On November 16, 2020 Alligator Bioscience ("Alligator") (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy and Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR bispecific technology platform, reported an update on ALG.APV-527, a novel immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen (Press release, Alligator Bioscience, NOV 16, 2020, View Source [SID1234571191]).

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Aptevo and Alligator are advancing ALG.APV-527 into Phase I clinical development in a co-development 50/50 partnership. The companies anticipate filing a Clinical Trial Authorization during the first half of 2021 to initiate Phase I clinical development in multiple sites in the European Union. Aptevo and Alligator will continue to explore licensing opportunities as ALG.APV-527 moves into clinical development.

"We are very excited about taking ALG.APV-527 into the clinic now, as recent APVO436 complete remission data in two patients in cohort 6 of that Phase I clinical trial speaks to the potential of our ADAPTIR platform. As a potential first-in-class molecule, ALG.APV-527 showcases the versatility of our ADAPTIR platform in generating bispecific antibodies with unique mechanisms of action and a therapeutic profile that is more consistent with traditional antibodies, including an extended half-life, desirable antibody-like manufacturing characteristics and optimized for potency and stability," said Mr. Marvin White, President and CEO of Aptevo.

"Our collaboration with Alligator Bioscience continues to yield encouraging data supporting the potential advantages of this novel pathway for targeted immunotherapy of cancer. For these reasons, and given recent improvements in our financial position, we are excited to advance this asset into the clinic with the desire to enable potential additional value creation for shareholders as we develop the asset," concluded Mr. White.

"Aptevo’s clinical candidate APVO436 is based on the same ADAPTIR platform as ALG.APV-527. It is my belief that the response data observed in the APVO436 Phase I trial validates the bispecific format of ALG.APV-527, and strengthens our view that it has the potential to become a successful cancer therapy," said Per Norlén, CEO of Alligator Bioscience.

ALG.APV-527 is designed to simultaneously target 5T4 and the co-stimulatory receptor 4-1BB (CD137) to promote potent, tumor-directed immune T-cell activation. 5T4 is a well-defined tumor antigen expressed on many different types of malignancies including non-small cell lung, renal, pancreatic, prostate, breast, colorectal, gastric, ovarian and cervical cancers and mesothelioma. Conversely, 5T4 has limited expression on adult normal tissues, making it an attractive target for cancer immunotherapy.

Presentation at the SITC (Free SITC Whitepaper) 35th Annual Meeting

As announced on Monday, November 9, Aptevo is presenting two new posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting, including one on ALG.APV-527. The poster will present preclinical data demonstrating that ALG.APV-527 has a potentially favorable safety profile with no indication of systemic immune activation or liver toxicity in NHP or murine models. ALG.APV-527 induces robust in vitro killing of tumors that is dependent on 5T4 engagement. In vivo, ALG.APV-527 augmented anti-tumor responses and promoted tumor-specific memory.

Details of the Poster Presentation are as follows:

ALG.APV-527: Potent tumor-directed T cell activation and in vivo tumor inhibition induced by a 4-1BB x 5T4 ADAPTIR bispecific antibody

The abstracts and the accompanying posters will be available in the Virtual Poster Hall to registered attendees from 8:00 am EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 on the SITC (Free SITC Whitepaper) abstract website

About ALG.APV-527

ALG.APV-527 is a novel immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen. 5T4 is an antigen that is highly expressed in a large percentage of solid tumors, including, non-small cell lung cancer (NSCLC), head and neck cancer and mesothelioma. ALG.APV-527 is designed to activate anti-tumor responses by inducing signaling through the co-stimulatory receptor 4-1BB (CD137), which is an immune receptor that is upregulated on activated T cells and natural killer (NK) cells.

On November 16, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported its participation in the following conference (Press release, Lexicon Pharmaceuticals, NOV 16, 2020, View Source [SID1234571111]):

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Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020
Lonnel Coats, Lexicon’s president and chief executive officer, and Jeffrey L. Wade, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat on Wednesday, November 18, 2020 at 2:40 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

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 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will present data from its clinical test – NeXT DxTM – at the virtual AMP Annual Meeting from Nov 16-20, 2020 (Press release, Personalis, NOV 16, 2020, View Source [SID1234571165]).

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The poster presentation, titled "An exome and transcriptome based NeXT DxTM test enables therapy selection for cancer patients and offers insights into emerging composite biomarkers for immunotherapy" will be presented on Tuesday, Nov 17th between 1-2pm EST. The NeXT Dx test utilizes Personalis’ ImmunoID NeXT Platform, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The Personalis NeXT Dx Test provides a diagnostic report to the ordering provider which includes genomic alterations identified in 247 cancer-related genes, therapy recommendations, clinical trial matching and results from immunotherapy-related biomarkers such as microsatellite instability (MSI) status and exome-wide tumor mutational burden (TMB). Research data supporting identification of novel biomarkers from tumor exome and transcriptome can be provided upon physician’s request.

On November 16, 2020 PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, reported that the European Patent Office (EPO) has informed the company that a new European patent has been granted (Press release, PCI Biotech, NOV 16, 2020, View Source [SID1234585149]). The European patent covers the intended use of fimaChem in combination with gemcitabine for the treatment of cholangiocarcinoma (bile duct cancer).

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Per Walday, CEO, comments: We are very happy to see this patent granted in Europe, which provides an extended protection of the intended use of fimaChem lasting several years beyond the potential market exclusivity offered by the orphan designation. Our full focus is now on the successful delivery of the global pivotal RELEASE study.

Today’s announced European patent secure protection until 2037. The patent application is still pending in US and key Asian markets.