On August 24, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that Rubraca (rucaparib) is now available and reimbursed in Switzerland (Press release, Clovis Oncology, AUG 24, 2021, View Source [SID1234586850]). The Swiss authority responsible for the authorization and supervision of therapeutic products (Swissmedic)i gave a positive recommendation for Rubraca as maintenance treatment for recurrent platinum sensitive ovarian cancer.2 Rubraca is indicated for eligible patients regardless of BRCA status, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.2

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"PARP inhibition is the major improvement of the last years in the treatment of ovarian cancer," said Prof. Dr. med. Viola Heinzelmann-Schwarz, Head of the Department of Gynaecology and Gynaecological Oncology at the University Hospital Basel.

Approximately 600 women are diagnosed with ovarian cancer in Switzerland every year, which equates to 1 to 2 new diagnoses every day.3 It is the third most frequent gynecological cancer in Switzerland.4 In addition, up to approximately 25 percent of patients harbor a germline BRCA1/2 mutation correlating to responsiveness to therapy, while the majority of women who are diagnosed are BRCA wild-type will have a worse prognosis and limited therapeutic options.5,6 Despite advancements in treatment and care, on average 500 women in Switzerland still die each year.7

The Swissmedic authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial, which found that Rubraca significantly improved PFS in all ovarian cancer patient populations studied.1 ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).1,2 In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated (ITT), regardless of BRCA status (median 13.7 months vs 5.4 months).2 The overall safety profile of Rubraca is based on data from 937 patients with ovarian cancer treated with Rubraca monotherapy in clinical trials.2

"We are pleased to make Rubraca available in Switzerland and offer a new maintenance treatment option for eligible women with relapsed ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "There has been a significant need for additional treatment options for women with relapsed ovarian cancer, and we are proud that women who may benefit will have access to rucaparib. We remain committed to making rucaparib available to eligible patients in the US and Europe."

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancer (mCRPC), as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Click here and search for Rubraca to access the Swiss PI.

Healthcare professionals should report any suspected adverse reactions via their national reporting systems. Click here to access the Swiss national reporting system.

Rubraca (Rucaparib) 200mg, 250mg and 300mg film-coated tablets:

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected new or serious adverse reactions. Active substance: rucaparib. Composition: film-coated tablet containing 200 mg, 250 mg or 300 mg rucaparib as rucaparib camsylate. Excipients: Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133), indigo carmine aluminium lake (E132). Indications/Uses: Rubraca is indicated for the maintenance therapy of adult patients with advanced, platinum-sensitive, relapsed, high-grade serous ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial remission following a platinum-based chemotherapy. Contraindications: hypersensitivity to the active substance or any of the excipients listed under Composition. Breastfeed during treatment with Rubraca and for 2 weeks following the last dose. Undesirable effects: Very common: anaemia, thrombocytopenia, neutropenia, decreased appetite, blood creatinine increased, dysgeusia, dizziness, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, photosensitivity reaction, fatigue, pyrexia. Common: myelodysplastic syndrome / acute myeloid leukaemia, leukopenia, lymphopenia, febrile neutropenia, dehydration, hypercholesterolaemia, dyspnoea, transaminases increased, rash maculo-papular, palmar-plantar erythrodysaesthesia syndrome, erythema. Prescription status: prescription. Other information: see product information. Marketing authorisation holder: Clovis Oncology Switzerland GmbH, Seefeldstrasse 69, 8008 Zurich. Medical information: Email: [email protected]. Toll-free phone line: +41 (0)800677526. Date of revision: November 2020.

On August 24, 2021 Quest Diagnostics, the nation’s leading provider of diagnostic information services, reported it has acquired select assets of Nationwide Laboratory Services (NLS), an independent clinical diagnostics laboratory headquartered in Boca Raton, FL with over 25 years of patient centric service throughout the country (Press release, Quest Diagnostics, AUG 24, 2021, View Source [SID1234586900]).

