On October 25, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809), reported preliminary and unaudited results for the first nine months ended 30 September 2021 (Press release, Evotec, OCT 25, 2021, View Source;announcements/press-releases/p/evotec-provides-preliminary-nine-month-financial-results-6104 [SID1234591925]).

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Evotec expects revenues from contracts with customers for the first nine months of 2021 to be in the range of € 425 – 435 m; significantly above the € 360.4 m posted in the prior year’s period. Like-for-like growth (excluding Sanofi payments of € 8.6 m in Q1 2020 and negative fx-effects) is expected to be in the range of 24 – 27%
Adjusted Group EBITDA for the first nine months of 2021 is expected to reach € 68 – 72 m, compared to € 76.9 m as of 30 September 2020, affected primarily by planned capacity build-up ahead of imminent production start of J.POD 1 US, Redmond. Like-for-like growth (adjusting for Sanofi and negative fx-effects) is expected to be within a range of 12 – 18%
Evotec expects unpartnered R&D expenses in the period to be between € 41 – 44 m, between € 8 – 11 m higher than in 9M 2020
The expected financial results discussed in this press release are based upon information available to Evotec as of the date hereof. This data is not a comprehensive statement of the Company’s financial results for the nine months ended 30 September 2021, and the closing process and related auditor review have not been completed. During the preparation of Evotec’s comprehensive financial statements adjustments to the preliminary estimated financial information presented herein may be identified, and such changes could be material. There can be no assurance that these estimates will be realised, and these estimates are subject to risks and uncertainties, many of which are not within the Company’s control. The timing of this disclosure is unique to this quarter given the timing of the Company’s application to list on the Nasdaq Global Select Market, and it does not intend to report preliminary results in future quarters. Evotec will issue complete financial results in connection with its 9M conference call on 11 November 2021.

On October 25, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported top-line results from its Phase 3 TRYbeCA-1 clinical trial evaluating eryaspase as second-line treatment in 512 patients with metastatic pancreatic cancer (Press release, ERYtech Pharma, OCT 25, 2021, View Source [SID1234591875]). The trial did not meet its primary endpoint of overall survival (OS).

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In the TRYbeCA-1 trial, eryaspase demonstrated an improvement in the primary endpoint of OS compared to chemotherapy alone with a hazard ratio (HR) of 0.92 (95% confidence interval (CI), 0.76-1.11) in the intent-to-treat population, and the difference was not statistically significant (p-value 0.375). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months (95% CI, 6.5-8.3), compared to 6.7 months (95% CI, 5.4-7.5) for chemotherapy alone.

Interestingly, while the patients treated with gemcitabine plus nabpaclitaxel did not experience a survival benefit from the addition of eryaspase, patients treated with eryaspase and an irinotecan-based chemotherapy regimen showed nominal survival benefit with a HR of 0.77 (95% CI, 5.7-1.05) over those treated with chemotherapy alone. This prespecified subgroup had a median OS of 8.0 months in the eryaspase-treated arm versus 5.7 months in the control arm (per protocol population).

Key secondary endpoints of the trial, including progression-free survival, disease control rate and objective response rate, showed benefit in favor of eryaspase.

The safety profile of eryaspase observed in the TRYbeCA-1 trial was consistent with earlier observations and previous safety reviews by the trial’s independent data monitoring committee (IDMC).

Further analysis of the data will be performed, and full results will be presented at an upcoming medical conference.

ERYTECH will now focus on its late-stage program in acute lymphoblastic leukemia (ALL) and pursue a path to approval in hypersensitive ALL based on positive results of NOPHO-sponsored Phase 2 trial. The Company reiterates its intention to submit a BLA before the end of the year.

"While the results are disappointing, we congratulate the company for a very well managed trial in this difficult disease. With a median survival of 7.5 months, ERYTECH has created a new reference standard for clinical evaluation in second line pancreatic cancer", said Prof. Pascal Hammel, MD, PhD, gastroenterologist-oncologist at Beaujon Hospital in Paris and co-principal investigator of the TRYbeCA-1 trial.

"I agree with Prof Hammel, and want to add that the results in the subgroup of fluoropyrimidine-based treatments are, with a median survival of 8 months, really remarkable and merit further investigation. Especially since this was also the better subgroup in the Phase 2b trial", said Prof. Manuel Hidalgo, M.D., Ph.D., Weill Cornell Medicine/NewYork-Presbyterian Hospital, and co-principal investigator of the study.

"Pancreatic cancer is a very challenging, heterogeneous disease, and the results of the TRYbeCA-1 Phase 3 trial have now also encountered this significant hurdle." said Dr Iman El Hariry, Chief Medical Officer of ERYTECH. "It is very disappointing that the clinical benefit eryaspase demonstrated in the Phase 2 trial was not confirmed; however, the study has addressed important questions in the management of pancreatic cancer patients. I want to thank the patients, their families and healthcare providers, our vendors, as well as our colleagues at ERYTECH, who overcame many obstacles, including the COVID-19 pandemic, to execute this important trial. Targeting the altered asparagine and glutamine metabolism of cancer cells, well established in ALL, remains an important field of development, also for the field of solid tumors. The ERYTECH team along with its clinical advisors will review the full data analyses including the secondary and exploratory endpoints and provide a more detailed update on additional subgroup analysis after these are completed".

