On May 24, 2018 BioCryst Pharmaceuticals, Inc. ("BioCryst") (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), reported that they will be presenting at the Jefferies 2018 Global Healthcare Conference on Thursday, June 7, 2018 at 8:30 A.M. E.T (Press release, BioCryst Pharmaceuticalsa, MAY 24, 2018, View Source [SID1234526875]).

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!

Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com and in the Investors and Media section of Idera’s website at View Source

On May 24, 2018 AstraZeneca and MedImmune,reported its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 1-5 June 2018, with an expanded portfolio in Oncology (Press release, AstraZeneca, MAY 24, 2018, View Source [SID1234526873]).

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!

Having achieved 16 regulatory approvals across major markets (US, EU, Japan and China), AstraZeneca will be sharing its R&D momentum at ASCO (Free ASCO Whitepaper) with seven "Best of ASCO (Free ASCO Whitepaper)" presentations and 14 oral presentations from a total of 91 accepted abstracts. These presentations will showcase AstraZeneca’s four scientific platforms: Immuno-Oncology (IO), DNA Damage Response (DDR), Anti-Drug Conjugates (ADCs), and Tumour Drivers and Resistance.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit said: "In just four years, AstraZeneca has launched four innovative medicines to treat serious cancers: Lynparza in ovarian and metastatic breast cancers, Imfinzi in bladder cancer and unresectable stage III non-small cell lung cancer, Tagrisso in epidermal growth factor receptor-mutated non-small cell lung cancer and Calquence as the first haematology medicine in mantle cell lymphoma. At this year’s ASCO (Free ASCO Whitepaper) meeting, the Company will showcase a strong portfolio, a rich pipeline and a focus on impactful industry partnerships which will fuel continued advances in oncology and haematology."

Lynparza: Study 08 data in prostate cancer

An oral presentation of Study 08, evaluating Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer, will highlight the potential of PARP inhibition beyond ovarian and metastatic breast cancers, regardless of homologous recombination repair mutation status (Abstract #5003). Lynparza is being jointly developed and commercialised by AstraZeneca and MSD, known as Merck in the US and Canada.

Progress in haematology

Response rates and safety data from the Phase III (‘1053’) multicentre trial of the investigational ADC moxetumomab pasudotox in relapsed or refractory hairy cell leukaemia (HCL) patients (Abstract #7004) will be presented. The FDA has granted the moxetumomab pasudotox Biologics License Application Priority Review status; if approved, it will be a first-in-class treatment for patients with relapsed refractory HCL.

New data will also be presented for Calquence (acalabrutinib), a selective Bruton’s tyrosine kinase (BTK) inhibitor and AstraZeneca’s first medicine approved in haematology. Findings will be shared in an oral presentation of the Phase II clinical trial (WM-001) of patients with treatment-naïve, relapsed or refractory Waldenström macroglobulinemia (Abstract #7501).

Investigator-led studies highlight the value of collaboration in new areas of unmet need

AstraZeneca’s broad network of industry and academic partners is broadening exploration of the company’s pipeline into additional tumour types where unmet patient needs remain. The US National Cancer Institute (NCI), a division of the US National Institutes of Health (NIH), will present Phase II data from the ongoing SPRINT trial evaluating MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886), a potential new medicine within the AstraZeneca and MSD partnership, in paediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (Abstract #10503). The SPRINT abstract was awarded the 2018 Conquer Cancer Foundation of ASCO (Free ASCO Whitepaper)/Bradley Stuart Beller Special Merit Award.

Additional investigator-sponsored research includes a late-breaking oral presentation on the Phase II GeparNuevo trial of neoadjuvant treatment with Imfinzi (durvalumab) in triple-negative breast cancer (TNBC). AstraZeneca initiated this study alongside the German Breast Group and Celgene (Abstract #104), and the DREAM Phase II trial of Imfinzi in combination with chemotherapy in first-line mesothelioma (Abstract #8503).

Early pipeline powered by combinations

AstraZeneca’s early-stage pipeline will also be showcased at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting with 39 abstracts highlighting its breadth and depth.

In an oral presentation, data from PAKT, a Phase II trial of capivasertib (AZD5363), a highly selective, oral, AKT inhibitor with paclitaxel, demonstrate the impact of this combination on progression free survival and overall survival in previously untreated, metastatic TNBC (Abstract #1007). This trial was sponsored and led by Queen Mary University London and the Bart’s Cancer Institute.

Additionally, progress against PD(L)-1 insensitive tumours will be highlighted with presentations of two first-in-human studies from the early IO pipeline; the investigational anti-CD73 human monoclonal antibody oleclumab alone or in combination with Imfinzi in advanced pancreatic cancer and colorectal cancer (Abstract #4123), and monalizumab (NKG2A) in combination with Imfinzi in patients with metastatic microsatellite-stable colorectal cancer (Abstract #3540).

