1stOncology™: Cancer Intelligence Service – Page 8794 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Phase 1b Trial of Oasmia’s Docetaxel Micellar in Advanced Prostate Cancer is Granted Ethical Committee Approval and can be Initiated

On April 21, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that Swissmedic and Swissethics approval has been received to initiate a Phase 1b clinical trial with the Swiss Group for Clinical Cancer Research (SAKK) of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer (Press release, Oasmia, APR 21, 2021, View Source [SID1234578283]). Trial initiation is expected to commence in the first half of 2021.

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!

Bone metastases in advanced prostate cancer are common and cause bone fragility. During the long course of the disease, corticosteroids are used, and corticosteroid premedication is mandatory with solvent-based docetaxel. High-dose steroid use is known to change the bone metabolism and further increase the fragility risk in these patients. Bone fractures impact patients’ quality of life and may also reduce survival time.

Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication while providing an effective treatment option. Docetaxel is approved for a wide range of solid malignancies and is a standard of care for advanced prostate cancer.

The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver and renal function. Using a standard Phase I trial design, the primary objective of this study is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC. The secondary objectives are to evaluate the safety of Docetaxel micellar, to assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics of Docetaxel micellar in this population. The treatment will be a 21-day cycle of one of three dose levels of Docetaxel micellar until progression or occurrence of unacceptable toxicity or withdrawal, for a maximum of 10 cycles.

Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.

SAKK is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer.

Professor Markus Jörger, President Project Group Developmental Therapeutics, at
SAKK commented: "We approached Oasmia about collaborating on a clinical trial in advanced prostate cancer using Docetaxel micellar as we saw the potential to remove pre-treatment with corticosteroids, thereby greatly reducing the incidence of adverse events such as bone fractures and other skeletal related events. We are optimistic that Docetaxel micellar could provide a much-needed treatment option for patients with advanced prostate cancer."

Commenting on the clinical trial approval, Heidi B. Ramstad, M.D., Chief Medical Officer of Oasmia, said: "SAKK approached us to collaborate on this clinical trial and we are delighted to be partnering with such a prestigious organization in oncology with a distinguished history in clinical trials. We believe that Docetaxel micellar could provide a new treatment option for patients with advanced prostate cancer, without the mandatory steroid use that is necessary with existing, solvent-based docetaxel formulations."

Roche reports solid results in the first quarter of 2021

On April 21, 2021 Roche reported that solid results in the first quarter of 2021 (Press release, Hoffmann-La Roche, APR 21, 2021, View Source [SID1234578282])

Group sales increase 3%1 at constant exchange rates (CER); 1% decline in Swiss francs, as a result of the appreciation of the Swiss franc
Pharmaceuticals Division sales:
Continued strong growth of new medicines (+20%)
As expected, significant impact from biosimilars (CHF -1.6 billion)
Base effect from the strong first quarter 2020 (negative impact of the pandemic only since April 2020)
Overall, this results in a 9% decline in sales.
Diagnostics Division sales:
All businesses contribute to very strong growth of 55%
Roche’s contributions to the fight against the COVID-19 pandemic in the first quarter:
SARS-CoV-2 Rapid Antigen Test Nasal to quickly identify people with the highest risk to be infectious (using simple nasal swabs) receives CE mark and special approvals for self-testing in several countries
Research-use cobas SARS-CoV-2 Variant Set 1 Test launched to help monitor coronavirus mutations
Continued ramp-up of production capacity for COVID-19-related diagnostics and medicines
Partnership with Regeneron: Antibody combination casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. the US, Germany, Italy, France and Switzerland
Positive results of phase III studies in both COVID-19 prevention (reduction of symptomatic infections by 81%) and treatment (reduction of hospitalisation or death by 70%)
Positive phase III results for Tecentriq in early lung cancer and for eye medicine faricimab
Important approvals for medicines in the first quarter:
USA: Actemra/RoActemra for a rare lung disease; Xolair as a pre-filled syringe (eg, allergic asthma)
Europe: Evrysdi for spinal muscular atrophy
Roche signs definitive merger agreement with GenMark Diagnostics
Outlook for 2021 confirmed
Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said: "In 2021, Roche remains strongly committed to the fight against COVID-19. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines. Our broad product pipeline keeps making good progress. I am particularly pleased about the highly encouraging study results of our immunotherapy Tecentriq in early lung cancer and of faricimab in ophthalmology. The upcoming acquisition of GenMark underlines our commitment to help control infectious diseases and antibiotic resistance. Based on the results of the first quarter of 2021, we confirm the outlook for the full year."