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With the acquisition, Quest will broaden access to diagnostic innovation and insights empowering better health for more communities in South Florida. Testing services provided by NLS will transition to Quest’s full-service laboratory in Miramar, FL. Quest will also acquire select patient service sites in South Florida.

"Access to quality, innovative and cost-effective laboratory services is more important now than ever, given the twin health threats of COVID-19 and delays in medical care caused by the pandemic," said Alan Myers, Vice President and General Manager, Southeast Region, Quest Diagnostics. "We look forward to delivering diagnostic insights for COVID-19 and a range of other medical conditions to help empower better care and outcomes, particularly for communities in South Florida."

"It was vital to pass our valued clients and patients to an organization with the same guiding principles and patient-centric focus," said Dean Morris, CEO and Corporate Counsel, Nationwide Laboratory Services. "It was a competitive bidding process, but Quest’s vision, reputation and leadership made the choice clear cut."

Based in Secaucus, NJ, Quest Diagnostics operates major laboratory facilities in Tampa as well as Miramar and over 50 patient sites across Florida. Its services include COVID-19 testing through several leading retail providers and its own QuestDirect consumer-initiated testing platform, which offers a $0 out-of-pocket cost test option.

In addition, Quest collaborates with community and healthcare organizations to help close gaps in care for underserved communities in Florida through its Tackle Your Testing program.

On August 23, 2021 Samyang Biopharm USA, Inc. (View Source) a global biotech subsidiary of the Samyang Holdings Pharmaceuticals Corp. (View Source), reported that the company has entered into a three-year research collaboration with Dr. Hyun-Sung Lee, Assistant Professor of Surgery and Director of the Systems Onco-Immunology Laboratory (SOIL) at Baylor College of Medicine (Press release, Samyang Biopharmaceuticals, AUG 23, 2021, View Source [SID1234586816]). Samyang has awarded Dr. Lee a sponsored research grant which will utilize the capabilities of his laboratory to investigate the potential role of SYB-010, Samyang’s lead Immuno-Oncology asset, in sensitizing the tumor-immune microenvironment to immune checkpoint inhibitors.

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"This alliance leverages Dr. Lee’s proven approach to immuno-oncology drug discovery and provides Samyang with the ideal research partner for this program," stated Barbara Natke, Ph.D., MBA, Head of Translational Sciences and Acting Vice President of Business Development, Samyang Biopharm USA. "Samyang is constantly looking for novel drug discovery platforms with the potential to transform drug development to address the unmet needs of patients. This strategic collaboration is a significant step in meeting that goal."

The primary goal of this study is to determine the predictive role of soluble MHC Class 1 Chain-Related Protein (sMIC) in identifying non-responders to immune checkpoint therapy and to determine the role of SYB-010, an anti-MIC therapy, in overcoming such resistance.

"Improving outcomes for cancer patients is only possible through a clear understanding of the potential of investigational drugs like SYB-010" said, Dr. Hyun-Sung Lee. "This partnership and financial support will leverage our established expertise in studying cancer-immune system networks through state-of-the-art single-cell platforms to answer questions around resistance to checkpoint immunotherapy, which is a significant hurdle in realizing the full potential of such therapies."

"Dr. Lee’s expertise and deep understanding of cancer research; particularly in the areas of systems biology and immunology, will provide valuable insights into the potential of SYB-010, which in pre-clinical models has shown a clear immunomodulatory effect along with a reduction in tumor growth," said Helen Hyun Jung Lee, President & CEO, Samyang Biopharm USA, Inc. "Samyang is delighted at the opportunity to partner with a scientist of Dr. Lee’s stature and we look forward to this collaboration as it will provide a foundation for the advancement of our compound into 2022 clinical trials and the opportunity to treat patients."

About SYB-010
SYB-010 (formerly CuraB-10), is a first-in-class therapeutic acquired by Samyang Biopharm USA from CanCure, LLC, in 2019. In cancer model systems, SYB-010 potently activates both the T lymphocyte and NK (natural killer) cell arms of the anti-tumor immune response. In animal models that are not responsive to inhibitors of PD-1, PD-L1 or CTLA-4, SYB-010 has the potential to work synergistically when combined with to those therapies to broaden the potential for an immune attack on cancer alone. The compound is currently in Investigational New Drug (IND)-enabling studies.

