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]).

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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.

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]).

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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.

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.

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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]).

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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.

On February 5, 2021 The Board of Jubilant Pharmova Limited reported to approve financial results for the quarter ended December 31st, 2020 (Press release, Jubilant Pharma, FEB 5, 2021, View Source [SID1234575193]).

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Commenting on the Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, CoChairman & Managing Director, Jubilant Pharmova said: "Q3’FY21 has witnessed a substantial improvement over the previous quarter despite continued adverse impact of the COVID-19 pandemic.

Pharma business delivered strong performance led by CDMO and Generics. We continue to see new business opportunities in CDMO, Generics and Specialty Pharma segments.

The company’s performance in the LSI business has been better due to good demand and improved pricing of select products.

Contract Research and Development Services business witnessed strong year-on-year growth in revenues led by healthy demand from customers.

We continue to expect strong performance in our businesses in Q4’FY21. During 9M’FY21, the Company reduced net debt on a constant currency basis by Rs 570 Crore. This is in addition to Rs 514 crore reduction in net debt during FY20.

We received the final NCLT order approving the demerger of our LSI business. The demerger is effective from February 1, 2021 and creates separate and focused entities: Jubilant Pharmova for pharmaceuticals, contract research and development services and proprietary novel drugs businesses and Jubilant Ingrevia for life science products and innovative solutions business; that will help in unlocking shareholder value."

Q3’FY21 Highlights
A. Consolidated
 Revenue at Rs 2,664 Crore, as compared with Rs 2,315 Crore in Q3’FY20; up 15% YoY
 Reported EBITDA at Rs 653 Crore as compared with Rs 513 Crore in Q3’FY20; up 27% YoY. EBITDA margin at 24.5% vs. 22.2% in Q3’FY20
 Finance costs at Rs 59 Crore vs. Rs 72 Crore in Q3’FY20
Net Profit at Rs 310 Crore versus Rs 203 Crore in Q3’FY20. EPS of Rs 19.5 vs. Rs 12.8 in Q3’FY20; up 52% YoY
 Capital expenditure for the quarter was Rs 104 Crore Jubilant Pharmova Limited 1A, Sector 16A, Noida – 201301, India Tel.: +91 120 4361000 www.jubilantpharmova.com Segment Wise Analysis B. Pharmaceuticals Segment
Pharmaceuticals revenue was at Rs 1,692 Crore vs. Rs 1,450 Crore in Q3’FY20
 Pharmaceuticals EBITDA recorded at Rs 499 Crore as compared with Rs 411 Crore in Q3’FY20 with a margin of 29.5% as compared to 28.4% in Q3’FY20
 R&D spent during the quarter of Rs 45 Crore – 2.6% to segment sales. R&D debited to P&L is Rs 47 Crore – 2.8% to segment sales
 CMO business’ revenue grew based on strong demand from customers as well as new deals
 Five separate clinical and commercial supply agreements for COVID-19 treatment and vaccine candidates signed in 9M’FY21. Remdesivir of Gilead approved by the US FDA has been contributing to CMO revenue growth
 Started contract manufacturing of Eli Lily’s Bamlanivimab, a drug that has been granted Emergency Use Authorization by the US FDA for treatment of COVID-19 and COVID-19 vaccine candidate NVX-CoV2373 of Novavax, biotechnology company developing next-generation vaccines for serious infectious diseases
 Revenue growth during the quarter was also led by strong performance in key products in Generics segment, especially in the US market and also by launch of Remdesivir in various countries including India C. Life Science Ingredients Segment
 LSI revenue was at Rs 893 Crore against Rs 797 Crore in Q3’FY20
 Strong growth witnessed in Nutrition and Health Solutions and Life Science Chemicals business driven by improved pricing in both the segments
 EBITDA at Rs 155 Crore increased by 55% YoY with margin of 17.4% as compared to 12.6% in Q3’FY20
 Strong improvement in profitability is driven by improvement in prices across several products as well as recovery in volumes in Nutrition and Life Sciences Chemicals D. Contract Research and Development Services Segment
 Revenue at Rs 79 Crore increased by 17% YoY
 Reported EBITDA at Rs 29 Crore vs. Rs 22 Crore in Q3’FY20 with a margin of 36.4% vs. 32.9% in Q3’FY20
 Higher demand from biotech companies for integrated services, functional chemistry and DMPK
 Company continues to witness strong demand conditions in this business 9M’FY21 Highlights E. Consolidated
 Consolidated Revenue at Rs 6,932 Crore vs. Rs 6,763 Crore in 9M’FY20
 EBITDA at Rs 1,457 Crore vs. Rs 1,438 Crore in 9M’FY20. EBITDA margin at 21.0% vs. 21.3% in 9M’FY20
 Finance costs at Rs 199 Crore down 8% YoY
 Net Profit at Rs 622 Crore vs. Rs 638 Crore in 9M’FY20. EPS of Rs 39.1 vs. Rs 40.0 in 9M’FY20  Capex of Rs 285 Crore in 9M’FY21
Net debt reduced by Rs 570 Crore during 9M’FY21 Segment Wise Analysis F. Pharmaceuticals Segment
Pharmaceuticals revenue at Rs 4,304 Crore vs. Rs 4,231 Crore in 9M’FY20
 EBITDA at Rs 1,020 Crore vs. Rs 1,127 Crore in 9M’FY20. Margin of 23.7% as compared to 26.6% in 9M’FY20 G. Life Science Ingredients Segment
 LSI revenue at Rs 2,413 Crore vs Rs 2,356 Crore in 9M’FY20
EBITDA at Rs 418 Crore up 34% YoY with margin of 17.3% as compared to 13.3% in 9M’FY20 H. Contract Research and Development Services Segment
 Revenues at Rs 211 Crore up 20% YoY
 EBITDA was at Rs 67 Crore up from Rs 52 Crore in 9M’FY20

I. Business Outlook
 We continue to see improvement in demand in most of our business segments be it CMO, Generics, API or Life Science Ingredients
 Given the strong demand recovery and new business sign-ups, we believe COVID-19 is not likely to have a material impact on our overall performance during FY21, provided the pandemic situation does not materially deteriorate going forward
 Overall, we continue to see strong performance in our businesses in Q4’FY21
 For Pharmaceutical business, we continue to see strong performance in Q4
 For LSI business, we expect to achieve close to double-digit revenue growth and significant growth in EBITDA with higher margin and a very healthy cash generation in FY21