Outlook confirmed for 2021
Despite the continued strong impact of biosimilars, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.

Group results
In the first quarter of the year, Group sales rose 3% (-1% in CHF) to CHF 14.9 billion. The appreciation of the Swiss franc against many currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, mainly because of the continued biosimilars competition and the COVID-19 pandemic. As expected, the first quarter of 2021 was particularly challenging due to base effects, as the pandemic only started to have a significant business impact at Roche as of April 2020.

The impact of biosimilars on sales of the established cancer medicines MabThera/Rituxan, Avastin and Herceptin remained significant (combined sales reduction of CHF 1.6 billion), especially in the US.

Moreover, the pandemic continued to have a negative impact overall on the division’s sales, especially for medicines where regular visits to hospitals or health practices are needed (ie, for infusions). This was partly compensated by additional sales of medicines used to treat COVID-19 (Actemra/RoActemra +22%, mostly for treating patients with severe COVID-19-associated pneumonia2, plus the recently launched antibody combination casirivimab/imdevimab).

The new medicines (launched since 20123) grew by 20% (or CHF +880 million) and generated sales of CHF 5.2 billion. Overall, demand continued to grow encouragingly, though here too the impact of the lower number of doctor’s visits was clearly noticeable.

In the United States, sales decreased by 14%, as a result of the continued competition from biosimilars for the above mentioned cancer medicines (combined CHF -1.0 billion). This decline was partially compensated for by the new products (mainly Evrysdi, Ocrevus, Hemlibra and Tecentriq) and Actemra/RoActemra for COVID-19-associated pneumonia.

In Europe, sales decreased by 6%, as demand for the new products (including the antibody combination casirivimab/imdevimab) was only partly able to offset the impact of lower sales for the established cancer medicines (mainly Avastin) and impacts of the COVID-19 pandemic.

In Japan, sales decreased by 7%. This decline was mainly driven by the osteoporosis medicine Edirol and the competition from biosimilars. This was partially offset by sales of cancer immunotherapy Tecentriq.

In the International region, sales were stable. The impact of biosimilars was compensated by new products (Perjeta, Tecentriq and Ocrevus) and COVID-19 related Actemra/RoActemra sales.

The Diagnostics Division reported very strong sales growth of 55% to CHF 4.3 billion, mainly due to Roche’s comprehensive and growing portfolio of COVID-19 tests. The Point of Care and Molecular Lab businesses made the largest contributions (+281% and +86%, respectively) with COVID-19 testing.

Routine diagnostic testing, which was also greatly affected by the COVID-19 pandemic during 2020, recorded strong growth.

Additional product launches in the first quarter, such as a research-use PCR test to help monitor SARS-CoV-2 mutations, further strengthened Roche’s position as the world’s leading supplier of COVID-19 tests.

All regions reported very strong sales growth: EMEA4 and Asia-Pacific (both +62%), North America (+34%) and Latin America (+71%).

In March, Roche signed a definitive merger agreement with GenMark Diagnostics for approx. USD 1.8 billion5. Acquiring GenMark will give Roche access to a novel technology that can test a wide range of pathogens with one patient sample. It will broaden Roche’s molecular lab portfolio, including tests for COVID-19. The transaction is expected to close in the second quarter of 2021.

Marketing Authorization Application for Luye Pharma’s Bevacizumab Injection Accepted in China

On April 20, 2021 Luye Pharma Group reported that the marketing authorization application for the company’s oncology product, LY01008 (Bevacizumab injection), has been accepted by the China Center for Drug Evaluation of National Medical Products Administration (Press release, Luye Pharma, APR 20, 2021, View Source [SID1234595091]). LY01008 is a biosimilar of Avastin indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer .

A leading anti-angiogenic oncology drug, Bevacizumab is a standard therapy recommended by global guidelines for treating multiple malignant cancers and also ranks as one of the top 10 best-selling drugs in the world. According to public financial reports, Avastin achieved sales of 7.07 billion Swiss francs globally in 2019, while according to IQVIA its 2019 sales in China were RMB2.88 billion.

