On December 3, 2020 Merck KGaA, Darmstadt, Germany, a leading science and technology company and Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company developing a broad pipeline of precision medicines for the treatment of cancer, reported a global three year strategic research collaboration to discover and develop multiple precision oncology drugs (Press release, Merck KGaA, DEC 3, 2020, View Source [SID1234572134]).

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"Our platform has the potential to revolutionize targeted treatment in cancer and deliver on the promise of precision medicine. This collaboration will leverage the potential of our unique discovery platform of novel DNA repair nuclease inhibitors and targets that we have been developing. The partnership puts us in an exceptional position to focus internal efforts on our leading portfolio of assets which includes a small-molecule ATR inhibitor and a Polθ programme, both in candidate IND evaluation," said Niall Martin, Chief Executive Officer at Artios Pharma.

"Targeting DNA damage response has the potential to provide an important therapeutic option for many patients in need of new treatments. We are excited about working with Artios to develop novel precision oncology medicines as we move towards changing the current paradigm in cancer treatment. This collaboration further strengthens our leadership and expertise in the field and discovery of DDR inhibitors and complements our multiple innovative assets currently being evaluated in several Phase I and Phase II clinical studies," said Andree Blaukat, SVP and Head Translational Innovation Platform Oncology & Immuno-Oncology, at Merck KGaA, Darmstadt, Germany.

Under the terms of the agreement, the companies will leverage Artios’s proprietary nuclease targeting discovery platform to jointly identify multiple synthetic lethal targets for precision oncology drug candidates. During this joint research collaboration, Merck KGaA, Darmstadt, Germany will contribute its significant expertise and resources in the field of DDR and will have exclusive worldwide rights to develop and commercialize selected therapeutics discovered under the collaboration. The collaboration does not include Artios’s lead programmes, Polθ and ATR inhibitors, for which Artios will retain all rights.

Nucleases are critical enzymes involved in the maintenance of genomic integrity. Cancer cells are dependent on nucleases for their survival in response to DNA damage. Also, in certain cancers which exhibit mutations in DNA damage response pathways, inhibiting key nucleases can lead to selective cancer cell killing i.e. synthetic lethality.

As part of the agreement, Artios will receive a payment of US$30 million in the form of an up-front and near-term payments. If Merck KGaA, Darmstadt, Germany chooses to exercise the option, subject to double-digit option fees, Artios will be eligible to receive up to US$860 million per target, in addition to up to double digit royalty payments on net sales of each product commercialized by Merck KGaA, Darmstadt, Germany.

Subject to certain conditions, Artios has opt-in rights for joint development and commercialization with Merck KGaA, Darmstadt, Germany for the programmes.

On December 3, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it will present animal data demonstrating highly improved activity against acute myeloid leukemia ("AML") in combination with the commonly used antileukemic drug Ara-C (also referred to as "cytarabine") versus single agent at the 62nd Annual Meeting & Exposition of the American Society for Hematology ("ASH") under the title: "High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model (Press release, Moleculin, DEC 3, 2020, View Source [SID1234572133])."

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are extremely encouraged by the strong pre-clinical efficacy demonstrated by the combination of Annamycin and Ara-C against AML," commented Walter Klemp, Chairman and CEO of Moleculin. "While we firmly believe in the promise and efficacy Annamycin has demonstrated as a single agent against AML in our two current Phase 1 clinical trials, we believe this discovery warrants further consideration to the potential expansion of its clinical development into clinical trials for the combination of Annamycin with Ara-C ("AnnAraC") against AML."

Mr. Klemp concluded, "The combination of Annamycin with Ara-C is particularly intriguing considering the current first-line therapy for AML patients is "7+3", where Ara-C is administered daily for 7 days in parallel with 3 daily doses of an anthracycline. Substituting a currently used anthracycline such as doxorubicin with Annamycin would be a familiar and well-practiced treatment modality. Furthermore, the combination of Annamycin with Ara-C may offer potential advantages given Annamycin’s demonstrated lack of cardiotoxicity and activity against tumor cells resistant to doxorubicin. We look forward to further discussing the promise of this combination at the 62nd Annual Meeting & Exposition of the American Society for Hematology."

As previously announced, the study was conducted in a highly aggressive AML mouse model where median survival, left untreated, is approximately 13 days. Median survival in animals treated with the combination of Annamycin and Ara-C ranged from 56 to 76 days, expanding median survival by 585%. Notably, several animals in the study were completely cured. The Company believes these experiments support initiation for the clinical development of the combination of Annamycin and Ara-C in AML patients.

On December 3, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will present additional data on its lead partnered asset, monalizumab, at the ESMO (Free ESMO Whitepaper) Immuno-oncology Virtual Congress being held from Dec. 9-12, 2020 (Press release, Innate Pharma, DEC 3, 2020, View Source [SID1234572132]). Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

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The presentation will include updated results from a Phase 2 study investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with a platinum-based chemotherapy and PD-(L)1 inhibitor.

The e-poster presentation (#81P, abstract #235) entitled, "Monalizumab in combination with cetuximab post platinum and anti-PD-(L)1 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Updated results from a phase 2 trial" will be available on Dec. 9th.

