Celyad Announces Closing of $20 Million Global Offering

On September 16, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the closing of a global offering of 2,000,000 ordinary shares comprised of 1,675,000 ordinary shares in the form of American Depositary Shares ("ADSs") offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $10.00 (the "U.S. offering"), and 325,000 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €9.08 (together with the U.S. offering, the "global offering") (Press release, Celyad, SEP 16, 2019, View Source [SID1234539580]). Each ADS represents the right to receive one ordinary share. The gross proceeds to Celyad from the global offering amounted to approximately $20.0 million (approximately €18.2 million), before deducting underwriting discounts and commissions and estimated offering expenses. In connection with the global offering, Celyad has granted the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs) on the same terms and conditions.

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!

Our ADSs and our ordinary shares are listed under the symbol "CYAD" on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris, respectively.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited acted as joint bookrunning managers for the offering. Kempen & Co U.S.A., Inc. acted as co-manager for the offering. LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities were offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A final prospectus supplement dated September 11, 2019 and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on September 12, 2019, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email to [email protected]; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at [email protected]; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

Kura Oncology Doses First Patient in Phase 1 Clinical Trial of Menin-MLL Inhibitor KO-539 in Acute Myeloid Leukemia

On September 16, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that the first patient has been dosed in a Phase 1 clinical trial of KO-539, the Company’s first-in-class inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction, in patients with relapsed or refractory acute myeloid leukemia (AML) (Press release, Kura Oncology, SEP 16, 2019, View Source [SID1234539547]).

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!

"We believe KO-539 represents a differentiated approach to the treatment of patients with AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Our preclinical data for KO-539 support the potential for potent, anti-tumor activity in multiple, genetically defined subsets such as tumors with MLL fusions and rearrangements and NPM1 mutations. With the initiation of this trial, Kura now has three wholly-owned, clinical-stage oncology assets, along with the financial resources to advance each program through important inflection points."

This Phase 1, open-label, dose-escalation study is designed to determine the maximum tolerated dose (MTD) of KO-539 in patients with relapsed or refractory AML. KO-539 will be administered as a once daily oral dose in 28-continuous-day cycles. Upon completion of the dose-escalation portion of the trial, expansion cohorts are planned to further asses the safety and activity of KO-539 in specific genetic subgroups, such as NPM1. Additional information about the Phase 1 trial of KO-539 can be found at ClinicalTrials.gov using the identifier NCT04067336.

In July 2019, the U.S. Food and Drug Administration granted Orphan Drug Designation to KO-539 for the treatment of AML, recognizing the potential for KO-539 to address a population of patients with high unmet need.

About KO-539

KO-539 is a potent and selective small molecule inhibitor of the menin-MLL protein-protein interaction. MLL-rearranged leukemias are characterized by chromosomal translocations of the KMT2A gene that are primarily found in patients with AML and acute lymphoblastic leukemia (ALL). These translocations form oncogenes encoding MLL fusion proteins, which play a causative role in the onset, development and progression of MLL-rearranged leukemias. The target genes of the MLL fusion proteins are also found to be overexpressed in a broader subset of AMLs characterized by oncogenic driver mutations in genes, such as NPM1. These mutations also appear to be dependent on the interaction between menin and MLL, suggesting that the menin-MLL complex is a central node in epigenetic dysregulation driven by distinct oncogenic driver mutations known to be important in AML and other hematologic malignancies.

In preclinical studies, KO-539 has demonstrated potent and selective inhibition of the proliferation of MLL-rearranged leukemia cell lines. Kura has also generated preclinical data showing robust and durable anti-tumor activity in multiple in vivo models of AML characterized by MLL-rearrangements or oncogenic driver mutations in genes, such as NPM1.

INmune Bio Invited to Speak on Company’s Advancements in Cancer Treatments at the Targeting Innate Immunity Congress and MarketsandMarkets Next Gen Immuno-Oncology Congress

On September 16, 2019 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that RJ Tesi, M.D., Co-Founder and CEO, and Mark Lowdell, Ph.D., Co-Founder and Chief Scientific Officer, will present at the first ever Targeting Innate Immunity Congress, taking place in the biotech hub of Cambridge, Mass. from Sept. 23 through 25 (Press release, INmune Bio, SEP 16, 2019, View Source [SID1234539636]).

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!

The conference is an opportunity for INmune Bio to showcase its two leading innate compounds in the hopes of improving the treatment of cancer to industry leaders, experts, academic researchers and clinicians in the field of innate immunity. In addition to presenting at the conference, Dr. Tesi and Dr. Lowdell will be instructing a course on the role of the tumor microenvironment (TME) in immunosuppression.

"This panel will bring together other experts from industry and academia to explore the role of the innate immune system in the TME and in cancer drug development," said Dr. Tesi.

In addition to speaking at the Targeting Innate Immunity Congress this month, Dr. Tesi will also take part in a speaking engagement at the second annual MarketsandMarkets Next Gen Immuno-Oncology Congress on Sept. 19 in Philadelphia.

Below is a schedule of upcoming presentations:

MarketsandMarkets Next Gen Immuno-Oncology Congress
Thursday, September 19 at 11:40 a.m.
"Reversing Trastuzumab Resistance in HER2+ Breast Cancer"
Dr. Tesi will discuss Mucin 4 (MUC4) protein and how it predicts trastuzumab resistance in HER2+ breast cancer, the role of soluble tumor necrosis factor (TNF) in MUC4 expression and how INmune Bio’s drug candidate, INB03 works in combination with trastuzumab to reverse resistance in MUC4/HER+ breast cancer.

