On September 4, 2020 AbbVie (NYSE: ABBV) and I-Mab (Nasdaq: IMAB) reported that AbbVie and I-Mab have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers (Press release, AbbVie, SEP 4, 2020, View Source [SID1234564474]). In addition, the two partners have the potential to expand the collaboration to additional transformative therapies.

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Lemzoparlimab is one of the leading drug candidates among I-Mab’s proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development. Topline results of the recent phase 1 clinical trial confirm possible differentiation of lemzoparlimab in drug safety and a more favorable pharmacokinetics profile in cancer patients. Results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without any priming dose. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year.

"Cancer is the second-leading cause of death globally and the need for novel cancer therapies has never been more acute. The addition of I-Mab’s novel CD47 programs complements our global clinical strategy in hematology and immuno-oncology," said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. "We have been impressed with what I-Mab has been able to accomplish in research and clinical development and we look forward to working together to make a meaningful difference in the lives of millions of patients globally."

"At the forefront of drug innovation, our goal at I-Mab has always been to bring transformational therapies to patients globally. This strategic collaboration reinforces I-Mab’s leading position in immuno-oncology and enables us to realize the full potential of our innovation," said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab. "We are extremely proud to partner with AbbVie. By leveraging the combined development strength of our companies, we aim to speed lemzoparlimab to market for patients in need around the world."

Collaboration Details
The collaboration established today provides AbbVie with an exclusive global license, excluding greater China, to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and to commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents. Each party will have the opportunity subject to further licenses to explore each other’s related programs in their respective territories.

The companies will share manufacturing responsibilities with AbbVie being the primary manufacturer for global supply. The collaboration will accelerate I-Mab’s establishment of commercial production operations in China.

Financial Terms
Under the terms of the agreement, AbbVie will pay I-Mab $180 million in an upfront payment to exclusively license lemzoparlimab, along with $20 million in a milestone payment based on the Phase 1 results, for a total of $200 million. In addition, I-Mab will be eligible to receive up to $1.74 billion in success-based milestone payments for lemzoparlimab, of which $840 million are based on clinical development and regulatory approval milestones, with the remainder based on commercial milestones. Upon commercialization of lemzoparlimab, AbbVie will also pay tiered royalties from low-to-mid teen percentages on global net sales outside of greater China.

On September 4, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the last patient has been successfully enrolled in the pivotal phase 3 study OCEAN in relapsed refractory multiple myeloma (RRMM) (Press release, Oncopeptides, SEP 4, 2020, View Source [SID1234564470]). The original enrollment target of 450 patients was reached in May 2020, but an analysis indicated that patients were staying longer on treatment than initially estimated. Thus, a decision was made to leave recruitment open to ensure that the number of disease progression events needed to complete the study would be reached within a reasonable timeframe. An additional 45 patients have now been recruited. The company has closed enrollment and reiterates that the topline results will be available in the first half of 2021.

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OCEAN is a randomized, comparative study between melflufen (INN melphalan flufenamide), and pomalidomide in patients with RRMM. The study was initiated in 2017 and today includes 495 patients from more than 100 hospitals around the world. The patients have previously been treated with at least an immunomodulator (IMiD) and a proteasome inhibitor (PI) and have all developed resistance to their last line of therapy and to lenalidomide (IMiD), the most commonly used multiple myeloma drug. The primary endpoint of the phase 3 OCEAN study is Progression Free Survival. The data will be evaluated once 339 patients have progressed in their disease.

"This is very exciting news. Thanks to the dedicated participation from patients, investigators and study teams around the world, we have managed to reach our extended enrollment target faster than anticipated, despite these challenging times", says Marty J Duvall, CEO of Oncopeptides AB. "I am really impressed by the journey that Oncopeptides has made ever since the study start in 2017, from being a small Stockholm based R&D company, to becoming a fully- fledged, integrated, global biopharma company, preparing the first commercial launch".

The U.S. Food and Drug Administration, FDA, has recently granted priority review for Oncopeptides´ New Drug Application seeking approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple class refractory multiple myeloma. The decision was based on the results from the ongoing pivotal phase 2 study HORIZON, evaluating melflufen in RRMM patients.

This information was submitted for publication on September 4, 2020, at 08:00 (CET).

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

On September 4, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada,reported that Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, is scheduled to participate in a fireside chat at the Citi 15th Annual BioPharma Virtual Conference on Sept. 10, 2020, at 8:00 a.m. EDT (Press release, Merck & Co, SEP 4, 2020, View Source [SID1234564468]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On September 4, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it plans to participate in the following upcoming virtual investor conferences in September 2020 (Press release, Innate Pharma, SEP 4, 2020, View Source [SID1234564467]):

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Citi’s 15th Annual BioPharma Virtual Conference – September 08-11, 2020
Goldman Sachs 10th Annual Biotech Symposium 2020 – September 11, 2020
H.C. Wainwright 22nd Annual Global Investment Conference – September 14-16, 2020

On September 4, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it has initiated FRESCO-2, a Phase III registration study of fruquintinib for the treatment of patients with metastatic colorectal cancer ("CRC") in the U.S., Europe and Japan (Press release, Hutchison China MediTech, SEP 4, 2020, https://www.chi-med.com/chi-med-initiates-fresco-2-a-global-phase-iii-trial-of-fruquintinib-in-metastatic-crc/ [SID1234564465]). The first patient was dosed on September 3, 2020, in the U.S.

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FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial being conducted in patients with metastatic CRC. The primary endpoint of the study is overall survival. This large phase III trial will be enrolled in approximately 130 sites in 10 countries. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.

The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020. Clinical data including the completed Phase III FRESCO study in Chinese patients and this FRESCO-2 global study, if positive, would support a future New Drug Application (NDA) for the treatment of patients with advanced metastatic CRC (third-line and above), based on our agreement with the FDA. The FRESCO-2 study design was also reviewed and endorsed by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

About CRC
CRC is cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, causing more than 860,000 deaths in 2018.[1] In the U.S., it is estimated that 150,000 people will be diagnosed with CRC and 53,000 people will die from CRC in 2020.[2] In Europe, CRC is the second most common cancer, with an estimated 490,000 new cases and 240,000 deaths in 2018.[3] In Japan, CRC is the most common cancer, with an estimated 150,000 new cases and 57,000 deaths in 2018.[4]

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company ("Lilly") in China.

About Fruquintinib in metastatic CRC
Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with metastatic CRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

In December 2017, Chi-Med initiated a multi-center, open-label, Phase I/Ib clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier: NCT03251378). Proof-of-concept cohorts in patients with metastatic CRC and metastatic breast cancer were added in 2019.

Other Fruquintinib Development
Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier NCT03223376). In June 2020, Chi-Med completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.), Tyvyt (sintilimab, IBI308, developed by Innovent Biologics, Inc.) and geptanolimab (GB226, developed by Genor Biopharma Co. Ltd.).