On March 27, 2019 Crown Bioscience, a global drug discovery and development services company, providing translational platforms to advance oncology, inflammation and autoimmune, cardiovascular and metabolic disease research reported that parent company, JSR Corporation, has entered into a strategic partnership with Hubrecht Organoid Technology (HUB) (Press release, JSR, MAR 27, 2019, View Source [SID1234553813]).

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 agreement provides CrownBio, a wholly owned subsidiary of JSR Corporation, with an exclusive license to provide preclinical oncology drug development and validation services using HUB Organoid Technology, including access to HUB’s highly characterized tumor organoid biobank. CrownBio and HUB will also launch a collaborative research & development program to accelerate further development of Organoid Technology, while CrownBio will establish a new operations center in Utrecht, Netherlands.

HUB’s adult stem cell-derived organoids, developed by Prof. Hans Clevers at the Hubrecht Institute in Utrecht, are generated using highly standardized, proprietary culture methods. The Organoids faithfully recapitulate tumors in patients and are extensively characterized by pathology, genomics, and sensitivity to known and experimental drugs.

"This agreement is a pivotal moment in our growth and the evolution of the company," said Dr. Jean-Pierre Wery, CEO of CrownBio. "This partnership positions CrownBio at the forefront of global preclinical research by creating an unparalleled translational platform to accelerate drug development and validation."

Building on a global leadership in Patient-Derived Xenografts (PDX), CrownBio will offer comprehensive pharmacology and translational services based on HUB Organoid Technology, establishing a unique platform that incorporates in vitro screening of Patient-Derived Organoids (PDO) and PDX derived organoids (PDXO), matched to downstream in vivo models.

"We are delighted with the increased access to HUB Organoid Technology for researchers worldwide through CrownBio’s global reach and preclinical service expertise," said Dr. Robert Vries, Executive Director of HUB. "Our partnership with CrownBio equips the drug development community with powerful new translational tools to guide the creation of novel and improved treatments for cancer."

On March 27, 2019 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, reported the pricing of an underwritten public offering of an aggregate of 5,250,000 units at a public offering price of $1.00 per unit (Press release, Moleculin, MAR 27, 2019, View Source [SID1234534675]). Each unit is comprised of one share of common stock and 0.5 of a warrant to purchase one share of common stock for a total of 5,250,000 shares of common stock and warrants to purchase 2,625,000 shares of common stock.

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!

Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company focused on the treatment of highly resistant cancers. (PRNewsfoto/Moleculin Biotech, Inc.)

Each warrant will have an exercise price of $1.10 per share and is exercisable immediately. The warrants will expire five years from the date of issuance. The shares of common stock and the accompanying warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about March 29, 2019, subject to customary closing conditions.

The gross proceeds of the offering are expected to be $5.25 million, prior to deducting the underwriting discount and other estimated offering expenses.

Oppenheimer & Co. Inc. is acting as the sole underwriter for the offering. Roth Capital Partners, LLC and Maxim Group LLC are acting as financial advisors to the Company.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying prospectus forming part of a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 27, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported that the Company will host a Key Opinion Leader (KOL) Symposium focused on the potential of TAVO (tavokinogene telseplasmid), its lead immunotherapy investigational product candidate, on Friday, April 5, 2019 at 8:00 a.m. ET in New York City (Press release, OncoSec Medical, MAR 27, 2019, View Source [SID1234534659]).

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 KOL Symposium will feature a keynote presentation from Adil Daud, M.D., the Lead U.S. Investigator for KEYNOTE-695 and Clinical Professor of Medicine and Dermatology at University of California, San Francisco (UCSF), and Director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center.

Among other important topics, Dr. Daud’s presentation will:

Outline the significance of the emerging data from the KEYNOTE-695 trial where patients with anti-PD-1 checkpoint refractory metastatic melanoma are being treating with the combination of TAVO + KEYTRUDA
Provide insights of how TAVO is differentiated from other therapeutic approaches for patients with checkpoint refractory metastatic melanoma
Following Dr. Daud’s presentation, OncoSec’s management team will:

Outline the U.S. and EU accelerated approval pathway and timelines for the approval of TAVO to treat metastatic melanoma patients who are refractory to anti-PD-1 checkpoint therapy
Showcase OncoSec’s newly-developed proprietary visceral lesions applicator or VLA, which is designed to treat a variety of deep visceral tumors including gastrointestinal (GI) tumors, pancreatic tumors and hepatocellular carcinomas (HCC)
Provide an overview of data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, highlighting OncoSec’s novel anti-tumor therapeutic product candidate
The FDA designated Fast Track Development Program status to OncoSec’s TAVO in combination with KEYTRUDA to stop or cause the regression of the tumor of patients with Stage III/IV melanoma who are progressing on either KEYTRUDA or OPDIVO. A drug that receives Fast Track designation is eligible for Accelerated Approval, if relevant criteria are met.

