On April 16, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (Press release, Oncopeptides, APR 16, 2021, View Source [SID1234578134]). Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.

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"Following Oncopeptides´ launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations", says Marty J Duvall, Chief Executive Officer at Oncopeptides. "This major milestone marks the commitment of our organization to bring hope to multiple myeloma patients around the world, through innovative science".

"This is vitally important and supports the development of a dedicated organization across Europe", says Andrea Passalacqua, General Manager Europe, Oncopeptides. "We believe that melflufen may address a growing medical need in patients with relapsed refractory multiple myeloma in Europe. In order to help accomplishing this, we have also introduced an Early Access Program that offers eligible patients access to melflufen ahead of a potential marketing authorization".

According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data.

On February 26th the U.S. Food and Drug Administration, FDA, approved PEPAXTO (melphalan flufenamide), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on April 16, 2021, at 08:00 (CET).

On April 16, 2021 Shenzhen Chipscreen Biosciences, a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform, reported that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 1b/2 clinical trial of Chiauranib/CS2164, a potential treatment for multiple oncological indications including Small Cell Lung Cancer (SCLC), Ovarian Cancer, Liver Cancer, and Breast Cancer, etc (Press release, Shenzhen Chipscreen Biosciences, APR 16, 2021, View Source [SID1234578133]). Chiauranib is the third novel drug candidate discovered and developed by Chipscreen to be marketed, submitted NDA or in the late-stage phases of clinical studies.

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Chiauranib is an innovative, 3-pathway targeted kinase small molecule inhibitor with high selectivity against Auroa B /VEGFRs/CSF1R currently entering Phase III clinical trials in China. Its treatments to SCLC and Ovarian Cancer have been just designated as "breakthrough therapies" by National Medical Products Administration (NMPA) of China in the past months. The molecular mechanism of Chiauranib is to inhibit the rapid proliferation of tumor cells via targeting novel DNA replication pathway, as well as enhancement of antitumor immunity and inhibition of tumor angiogenesis concomitantly.

The primary objective of this Phase Ib/2 study in the USA is to demonstrate safety, tolerability and efficacy of Chiauranib as a monotherapy in 24 to 36 patients with SCLC.

"With this clearance of US FDA IND application for CS2164, it will certainly increase success of our global development strategy based on early efficacy and safety data obtained from China trials," said Dr. Xianping Lu, Chairman and President of Chipscreen.

On April 16, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported clinical data from the ongoing Phase 1/2 trial evaluating darovasertib (IDE196) monotherapy and binimetinib combination therapy in patients with solid tumors, including Metastatic Uveal Melanoma (MUM) and Skin Melanoma (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, APR 16, 2021, View Source [SID1234578132]).

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"The darovasertib single-agent one-year survival data in MUM is encouraging and compares favorably to historical survival rates in this indication, where a therapy has yet to be approved," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN. "The early partial responses observed in the darovasertib and binimetinib combination in MUM are exciting where historical response rates have been from zero to low to mid-single-digit percent, and we look forward to seeing the data set mature," said Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center.

Darovasertib Monotherapy Clinical Efficacy in Solid Tumors
There have been 81 darovasertib monotherapy BID MUM and 7 Skin Melanoma patients enrolled across the IDEAYA and Novartis Phase 1/2 clinical trials at the time of data and analyses cutoff on April 13th, 2021, with an aggregate of 88 patients evaluable for safety and 81 evaluable for efficacy based on RECIST 1.1. Reported data is preliminary and based on an unlocked database. Evaluation and follow-up of the monotherapy arm of the clinical trial continues.

Darovasertib Monotherapy Preliminary Results Summary

57% 1-Year Overall Survival (OS) Rate was observed in predominantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) Metastatic Uveal Melanoma (MUM) patients with 95% CI (44%, 69%); Historical 1-Year OS Rate in similar MUM populations has been reported at 37% (Source: Rantala 2019, Immunocore March 2021 presentation, Synthetic Control Arm, 2+ L)
Median OS of 13.2 months was observed in predominanantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) MUM patients with 95% CI (10.7 months, Not Reached); Historical median OS in similar MUM populations has been reported at approximately 7 months (Source: Rantala 2019, Immunocore March 2021, Synthetic Control Arm, 2+ L)
61% (n=46) of MUM patients out of 75 evaluable had tumor reduction per RECIST 1.1. evaluation, including 15 patients (20%) with >30% target lesion reduction and one confirmed complete response. In the Skin Melanoma cohort, 80% (n=4) of evaluable patients (n=5) had tumor reduction per RECIST 1.1. evaluation, including one confirmed partial response
Darovasertib Monotherapy Clinical Safety
Overall safety profile of darovasertib monotherapy is consistent with prior reports (Ref. 2019 AACR (Free AACR Whitepaper)) and includes primarily common low grade but manageable GI toxicities and hypotension.