On August 23, 2021 Lightpoint Medical, a leading medical device company developing and marketing miniaturized imaging and sensing tools for minimally-invasive and robot-assisted surgery, repored that it has signed a strategic collaboration agreement with Telix Pharmaceuticals Limited (Press release, lightpoint medical, AUG 23, 2021, View Source [SID1234586832]). Under the agreement, the two companies will explore how Lightpoint and Telix technologies may be used together for real-time intra-operative cancer detection.

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SENSEI, Lightpoint Medical’s miniature surgical gamma probe, to be used with Telix’s imaging agent TLX599-CDx in prostate cancer surgery
SENSEI, Lightpoint Medical’s miniature surgical gamma probe, to be used with Telix’s imaging agent TLX599-CDx in prostate cancer surgery
Lightpoint has developed SENSEI, a miniaturized surgical gamma probe for minimally-invasive and robot-assisted cancer surgery, approved for sale in the US, EU, UK and Australia. SENSEI can be used with molecularly-targeted imaging agents, promising direct detection of cancer during surgery to help guide surgeons in the removal of cancer and the sparing of healthy, functional tissue.

Lightpoint and Telix will first evaluate the use of SENSEI with Telix’s investigational prostate cancer single photon emission computed tomography (SPECT) imaging agent TLX599-CDx (99mTc-HYNIC-iPSMA) for the intra-operative detection of cancerous pelvic lymph nodes. The objective of the collaboration is regulatory approval and commercialization of SENSEI and TLX599-CDx for prostate cancer surgery.

Lightpoint CEO, Graeme Smith said "This strategic partnership agreement with Telix marks an important milestone for Lightpoint Medical. The combination of our miniaturized surgical gamma probe, SENSEI, alongside Telix’s ground-breaking imaging agents is intended to create an extremely precise technique to help surgeons detect cancer that might not otherwise be found during surgery, or conversely, confirm the absence of disease to help surgeons retain healthy, functional tissue. The collaboration between our two companies has the potential to transform surgical outcomes for patients across a range of major cancer types, starting with prostate cancer."

Telix CEO, Dr. Christian Behrenbruch added "Bringing molecular imaging into the operating theatre is a key part of our portfolio strategy for urologic oncology, and the combination of Telix and Lightpoint technologies has the potential to transform treatment options for patients with cancer. This collaboration helps to reinforce Telix’s position as a leader in developing advanced surgical technologies using highly targeted imaging techniques."

About TLX599-CDx

TLX599-CDx is an investigational product being developed by Telix to facilitate patient access to advanced prostate cancer imaging in countries where SPECT imaging is predominant in healthcare facilities. Whereas Telix’s lead investigational product, Illuccix for prostate cancer imaging, utilises positron emission tomography (PET), TLX599-CDx employs SPECT, a diagnostic imaging technology that is more widely available in healthcare facilities throughout the world. In April 2021 Telix announced the launch of the NOBLE Registry[1], a global consortium of investigator-led studies exploring the clinical utility of TLX599-CDx, with the objective to generate data and facilitate the design of future formal registration clinical trials.

On August 23, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported its 2021 second quarter unaudited financial results (Press release, Legend Biotech, AUG 23, 2021, View Source [SID1234586817]).

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"We have made exciting progress in advancing our first investigational CAR-T therapy cilta-cel in the past few months, with key regulatory, data and manufacturing updates. This includes the acceptance of our applications for cilta-cel by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the presentation of additional efficacy and safety data from the CARTITUDE cilta-cel clinical development program at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) Annual meetings," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We look forward to a momentous second half of the year as we work towards bringing cilta-cel to patients living with multiple myeloma and providing their healthcare providers a new therapeutic option, in collaboration with Janssen."