The application for LY01008 was based on clinical data generated from two clinical comparative studies with Avastin, the first a pharmacokinetics ("PK") study in healthy subjects, the second a comparative study of efficacy and safety in metastatic or recurrent non-squamous non-small-cell lung cancer patients. Both studies met pre-defined primary endpoints, demonstrating that LY01008 and Avastin are similar in terms of PK and equivalent in efficacy.

LY01008 is indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. Patient numbers show that lung cancer and colorectal cancer are the most common and the third most common cancers in China. There were about 774,000 new lung cancer cases in China in 2018. Non-small-cell lung cancer accounts for approximately 85% of all lung cancers. Colorectal cancer is the third most common cancer in China after lung cancer and gastric cancer, with 429,000 estimated new cases and 281,000 deaths in 2018. Due to the huge and rapidly increasing number of patients, medications available to treat this disease rank far short of those required.

LY01008 has stolen a march on the competition by filing the marketing authorization application in China. With an expected increase in market players to come, the size of the market for the biosimilars of Bevacizumab will grow steadily in China—this will also help to alleviate the financial pressure on patients. According to a report by Frost & Sullivan , with the ongoing launch of biosimilars and the use of Bevacizumab in combination with other drugs, the size of the Chinese market for Bevacizumab is expected to reach RMB 17.7 billion by 2030.

As a broad-spectrum monoclonal anticancer drug, Bevacizumab has a unique advantage when being used in combination with other drugs. It can be used in combination with paclitaxel-based chemotherapy drugs including paclitaxel liposome, and multiple related indications have been approved in China and abroad. A Luye Pharma Group management representative said: "We will actively drive the launch and commercialization of LY01008. The company will employ its strength in marketing and its wide market coverage in oncology therapy to support the future launch of LY01008, and build a powerful synergy with existing products."

In addition to LY01008, Luye Pharma also has a series of antibody drugs under development, including both biosimilars and innovative biological drugs. In China, LY06006 (a biosimilar of Prolia) is under Phase III clinical trials, and both LY09004 (a biosimilar of Eylea) and LY01011 (a biosimilar of Xgeva) are under Phase I clinical trials. In addition, Luye Pharma is also using its in-house antibody development platforms such as the "human antibody transgenic mouse" and collaborating with multiple cutting-edge overseas biotech companies to develop the next-generation innovative antibodies in immuno-oncology and increase the pipeline and supply of new biologics. Currently, Luye Pharma has established a complete industry chain covering R&D, manufacturing and commercialization in the biopharmaceutical field.

Zai Lab Announces Pricing of Public Offering of American Depositary Shares and Ordinary Shares

On April 20, 2021 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported the pricing of its underwritten public offering of 4,776,000 American depositary shares ("ADSs"), each representing one ordinary share of the Company, at a price of US$150.00 per ADS, and 224,000 ordinary shares, at a price of HK$1164.20 per ordinary share, which will be settled in Hong Kong dollars, based upon each ADS representing one ordinary share and an exchange rate of HK$7.7613 to US$1.00, the spot rate of exchange at the time of pricing (Press release, Zai Laboratory, APR 20, 2021, View Source,(%E2%80%9CADSs%E2%80%9D)%2C%20each [SID1234578770]).

The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately US$750 million. Subject to customary closing conditions, the underwriters expect to deliver the ADSs against payment to the purchasers on or about April 23, 2021, on a "T+2" basis, and to deliver the ordinary shares against payment therefor through the facilities of the Central Clearing and Settlement System on or about April 28, 2021, on a "T+5" basis. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 716,400 ADSs at the public offering price, less underwriting discounts and commissions, which purchase will be settled only in ADSs.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs.

The ADSs and ordinary shares are offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2021.

The offering is being made only by means of a prospectus supplement and an accompanying prospectus included in Form-S-3ASR. The registration statement on Form S-3ASR and the prospectus supplement are available at the SEC’s website at: View Source Copies of the prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at [email protected], (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected], (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at [email protected], (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at [email protected].

