On December 3, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT drug candidate for prostate cancer (Press release, Advaxis, DEC 3, 2019, View Source [SID1234551866]).

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"We are pleased to announce continued clinical progress of our ADXS-HOT program," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Results from our ADXS-NEO program provided important proof-of-concept data demonstrating the generation of CD8+ T cells against hotspot mutations. Based on these encouraging results, and the convenient and broadly accessible off-the-shelf approach of our HOT therapies, we are focused on expanding the HOT program to additional cancer-specific trials through various, capital-efficient avenues. In addition, we look forward to reporting immune data from the monotherapy arm of our ongoing Phase 1/2 HOT clinical trial in non-small cell lung cancer (NSCLC) in early 2020."

ADXS-504 is part of the company’s ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates. Advaxis has designed over ten ‘HOT’ drug candidates that are in various stages of development, with the company’s Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers. Advaxis anticipates reporting the immune data from the first dose level of ADXS-503, Part A, in monotherapy, and expects to dose the first patient in Part B, which is studying ADXS-503 in combination with the checkpoint inhibitor pembrolizumab, in early 2020.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofectal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment approach designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

On December 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference (Press release, Oncolytics Biotech, DEC 3, 2019, View Source [SID1234551864]). The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey’s corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 – 5 at the Westin Waterfront Hotel in Boston, MA.

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"Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I’m excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I’m also looking forward to presenting data to our peers that outlines pelareorep’s ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

Presentations

December 4, 1:40 pm ET

Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
Combination therapy with checkpoint blockade in breast cancer.
Adaptive immune activation following IV delivery and the development of a potential biomarker
December 4, 3:10 pm ET

Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

Decide whether OV treatments are most effective when injected directly into the tumour or systemically
Weigh the risks of IT administration with the benefits of a more targeted approach
Consider the views of physicians
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On December 3, 2019 ImmuPharma PLC (LSE:IMM), a specialist drug discovery and development company, is reported that it will be presenting at the Biotech Showcase 2020, to be held between 13–15 January 2020, at the Hilton, San Francisco Union Square (Press release, ImmuPharma, DEC 3, 2019, View Source [SID1234551863]).

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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

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Dr Tim Franklin, Commercial Advisor to ImmuPharma, will be presenting to conference attendees on 14th January 2020 at 10:30am (EST) in room Yosemite C (Ballroom Level). If you are attending the event and would like to meet with Dr Franklin for a one to one meeting, please contact Lisa Baderoon, Head of Investor Relations, who will be able to arrange a meeting: [email protected].

On December 3, 2019 Alphamab Oncology is reported to raise about HK$1.7 billion ($221.1 million) in an IPO on the Hong Kong stock exchange next week in an offering that would value the company at HK$8.7 billion if priced at the midpoint of the proposed range (Press release, BioCentury, DEC 3, 2019, View Source [SID1234551856]).

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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

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The pre-profit company proposed to sell 179.4 million shares at HK$9.10-HK$10.20 on the exchange’s biotech chapter.

The announcement came on the heels of an IPO on the exchange by Pharmaron Beijing Co. Ltd. (Shenzhen:300759; HKSE:03759), which began the year by listing on the Shenzhen exchange and closed it out with a raise of HK$4.6 billion in Hong Kong on Nov. 27.

Alphamab Oncology Ltd. spun out of Suzhou Alphamab Co. Ltd. last year to focus on oncology (see "Alphamab’s Cancer Cash").

The company has eight biologics in development, including four in clinical testing.

About 75% of the financing will support clinical development of KN046, a bispecific mAb targeting CTLA-4 and PD-L1 in Phase Ib/II for various solid tumors; KN026, a bispecific mAb targeting two HER2 epitopes, in Phase I to Phase II testing for solid tumors including breast and gastric cancers; and the Nulojix belatacept biosimilar KN019, which the company plans to take into a Phase II trial in August for rheumatoid arthritis.

Alphamab Oncology plans to submit BLAs for KN046 and KN026 in 3Q21 and 4Q22, respectively.

Morgan Stanley, CLSA and Jefferies are underwriters. If priced at the midpoint, cornerstone investors Matthews Funds, OrbiMed, Greenwoods, MSAL, Lake Bleu Capital, Luye Pharma and Taiking Life would be eligible to purchase 60% of the offering.

Entities associated with founder, Chairman and CEO Ting Xu will hold a 37% post-IPO stake in the company. Xu holds a 51% stake in Suzhou Alphamab, of which he is chairman.

Alphamab Oncology expects to announce the IPO price on Dec. 11 and begin trading Dec. 12.

The exchange’s pre-revenue chapter is showing signs of life after a summer lull, with three biotechs going public since September (see "After Lull, Local Demand Boosts Ascentage")

Pharmaron prices

In its first day of trading Nov. 28, Pharmaron’s stock gained HK$2.75 to HK$42.25 in Hong Kong before dipping to a close of HK$40.45 on Monday.

The Beijing-based company sold 117 million shares at HK$39.50 in the deal, which was underwritten by Goldman Sachs, CLSA, Orient Securities and China Renaissance. The dual listing valued the CRO at HK$30.7 billion.

