On February 27, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported new pre-clinical findings in connection with its on-going collaboration with Univo Pharmaceuticals (TASE:UNVO), demonstrating CBD’s robust anti-neoplastic effect in pre-clinical studies against liver cancer (Press release, Can-Fite BioPharma, FEB 27, 2020, View Source [SID1234554860]). The studies were carried out on human liver cancer cells and utilized cannabinoid fractions enriched for CBD, in nano and pico molar concentrations. Marked inhibition of Hep-3b, liver cancer cell proliferation was noted and was mediated via the A3 adenosine receptor, the target of Can-Fite’s drug platform.

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Can-Fite is greatly encouraged and sees clinical potential in treating patients with minute CBD dosages which are effective and at the same time may minimize potential adverse effects. Based on this approach, an expansion of the agreement with Univo Pharmaceuticals has been entered into to allow the testing of minute CBD concentrations/dosages in combination with Namodenoson on liver cancer and additional oncological indications. As part of the expansion, Can-Fite will fund the research and development activities for the two new indications, to be jointly performed, for an amount of US$200,000 per indication.

Dr. Michael Silverman, M.D., Can Fite Medical Director, commented on the new findings, "Many of the liver cancer patients are already treated with cannabinoids for management of constitutional symptoms such as anorexia, nausea, and fatigue. These novel findings of anti-cancer cell effects found with minute dosages of CBD may open up new avenues of utilizing cannabinoids to treat cancer patients while minimizing adverse effects."

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026.

On February 27, 2020 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the use of motixafortide (BL-8040), a novel immunotherapy compound, combined with any PD-1 inhibitor, for the treatment of any type of cancer (Press release, BioLineRx, FEB 27, 2020, View Source [SID1234554859]).

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The PD-1 antagonist can be any agent that prevents and/or inhibits the biological function and/or expression of PD-1, such as pembrolizumab (KEYTRUDA). The targeted cancer can be solid, non-solid, and/or a cancer metastasis.

This patent, when issued, will be valid until July 2036 with a possibility of up to five years patent term extension. Additional corresponding patent applications are pending in Europe, Japan, China, Canada, Australia, India, Korea, Mexico, Brazil and Israel.

"We are extremely pleased to receive this valuable notice of allowance from the USPTO, which entitles us to long-term, highly enforceable and broad patent protection for our lead product, motixafortide, in combination with any PD-1 inhibitor, and more importantly, for all cancer indications, including, of course, any solid tumor," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This important patent allowance also supports our ongoing Phase 2a COMBAT/KEYNOTE-202 trial in stage IV metastatic pancreatic cancer patients, for which we have recently completed patient recruitment in the triple combination arm investigating the safety, tolerability and efficacy of motixafortide, KEYTRUDA and chemotherapy. Following promising initial results demonstrating robust and durable responses to the triple combination treatment, we look forward to the progression-free and overall survival data from the triple combination arm expected in mid-2020."

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the dual combination of motixafortide and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of motixafortide, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study. In January 2020, the Company announced completion of recruitment of the 40 patients planned for the triple combination arm of the study.

About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

On February 27, 2020 GlaxoSmithKline plc reported that the European Medicines Agency (EMA) has validated the company’s Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status (Press release, GlaxoSmithKline, FEB 27, 2020, View Source [SID1234554851]). Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP).

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The submission is based on data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically meaningful outcomes of niraparib treatment in the first-line maintenance setting.[1] Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine. The PRIMA study enrolled women who responded to first-line treatment with platinum-based chemotherapy, including those with high risk of disease progression, a population with high unmet need and previously under-represented in first-line ovarian cancer studies.

In Europe, ovarian cancer is the sixth deadliest cancer among women and more than 65,000 women are diagnosed each year.[2] Most women are diagnosed with advanced (stage III or IV) ovarian cancer and have a five-year survival rate of ~30%.[3] Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of women with advanced ovarian cancer will see their disease return.[4] With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter.

About PRIMA

PRIMA is a double-blind, randomised Phase III study designed to evaluate niraparib versus placebo in women being treated first-line for stage III or IV ovarian cancer. The study assessed the efficacy of niraparib as maintenance therapy, as measured by progression free survival. Patients in complete or partial response to first-line platinum-based chemotherapy were randomised 2:1 to niraparib or placebo.

About Zejula (niraparib)

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including a Phase III study as a first-line triplet maintenance treatment in ovarian cancer (FIRST).

Important Information for ZEJULA
Zejula approved indication:

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum‑based chemotherapy.

Important Safety Information
Contraindications: Hypersensitivity to niraparib or to any of the excipients and breast-feeding.