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

SHINE, Phoenix merger focused on advancing fusion technology

On April 20, 2021 SHINE Medical Technologies LLC and Phoenix LLC reported that the companies have completed a merger under which Phoenix has become a wholly owned subsidiary of SHINE (Press release, Shine Medical Technologies, APR 20, 2021, View Source;pk_kwd=shine-phoenix-merger-focused-on-advancing-fusion-technology [SID1234578280]).

SHINE is a next-generation nuclear technology company focused on unlocking the power of fusion technologies to benefit the planet and humankind. The company’s goal is to deliver on the long-term promise of clean fusion energy by advancing fusion technology starting with the commercialization of medical isotopes. Phoenix designs and manufactures the world’s strongest steady-state fusion neutron generators used for advanced industrial imaging and other applications for improving safety and quality in the aerospace, defense, medical and energy sectors.

The combined company represents the first two phases of the long-term vision of Greg Piefer, the founder of both companies, for producing clean energy from fusion (see "SHINE’s Four-Phase Progression to Clean Energy Production" below). The goal of each phase of SHINE’s approach is to build additional capacity and capability, and deepen scientific understanding of fusion technology as it progresses to clean fusion energy production. Each step through the four phases is expected to provide further proof of the technology’s robustness, a foundation for ongoing innovation in the next phase and the creation of value for the company, its customers, and shareholders.

"SHINE and Phoenix have shared a common long-term vision and operated in close collaboration during the past 11 years, but it’s always been inefficient to operate as separate companies," said Greg Piefer, CEO of SHINE. "Coming together will enable us to advance fusion technology more quickly by aligning interests and combining complementary core competencies. Through the four phases, we are taking a deliberate approach to building a company that can ultimately deliver cost-effective, clean fusion energy to billions, while serving important near-term market needs like advanced industrial imaging and medical isotopes, along the way." For a video of additional comments from Greg Piefer, please click here (:46 broadcast-quality available for the media).

Phoenix has developed a strong track record of commercialization and revenue generation by applying its fusion-based technology to applications such as advanced industrial imaging, which can image modern materials in great detail, addressing quality assurance and safety needs in the aerospace, defense, energy, and other industries. These applications are part of Phase 1 of the four-phase approach.

The second phase of the approach involves applications of nuclear fusion to replace nuclear reactors used in the production of life-saving medical isotopes for diagnostic imaging, like molybdenum-99 (Mo-99), and with potential use as cancer therapeutics like lutetium-177 (Lu-177). This month, SHINE kicked off Phase 2 commercialization when it began producing Lu-177. In 2022, SHINE expects to commence production of up to 20 million doses of Mo-99 per year in its fusion-powered production facility in Janesville, Wis. The facility is expected to be the world’s largest-capacity medical isotope production plant.

"This merger is a natural evolution of our strong existing partnership with SHINE, rooted in our common origin and shared mission," said Evan Sengbusch, general manager of SHINE’s Phoenix division. "Phoenix’s track record of successfully deploying our core neutron generation technology across multiple demanding market sectors has provided important commercial validation and risk reduction for critical technologies that underpin execution in Phase 2. We are excited to join with SHINE and leverage our complementary nuclear capabilities to advance towards clean fusion energy production." For a video of additional comments from Evan Sengbusch, please click here (1:24 broadcast-quality available for the media).

Phoenix was founded in 2005 by Piefer to develop and commercialize a unique technology that generated neutrons through fusion. He spun SHINE out of Phoenix in 2010 to apply that technology to medical isotope production and other applications through the four-phase approach.

Evercore Group L.L.C. served as exclusive financial advisor to SHINE. Foley & Lardner served as lead legal counsel to SHINE. SVB Leerink served as exclusive financial advisor to Phoenix. Godfrey & Kahn S.C. served as lead legal counsel to Phoenix.

SHINE’s Four-Phase Progression to Clean Energy Production

Phase 1: Advanced industrial imaging – uses neutrons for detailed imaging to improve the quality and safety of products in the aerospace, defense, energy, and other industries.
Phase 2: Medical isotopes (small-scale transmutation) – uses fusion technology to produce medical isotopes that diagnose and treat heart disease, cancer and a wide range of diseases
Phase 3: Nuclear waste recycling (large-scale transmutation) – scale up of phase 2 processing and fusion technology to recycle nuclear waste
Phase 4: Fusion Energy – establishes nuclear fusion as a technically and commercially viable global source of energy