On December 3, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in virtual investor meetings and present at The JMP Securities Hematology and Oncology Summit that will be held December 6-7, 2021 (Press release, Hookipa Biotech, DEC 3, 2021, View Source [SID1234596444]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Corporate Presentation: Tuesday, December 7, 2021 at 1:20 PM EST

The webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On December 3, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include ZEJULA (niraparib) as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status (Press release, Zai Laboratory, DEC 3, 2021, View Source [SID1234596445]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"A key part of Zai Lab’s mission is to bring transformative medicines to patients in China," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The inclusion of ZEJULA in the NRDL for first-line maintenance treatment of ovarian cancer is an important step in achieving that mission. We are grateful for this action by the NHSA to make ZEJULA more accessible to Chinese patients with ovarian cancer."

"NHSA reimbursement will increase ZEJULA’s availability for many patients in need across China," said William Liang, Chief Commercial Offer. "It is the only PARP inhibitor approved as monotherapy for first-line and recurrent maintenance therapy for ovarian cancer patients regardless of biomarker status in China. This action underscores ZEJULA’s clinical value for a broad range of ovarian cancer patients."

In November 2021, Zai Lab announced that the Phase 3 PRIME study of ZEJULA as maintenance therapy met its primary endpoint and demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit with a manageable safety profile in Chinese patients with newly diagnosed advanced ovarian cancer following a response to platinum-based chemotherapy, regardless of biomarker status.

In December 2020, ZEJULA was included in the NRDL as a maintenance treatment of adult patients with platinum-sensitive, recurrent ovarian cancer.

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China, with over 55,000 newly diagnosed cases and 37,000 deaths in China annually1. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. New agents that prolong the duration of response following platinum-based treatment and delay the relapse of ovarian cancer will benefit patients with ovarian cancer in China.

Globocan 2020.

About ZEJULA (niraparib)

ZEJULA (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the maintenance treatment of adult patients with advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first- and second-line platinum-based chemotherapy.

Zai Lab has completed several studies in Chinese patients with ovarian cancer:

In November 2021, Zai Lab announced positive topline results from the company’s Phase 3 PRIME study of ZEJULA as maintenance therapy for Chinese patients with first-line platinum-responsive, advanced ovarian cancer, regardless of biomarker status.

In September 2020, Zai Lab announced that ZEJULA demonstrated a significant PFS benefit with an improved safety profile in the company’s Phase 3 NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer, regardless of biomarker status.

A Phase 1 pharmacokinetic (PK) study of ZEJULA was conducted in Chinese patients with ovarian cancer.

ZEJULA is also being evaluated in China in a Phase 1b/2 study in combination with tebotelimab (PD-1 x LAG-3 DART molecule) for advanced gastric cancer, triple negative breast cancer, biliary tract cancer, and endometrial cancer.

Zai Lab has a collaboration and license agreement with GSK for the development and commercialization of ZEJULA in mainland China, Hong Kong, and Macau.

On December 3, 2021 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported a research collaboration with University of Bern, to advance the development of the Company’s wholly owned acute myeloid leukemia (AML) candidate, MP0533, into the clinic (Press release, Molecular Partners, DEC 3, 2021, View Source [SID1234596446]). MP0533 is a DARPin designed to engage CD3 on T cells and target AML cells by the tumor associated antigens (TAAs) CD33, CD123 and CD70. The collaboration aims to leverage Molecular Partners’ proprietary DARPin technology and the University of Bern group’s expertise in AML, and specifically in leukemic stem cells (LSC), a hard-to-target cancer progenitor cell population.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"AML is a fast-progressing cancer with a high mortality rate. Current treatments carry high safety risks and can be very harsh, especially for older and frail patients. Our preclinical results so far show MP0533 to be highly specific, fast acting and with a wide therapeutic window, and we hope these traits will translate well for patients in need," said Nicolas Leupin, M.D., Ph.D., Molecular Partner’s CMO. "Our new collaboration with the Bern team provides us with access to advanced AML methodologies and patient samples, and, more importantly, guidance from two of the world’s leading AML researchers, who have previously helped develop anti-CD70 antibodies to the clinic and can share from their invaluable experience."