Warnings and precautions: Test complete blood counts weekly for the first month of treatment, then monthly thereafter. If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued. Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution. If MDS and/or AML are confirmed while being prescribed Zejula , treatment should be discontinued, and the patient treated appropriately. Hypertension, including hypertensive crisis, has been reported with the use of Zejula. Pre‑existing hypertension should be adequately controlled before starting Zejula treatment. Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. Patients with galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Tartrazine may cause allergic reactions. Paediatric safety and efficacy has not yet been established.

Undesirable effects: The most common serious adverse reactions were thrombocytopenia and anaemia.

Very common (≥1/10): urinary tract infection, thrombocytopenia, anaemia, neutropenia, decreased appetite, insomnia, headache, dizziness, dysgeusia, palpitations, hypertension, dyspnea, cough, nasopharyngitis, nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia, back pain, arthralgia, fatigue, asthenia.

Common (≥1/1000 to <1/10): bronchitis, conjunctivitis, leukopenia, hypokalemia, anxiety, depression, tachycardia, epistaxis, dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis, photosensitivity, rash, myalgia, oedema peripheral, Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased.

Refer to the Zejula Prescribing Information for a full list of adverse events and the complete important safety information.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On February 27, 2020 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported its financial results for the full year 2019 and provided a fourth quarter business update and outlook for 2020 (Press release, argenx, FEB 27, 2020, View Source [SID1234554849]).

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"The significant achievements we made throughout 2019 have provided the foundation for us to execute yet another exciting year ahead as we advance our ‘argenx 2021’ vision to become a global, integrated immunology company," commented Tim Van Hauwermeiren, CEO of argenx. "We are progressing our entire FcRn pipeline across four indications with a fifth to be announced this year and are planning for a 2021 launch of efgartigimod in gMG, which could be the first approved FcRn antagonist."

"We continue to build innovation into every step of our development, highlighted by our collaborative Innovative Access Program translating immunology breakthroughs into medicines, our unique trial designs incorporating input from our patients, and our integrated commercial thinking with the launch of the first real-world evidence study in MG. We have demonstrated our ability to perform across our late-stage pipeline and will prioritize maintaining this reputation for execution in 2020 with up to five registrational trials to be ongoing."

FOURTH QUARTER 2019 AND RECENT HIGHLIGHTS
argenx continues to execute on its "argenx 2021" vision to become a fully integrated, global immunology company, which includes the building of two initial commercial franchises in neuromuscular disorders and hematology/oncology and the expanding of its global presence to support its anticipated first commercial launch of efgartigimod in 2021.

Efgartigimod: First-in-class opportunity across range of high-value autoimmune indications

Efgartigimod is a human IgG1 Fc fragment engineered for optimal blocking of FcRn and targeted reduction of IgG autoantibodies. argenx expects to have up to five registrational trials ongoing in 2020. Efgartigimod is currently being evaluated in four targeted indications where IgG autoantibodies are directly pathogenic, including:

Generalized Myasthenia Gravis (gMG)
Completed enrollment of 167 patients in global, multi-center Phase 3 ADAPT trial with 10mg/kg intravenous (IV) efgartigimod. Topline results from ADAPT expected in mid-2020
Received Fast Track designation for efgartigimod in MG from U.S. Food and Drug Administration (FDA)
Biologics License Agreement (BLA) expected to be filed in fourth quarter of 2020 with launch planned for 2021
Plans to engage with FDA in 2020 on potential bridging strategy for 1000mg subcutaneous (SC) ENHANZE-efgartigimod
Primary Immune Thrombocytopenia (ITP)
Global Phase 3 registrational program includes:
Ongoing Phase 3 ADVANCE trial evaluating approximately 150 primary ITP patients dosed with 10mg/kg IV efgartigimod for both induction and maintenance of platelet response
ADVANCE SC trial expected to initiate in second half of 2020 evaluating 10mg/kg IV efgartigimod for induction of platelet response and fixed dose of SC efgartigimod for maintenance
Small confirmatory IV trial expected to initiate in first half of 2020
Presented previously announced data from completed Phase 2 proof-of-concept trial in December 2019 at 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating that efgartigimod was well-tolerated and showed correlation of reduced IgG levels, increased platelet counts and reduced bleeding in ITP patients
Published Phase 2 data in American Journal of Hematology in article titled, "Phase 2 study of efgartigimod, a novel FcRn antagonist, in adult patients with primary immune thrombocytopenia"
Pemphigus Vulgaris (PV)
Announced positive proof-of-concept data in 23 patients from Phase 2 trial evaluating 10mg/kg and 25mg/kg IV efgartigimod, which support advancement to registrational trial anticipated to start in second half of 2020
78% (18/23) of patients achieved rapid disease control (DC); median time to DC for both monotherapy and combination therapy is 14-15 days
Fast complete clinical remission (CR) observed within 2-10 weeks of treatment in 70% (5/7) of patients receiving optimized dosing regimen
Established optimized dosing regimen to be weekly or bi-weekly dosing of efgartigimod in combination with oral prednisone (0.25-0.5mg/kg)
Patients still in trial in extended dosing cohort; detailed results of Phase 2 data to be presented during Society for Investigative Dermatology Annual Meeting in May 2020
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Launched Phase 2 ADHERE trial with SC ENHANZE-efgartigimod
Fifth efgartigimod indication expected to be announced in 2020
argenx has established proof-of-concept in all three beachhead indications in neuromuscular disorders, hematology and dermatology therapeutic areas for efgartigimod.