Key AstraZeneca/MedImmune presentations at ASCO (Free ASCO Whitepaper) 2018
Lead author

Abstract title

Presentation details

DNA Damage Response

Clarke N

Olaparib combined with abiraterone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): a randomized Phase II trial

Oral

Genitourinary (Prostate) Cancer

Monday 4th June, 15:00-18:00

Presentation Time: 16:00-16:12

Location: Hall D1

Abstract #5003

Westin SN

Phase 1 trial of olaparib (PARP inhibitor) and vistusertib (mTORC 1/2 inhibitor) in recurrent endometrial, ovarian and triple-negative breast cancer

Oral

Gynecologic Cancer

Tuesday 5th June, 10:57-11:09

Location: S100a

Abstract #5504

Johnson M

A phase I, open-label, multicenter dose escalation study to assess the safety, tolerability, and pharmacokinetics of AZD2811 nanoparticle in patients with advanced solid tumors

Poster

Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics

Monday 4th June, 08:00-11:30

Abstract #2592

Poster #418

Heymach J

An open-label, multidrug, biomarker-directed, multicentre phase II umbrella study in patients with non-small cell lung cancer, who progressed on an anti-PD-1/PD-L1 containing therapy (HUDSON)

Poster

Developmental Therapeutics – Immunotherapy

Monday 4th June, 08:00-11:30

Location: Hall A

Abstract #TPS3120

Poster #324b

Immuno-Oncology

Loibl S

Randomized Phase II neoadjuvant study (GeparNuevo) to investigate the addition of durvalumab to a taxane-anthracycline containing chemotherapy in triple-negative breast cancer (TNBC)

Oral

Compelling Combinations: Raising the Bar With Immunotherapy

Sunday 3rd June, 09:45-11:15

Presentation Time: 09:57-10:09

Location: Hall D1

Abstract #104

Nowak AK

DREAM: A phase II study of durvalumab with first line chemotherapy in mesothelioma—First results.

Oral

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Monday 4th June, 08:00-11:00

Presentation Time: 09:00-09:12

Location: Hall B1

Abstract #8503

Garassino MC

Durvalumab in ≥3rd-line advanced NSCLC: updated results from the Phase 2 ATLANTIC study

Poster

Lung Cancer—Non-Small Cell Metastatic

Sunday 3rd June, 08:00-11:30

Location: Hall A

Abstract #9058

Poster #381

Segal NH

First-in-human dose escalation of monalizumab plus durvalumab, with expansion in patients with metastatic microsatellite-stable colorectal cancer

Poster

Gastrointestinal (Colorectal) Cancer

Sunday 3rd June, 08:00-11:30

Location: Hall A

Abstract #3540

Poster #33

Overman M

Safety, Efficacy and Pharmacodynamics (PD) of MEDI9447 (oleclumab) Alone or in Combination with Durvalumab in Advanced Pancreatic Cancer (panc) or Colorectal Cancer (CRC)

Poster

Gastrointestinal (Noncolorectal) Cancer

Sunday 3rd June, 08:00-11:30

Location: Hall A

Abstract #4123

Poster #312

Tumour Drivers & Resistance

Gross A

SPRINT: Phase II study of the MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886) in children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN)

Oral

Pediatric Oncology I

Saturday 2nd June, 15:00-18:00

Presentation Time: 16:00-16:12

Location: S504

Abstract #10503

Owen R

Acalabrutinib in patients (pts) with Waldenström macroglobulinemia (WM)

Oral

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sunday 3rd June, 09:45-12:45

Presentation Time: 09:57-10:09

Abstract #7501

Schmid P

AZD5363 plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (PAKT): a randomised, double-blind, placebo-controlled, phase II trial

Oral

Breast Cancer – Metastatic

Sunday 3rd June, 08:00-11:00

Presentation Time: 10:12-10:24

Location: Hall D2

Abstract #1007

Antibody-Drug Conjugates

Kreitman R

Moxetumomab pasudotox in heavily pretreated patients with relapsed/refractory hairy cell leukemia: results of a pivotal international study

Oral

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Saturday 2nd June, 15:00-18:00

Discussion Time: 16:12-16:24

Location: E450

Abstract #7004

On May 23, 2018 mAbxience, a company specialized in the research, development, manufacturing and global commercialization of monoclonal antibody biosimilars -part of the Insud Pharma Group- and Amneal Pharmaceuticals, Inc., an integrated specialty pharmaceutical company powered by a robust U.S. generics business, have signed an exclusive licensing and supply agreement in the United States for mAbxience´s bevacizumab, a biosimilar candidate for Avastin (Press release, mAbxience, MAY 23, 2018, View Source [SID1234611988]).

