On March 27, 2019 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative oncology therapies and a pipeline of biosimilars, reported the company will present two posters at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting taking place March 29 – April 3, 2018 in Atlanta, Georgia (Press release, BioThera Solutions, MAR 27, 2019, View Source [SID1234534678]).

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The first poster, entitled "BAT8001, a potent anti-HER2 antibody drug conjugate with a novel uncleavable linker to reduce toxicity for patients with HER2-positive tumor," will highlight Phase I clinical data demonstrating the safety and efficacy of BAT8001 in HER2-positive cancer patients. An abstract of the presentation will be available on AACR (Free AACR Whitepaper) website on the day of the presentation.

Presentation details are as follows:

Session Category: Clinical Trials
Session Title: Phase I Clinical Trials: Part 2
Session Date and Time: Monday, April 1, 2019, 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17
Poster Board Number:
Abstract Number:

10
CT053

The second poster, entitled "Development of a potent Trop-2 antibody-drug conjugate, BAT8003, for the treatment of Trop-2 positive gastric tumors," will present preclinical data that highlight advantages of BAT8003 as a potential treatment for gastric cancer patients. The IND for a Phase I clinical trial evaluating the safety and pharmacokinetics of BAT8003 was approved earlier this year by the China NMPA. Dosing of the first patient in this Phase I clinical trial is expected to occur during April 2019. An abstract of the presentation is currently available on AACR (Free AACR Whitepaper) website.

Presentation details are as follows:

Session Category: Experimental and Molecular Therapeutics
Session Title: Targeted Therapies
Session Date and Time: Wednesday Apr 3, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 14
Poster Board Number:

9

Abstract Number:

4821

Copies of both posters will be made available on the Company’s website after they are presented.

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8001 is currently being evaluated as a single agent in a Phase III metastatic breast cancer trial and in combination with an anti-PD1 antibody in gastric cancer. Both clinical studies are being run in China.

About BAT8003

BAT8003 is an investigational Trop2-ADC being evaluated in multiple tumor types. Trop-2 is a naturally occurring receptor that is overexpressed in many types of cancer, including triple negative breast cancer and gastric cancer. BAT8003 utilizes Bio-Thera Solutions’ proprietary linker-payload combination, Batansine. The antibody component of BAT8003 is engineered for site-specific conjugation to allow for better control of the ADC DAR, providing a more homogenous product. The linker is non-cleavable ensuring superior delivery of the payload to the cancer cells and improving the safety profile of the ADC. BAT8003 is being developed for use as a single agent and in combination with other agents for the treatment of Trop2 positive cancers. A Phase I clinical trial evaluating the pharmacodynamics and safety of BAT8003 will begin dosing patients during April 2019.

On March 27, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies that harness the evolutionary power of the immune system, reported the publication of a proof-of-concept study in Science Translational Medicine entitled "GPRC5D is a target for the immunotherapy of multiple myeloma with rationally designed CAR-T cells (Press release, Eureka Therapeutics, MAR 27, 2019, View Source [SID1234534677])." The study was led by researchers from Eureka, Memorial Sloan Kettering Cancer Center (MSK) and Juno Therapeutics (Juno).

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Antibody-based therapies, including bi-specific antibodies and chimeric antigen receptor (CAR) T-cell therapies targeting B cell maturation antigen (BCMA) for multiple myeloma, have shown promising clinical results, but relapses associated with low-to-negative expression of BCMA have been reported, necessitating additional targets for multiple myeloma.

The orphan G protein-coupled receptor GPRC5D has been previously identified in bone marrow cells in patients with multiple myeloma. However, the protein expression profile of GPRC5D remained elusive. Through immunohistochemical analyses, the study demonstrated that GPRC5D is expressed on malignant bone marrow plasma cells, while normal tissue expression is limited to the hair follicle, an immune-privileged site.

In 83 evaluated primary myeloma marrow samples, 65% of samples have GPRC5D expression above a 50% antigen expression cutoff on CD138+ cells. More importantly, GPRC5D expression on CD138 multiple myeloma cells was independent of BCMA expression, suggesting GPRC5D as an ideal clinical target.