The Bern team is led by Prof. Adrian Ochsenbein, M.D., Chairman, Department of Medical Oncology, and Prof. Carsten Riether, Ph.D., who study the interaction of immune cells and leukemic cancer cells to develop improved immunotherapies for different types of cancer. Prof. Ochsenbein won the prestigious 2016 Otto Naegeli Prize for breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients. The two professors’ main research focus is the so-called LSC. These cells are considered the origin of the disease and responsible for relapse after successful chemotherapy. Under the agreement, the researchers will work with Molecular Partners to investigate the effect and mechanism of action of the Company’s DARPin candidate T-cell engager (TCE) in AML, using in vitro and in vivo models, as well as patient samples.

"The main reason AML is so hard to treat is a small population of therapy-resistant leukemia stem cells, which drives the relapse of the disease after initial successful treatment. Novel therapies will have to aim at targeting and eliminating these treatment-resistant LSCs," said Professor Ochsenbein. "We are excited to join forces with Molecular Partners to work to evaluate this novel therapeutic option. Hopefully, emerging therapeutics like MP0533 will be able to provide a much-needed solution for AML patients."

About Molecular Partners’ acute myeloid leukemia (AML) program
Molecular Partners’ T-cell engager (TCE) programs leverage the cell surface protein CD3 as a powerful immune activator, complemented by novel control mechanisms designed to help direct CD3-mediated cytotoxicity with heightened precision. Molecular Partners first TCE candidate is being developed as a unique multi-specific treatment for AML. Its component DARPin modules are designed to deliver a deeper attack on a broader range of highly variable tumor cells while lowering the risk to healthy cells. This may allow Molecular Partners to significantly shift the therapeutic window for TCE use in AML and potentially avoid the trade-off between effective dosage and safety that other therapeutic developers have had to make.

About Molecular Partners’ Immuno-oncology Product Candidates
Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin technologies potentially applicable against a wide range of tumor types, including DARPin candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin platform, to provide precise control over immune activation and potentially enable more effective cancer immunotherapies.

On December 3, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported a share capital increase arising from subscription right exercises (Press release, Galapagos, DEC 3, 2021, View Source [SID1234596466]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Galapagos issued 22,600 new ordinary shares on 3 December 2021, for a total capital increase (including issuance premium) of €578,700.00.

Pursuant to the subscription right exercise program of Galapagos’ management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one management board member exercised 5,000 subscription rights.

In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €354,582,005.11, the total number of securities conferring voting rights amounts to 65,552,721, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 8,709,735 subscription rights under several outstanding employee subscription right plans, which equals 8,709,735 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

On December 3, 2021 Servier and the pharmatech Aqemia reported that they have entered into a collaboration agreement to accelerate the discovery of small molecule therapeutic drug candidates in immuno-oncology (Press release, Servier, DEC 3, 2021, View Source;utm_medium=rss&utm_campaign=immuno-oncologie-servier-et-aqemia-cooperent-pour-la-decouverte-de-medicaments-a-laide-de-lia [SID1234596431]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This collaboration will use Aqemia’s technology based on artificial intelligence and quantum physics. Aqemia will take responsibility for the AI-based design to deliver optimized molecules that fulfill several small molecule design goals. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the project from the earliest stage of the drug discovery by generating its own data with quantum and statistical physics-based calculations.

Olivier Nosjean, Head of Open Innovation and Scientific Affairs at Servier R&D: "This collaboration with Aqemia is a concrete example of Servier working side by side with a start-up to create value for both parties, working jointly to accelerate therapeutic innovation for patients. This collaboration is the result of the Start-up @ Servier program, where an initial phase of joint work allows us to carry out a key study or pilot application of a technology, before entering into a classic collaboration. This is our first application of this Start-up @ Servier model, and we are very happy to see it take shape with Aqemia, which is such a promising collaboration."