlas Biotech Pvt. Ltd. of India to commercialize ArtiShield /ARTIVeda, the Company’s lead ethnobiology dru,g designed to be a readily available and cost-effective agent to combat COVID-19;
oArtiShield /ARTIVeda approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), license number UK.AY-401/2018, for the treatment of various symptoms like fever and inflammation frequently seen in COVID-19 patients;
oDr. Suhas Kshirsagar, B.A.M.S, M.D. (Ayurveda), a worldwide renowned ayurvedic expert, joined Mateon as an advisor for Mateon’s Ayurvedic product ARTIShield /ARTIVeda in its commercialization for COVID-19;
oDr. Suhas Kshirsagar led a successful symposium entitled: "Advancing Ayurveda Through Ethnobiology Drug Development." Topics included Mateon’s ARTIShield/ ARTIVeda for the Treatment of COVID-19 and COVID-19/Influenza Coinfection. Presentations can be viewed at View Source;feature=youtu.be.
oCommenced patient enrollment for its ARTI-19 Phase IV multi-center interventional study to evaluate the safety and efficacy of ArtiShield in the treatment of adults with COVID-19 in India. This global study will evaluate the safety and efficacy of ArtiShield upto 3,000 total patients, 120 of whom are currently from India and further expandable to 300 patients from India. Top line data from ARTI-19 in India is expected between Q4 2020 and Q1 2021;

●OT-101/COVID-19 program
oReceived clearance from regulatory authorities in Argentina and Peru to initiate a Phase II clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection. Top line data from the study is currently expected during or before Q1 2021. If the outcome is positive, the data will form the basis for Emergency Use Approval (EUA) application to global regulatory bodies. Including the US Food and Drug Administration (FDA);

oContinuing our partnership with Golden Mountain Partners (GMP) and/or their designee with drawdown of the $2.0 M debt financial instrument with GMP to conduct OT-101/COVID-19 clinical trial.

●Oxi4503/ Melanoma

oAnnounced that the US FDA granted Rare Pediatric Disease (RPD) designation to OXi4503 (combretastatin A1-diphosphate; CA1P) for the treatment of acute myeloid leukemia due to genetic mutations that disproportionately affect pediatric patients. The FDA grants RPD designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.; and

●Strengthened our scientific and management teams with the appointments of Anthony Maida, III, Ph.D., MA, MBA as Chief Clinical Officer – Translational Medicine to drive the Company’s clinical development activity.
"We are very encouraged by the progress being made at Mateon through the first nine months of 2020," said Dr. Vuong Trieu, CEO of Mateon. "While our product portfolio addresses significant unmet needs with respect multiple disease states, including glioblastoma, melanoma, and pancreatic cancer, we are most excited by our strategy to focus on COVID-19 and COVID-19/influenza coinfection. We look forward to multiple clinical trial catalysts – notably top line data from our ARTI-19 Phase IV trial between Q4 2020 and Q2 2021 the end of this year – and are excited about the transformational opportunities that our therapies may provide."

"We are excited about the commercialization of ARTIVeda in India. It is expected to be a cost-effective treatment and prophylactic for COVID-19. This is transformational for the Company, as we establish a consortium of manufacturers, distributors, and marketers for the equitable distribution of this COVID-19 therapy," said Amit Shah, CFO of Mateon.

On November 16, 2020 Istari Oncology, Inc., a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for a Phase 2 clinical trial, LUMINOS-102, to investigate the efficacy and safety of PVSRIPO alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor in patients with treatment-refractory melanoma (Press release, Istari Oncology, NOV 16, 2020, View Source [SID1234571144]).

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PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response. Following positive Phase 1 results in patients with unresectable and/or metastatic melanoma, the new IND will enable continued development of PVSRIPO for advanced melanoma. LUMINOS-102 (NCT04577807) will assess PVSRIPO’s impact on patients who have failed anti-PD-1 therapy.

"There is a massive need for treatments targeted at patients who experience primary or acquired resistance to anti-PD-1 therapies," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "PVSRIPO has shown promise in treating patients that have failed primary treatment options across multiple solid tumor types. We look forward to building on the positive results of our initial Phase 1 trial in melanoma with LUMINOS-102."

Following a safety run-in, approximately 50 participants with cutaneous or mucosal melanoma who previously failed anti-PD-1 blockade will be randomized 1:1 to receive either PVSRIPO or PVSRIPO plus an anti-PD-1.

Site initiation activities are underway for this Phase 2 trial, which the Company anticipates will begin in the first quarter of 2021. An interim analysis is planned once 20 patients have been randomized and treated for 3 months. Patient outcomes, including objective response rates (by RESICST criteria), durability of responses, and overall survival will be measured over a 24-month time frame.

In a Phase 1 study of PVSRIPO monotherapy in anti-PD1 refractory advanced melanoma presented by Dr. Georgia Beasley and colleagues at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2020 Annual Meeting last week, the overall response rate in subjects who received three single intralesional injections three weeks apart (maximum number administered in the study) was 67% (4/6), suggesting that PVSRIPO was able to initiate or rekindle responses in patients who have failed anti-PD-1 therapy. Responses were observed in both injected and uninjected tumors (e.g. an abscopal response). No serious adverse events or dose limiting toxicities were observed.

For more information about Istari Oncology and their ongoing clinical trials, visit istarioncology.com.

About PVSRIPO
PVSRIPO is a virus based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. Unlike other viral immunotherapies, PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via sublethal infection of antigen presenting cells in the tumor, which unleash an inflammatory cascade resulting in sustained systemic antitumor immunity. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma.