Preliminary Darovasertib and Binimetinib Combination Clinical Efficacy in MUM
The combination of darovasertib plus binimetinib is being evaluated pursuant to a clinical trial collaboration and drug supply agreement with Pfizer, which the companies have amended to support a target enrollment of approximately 40 patients in the darovasertib and binimetinib clinical combination arm in MUM. At the time of the data and analyses cutoff on April 13th, 2021, twenty four MUM patients have enrolled in the darovasertib and binimetinib combination study, including 8 patients dosed in the Phase 1/2 dose expansion cohort of the combination study. Reported data is preliminary and based on an unlocked database. Enrollment in the darovasertib and binimetinib combination arm of the clinical trial is ongoing.

Darovasertib and Binimetinib Combination Therapy Preliminary Data Summary

2 partial responses observed out of nine MUM patients with at least 2 post-baseline scans (22%) by RECIST 1.1 guidelines, including 1 confirmed partial response and 1 unconfirmed partial response (-40.5%) awaiting a confirmatory scan
79% of evaluable MUM patients with at least 1 post-baseline scan show tumor reduction; follow-up for overall response is still immature
Combination doses for Phase 1/2 dose expansion have been selected based on anticipation of activity and overall tolerability in a larger treatment cohort
Treatment-related adverse events observed in the darovasertib and binimetinib combination arm in MUM primarily include: nausea, vomiting, diarrhea, rash, edema, AST/ALT increase and CK increase (>10%); and hypotension (<10%)
IDEAYA’s clinical development strategy in MUM is focused on darovasertib combinations, including with binimetinib, a MEK inhibitor, and in a separate clinical study with crizotinib, a cMET inhibitor, each pursuant to the clinical trial collaboration and drug supply agreement with Pfizer.

Darovasertib Investor Day Webcast
IDEAYA will host an investor webcast with a presentation at 8:00 a.m. ET today. A link to the webcast and a copy of the presentation is posted on the Investor Relations Events section of the Company’s website at View Source The update may also be accessed by dialing 1-866-248-8441 (domestic) or 1-720-452-9102 (international) five minutes prior to the start of the call and providing the passcode 2793795. An archived replay of the webcast will be accessible for 90 days following the event.

Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, and Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center, will participate in the webcast.

On April 16, 2021 Peptron, Inc. ("Peptron", KOSDAQ: 087010), a South Korea-based biotech company, and Qilu Pharmaceutical ("Qilu"), a leading vertically integrated pharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative medicines reported that the companies have entered into an exclusive licensing agreement for the manufacturing, development and commercialization of Peptron’s PAb001-ADC, the antibody-drug conjugate (the "ADC") product containing the anti-MUC1 monoclonal antibody PAb001 as effective of March 26, 2021 (Press release, Qilu Pharmaceutical, APR 16, 2021, View Source [SID1234578131]).

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Under the terms of the agreement, Peptron grants Qilu an exclusive global right and license to develop, manufacture, sell, and commercialize PAb001-ADC for the treatment of cancers.

PAb001-ADC is a pre-clinical ADC entering into Investigational New Drug ("IND") enabling studies. It targets MUC1, a high-potential ADC target for multiple solid and hematological malignancies. MUC1 is overexpressed in many cancers and is recognized as a promising molecular target for therapeutic development for various types of cancers.

"We are excited to collaborate with Qilu to achieve the global opportunity of this potentially differentiated PAb001-ADC developed by us," said Ho-il Choi, CEO of Peptron. "Qilu is one of the leading pharmaceutical companies with global expertise and capacity in innovative R&D, manufacturing and marketing in China."

"We are very pleased to establish the partnership with Peptron to obtain global rights to the asset with highly differentiated attributes," said Dr. Binhui (Ben) Ni, Chief Investment Officer and Chief Business Officer, Corporate Vice President of Qilu Pharmaceutical, "We look forward to working closely with Peptron and The National Medical Products Administration (NMPA) to bring it to the patients."

On April 16, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that a recent study announced positive early results from a PSMA 617-Lu177 study conducted by a leading global pharmaceutical company (Press release, AIkido Pharma, APR 16, 2021, View Source [SID1234578130]). The report provides strong indications for analogous success in similar technology the Company is helping to develop.

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Anthony Hayes, CEO of AIkido Pharma, stated, "As a rising tide lifts all boats, these results indicate the strength of our prior investment in this technology field. These early reports indicate there is strong evidence that developing radioligand therapies have the potential to be an alternative cancer treatment and provide positive outcomes for patients with advanced prostate cancer. The Company’s stock price has been down recently, but we believe these positive results from the Novartis Phase III study provides an incremental proof point that reinforces our confidence in the radiopharmaceutical space, PSMA and our investment in this technology. With testing data for our technology expected in Q2 of this year, we are excited about the results and the advancement of this technology."