Targeting Innate Immunity Congress
Monday, September 24 at 3:30 – 6:00 p.m.
Short Course: "Understanding and Modulating Tumor Microenvironment for Immunotherapy"
Dr. Tesi and Dr. Lowdell will instruct an interactive short course on the role of the tumor microenvironment (TME) in immunosuppression. They will discuss strategies to change the immunosuppressive nature of the TME to one that supports immune responses and enhances the impact of tumor immunotherapy. Those who attend will walk away with an understanding of the following:

•Role of the TME in immunosuppression
•Checkpoint inhibitor optimization
Targeting of regulatory cells
•Reprogramming of immunosuppressive cells
•Modulation of chemokines and cytokines in the TME
•Modification of tumor-reactive lymphocytes to evade the TME
Wednesday, September 25 at 11:40 a.m.
"Myeloid Derived Suppressor Cell (MDSC): The Queen Bee of the Tumor Microenvironment (TME)"
As part of the "Modulating Macrophages in the Tumor Microenvironment" panel, Dr. Tesi will discuss targeting myeloid derived suppressor cells (MDSCs) as an efficient way to reverse tumor microenvironment (TME) immunobiology. His discussion will address the complexity of TME and how it contributes to failure of therapy, as well as understanding how targeting soluble tumor necrosis factor (TNF) offers a solution to the resistance to therapy when part of combination therapy. Dr. Tesi will also discuss the results of the Phase I trial for INmune Bio’s drug candidate, INB03 in patients with advanced cancer.

Wednesday, September 25 at 1:45 p.m.
"What do Tumor Cells do to NK Cells? – Harnessing the Tumor-NK Interaction for Clinical Benefit"
Dr. Lowdell will participate in the "Advancing Innate Cell Therapies to the Clinic" portion of the conference to discuss how relapsed cancer cells evade natural killer (NK) cells, and how priming NK cells could effectively kill these cancer cells. Dr. Lowdell will also discuss INmune Bio’s INKmune drug candidate.

Onconova Therapeutics Announces Presentation on Rigosertib at the RAS-Targeted Drug Discovery Summit

On September 16, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS),reported that it will present at the RAS-Targeted Drug Discovery Summit being held September 17-19 in Boston, Massachusetts (Press release, Onconova, SEP 16, 2019, View Source [SID1234539548]). Dr. Steven Fruchtman, President & CEO, will be presenting. Also attending the conference will be Avi Oler, VP Corporate Development.

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!

ABOUT RAS AND RIGOSERTIB:

There is a high frequency of Ras mutations in cancer that leads to the belief that mutations of the Ras Pathway provide a proliferative advantage and thus is involved in the pathogenesis of cancer. As a result, targeting the Ras pathway has been the objective of scientific research for decades. As published in the journal Cell in 2016, and now under investigation in a pivotal Phase 3 Trial, rigosertib targets the mutated RAS pathway by its interaction with Ras effector proteins containing the Ras Binding Domain. The RAS-Targeted Drug Discovery Summit provides an opportunity to showcase the potential for rigosertib in MDS and in other RAS-driven cancers, such as KRAS-mutated lung cancer and colorectal cancer, and Ras- driven pediatric cancers as well. Onconova will review its INSPIRE Trial for which the Company anticipates reporting top-line data for second-line, higher-risk MDS patients in the first half of 2020 following full enrollment and 288 death events. Onconova’s representatives look forward to joining colleagues at the Summit to discuss advancements in rigosertib’s development and the progress the Company and others have made in targeting RAS.

DETAILS OF THE PRESENTATION:

Title: Rigosertib: Targeting the Ras+ Pathway and Clinical Trials in MDS and Beyond
Date/Time: Thursday, September 19th, 10:30 a.m.
Presenter: Steven M. Fruchtman, M.D.

Genome Editing Biotech EdiGene Raises $11 M in Series Pre-B2 Financing and Forms Research Collaboration to Develop Allogeneic T-cell Therapeutics for Cancer

On September 16, 2019 EdiGene, Inc., which develops genome editing technologies into novel therapeutics for a broad range of diseases and into creative solutions to advance drug discovery, reported the successful completion of raising approximately $11 Million in a Series pre-B2 financing (Press release, EdiGene, SEP 16, 2019, View Source [SID1234539565]). EdiGene’s Series A lead investor IDG Capital and Series pre-B lead investor Lilly Asia Ventures (LAV) invested in this round.

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!

Separately, EdiGene has formed research collaboration with a clinical stage biopharmaceutical company developing novel T-cell therapies to explore new allogeneic T-cell therapeutic approaches for cancer. Company name and deal terms are not disclosed.

"Allogeneic T-cell therapeutics has tremendous potential in China and beyond, by offering innovative T-cell therapies "off the shelf" with more effective quality control and lower cost. We have been building the Allogeneic CAR-T Platform and this new research collaboration further demonstrates our commitment to develop such therapeutics to help the cancer patients in need," said Dong Wei, Ph.D., MBA, CEO of EdiGene. "We are pleased to complete the new round of financing by our lead investors IDG and LAV. We look forward to working with them and other current investors to advance our exciting portfolio into the next stage."