On November 22, 2021 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos, will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference being held from November 30 – December 2, 2021 (Press release, Aligos Therapeutics, NOV 22, 2021, View Source [SID1234595878]). The Aligos management team will also participate in virtual investor 1×1 meetings during the conference.

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The webcast of the pre-recorded presentation will be available starting November 22, 2021, 10:00 AM EST on the events section of the Aligos Website or by using the Webcast Registration Link. A replay will be available following the presentation for approximately 90-days.

Please contact your Piper Sandler representative to schedule virtual one-on-one meetings with Aligos during the conference. For more information about the Piper Sandler 33rd Annual Virtual Healthcare Conference, please refer to the Conference Website.

On November 22, 2021 AB Science SA (Euronext – FR0010557264 – AB) reported that its Phase I/II study (AB18001) evaluating AB8939 in patients with refractory and relapsed AML and refractory myelodysplastic syndrome (MDS) has received Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA) (Press release, AB Science, NOV 22, 2021, View Source [SID1234595896]).

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Study AB18001 is titled ‘A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia’. The study has a multi-stage design. The first part is a dose escalation study that aims to determine the safety and tolerability of intravenous AB8939 in patients with refractory or relapsed AML or patients with refractory MDS, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy (response rate) assessment of AB8939.

Study AB18001 has also been approved in France and in Canada.

AB8939 is a new synthetic microtubule-destabilizing drug. Preclinical data show that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has strong potential to be developed in numerous oncology indications.

The first indication AB8939 is being developed for is acute myeloid leukemia (AML). Cytarabine (Ara-C) and azacytidine are standard chemotherapies for AML treatment, however, drug resistance is a major limitation to successful therapy. In vivo data from a highly resistant Ara-C patient derived xenograft (PDX) mouse model showed that AB8939, administered alone or in combination with Ara-C, increased survival relative to single agent Ara-C, with an accompanying significant reduction of blasts in blood and decrease in tumor growth. Further evidence of therapeutic potential was demonstrated using an azacytidine resistant PDX model with AB8939, administered alone or in combination with azacytidine, showing a significant reduction of blasts relative to single agent azacytidine. Moreover, while azacytidine was associated with strong treatment related hematotoxicity, AB8939 did not induce hematotoxicity throughout its 4-week treatment period.

AB8939 was granted orphan drug designation for AML from the U.S. Food and Drug Administration (FDA).

AB8939 was entirely discovered by the laboratories of AB Science, which retains full ownership of intellectual rights, and is an example of AB Science’s focus on innovative drug development focused on improving patients’ lives.

About acute myeloid leukemia (AML)
Acute myeloid leukemia (AML) is a serious, life-threating condition and the most common cause of leukemia-related mortality, with a majority of patients facing a highly unsatisfactory prognosis. As such, AML represents an unmet medical need, with limited therapeutic options for patients who are refractory or too frail to benefit from potentially curative but highly toxic treatment, or for those patients that have relapsed following a first complete response. The prevalence of AML in western countries is around 1 per 5,000 persons, corresponding to around 100,000 cases in Europe and 60,000 in the USA. Among AML patients, it is estimated that approximately 50% of the patients will not have stem cell transplantation and will relapse. Therefore, the estimated targeted population of AB8938 in AML is around 80,000 people in Europe and the US.

On November 22, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported its participation in the following upcoming virtual investor conferences (Press release, Moderna Therapeutics, NOV 22, 2021, View Source [SID1234595915]):

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NASDAQ 45th Investor Conference on Wednesday, December 1st at 9:30 a.m. ET
Piper Sandler 33rd Annual Virtual Healthcare Conference on Wednesday, December 1st at 2:00 p.m. ET
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for at least 30 days following the presentation.

On November 22, 2021 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported that the company has entered into a clinical collaboration agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA,, for clinical study of Q702, a triple inhibitor of Axl/Mer/CSF1R) in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) (Press release, Qurient Therapeutics, NOV 22, 2021, View Source [SID1234595931]).

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Under this agreement, Qurient will conduct a phase 1b/2 study in the U.S. and Korea to evaluate safety and efficacy of Q702 and KEYTRUDA in combination for the treatment of selected advanced solid tumors, including esophageal, gastric, hepatocellular, and cervical cancers.

Kiyean Nam, Ph.D., CEO of Qurient, said, "We are pleased to collaborate with MSD to evaluate Q702 in combination with KEYTRUDA for the treatment of esophageal, gastric, hepatocellular, and cervical cancers, where limited immuno-oncology treatment options are currently available. We have previously shown the potential additive benefit of Q702 in combination with anti-PD-1 therapy in preclinical models, so this combination study is designed to evaluate clinical benefit of Q702 and KEYTRUDA for patients."

Terms of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Q702

Q702 is an orally available novel Axl/Mer/CSF1R inhibitor and is designed to modulate innate immune components leading to T cell activation. Q702 was also shown to increase antigen presentation in the tumor cells demonstrating dual mode of action. A phase 1/2 clinical trial is currently underway in the U.S. (Clinical Trials.gov Identifier: NCT04648254) to evaluate safety and efficacy of Q702 as a monotherapy treatment for solid cancers.

On November 22, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported two poster presentations featuring clinical data for its anti-CD137 agonist, ADG106, and anti-CTLA-4 monoclonal antibody, ADG116, at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) 2021 (Press release, Adagene, NOV 22, 2021, View Source [SID1234595952]).

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The conference abstracts are expected to be published on the ESMO (Free ESMO Whitepaper)-IO website on Thursday, December 2, 2021 and posters available on Monday, December 6, 2021 in advance of the hybrid meeting being held virtually and in Geneva, Switzerland from December 8 to 11, 2021.

"These clinical data from two of our ongoing NEObody clinical programs showcase the importance of our pioneering approach to target a unique epitope and reflect the dynamic interactivity between an antibody and antigen," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "The pharmacodynamic biomarker findings from our ongoing ADG106 trial with the anti-PD-1 toripalimab reinforce the potential synergistic combination for strong T-cell activation. For our novel anti-CTLA-4 program, data from the ongoing dose escalation of ADG116 monotherapy support the robust safety profile and dose dependent T-cell activation in both hot and cold tumors, suggesting potential clinical benefit following our translational studies. Each of these analyses highlights the promise of our tailor-made programs to achieve the fine balance between safety and efficacy – thereby unlocking the full value of some of the most promising yet challenging immuno-oncology targets today."

Details for the poster presentations during ESMO (Free ESMO Whitepaper)-IO 2021 include:

·Title: Assessment of Biomarker Kinetics for ADG106 (anti-CD137 agonist) as monotherapy or combined with toripalimab
Presentation Number: 43P

Date: Monday, December 6, 2021

Time: 12:00 Central European Time

·Title: Phase 1 dose-finding study of a novel anti–CTLA-4 antibody ADG116 as monotherapy in patients with advanced solid tumors
Presentation Number: 137P

Date: Monday, December 6, 2021

Time: 12:00 Central European Time

Both the ADG106 and ADG116 programs use Adagene’s innovative NEObody technology, which enables targeting of unique and highly conserved epitopes against a broad range of antigens. These species cross-reactive antibodies not only have the potential to reveal new biological functions of the targets, but also facilitate preclinical studies using various immune intact animal models, resulting in high fidelity translation from preclinical to clinical studies. The company is also developing an anti-CTLA-4 antibody, ADG126, using its SAFEbody precision masking technology.