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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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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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

On December 2, 2019 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported the U.S. launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility (Press release, Mylan, DEC 2, 2019, View Source [SID1234565290]). Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.

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Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila, a biosimilar to Neulasta. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products.

Mylan President Rajiv Malik commented: "As one of the largest suppliers of oncology medicines in the U.S., we are proud to offer Ogivri, biosimilar trastuzumab, in both the 420mg and 150mg strengths and help increase more affordable access to this important treatment option for breast and gastric cancer patients. With regulatory approval for our biosimilar trastuzumab in more than 80 countries worldwide, we are bringing vast global biosimilars experience to the U.S. and look forward to continuing our work with all stakeholders in the healthcare system to reduce costs, improve access and advance care. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients.

Malik continued, "Today’s launch has been achieved through years of hard work as a result of our successful collaboration with Biocon. Our early settlement and license with Roche to bring this product to market allows us to launch Ogivri without legal risk."

Dr. Christiane Hamacher, CEO, Biocon Biologics, said: "The U.S. launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S. As a global frontrunner in biosimilars, Biocon Biologics is committed to fulfil unmet patient needs by providing greater affordability for enhanced patient access. We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$ 1bn by FY22.

"Ogivri is the second biosimilar from our partnered portfolio being commercialized by Mylan in the U.S. Last year, through the launch of Fulphila we helped in expanding patient access to biosimilar pegfilgrastim," she added.

FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. Long-term results of the landmark HERITAGE study including overall survival data at 36 months were presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Dr. Hope S. Rugo, professor of medicine at the University of California, San Francisco, and lead author of the HERITAGE study commented: "Trastuzumab-dkst (Ogivri) has many firsts to its credit. It was one of the first biosimilar oncology products to get a unanimous approval vote at an ODAC meeting, and it was the first biosimilar study to be published in the Journal of the American Medical Association. In this context, the HERITAGE study had a unique trial design that not only evaluated objective response rate at week 24 as its primary endpoint but also assessed key endpoints including progression-free survival rate and overall survival at 36 months. The concordant efficacy data across all three endpoints conclusively demonstrated that Ogivri was similar to Herceptin, and patients without progression now continue on Ogivri as maintenance therapy. We are pleased that patients with HER2-positive cancers now have an additional treatment option backed by robust safety and efficacy data, including long-term 36-month data. The worldwide introduction of this agent has already improved access to trastuzumab."

Ogivri is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in the U.S. and the second FDA-approved biosimilar through this collaboration to support cancer patients. Mylan and Biocon launched the world’s first biosimilar trastuzumab in India in 2014. Today, Mylan has one of the largest and most diverse biosimilars portfolios, with 20 biosimilar and insulin analog products in development or on the market.

A full suite of patient services for Ogivri will be offered through the Mylan Advocate program.

About the HERITAGE Study

HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly known as MYL-1401O) versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either trastuzumab-dkst or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include progression free survival, overall survival, and safety. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for trastuzumab-dkst versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).The primary endpoint has previously been reported: the overall response rate in patients with HER2-positive metastatic breast cancer at week 24 was equivalent between the trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA. 2017;317:37-47).

Bringing Access to Biologics

Biologic drugs, like Herceptin, represent a large and increasing portion of the overall prescription drug market. They are important in the treatment of many chronic and acute diseases, including cancer. However, these drugs can cost far more than traditional prescription drugs, and their cost can prohibit access. One study found that nearly 40% of women were at least somewhat worried about finances because of their breast cancer treatment. Biologics now account for about 40% of all U.S. drug spending and 70% of spending growth from 2010 to 2015.

Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It’s estimated that the introduction of biosimilars in the U.S. could save the nation’s healthcare system up to $150 billion between 2017 and 2027.

Ogivri will be launched at a competitive discount for customers to help ensure access and increase treatment options for patients.

About the Biocon and Mylan Partnership

Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar trastuzumab is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

On December 2, 2019 RhoVac AB ("RhoVac") reported that the collaboration agreement with Colpman Consulting Ltd ("Colpman Ltd") has been terminated by mutual agreement, in the light of RhoVac’s aim to secure an agreement with a partner after completion of the current clinical phase IIb study (Press release, RhoVac, DEC 2, 2019, View Source [SID1234555926]).

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The agreement that RhoVac signed with Colpman Ltd in March 2018 to find a development partner for RV001 has been formally terminated by mutual agreement. In the future, RhoVac’s CEO, Anders Månsson, will lead the company’s business development efforts, which aim to secure an agreement with a partner that can further develop the RV001 project in clinical phase III in prostate cancer, and also in other potential metastatic cancer indications, and subsequently launch the product.

CEO Anders Månsson comments:

"Since I started at RhoVac, I have been involved in the work and the dialogues that Colpman Ltd has initiated on RhoVac’s behalf. Colpman Ltd has done a good job, but as Rhovac chose to proceed with the value-adding clinical phase IIb study in-house, both the time perspective and the offer to our potential partners have changed. RV001 is now a project that, after completion of the current clinical phase IIb study in prostate cancer, can be taken directly into phase III, the last stage of development before market approval. With the great potential that RV001 can have for treating metastatic prostate cancer specifically – and metastatic cancer in general – I look forward to further intensifying our own business development efforts as we approach the end of the ongoing clinical phase IIb study."