XBiotech Announces Receipt of $75 Million from Sale of Antibody

On June 30, 2021 XBiotech (NASDAQ: XBIT) reported it received $75 million from funds escrowed as part of its December 2019 sale of bermekimab (Press release, XBiotech, JUN 30, 2021, View Source [SID1234584513]). The True Human antibody developed by the company to treat inflammatory disorders, including skin diseases, was sold in a uniquely structured Pharma deal that allowed XBiotech to continue to develop new anti-inflammatory antibodies against the same target. With the receipt of $75 million, XBiotech has now received a total of $750 million pursuant to the deal.

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XBiotech developed technology to clone monoclonal antibodies from the peripheral blood of humans with natural immunity against diseases. Bermekimab is a naturally occurring antibody capable of neutralizing one of the body’s most potent, and potentially destructive, inflammatory substances. In the sale agreement, XBiotech maintained the right to discover and develop new True Human antibody molecules with similar activity as bermekimab. According to the purchase agreement, XBiotech can develop these new True Human antibodies for all indications in medicine with the exception of dermatological indications. XBiotech could potentially receive up to $600 million more in cash from the deal by agreeing to provide exclusivity for certain additional indications with bermekimab.

As part of the sale agreement for bermekimab, XBiotech agreed to continue under contract to manufacture the antibody and supply finished product. As well, XBiotech engaged in a services agreement to provide its clinical operations to support clinical trial activities with the antibody therapy. These services have been ongoing and have been a significant source of revenue.

Since the sale, XBiotech has focused on research and development of other True Human antibodies that target the same inflammatory pathway as bermekimab. XBiotech has recently commenced a clinical program with just such a new antibody, XB2001, in pancreatic cancer.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Viewpoint Molecular Targeting® Appoints Ewa Matczak MD, as Chief Medical Officer

On June 30, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the appointment of Ewa Matczak MD to the company as Chief Medical Officer (Press release, Viewpoint Molecular Targeting, JUN 30, 2021, https://viewpointmt.com/viewpoint-molecular-targetingr-appoints-ewa-matczak-md-as-chief-medical-officer/ [SID1234585492]).

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Dr. Matczak is a medical oncologist/hematologist who spent the first 10 years of her career in basic science research, clinical research and teaching. Her post-medical training included fellowships and research positions at the National Cancer Institute, Columbia Presbyterian Medical Center and Harvard Medical School. She then transitioned to industry and has over 20 years of experience in early and late-stage drug development, particularly in solid tumors and hematology/oncology. Dr. Matczak has held clinical development roles at multiple leading global pharmaceutical companies including, Bayer, Novartis, Eisai and Pfizer.

"We are incredibly pleased to welcome Dr. Matczak as our Chief Medical Officer. She has an impressive track record in early and late-stage drug development with extensive experience working for multiple global pharmaceutical companies. We look forward to leveraging her expertise as we advance our novel theranostics for the treatment and diagnosis of oncology indications with significant unmet need," commented Frances Johnson MD, CEO of Viewpoint.

Dr. Matczak most recently served as VP, Clinical Sciences at Glenmark Pharmaceuticals, where she was responsible for leading development with focus on immune-oncology and building the oncology team. Prior to that, she served as the Associate VP, Oncology at Hengrui Therapeutics where she played a key role in development, oversight and establishment of the company’s Oncology program. For nearly a decade she held roles at Pfizer, including Director and Senior Director of Global Medical Affairs as U.S. Sutent Lead and RCC Lead; and Bosutinib Global Clinical Lead in Clinical Development. During her time at Pfizer, she provided leadership in commercial and drug development strategies, clinical trial design, Investigator-initiated research strategies and implementation. Additionally, Dr. Matczak served as Senior Director /International Program Team Leader at Eisai Pharmaceuticals for two targeted therapy agents in early development; Medical Director/Clinical Investigations Leader in the Research & Development Oncology Business Unit, Novartis Pharmaceutical Corporation; and Associate Medical Director/Medical Expert for Clinical Pharmacology at Bayer HealthCare Pharmaceutical. Prior to industry she spent over a decade in basic science research, clinical research and teaching at Columbia Presbyterian Medical Center, the US NIH National Cancer Institute, and Harvard Medical School.

Dr. Matczak added, "The Viewpoint platform technology is among the most innovative and potentially disruptive technologies in alpha-particle therapeutics that I have seen to-date. I am excited to be joining the Company at such a pivotal moment as we enter human clinical studies and gain momentum across multiple fronts. I look forward to further working alongside the team to propel the Company’s potentially transformative new class of cancer therapeutics and complementary diagnostic imaging agents forward to provide solutions to cancer patients where there remains significant unmet need."