As recently announced, AstraZeneca dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in R/M SCCHN patients who have been previously treated with a platinum-based chemotherapy and PD-(L)1 inhibitors.

On December 3, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that shared an update from its partner, Elevar Therapeutics, on the development plan for Apealea (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel, in ovarian cancer (Press release, Oasmia, DEC 3, 2020, View Source [SID1234572131]). Since acquiring rights to Apealea at the end of March 2020, Elevar has had interactions with the FDA and received guidance for further advancing the development program for Apealea. Following these interactions, Elevar has decided to complete two new studies with Apealea, which will both be initiated in the first half of 2021 before filing a new drug application (NDA) with the U.S. Food and Drug Administration (FDA).

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The first study planned by Elevar is a pharmacokinetics study, which Elevar aims to initiate in the first half of 2021. The study is expected to take approximately 12 months to complete.
Elevar is also planning to initiate a pivotal superiority study to investigate the safety and efficacy of Apealea in epithelial ovarian cancer. Elevar is working closely with The GOG Foundation (GOG-F) through its GOG Partners program in the U.S. to plan and execute this global study in the first half of 2021. This study is expected to take approximately 24-36 months to complete.
"Despite the global pandemic, Elevar has made great strides advancing the ovarian cancer development program for Apealea. We have designed a clinical program for Apealea with advice from the FDA as well as advisory boards consisting of global thought leaders," said Alex Kim, Chief Executive Officer of Elevar Therapeutics. "Paclitaxel is a well-known chemotherapy agent that has been proven effective to treat ovarian cancer, yet in the U.S. the approved formulations use Cremophor-EL, which may induce serious side effects, require longer infusion times, and may not be suitable for patients who have certain co-morbidities or cannot tolerate steroids pre-treatment. Elevar is dedicated to making Apealea available to patients with epithelial ovarian cancer worldwide, and we expect that it will be the first non-cremophor formulation approved in this indication by the U.S. FDA."

"The clinical benefit of paclitaxel has been well-established in oncology," said David M. O’Malley, M.D., Professor and Director, Division of Gynecologic Oncology, Co-Director, Gyn Oncology Phase I Program, The Ohio State University and the James Cancer Center. "Having a non-Cremophor formulation of paclitaxel micellar has the potential to contribute to improved clinical outcomes and treatment experiences for epithelial ovarian cancer patients."

In addition, Elevar is exploring the potential utility of Apealea in other indications beyond ovarian cancer.

Apealea received market authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in epithelial ovarian cancer. Apealea has received Orphan Drug Designation from the FDA for the treatment of epithelial ovarian cancer, which could lead to potential benefits including seven years of market exclusivity.

"These two new studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label – critical for commercial success. Through our partnership with Elevar, Oasmia will, as previously stated, receive double digit royalties on all sales and milestones associated with any indication successfully approved," commented François Martelet, M.D., Chief Executive Officer of Oasmia.

Since March, Elevar has also made significant progress to enable patients to access Apealea outside of the U.S.:

Elevar and Tanner Pharma launched a global named patient program to provide access to Apealea in areas outside of the U.S. where Apealea is not commercially available.
Elevar signed an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea in the Middle East and North Africa Region.
Elevar is in active discussion with a number of other potential commercial partners for Apealea in regions around the world, including Europe.

Conference Call Details
Elevar and Oasmia will host an audiocast and telephone conference on December 3, 2020, at 16:00 CET, with the following participants:

Francois Martelet, CEO of Oasmia Pharmaceutical AB
Alex Kim, CEO of Elevar Therapeutics Inc.
Mark Gelder, MD, Head of Medical Affairs at Elevar Therapeutics Inc.
Weblink: View Source

About Apealea (paclitaxel micellar)
Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received market authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer.

About Ovarian Cancer
Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs. It is the fifth most common cancer among women in the U.S., with a prevalence rate of nearly 230,000 women, and accounts for more deaths than any other cancer of the female reproductive system., About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis.iii,

On December 3, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of data presentations at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held virtually December 5 – 8, 2020 (Press release, TG Therapeutics, DEC 3, 2020, View Source [SID1234572130]).

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ASH 2020 PRESENTATION DETAILS:

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study
Publication Number: 543
Oral Session: 642. CLL: Therapy, excluding Transplantation
Session Date and Time: Monday, December 7, 2020; 7:00 AM – 8:30 AM (Pacific Time)
Presentation Time: 7:15 AM (Pacific Time)
Presenter: John G. Gribben, MD, D.Sc., Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom;
Poster Presentation Title: Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global UNITY-NHL Trial
Publication Number: 2934
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Pier Luigi Zinzani, MD, PhD, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, Italy

Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Publication Number: 3137
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, NY

Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies
Publication Number: 1130
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
Date and Time: Saturday, December 5, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia
Following each presentation during ASH (Free ASH Whitepaper) 2020, the data presented will be available on TG’s corporate website at View Source TG abstracts are publicly available via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org or on the company’s corporate website.