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FDA grants Breakthrough Device Designation for Roche’s Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

On February 8, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment (Press release, Hoffmann-La Roche, FEB 8, 2021, View Source [SID1234574714]). This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc.’s (NYSE: PFE) investigational drug PF-06946860.

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Cachexia is a metabolic disorder and comorbidity that occurs with several chronic diseases including cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD). It impacts more than 30 million people globally. Cachexia manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, progressing to significant functional impairment and increased risk of death.¹ Elevated GDF-15 is associated with cachexia in cancer patients. Cachexia is a highly prevalent complication of cancer, affecting between 50 to 80% of all cancer patients. This range depends on the tumour type, the patient response to tumour progression and on individual body type.²

"We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics", said Thomas Schinecker, CEO Roche Diagnostics. "The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships. The ability to detect elevated GDF-15 in patients who are experiencing weight loss may provide a precision-medicine approach to identifying patients likely to respond to a GDF-15 therapeutic treatment."

About Elecsys GDF-15
Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay (ECLIA) using the sandwich test format for the detection of GDF-15 in human serum. The Elecsys GDF-15 assay is indicated as an aid in identifying cachectic patients 18 years of age and older with solid tumours for treatment with PF-06946860. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers. GDF-15 has CE approval in several intended uses in cardiology including risk prediction of major bleeding events of atrial fibrillation patients, risk stratification of patients with acute coronary syndrome or chronic heart failure.

About Cachexia
Cachexia impacts more than 30 million people globally but is poorly understood due to its complexity. It has traditionally been seen as a complication of chronic diseases or end stages of cancer. The burden cachexia poses on patients, their caregivers and loved ones, as well as the healthcare system, is significant. Cancer cachectic patients experience numerous complications including, but not limited to, reduced effectiveness of chemotherapy, reduced mobility and reduced functionality of muscle-dependent systems, such as the respiratory and cardiovascular systems, leading to decreased quality of life and survival.

ERYTECH Announces TRYbeCA-1 Phase 3 Trial in 2L Pancreatic Cancer to Continue to Final Analysis

On February 8, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that TRYbeCA-1, a Phase 3 clinical trial evaluating eryaspase in second-line pancreatic cancer, will continue without modification following a planned interim superiority analysis conducted by an Independent Data Monitoring Committee (IDMC) (Press release, ERYtech Pharma, FEB 8, 2021, View Source,the%20fourth%20quarter%20of%202021.&text=%E2%80%9CThe%20trial%20will%20now%20continue,design%20hazard%20ratio%20of%200.725. [SID1234574713]).

The interim analysis was triggered when two-thirds of the total number of events had occurred and allowed the potential for stopping the trial early if the primary endpoint reached statistical significance, adjusting the statistical threshold for the interim review. As with the three previous IDMC reviews, no safety issues have been identified and the Company remains blinded to the primary and secondary endpoint efficacy data. The TRYbeCA-1 trial is fully enrolled and the Company continues to expect the final analysis in the fourth quarter of 2021.

"This IDMC review was the first combined efficacy and safety review. We are pleased that no safety issues were raised." said Gil Beyen, Chief Executive Officer of ERYTECH Pharma. "The trial will now continue to the final efficacy analysis. With 512 patients enrolled, the trial has approximately 90% power to detect the trial’s design hazard ratio of 0.725. Second-line pancreatic cancer is a devastating disease and remains a large unmet medical need. We are hopeful that TRYbeCA-1 can confirm the survival benefit we observed in the Phase 2b clinical trial and eryaspase can be a potential treatment for these patients. We look forward to sharing final results later this year."

About TRYbeCA-1

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial has enrolled 512 patients, slightly above the target enrollment of 482 patients, at approximately 90 clinical sites in Europe and the United States. Eligible patients were randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone.

The primary endpoint is overall survival (OS). At the target enrollment of 482 patients, the trial is powered to detect an OS benefit, measured as a hazard ratio (HR), of 0.725 (i.e. a reduction in risk of death rate by 27.5%) with 88% probability. The trial protocol includes one interim efficacy analysis, to be performed by the IDMC upon the accrual of 261 death events, and a final efficacy analysis upon reaching a total of 390 events.

About Pancreatic Cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. It is a particularly aggressive cancer, with a five-year survival rate below 10%. Pancreatic cancer currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030.

Every year, approximately 200,000 new cases of pancreatic cancer are diagnosed in the United States and Europe. Approximately half of these patients are diagnosed with metastatic disease for which limited therapeutic options are currently available. Notwithstanding significant efforts, very little innovation has occurred in advanced pancreatic cancer. Chemotherapy remains the main treatment modality. Approximately 40-50% of the patients treated with chemotherapy are eligible for second-line treatment.

Medivir Proposes Directed Issue of Approximately SEK 28 Million to the Company’s Existing Specialist Investor LINC

On February 7, 2021 The Board of Directors in Medivir AB (publ) ("Medivir" or the "Company") reported that has decided to summon an extraordinary general meeting on 11 March 2021 to propose a directed issue (the "Directed Issue") to the Company’s existing specialist investor LINC AB ("LINC"), controlled by the Company’s board member Bengt Julander (Press release, Medivir, FEB 7, 2021, View Source [SID1234574711]).