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!

Under the milestone based commercial agreement mAbxience will lead product, clinical development and subsequent manufacture while Amneal will guide the product through regulatory approval and have exclusive commercialisation rights in the United States.

"We are very proud to deepen our partnership with Amneal with the bevacizumab biosimilar agreement. We are passionate about increasing access and affordability of biologics in all countries around the world and this latest agreement with Amneal will be an important contribution to public health in the United States," said Emmanuelle Lepine, General Manager of mAbxience.

mAbxience is progressing its international expansion, and recently established partnerships in Europe and Australia for its bevacizumab biosimilar. Building long lasting partnerships is central to the company´s business philosophy. Biosimilars bring patients a safe, effective, efficient and affordable treatment option, which contributes to the sustainability of healthcare systems worldwide. More than 10,000 patients have now been treated with a mAbxience biosimilar.

On May 23, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported the closing of a global offering of 2,070,000 ordinary shares to purchasers in the United States, Europe and certain countries outside the United States and Europe, comprised of 568,500 ordinary shares in the form of American Depositary Shares (ADSs) at a price per ADS of $26.28, and 1,501,500 ordinary shares at a price per share of € 22.29 (the "global offering") (Press release, Celyad, MAY 23, 2018, View Source [SID1234532515]). Each ADS represents the right to receive one ordinary share. The number of ADSs and ordinary shares sold in the global offering reflects the full exercise of the underwriters’ option to purchase additional shares.

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 gross proceeds to Celyad from the global offering amounted to approximately $54.4 million (approximately €46.1 million), before deducting underwriting commissions and estimated offering expenses.

Celyad’s ADSs are currently listed on the NASDAQ Global Market under the symbol "CYAD" and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris.

Wells Fargo Securities, LLC and Bryan, Garnier & Co. acted as joint bookrunning managers for the offering. Bank Degroof Petercam NV acted as a co-manager for the private placement and LifeSci Capital LLC acted as a co-manager for the global offering. Kempen & Co NV was Celyad’s advisor in connection with the offering. No stabilization activity was undertaken in connection with the global 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 May 17, 2018 relating to and describing the terms of the offering was filed with the SEC on May 18, 2018 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities can be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or email a request to [email protected] or Bryan, Garnier & Co., 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].

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

On May 23, 2018 INmune Bio, Inc., an immunotherapy company developing therapies that reprogram the patient’s innate immune system to treat cancer, reported that it has initiated a Phase 1 clinical trial of its drug candidate INB03 in patients with advanced solid tumors (Press release, INmune Bio, MAY 23, 2018, View Source [SID1234529236]). INB03 is a novel innate immune system checkpoint inhibitor that targets MDSCs, cells of the innate immune system which create an immunosuppressive shield around the tumor and inhibit the patient’s immune system from attacking the cancer. By preventing the proliferation and function of MDSC, the company believes patients will have a stronger immune response to their tumor and may respond better to other cancer treatments including immunotherapy such as checkpoint inhibitors (CPI).

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!

"MDSC are a high priority target for the next advance in immuno-oncology," said RJ Tesi, MD, CEO and co-founder of INmune Bio. "INB03 decreases proliferation and function of MDSC. By eliminating the immunosuppressive effects of MDSC in the tumor microenvironment, we hope to provide therapeutic options for patients who are resistant to immunotherapy because of elevated levels of MDSC. This Phase I trial is the first step to meeting our goal of improving the response to CPI in patients who fail therapy due to increased MDSC in their tumor."

"In less than three years, INmune Bio has developed two immunotherapy platforms, INKmune and INB03 from bench-to-bedside. Both programs will enter the clinic this year," said Tim Schroeder, CEO of CTI Clinical Trials and Consulting Services (CTI) and an INmune Bio board member. "The company has remained focused on reprograming the patient’s innate immune system to better attack their cancer. By targeting the oft-ignored innate immune system, INmune Bio has a chance to make a difference in patients’ lives."

CTI Clinical Trial & Consulting Services Australia Pty Ltd., a subsidiary of CTI, is the CRO managing the INB03 Phase I clinical trial.

MDSCs are myeloid cells that appear in patients with cancer and other chronic inflammatory diseases. In patients with cancer, the number of MDSC in the blood and/or tumor microenvironment predict the severity of the cancer and prognosis. The more MDSC, the worse the prognosis. MDSC are recognized as a risk factor in predicting failure to immunotherapy including CPI. By eliminating MDSC, INB03 should allow an improved response to immunotherapy as well as an increased ability of the patient’s own immune system to attack the tumor. The INB03 Phase I trial uses biomarkers to select patients who should benefit from treatment. There are currently no approved drugs that have been developed to target MDSC.