Cusatuzumab: First-in-class opportunity with potential in hematological malignancies

Cusatuzumab is an anti-CD70 monoclonal antibody being developed under an exclusive global collaboration and license agreement with Janssen for the treatment of acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) and other hematological malignancies.

Enrollment ongoing in dose-confirming Phase 2 pivotal CULMINATE trial of cusatuzumab in combination with azacitidine for newly diagnosed, elderly AML patients who are unfit for intensive chemotherapy
Phase 1b platform trial underway in various AML subpopulations and settings with initial trial evaluating combinations of cusatuzumab, venetoclax and azacitidine; additional trials expected to launch under platform trial in first half of 2020
Randomized Phase 2 trial of cusatuzumab in combination with azacitidine in higher-risk MDS patients expected to launch in first half of 2020
Phase 1 trial of cusatuzumab in combination with azacitidine to launch in first half 2020 in Japanese patients with AML and MDS
Data update from cusatuzumab development expected in 2020

ARGX-117: First-in-class anti-C2 antibody expected to enter clinic in first quarter 2020

ARGX-117 is a complement-targeting antibody against C2 with potential therapeutic applications in multiple autoimmune diseases.

Phase 1 trial in healthy volunteers expected to begin in first quarter of 2020
Multiple doses and formulations (IV and SC ENHANZE-efgartigimod) to be evaluated as part of dose-finding work
Following analysis of Phase 1 data in fourth quarter of 2020, argenx plans to launch Phase 2 proof-of-concept trial in multifocal motor neuropathy (MMN) within its neuromuscular franchise and to develop in additional indications

Early-stage Pipeline

argenx continues to expand its early-stage pipeline with first-in-class antibodies against immunologic targets:

Lead optimization work ongoing of ARGX-118 for airway inflammation
New product candidate ARGX-119 expected to be announced in 2020
Collaborations

Received first development milestone payment under Janssen collaboration for achievement of enrollment milestone in Phase 2 pivotal CULMINATE trial
Awarded first clinical milestone payment under AbbVie collaboration for initiating first-in-human clinical trial with antibody product ABBV-151 (formerly named ARGX-115), which was created as part of argenx’s Innovative Access Program and exclusively licensed to AbbVie in 2016

YEAR 2019 FINANCIAL RESULTS (CONSOLIDATED)

Year Ended December 31,

in thousands of € 2019 2018 Variance
Revenue € 69,783 € 21,482 € 48,301
Other operating income € 12,801 € 7,749 € 5,052
Total operating income € 82,584 € 29,231 € 53,353

Research and development expenses
€
(197,665)
€
(83,609)
€
(114,056)
Selling, general and administrative expenses € (64,569) € (27,471) € (37,098)
Changes in fair value on financial assets 1,096 — 1,096
Operating loss € (178,554) € (81,849) € (96,705)

Financial income
€
14,399
€
3,694
€
10,705
Financial expense € (124) € — € (124)
Exchange gain/(losses) € 6,066 € 12,308 € (6,242)
Loss before taxes € (158,213) € (65,847) € (92,366)

Income tax expense
€
(4,752)
€
(794)
€
(3,958)
Loss for the year and total comprehensive loss € (162,965) € (66,641) € (96,324)

Net increase in cash, cash equivalents and current financial assets compared to year-end 2018 and 2017

€ 771,252 € 204,795
Cash, cash equivalents and current financial assets at the end of the period € 1,335,821 € 564,569
DETAILS OF THE FINANCIAL RESULTS

Cash, cash equivalents and current financial assets totaled €1,335.8 million for the year ended December 31, 2019, compared to €564.6 million for the year ended December 31, 2018. The increase in the year-end cash balance on December 31, 2019 resulted primarily from (i) the closing of the collaboration and license agreement for cusatuzumab with Janssen which resulted in a $300 million upfront payment and a $200 million equity investment in January 2019, and (ii) €479.0 million of net proceeds received from the global offering in November 2019.

Operating income increased by €53.4 million for the year ended December 31, 2019 to €82.6 million, compared to €29.2 million for the year ended December 31, 2018. The increase primarily related to (i) the partial recognition of the upfront payment and the recognition of research and development service fees under the collaboration and license agreement for cusatuzumab with Janssen and (ii) the recognition of the milestone payment following the initiation of a first-in-human clinical trial with ABBV-151 under the AbbVie collaboration.