Both of the Hong Kong IPO’s tranches were oversubscribed. The company initially offered to sell 11.6 million shares to Hong Kong investors and 104.9 million shares to the international community. The final IPO comprised 58.3 million shares to local investors and 58.3 million shares to international investors. Pharmaron received local investor applications for 1.3 billion shares, which prompted the international share re-allotment.

Cornerstone investors China Structural Reform Fund, Lake Bleu Prime Healthcare Master Fund, OrbiMed, Worldwide Healthcare Trust, Athos Asia Event Driven Master Fund and Oaktree purchased about 31.7 million shares of the offering

The company, which has operations in China, the U.S. and the U.K., provides laboratory, clinical development and CMC services to biotech start-ups and global pharma.

Pharmaron reported net profits of RMB156.7 million in 1H19, up 30% from RMB120.4 million in the same period last year. In 2018, North American, European and Chinese customers contributed 62%, 22% and 10% of the company’s revenues, respectively.

The company plans to use around 30% of the funding to expand its capabilities in China in response to increasing demand for its laboratory and CMC services. Pharmaron will allocate around 10% of the funds to expand its operations in the U.S and U.K., 20% to establish a biologics R&D platform and another 15% for acquisition of CRO and CMO companies in U.S., Europe, Japan or China.

In May, the company completed a series of equity purchases in Nanjing-based clinical CRO CR Medicon, gaining a 55.6% stake in return for RMB150 million in cash.

Targets: CTLA-4 (CTLA4; CD152) – Cytotoxic T-lymphocyte associated protein 4; HER2 (EGFR2; ErbB2; neu) – Epidermal growth factor receptor 2; PD-1 (PDCD1; CD279) – Programmed cell death 1

On December 3, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the presentation of new data in acute myeloid leukemia (AML) at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place Dec. 7-10 in Orlando, Fla (Press release, Astellas, DEC 3, 2019, View Source [SID1234551828]).

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Seven abstracts sponsored by Astellas focus on patients with relapsed (disease that has returned) or refractory (resistant to treatment) AML with a FLT3 mutation (FLT3mut+). The abstracts include new findings from the Phase 3 ADMIRAL trial – an oral presentation on emerging mutations in patients who develop resistance after an initial response to XOSPATA and two poster presentations focused on patient-reported outcomes – as well as data on cost-effectiveness, FLT3 testing and treatment patterns, and venetoclax combination therapy.

"Astellas is committed to elevating care in hard-to-treat cancers, and since the approval of XOSPATA one year ago, we have continued expanding our research program to better understand and address unmet medical needs of patients with FLT3 mutation-positive AML," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.

Oral Presentation:

Title: Emerging Mutations at Relapse in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myeloid Leukemia Who Received Gilteritinib Therapy in the Phase 3 ADMIRAL Trial (Abstract 14)

Presenter: Catherine C. Smith, M.D., Division of Hematology and Blood and Marrow Transplantation, University of California San Francisco

Session Date/Time: Saturday, Dec. 7, 7:45 a.m. EST
Location: Orange County Convention Center, W304 Level 3

Key Abstracts Presented During Poster Sessions or Available Online:

Title: The Relationship between Hospitalization and Patient-Reported Outcomes (PROs) in Patients with FLT3-Mutated (FLT3mut+) Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML): Results from the Phase 3 ADMIRAL Study (Abstract 1332)

Lead Author: Ellen K. Ritchie, M.D., Weill Cornell Medicine, New York

Session Date/Time: Saturday, Dec. 7, 5:30-7:30 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: The Relationship between Transplant Status and Patient-Reported Outcomes in Patients with FLT3-Mutated Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML): Results from the Phase 3 ADMIRAL Study (Abstract 3850)

Lead Author: David Cella, Ph.D., Northwestern University, Feinberg School of Medicine, Chicago

Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: Cost-Effectiveness Analysis of Gilteritinib Versus Salvage Chemotherapy (SC) for the Treatment of Relapsed or Refractory (R/R) FLT3-Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) (Abstract 3859)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: Venetoclax in Combination with Gilteritinib in Patients with Relapsed/Refractory Acute Myeloid Leukemia: A Phase 1b Study (Abstract 3910) (Supported by AbbVie, Astellas and Genentech)

Lead Author: Alexander E. Perl, M.D., Abramson Cancer Center of the University of Pennsylvania, Philadelphia.

Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: STREAMLINE – Study of Relapse or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML) Using Electronic Medical Records (EMR): First Analysis from a Multicenter, Retrospective Cohort Study (Abstract 5082)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Title: Cost-Effectiveness Analysis of Gilteritinib Versus Best Supportive Care (BSC) for the Treatment of Relapsed or Refractory (R/R) FLT3 Mutation-Positive (FLT3mut+) Acute Myeloid Leukemia (AML) (Abstract 5085)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Astellas-Supported Satellite Symposia
Astellas will support the following pre-meeting Friday Satellite Symposia

Title: Data + Perspectives: Exploring the Role of Novel Agents and Emerging Strategies in the Management of Acute Myeloid Leukemia

Session Date/Time: Friday, Dec. 6, 7-11 a.m. EST
Location: Hilton Orlando, Orange Ballroom (Lower Level)
Title: Treating Acute Myeloid Leukemia: Case Challenges and Emerging Therapies

Session Date/Time: Friday, Dec. 6, 6-10 p.m. EST
Location: Hyatt Regency Orlando, Plaza International D-F