Second Quarter 2021 Highlights

In May 2021, the rolling submission of the Biologics License Application (BLA) was accepted by the U.S. FDA for cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), following the submission by Legend Biotech’s collaborator, Janssen Biotech, Inc. (Janssen). As part of the BLA acceptance, the FDA granted cilta-cel priority review and set the Prescription Drug User Fee Act (PDUFA) target action date for November 29, 2021.
In May 2021, the Marketing Authorisation Application (MAA) submitted by Janssen was accepted by the European Medicines Agency (EMA) for cilta-cel for the treatment of adults with RRMM.
In addition, a submission for cilta-cel was made to the Brazilian Health Regulatory Agency by Janssen in April 2021.
Longer term data from the CARTITUDE-1 trial of cilta-cel in 97 heavily pretreated patients with RRMM, which was presented at the 2021 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) Annual meetings, showed 98 percent overall response rate, 80 percent stringent complete response rate (sCR), progression free survival rate of 66 percent and an overall survival (OS) rate of 81 percent at the 18-month follow-up. A full manuscript containing earlier data from the CARTITUDE-1 trial at 12.4-months of follow up was published in The Lancet in June 2021.
First results from Cohort A of the CARTITUDE-2 study of cilta-cel, which was featured at the 2021 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) Annual meetings, showed early and deep responses in the cohort of 20 patients with progressive MM after 1-3 prior lines of therapy, and who were lenalidomide refractory, with a safety profile consistent with what has been observed in the CARTITUDE clinical development program.
On June 22, 2021, Legend Biotech announced the establishment of a state-of-the-art manufacturing facility in Belgium as part of a joint investment with Janssen, to expand global manufacturing capacity of innovative cellular therapies.
On May 21, 2021, Legend Biotech completed the sale of 20,809,805 ordinary shares in a private placement at a purchase price of $14.41625 per ordinary share (equivalent to $28.8325 per American Depositary Share, or ADS) and the issuance of a warrant exercisable for up to an aggregate of 10,000,000 ordinary shares, exercisable for a two-year period at an exercise price of $20.00 per ordinary share (equivalent to $40.00 per ADS), in each case, pursuant to a subscription agreement dated May 13, 2021, with an institutional investor.
In June 2021, the CARTITUDE clinical program expanded to include the initiation of the CARTITUDE-5 study (NCT04923893), a Phase 3 randomized study evaluating cilta-cel in patients with newly diagnosed MM (NDMM) for whom autologous stem cell transplant (ASCT) is not planned as initial therapy. The CARTITUDE-5 study will evaluate bortezomib, lenalidomide and dexamethasone, known as VRd, followed by cilta-cel versus VRd, followed by lenalidomide and dexamethasone, or Rd, maintenance therapy.
The ongoing Phase 2 CARTITUDE-2 study (NCT04133636) was expanded with the addition of two cohorts: Cohort E (high-risk NDMM, transplant not planned) and Cohort F (standard-risk NDMM).
In May 2021, Legend Biotech achieved a $15 million milestone payment related to a cilta-cel development milestone, according to the terms and conditions of an agreement with Janssen.
*In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

Key Upcoming Milestones

As part of the acceptance of the BLA for cilta-cel for the treatment of adults with RRMM, the FDA has set the PDUFA target action date for November 29, 2021.
In collaboration with Janssen, Legend Biotech intends to present updated data from the CARTITUDE-1 and the CARTITUDE-2 studies at major medical conferences in 2021.
Legend Biotech anticipates supporting investigators to submit a manuscript on the clinical data update from LEGEND-2 study in 2021.
Legend Biotech intends to use the data from the CARTIFAN-1 study in support of a regulatory submission to the China Center for Drug Evaluation (CDE) in the second half of 2021, seeking approval of cilta-cel for the treatment of adults with RRMM.
Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Pharmaceuticals and Medical Devices Agency in the second half of 2021, seeking approval of cilta-cel for the treatment of adults with RRMM.
Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR T-cell lymphoma (TCL) in the United States in 2021.
Financial Results for Three Months and Six Months Ended June 30, 2021

Cash and Cash Equivalents and Time Deposits

As of June 30, 2021, Legend Biotech had approximately $488.2 million of cash and cash equivalents and approximately $174.6 million in time deposits.