Research and development expenses totaled €197.7 million and €83.6 million for the years ended December 31, 2019 and 2018, respectively. The increase is mainly the result of (i) increased external research and development expenses reflecting higher clinical trial costs and manufacturing expenses related to the development of argenx’s product candidate portfolio and (ii) higher personnel expenses as a result of increased costs of the share-based payment compensation plans related to the grant of stock options to its research and development employees and increased costs associated with additional research and development employees.

Selling, general and administrative expenses totaled €64.6 million and €27.5 million for the years ended December 31, 2019 and 2018, respectively. The increase of €37.1 million was principally due to an increase of personnel expense, resulting from (i) higher costs of the share-based payment compensation plans related to the grant of stock options to argenx’s selling, general and administrative employees and (ii) increased costs associated with additional employees recruited to strengthen its selling, general and administrative activities, notably in preparation of the potential commercial launch of efgartigimod in the U.S.

For the year ended December 31, 2019, financial income amounted to €14.4 million compared to €3.7 million for the year ended December 31, 2018. The increase of €10.7 million primarily related to an increase in the interest received on argenx’s cash, cash equivalents and current financial assets.

Exchange gains totaled €6.1 million for the year ended December 31, 2019 compared to €12.3 million for the year ended December 31, 2018 and were mainly attributable to unrealized exchange rate gains on argenx’s cash, cash equivalents and current financial assets position in U.S. dollars due to the favorable fluctuation of the EUR/USD exchange rate.

The total comprehensive loss for the year ended December 31, 2019 was €163.0 million compared to €66.6 million for the year ended December 31, 2018.

US SEC and statutory Financial Reporting

argenx’s primary accounting standard for quarterly earnings releases and annual reports is International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). Quarterly summarized statements of profit and loss based on IFRS as issued by the IASB are available on www.argenx.com.

In addition to reporting financial figures in accordance with IFRS as issued by the IASB, argenx also reports financial figures in accordance with IFRS as adopted by the EU for statutory purposes. The consolidated statement of financial position, the consolidated statements of profit and loss, the consolidated statements of cashflow, and the consolidated statement of changes in equity are not affected by any differences between IFRS as issued by the IASB and IFRS as adopted by the EU.

The consolidated statement of profit and loss data of argenx SE as of December 31, 2019, as presented in this press release is unaudited.

Annual Report 2019
argenx will publish its 2019 Annual Report based on IFRS as issued by the IASB and its 2019 Annual Report for statutory purposes based on IFRS as adopted by the EU on March 24, 2020. These Annual Reports will be available on www.argenx.com.

EXPECTED 2020 FINANCIAL CALENDAR:

May 14 2020: Q1 financial results & business update
July 30 2020: HY 2020 financial results & business update
October 22 2020: Q3 financial results & business update
CONFERENCE CALL DETAILS
The full year results will be discussed during a conference call and webcast presentation today at 3 pm CET/9 am ET. To participate in the conference call, please select your phone number below and use the confirmation code 2484158. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

Dial-in numbers:
Please dial in 5–10 minutes prior to 3 pm CET/ 9 am ET using the number and conference ID below.

On February 27, 2020 Taiho Pharmaceutical Co. Ltd., ("Taiho") reported its option exercise for AB122 (zimberelimab), an anti-PD-1 monoclonal antibody from Arcus Biosciences, Inc. ("Arcus"), in Japan and certain other territories in Asia (excluding China) (Press release, Taiho, FEB 27, 2020, View Source [SID1234554810]). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017. Taiho has already obtained exclusive rights of AB928 (adenosine receptor antagonist), and therefore this is the second option exercise of the Arcus program.

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AB122, an anti-PD-1 monoclonal antibody, has demonstrated clinical activity and safety profile that is consistent with those of currently approved anti-PD-1 therapies. AB122 in combination with AB928 and other standard therapies, is in a broad development program in selected tumor types that include prostate, colorectal, non-small cell lung, pancreatic, triple negative breast and renal cell cancers. As a monotherapy, AB122 is also being evaluated in a tumor-agnostic, biomarker-selected Phase 1b trial for cancers with no approved anti-PD-1 treatment options.

In exchange for the option exercise, Taiho has paid an exercise payment in December 2019, and will pay upon achievement, additional clinical, regulatory and commercialization milestones, as well as royalties on net sales for this program.

Through this collaboration, Taiho will further support the development and commercialization of AB122, and will continue its mission to deliver innovative drugs to patients and medical professionals.

About AB122
AB122 is an anti-PD-1 monoclonal antibody currently under development by Arcus. AB122 was originally in-licensed by Arcus from WuXi Biologics in 2017, for worldwide clinical development and commercialization in territories excluding China and Thailand.