About Melanoma
There are estimated to be over 12,000 new and recurrent cases of advanced, unresectable melanoma diagnosed in the U.S. each year, and around 7,000 deaths. While immune checkpoint inhibitors have dramatically improved the outlook for advanced melanoma patients today, most patients treated with these immunotherapies are either primary non-responders or eventually develop immune-refractory progressive disease and require additional therapy.

On November 16, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates" or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer and other serious diseases, reported that it will deliver presentations and participate in 1on1 meetings at the Stifel 2020 Virtual Healthcare Conference and the 3rd Annual Evercore ISI HealthCONx Conference (Press release, Molecular Templates, NOV 16, 2020, View Source [SID1234571142]). In addition, management will be available for virtual 1on1 meetings at the Jefferies Virtual London Healthcare Conference.

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Stifel 2020 Virtual Healthcare Conference
Conference Dates: November 16-18
Presentation Date and Time: November 17 at 9:20am ET

Jefferies Virtual London Healthcare Conference
Conference Dates: November 17 – 19
Available for 1on1 meetings

3rd Annual Evercore ISI HealthCONx Conference
Conference Dates: December 1-3
Presentation Date and Time: December 3 at 10:05am ET
Live webcasts of the Stifel and Evercore ISI presentations will be available in the "News and Events" section of the MTEM website at www.mtem.com. Additionally, replays of the webcasts will be available on the corporate website following the conferences.

On November 16, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and ALX Oncology Holdings Inc. (NASDAQ: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported they have entered into a clinical collaboration to evaluate the combination of Zymeworks’ zanidatamab (formerly ZW25), a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors (Press release, Zymeworks, NOV 16, 2020, View Source [SID1234571141]).

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Under the terms of the agreement, Zymeworks will conduct an open label, multi-center Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study. The first part of the trial will evaluate the safety of the combination treatment. The second part of the trial will evaluate the safety, tolerability and anti-tumor activity of the combination in separate cohorts of subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.

"In addition to broad anti-tumor activity, zanidatamab’s safety profile supports combination approaches with other therapeutics," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. "Our collaboration with ALX Oncology and their CD47 blocker, ALX148, has the potential to further expand the opportunity for zanidatamab to provide benefit to a broader population of patients, including those with advanced HER2-expressing breast cancer."

Zanidatamab is designed to have multiple mechanisms of action, including immune clearance of HER2-expressing tumor cells by macrophages through antibody-dependent cellular phagocytosis (ADCP). CD47 is a "don’t eat me" signal that acts as a checkpoint inhibitor to macrophages. Cancer cells that express CD47 are resistant to immune clearance even when targeted with therapeutic antibodies. Treatment with zanidatamab plus ALX148 has the potential to increase the immune clearance of HER2-expressing cancer cells by combining a biparatopic antibody capable of binding at higher density than monospecific antibodies with a molecule that blocks CD47 on the same targeted cancer cells.

"We are excited about this collaboration with Zymeworks that combines two promising next-generation anti-cancer agents, a HER2-targeted bispecific antibody with a CD47 blocker, to enhance their potential activity in treating patients with advanced breast cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ALX148 was designed for safe use in combination to maximize clinical activity with a range of anti-cancer agents. This collaboration builds on the promising anti-tumor activity observed in clinical trials of ALX148 combined with a HER2-targeted therapy in patients with advanced HER2-positive gastric and gastroesophageal cancer."

Zanidatamab is in advanced clinical development, actively enrolling a pivotal study in patients with previously-treated HER2 gene-amplified biliary tract cancer. In addition, five active Phase 2 programs are underway, and Zymeworks plans to initiate a second pivotal study for zanidatamab as first-line treatment for advanced HER2-positive gastroesophageal adenocarcinomas.

Phase 1 studies of ALX148 have been conducted in combination with tumor antigen targeted antibodies, a checkpoint inhibitor and chemotherapy. Preliminary results from ASPEN-01, the ALX148 Phase 1b study, were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting [abstract 404]. ALX148 displayed promising initial clinical activity in patients with solid tumors, including advanced HER2-positive gastric and gastroesophageal cancer where ALX148 was well tolerated in combination with an anti-HER2 specific antibody and chemotherapy with no maximum tolerated dose reached. ALX Oncology plans to continue the advancement of ALX148 as a potential treatment for a range of solid tumor indications and is currently also in development in patients with higher risk myelodysplastic syndromes (ASPEN-02).

On November 16, 2020 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that it has completed its previously announced private placement offering (the "Offering") of special warrants of the Company ("Special Warrants") (Press release, ProMIS Neurosciences, NOV 16, 2020, View Source [SID1234571140]). A total of 16,219,581 Special Warrants were issued in two closings at a price of $0.12 per Special Warrant, for gross proceeds of $1,946,349.72.

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The Company will be filing a short form prospectus to qualify the distribution of the Shares and Warrants issuable upon the deemed exercise of the Special Warrants (other than those Special Warrants issued to residents of Quebec). Each Special Warrant will convert, without payment of any additional consideration, into one common share of the Company and one transferable common share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one common share at an exercise price of $0.20 per share for a period of 60 months, subject to acceleration of the expiry date if the twenty-day volume-weighted average trading price of the common shares exceeds $0.60.

The Company issued 13,819,581 Special Warrants in the first closing on November 4, 2020 and 2,400,000 Special Warrants in the second closing on November 16, 2020. In connection with the second closing, the Company paid cash finders’ fees in the amount of $11,760 and issued a total of 70,000 compensation warrants, each such compensation warrant having the same terms as the Warrants. The Company also wishes to correct the quantum of finders fees disclosed in its November 5, 2020 news release. In connection with the first closing, the Company paid cash finders’ fees in the amount of $58,464 and issued a total of 487,200 compensation warrants,

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.