Dr. Matczak received her Medical Degree from SUNY Downstate, NY. She completed her internal medicine internship, and residency and oncology/hematology fellowship at Columbia Presbyterian under Dr. Karen Antman in New York and she completed her HIV Oncology training and research at Harvard Institute of Medicine/Beth Israel Deaconess with Jerome Groopman where she remained on faculty until she joined the Clinical Trial Evaluation Program (CTEP) at the National Cancer Institute (NCI). She was a National Institute of Health (NIH) Intramural Research Awardee in Dr. Bob Gallo’s Lab. Dr. Matczak organized and led multi-disciplinary translational research clinics in Kaposi’s Sarcoma and HPV. She was a NIH investigator, and an AIDS Malignancy Consortium and Eastern Cooperative Oncology Group member.

Oncolytics Biotech® to Present at the Ladenburg Thalmann Healthcare Conference

On June 30, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will present a corporate overview at the Ladenburg Thalmann Healthcare Conference, which is taking place virtually from July 13-14, 2021 (Press release, Oncolytics Biotech, JUN 30, 2021, View Source [SID1234584497]). Presentation details are listed below .

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Oncolytics Biotech Inc.

Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Wednesday, July 14, 2021
Time: 4:30 p.m. Eastern Daylight Time
Webcast Link: Please click here

The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Ladenburg Thalmann representative or email [email protected].

A live webcast of the presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for 90 days.

Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan

On June 30, 2021 Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") reported submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW) (Press release, Solasia, JUN 30, 2021, View Source [SID1234584514]). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world.

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Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year. If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.

Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows:
"No standard treatment has been established for relapsed or refractory PTCL as of yet. I firmly believe that darinaparsin, with its novel mechanism of action that differs from those of already approved drugs, will contribute to patients and healthcare providers at clinical sites as a new treatment option for relapsed or refractory PTCL. Since founding, Solasia has conducted R&D on five pipeline drugs. Of the five, we have successfully developed and brought to market two drugs, i.e., began providing them to patients, and today, we submitted an NDA for our first anti-cancer drug. Under our mission to provide patients with ‘Better Medicine for a Brighter Tomorrow’, we will continue aiming to contribute to patients’ treatment and enhanced quality of life. "

About darinaparsin (SP-02)
Darinaparsin, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the US and EU.
For more information, please visit at View Source

About Asian Multinational Phase 2 Study
The Asian Multinational Phase 2 Study was a multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in patients with relapsed or refractory PTCL conducted in Japan, Korea, Taiwan, and Hong Kong. (CT.gov Identifier: NCT02653976).
Solasia plans to present the results of the study at an international academic conference to be held in the near future.

Scopus BioPharma Expands Immunotherapy Pipeline with Acquisition of Olimmune

On June 30, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics, reported the acquisition of Los Angeles-based Olimmune Inc (Press release, Scopus BioPharma, JUN 30, 2021, View Source [SID1234584530]).

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Olimmune is a developer of groundbreaking oligonucleotide immunotherapies for treatment-resistant and metastatic cancers. Olimmune’s lead drug candidate, OLIM-01, is being developed for genitourinary and head and neck cancers. It is anticipated that INDs for these indications will be submitted by Q1 2023.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "The acquisition of Olimmune dramatically expands our reach in immuno-oncology. Both companies have been pioneering proprietary technologies to address traditionally "undruggable" targets, such as STAT3. This combination positions Scopus as a global leader in bifunctional oligonucleotide cancer therapeutics."

Olimmune was co-founded by Marcin Kortylewski, Ph.D., a leading immuno-oncologist and Professor in the Department of Immuno-Oncology at City of Hope. Dr. Kortylewski and his laboratory were instrumental in the seminal discovery that successful cancer immunotherapy needs to combine both TLR9 immunostimulation and STAT3 inhibition. This strategy underpins CpG-STAT3siRNA, Scopus’ lead drug candidate, which is covered by certain patents licensed from City of Hope. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

Dr. Kortylewski stated, "While it’s necessary to deliver STAT3 inhibitors to the proper cells, STAT3 inhibition, by itself, is not sufficient. You also need to stimulate immune activation. Fortunately, the short CpG sequence also serves as a TLR9 agonist, so you get release of immunosuppression by the STAT3 inhibitor and immune activation through TLR9 activation, both of which are necessary for a robust anti-cancer response."

Dr. Kortylewski added, "City of Hope and Scopus are working closely to initiate a Phase 1 clinical trial evaluating CpG-STAT3siRNA for non-Hodgkin lymphoma. Now, we will work towards expanding our collaboration to other challenging cancer indications, such as head and neck, kidney, or prostate cancers using alternative STAT3 inhibitors."

Alan Horsager, Ph.D., President and Chief Executive Officer of Olimmune, stated, "Scopus BioPharma is the ideal home for Olimmune. The combination of immuno-oncology assets creates a comprehensive portfolio of complementary cell-selective oligonucleotide therapeutics. Moreover, Scopus’ clinical development will provide us with invaluable insights, experience and expertise in bringing our drug candidates into the clinic."

Olimmune has exclusive, worldwide licenses to certain patents from City of Hope to develop and commercialize CpG-STAT3ASO and CpG-STAT3decoy.

Terms of the acquisition have not been disclosed.