In collaboration with MSK, Eureka developed antibodies targeting GPRC5D using Eureka’s proprietary E-ALPHA discovery platform. These antibodies, together with antibodies targeting BCMA and another undisclosed multiple myeloma target, were licensed by Eureka and MSK to Juno (now Celgene) in 2016 for use in CARs.

In a head-to-head comparison with BCMA-targeted CARs with an identical backbone, GPRC5-targeted CAR-T cells demonstrated efficient antigen-specific cytotoxicity in vitro, as well as comparable effect in inducing tumor regression and extending survival at different dose levels in vivo. The study further showed that tumor escape can be rescued by GPRC5D-targeted CAR T-cells in a model of BCMA-antigen loss mediated relapse.

"The study confirms GPRC5D as a viable target in multiple myeloma," said Eric Smith, M.D., Ph.D., a medical oncologist and the Director of Clinical Translation within the Cellular Therapeutics Center at MSK. "We look forward to moving this study into the clinic, including in relapsed patients after BCMA-targeted therapy."

"Targeting GPRC5D has the potential to improve the durability of response from current bi-specific and T-cell therapies that target only BCMA," said Dr. Cheng Liu, President and Chief Executive Officer at Eureka Therapeutics. "This study reflects our commitment to increasing the long-term clinical benefit for patients with multiple myeloma and other cancers, and we look forward to leveraging our E-ALPHA and ARTEMIS platforms to develop transformational new T-cell therapies that are potentially safer and more effective."

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]).

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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 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.

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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 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and, through our license to Santen Pharmaceutical Co. Ltd., wet age-related macular degeneration, reported that preclinical data from TRC105 and TRC253, as well as Phase 2 clinical data from TRC102, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, to be held from March 29 to April 3, 2019, in Philadelphia, PA (Press release, Tracon Pharmaceuticals, MAR 27, 2019, View Source [SID1234534674]).

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Dr. Mark Schoonderwoerd and colleagues from Leiden University will present a poster featuring data from preclinical studies of TRC105 and PD-1 checkpoint inhibitors. The presentation details are as follows:

Poster Title: Synergistic inhibition of cancer invasion and metastasis by combined anti-PD1-TRC105-mediated Endoglin targeting on cancer-associated fibroblasts and endothelial cells
Abstract Link: View Source!/6812/presentation/3044
Session Category: Combination Approaches to Novel Therapies
Location: Section 12, Poster Board 291/12
Date: Sunday, March 31, 2019
Time: 1:00pm – 5:00pm EDT
Dr. Tammy Bush and colleagues from Janssen Research and Development will present a poster featuring preclinical data from TRC253, a small molecule antagonist of mutant and wild-type androgen receptor. The presentation details are as follows:

Poster Title: Antitumor activity of JNJ-63576253 (TRC253), a small molecule antagonist of F877L mutant and wild-type androgen receptor
Abstract Link: View Source!/6812/presentation/6162
Session Category: Novel Therapeutics and Pathways
Location: Section 14, Poster Board 2179/1
Date: Monday, April 1, 2019
Time: 1:00pm – 5:00pm EDT
Dr. Geraldine Coyne and colleagues from the National Cancer Institute will present a poster featuring data from the Phase 2 clinical trial of TRC102 and Temodar (temozolomide) in subjects with colorectal cancer. The presentation details are as follows:

Poster Title: A Phase II trial of TRC102 (methoxyamine HCl) in combination with temozolomide in patients with relapsed metastatic colorectal carcinoma
Abstract Link: Late-Breaking Abstracts are embargoed until March 29, 2019
Session Category: Late-Breaking Research – Molecular and Cellular Biology/Genetics 2
Location: Section 41, Poster Board LB-293/10
Date: Wednesday, April 3, 2019
Time: 8:00am – 12:00pm EDT
Posters will be available on the company’s website following presentation.

About TRC105 (carotuximab)

TRC105, the oncology formulation of carotuximab, is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in patients with angiosarcoma as well as multiple Phase 1 and Phase 2 clinical trials in other tumor types. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the US and EU. The ophthalmic formulation of TRC105, DE-122, is currently being studied in the randomized Phase 2 AVANTE trial in patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 is currently being studied in a Phase 1/2 clinical trial in prostate cancer. For more information about the clinical trial, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.