In the rights issue, from which the preliminary results was announced on 5 February 2021 (the "Rights Issue"), Bengt Julander (through LINC) among others entered into subscription and guarantee commitments. The Rights Issue was substantially oversubscribed and no guarantee commitments needed to be utilized. Through an over-allotment option related to the Rights Issue (the "Over-allotment Option") the specialist investor Healthinvest Partners AB was added to the Company’s shareholder base. As a result of the strong interest in the Rights Issue and in order to further strengthen the Company’s institutional shareholder base, the Board of Directors has decided to summon an extraordinary general meeting on 11 March 2021 to propose a directed issue of approximately SEK 28 million to Bengt Julander (through LINC).

Since the Directed Issue is directed to a company controlled by board member Bengt Julander, part of the Company’s category of related parties referenced in the Swedish Companies Act (sw. ABL) chapter 16 (2005:551), the Directed Issue requires approval by the Company’s shareholders representing at least nine tenths of the votes casted as well as the shares represented at the extraordinary general meeting on 11 March 2021, for which a notice will be published separately. Bengt Julander did not participate in the decision regarding the Directed Issue by the Board of Directors.

The extraordinary general meeting will decide on the proposal to issue a total of 3,600,000 new series B shares, directed to Bengt Julander (through LINC), at a subscription price of SEK 7.73 per share, corresponding to the closing price as of 5 February 2021. The reason for deviating from the shareholders’ preferential rights in the Directed Issue is to strengthen the Company’ institutional shareholder base and the proceeds will be used to accelerate the Company’s existing business plan, mainly focusing on the development of MIV-818.

Through the Directed Issue, the number of shares in Medivir will increase from 52,135,651 series B shares, including the shares issued in connection with the Rights Issue and the Over-allotment Option, to 55,735,651 series B shares, corresponding to a dilutive effect of approximately 6.5 per cent of the total number of outstanding shares and votes in the Company. Following the completion of the Directed Issue, LINC will hold shares in the Company corresponding to approximately 10 per cent of the total number of outstanding shares in the Company.

Advisors
ABG Sundal Collier is the financial advisor and Vinge is the legal advisor to Medivir in connection with the transaction.

Isofol announces that an abstract has been approved for AACR in April 2021

On February 5, 2021 Isofol reported that an abstract has been approved for presentation at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Congress 2021 (Press release, Isofol Medical, FEB 5, 2021, View Source [SID1234576711]). The congress will take place during April 10-15, 2021 and a poster will be presented on April 10.

Leclaza Could Change Tagrisso-led Lung Cancer Drug Market

On February 5, 2021 Genosco reported its Yuhan’s Leclaza (ingredient: lazertinib), Korea’s 31st novel drug that treats lung cancer, has reached the commercialization stage, raising expectations for a new treatment option (Press release, Genosco, FEB 5, 2021, View Source [SID1234575420]).

The drug received approval from the Ministry of Food and Drug Safety on Jan. 18, on the condition that the company submits phase-3 trial data after the market release.

Hospitals can use the drug for treating non-small cell lung cancer (NSCLC) patients with positive EGFR T790M (epidermal growth factor receptor threonine at amino acid position 790) mutation.

Researchers in the anticancer field predict a major change in the lung cancer prescription market, currently dominated by AstraZeneca’s Tagrisso (Ingredient: Osimertinib), as clinical results of Leclaza has shown that it can provide new options for NSCLC patients.

"In the clinical trials of existing third-generation EGFR TKI first-line treatments, the drug’s efficacy was lower in Asians compared to the non-Asians population," Professor Ahn Myung-ju at the Department of Hematology-Oncology at Samsung Medical Center said during a news conference on Friday. "Therefore, it was necessary to verify the efficacy of NSCLC drugs in Koreans, including Asians."

Ahn added that researchers believe that the approval of Leclaza will resolve such concerns and address the unmet demand for EGFR TKI (tyrosine kinase inhibitor) as the drug showed excellent effects in terms of resistance and brain metastasis, she added.

Professor Cho Byoung-chul of Yonsei Cancer Center, who participated in the Leclaza study as principal investigator, stressed the importance of Leclaza’s approval.

"Leclaza’s product license is good news for Yuhan and Korean patients and patients worldwide as well," Professor Cho said. "Leclaza is the only third-generation EGFR mutant therapeutic agent that has been on the same level in terms of effectiveness as Tagrisso."

He stressed that Leclaza’s approval is important because a Korean pharmaceutical company obtained approval for Korean patients.

Cho explained the mechanism, efficacy, and safety of Leclaza based on its non-clinical and clinical trials’ main results.

"Researchers have high expectations as compared to other EGFR TKI treatments, Leclaza has excellent selectivity in distinguishing between normal and mutant EGFR, and exhibits excellent effects on brain metastasis tumors," Cho said.

According to Cho, the LASER201 clinical trials showed that the objective response rate (ORR) according to the independent central review and investigator evaluation of 76 T790M mutation-positive patients is 78 patients assigned to the 240mg dose group was 58 and 72 percent. At the same time, the median progression-free survival was 11 and 13.2 months.

Researchers also observed drug-related adverse reactions of CTCAE (common terminology criteria for adverse events) grade 3 or higher in only 5 percent of the test subjects. At the same time, cardiac safety results were also excellent.

"As a result, we could confirm that Leclaza showed a significant therapeutic effect and safety profile as a second-line treatment for EGFR T790M mutation-positive NSCLC," Cho said. "Starting with the local approval, I hope that Leclaza will become a symbol of hope for lung cancer patients around the world as Yuhan plans to conduct a global phase 3 clinical trial."

According to a company official, Yuhan has almost completed recruiting participants for the global phase 3 clinical trial, despite the ongoing Covid-19 epidemic.

"We still need to recruit additional Westerners to participate in the trial, but have reached our goal to recruit patients in Asia," the official said.