Revenue

Revenue for the three months ended June 30, 2021 was $20.2 million compared to $11.6 million for the three months ended June 30, 2020. The increase of $8.6 million was primarily due to two additional milestones achieved pursuant to Legend Biotech’s agreement with Janssen in the fourth quarter of 2020 and in the second quarter of 2021, respectively. Revenue for the six months ended June 30, 2021 was $33.9 million compared to $23.1 million for the six months ended June 30, 2020. The increase of $10.8 million was primarily due to the aforementioned two additional milestones achieved. Milestone payments are constrained as a result of the uncertainty of whether the milestone will be achieved, but included as customer consideration for revenue recognition when the associated milestone is achieved and the uncertainty relieved. In half year of 2021, this resulted in a larger amount of revenue recognized from the contract liabilities. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2021 were $83.5 million compared to $53.6 million for the three months ended June 30, 2020. This increase of $29.9 million was primarily due to a higher number of clinical trials with more patients enrolled and a higher number of research and development product candidates. Consistently, research and development expenses for the six months ended June 30, 2021 was $154.5 million compared to $101.6 million for the six months ended June 30, 2020 with an $52.9 million increase.

Administrative Expenses

Administrative expenses for the three months ended June 30, 2021 were $9.2 million compared to $4.5 million for the three months ended June 30, 2020. The increase of $4.7 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities. Due to the consistent business expansion, administrative expenses for the six months ended June 30, 2021 increased by $10.1 million, which was $18.0 million for the six months ended June 30, 2021 compared to $7.9 million for the six months ended June 30, 2020.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended June 30, 2021 were $16.8 million compared to $9.6 million for the three months ended June 30, 2020. This increase of $7.2 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same commercial preparation activities, selling and distribution expenses for the six months ended June 30, 2021 was $30.2 million compared to $16.1 million for the six months ended June 30, 2020.

Other Income and Gains

Other income and gains for the three months ended June 30, 2021 was $1.7 million compared to $1.3 million for the three months ended June 30, 2020. Other income and gains for the six months ended June 30, 2021 was $2.4 million compared to $3.8 million for the six months ended June 30, 2020. The decrease of $1.4 million was primarily due to larger government grant and interest income received in the first half of the year in 2020.

Other Expenses

Other expenses for the three months ended June 30, 2021 was $2.3 million compared to $0.04 million for the three months ended June 30, 2020. The increase of $2.26 million was primarily due to higher foreign currency exchange loss, loss from disposal of assets and other expenses in the second quarter of 2021. Consistently, other expenses for the six months ended June 30, 2021 was $4.4 million compared to $0.08 million for the six months ended June 30, 2020, with an increase of $4.32 million.

Finance Costs

Finance costs for the six months ended June 30, 2021 was $0.09 million compared to $4.1 million for the six months ended June 30, 2020. The decrease was primarily due to finance costs related to the issuance of convertible redeemable preferred shares in 2020, which were fully converted into ordinary shares upon the completion of Legend Biotech’s initial public offering in June 2020.

Fair Value Loss of Warrant Liability

Fair value loss of warrant liability for the six months ended June 30, 2021 was $1.6 million caused by changes of fair value of a warrant, which was issued to an institutional investor through a private placement in May 2021. Concurrently, 20,809,805 ordinary shares were offered and sold to the institutional investor. The warrant was assessed as a financial liability with a fair value of $83.3 million as of June 30, 2021 and a fair value loss of $1.6 million was recorded for the six months ended June 30, 2021.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the six months ended June 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon listing on the Nasdaq Global Market, all outstanding Series A Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

For the three months ended June 30, 2021, net loss was $91.6 million, or $0.33 per share, compared to a net loss of $134.9 million, or $0.63 per share, for the three months ended June 30, 2020. Net loss was $172.5 million, or $0.63 per share, for the six months ended June 30, 2021 compared to $179.1 million, or $0.86 per share, for the six months ended June 30, 2020.