A live webcast of the event will be available. To access the live webcast, please visit the Investor Relations section of OncoSec’s website at ir.oncosec.com. An archived replay of the webcast will also be available at the same location.

On March 27, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX▼ (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT) (Press release, Johnson & Johnson, MAR 27, 2019, View Source [SID1234534676]).

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 submission is supported by data from the Phase 3 CASSIOPEIA (MMY3006) study. Additional information about this study can be found at www.ClinicalTrials.gov (NCT02541383).

"With this regulatory submission, Janssen could help redefine treatment for transplant eligible patients by providing the opportunity to be treated with a daratumumab regimen for the very first time," said José Antonio Burón Vidal, Vice President, Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag, S.A. "We continue to deliver advances in multiple myeloma, and if approved, this could offer a broader range of frontline patients a new treatment option and improved outcomes."

Janssen has also submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of daratumumab-VTd for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

In Europe, daratumumab is indicated:1

in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy
in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
About the CASSIOPEIA Trial2

The randomised, open-label, two-arm, multicentre, Phase 3 study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. The study includes participants with previously untreated multiple myeloma eligible for high dose chemotherapy and ASCT. In the first part of the study, on which the filing is based, participants were randomised to receive either induction (before transplantation) and consolidation (after transplantation) treatment with daratumumab combined with bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR) rate after consolidation therapy. In the second part of the study, patients that achieved a response will undergo a second randomisation to either receive maintenance treatment of daratumumab or no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS). The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately five years after the last participant is randomised in the second phase of the study. Disease assessments will be performed every four weeks in the first phase of the study and then every eight weeks in the second phase of the study.

About daratumumab

Daratumumab is a first-in-class3 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.4 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.1 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.1 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.2,5,6,7,8,9,10,11 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.12,13 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.14

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.15 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.16 Almost 40 percent of patients with MM do not reach five-year survival.17

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.18 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.19,20 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.21 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.22 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.23

On March 27, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "ImmunoPrecise") (TSX VENTURE: IPA) (OTC PINK: IPATF) reported its financial results for Q3 ended January 31, 2019 (Press release, ModiQuest Therapeutics, MAR 27, 2019, View Source [SID1234534957]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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!

Financial Highlights:

Revenue. During the three months ended January 31, 2019, the Company increased revenues to $2,695,583 from $1,723,308 in 2018. This represents a 56% increase in revenue and stems from the acquisitions of U-Protein and ModiQuest, the Company’s ability to grow its core business and expand its market share in Europe, and an increase in projects for the B-cell lab.
Gross Margin. During the three months ended January 31, 2019, the Company increased its gross margin to $1,568,055 from $989,203 in 2018. In percentage terms, the Company’s gross margin increased to 58% from 57% in 2018. The higher gross margin in 2019 was mostly attributable to the fact that the Company focused on higher margin projects at its new B-cell lab and introduced additional efficiencies into its operations. The Company anticipates that gross margin on a percentage basis will continue to be over 50% for the balance of fiscal 2019.
Net Loss. The Company recorded a net loss of $1,187,056 during the three months ended January 31, 2019, which is consistent with the net loss of $1,211,591 for three months ended January 31, 2018. $577,720 of the costs incurred during the three months ended January 31, 2019 were one-time costs which are not expected to be incurred again. These one-time costs included costs incurred to improve operational efficiency across all the divisions, to integrate U-Protein and ModiQuest into IPA’s global network, and to continue to establish a global structure for reporting and oversight. In the current period the Company also made investments that would enable its future growth, such as new management hires, more training programs, and additional space
Adjusted EBITDA. For the three and nine months ended January 31, 2019, excluding the one-time costs of $577,720 and $1,251,613, respectively, EBITDA would have been $116,367 and ($301,477), respectively.

Corporate:

On August 20, 2018, the Company announced that Mr. Guy Champagne resigned from his position as a Director of the Company, and joined the Company’s Advisory Board.

On November 21, 2018, the Company announced that Paul Andreola was appointed as a Director of the Company at its annual general meeting ("AGM") held in Vancouver, BC on November 20, 2018. Mr. Andreola has over 20 years of business development and financial markets experience including senior management, marketing, and communications roles for early stage companies. Previously in his career, Mr. Andreola was a licensed investment advisor for over 10 years and has facilitated multiple early stage private and public companies in the resource and technology sectors. Mr. Andreola is currently the CEO and Director of NameSilo Technologies Corp. (CSE: URL) and Ironwood Capital Corp. (TSXV: IRN.P).