"These results are highly disappointing, not only for the ERYTECH team, but also for patients and healthcare providers as there continues to be a major unmet medical need in pancreatic cancer." added Gil Beyen, CEO of ERYTECH. "We continue to believe in the potential of cancer metabolism and our ERYCAPS platform to treat aggressive forms of cancer, and will, while evaluating the potential to continue the development in pancreatic cancer, now continue to focus on seeking approval of eryaspase for ALL patients who developed hypersensitivity to pegylated asparaginase. This is also an important medical need and a potentially attractive market opportunity for eryaspase. We confirm our previously announced intention to submit a BLA for this indication by year-end 2021. We will evaluate our strategic and partnering options in the coming weeks and will provide updated guidance on our global corporate strategy later in the year."

TRYbeCA-1 Top-line Results and Analysis Conference Call Details

ERYTECH management will hold a conference call and webcast on October 25, at 8:30am EDT / 2:30 pm CEST highlights the top-line results and plans for future approval and launch in 2022. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link: View Source (Conference ID : 2361482). Once registered, participants will receive a unique access code and the call number details to join the teleconference.
The webcast can be followed live online via the link: View Source
An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

An archived replay of the audio call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 2361482#.

On October 25, 2021 ArcticZymes Technologies reported for the third quarter 2021 on Thursday, 28. October 2021 at 08.30 a.m (Press release, Biotec Pharmacon, OCT 25, 2021, View Source [SID1234591894])

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The company will host an online presentation for investors, analysts, and media at 08:30 a.m on Thursday, 28 October 2021, which will be followed by a Q&A session.

CEO, Jethro Holter and CFO, Børge Sørvoll will hold the presentation.

Participants who want to participate in the live webcast are asked to send an email to [email protected] for a separate invitation, which will be distributed 1 day prior to the meeting. Participants who want to participate by telephone should dial in on +47 21 40 24 87 with conference id: 220 624 781#. It will be possible to post questions through the webcast and over the phone after the presentation is finished.

The report for the third quarter 2021 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 a.m. on Thursday, 28. October 2021.

On October 25, 2021 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel cancer therapies, reported that the first patient has been dosed in the global Phase 2 trial of taletrectinib in ROS1 fusion-positive lung cancer (TRUST-II) (Press release, AnHeart Therapeutics, OCT 25, 2021, View Source [SID1234591910]). Taletrectinib, the company’s lead candidate, is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations.

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ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. By targeting ROS1, taletrectinib is designed to deliver cancer-fighting therapeutics selectively to tumor cells, while sparing normal cells.

"Taletrectinib dosing of the first patient in our global Phase 2 ROS1 fusion-positive TRUST-II lung cancer trial represents a key milestone for our lead ROS1-directed clinical program," said Bing Yan, MD, Co-Founder and Chief Medical Officer of AnHeart Therapeutics. "Based on the broad expression of ROS1 fusions across different cancer types, and our recent clinical data presented at ASCO (Free ASCO Whitepaper) and CSCO showing taletrectinib antitumor activity with a promising safety and efficacy profile, we are proud of advancing this investigational candidate as a potential new therapy for ROS1 fusion-positive lung cancer."

The global Phase 2 study (TRUST-II) is a multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene. A total of 119 patients will be enrolled and divided into four cohorts, depending on past history of ROS1 tyrosine kinase inhibitor treatment. Taletrectinib will be administered 600 mg once-daily in 21-day cycles. The primary endpoint of the study is confirmed overall response rate (ORR). For additional information about the clinical trial (NCT04919811), visit www.clinicaltrials.gov.

About Taletrectinib

Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naive or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) trial, global TRUST II trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib (NCT04395677, NCT04919811 and NCT04617054, respectively) at www.clinicaltrials.gov.

On October 25, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that imetelstat, the Company’s first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit (Press release, Geron, OCT 25, 2021, View Source [SID1234591926]). The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines. Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans.

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"We are pleased to participate in this new expedited review pathway established by MHRA and look forward to working with them and their partner agencies as we collaborate to bring imetelstat to UK patients," said Sharon McBain, Geron’s Vice President, Global Regulatory Affairs. "We are pleased imetelstat met the three qualifying criteria for the Innovation Passport and believe that because of the durable transfusion independence across different patient subgroups and strong evidence of disease-modifying activity observed in our IMerge Phase 2 study, imetelstat’s novel telomerase inhibitor approach has the potential to be an important drug in this patient population."

Patients from the IMerge Phase 2 clinical trial achieved durable transfusion independence with imetelstat treatment, including transfusion-free periods greater than one year, irrespective of the disease subgroup, such as ringed sideroblast positive or ringed sideroblast negative. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia and the debilitating impact of serial blood transfusions. In addition, depletion of cytogenetic abnormalities and reductions in key driver mutations associated with lower risk MDS were observed, and these results were also correlated with transfusion independence. Taken together, the durability, molecular and cytogenetic data from IMerge Phase 2 provide strong evidence for disease-modifying activity of imetelstat which has the potential to differentiate it from other currently approved and investigational treatments in lower risk MDS today.

Imetelstat is currently being studied in two Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory myelofibrosis. Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 clinical trial to be available at the beginning of January 2023.

About ILAP and Innovation Passport

The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from MHRA, NICE, the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) England. To enter ILAP and receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile (TDP) that outlines a unique product-specific roadmap for regulatory and development milestones. Other benefits provided by ILAP include the potential for a 150-day accelerated assessment of a Marketing Authorization Application (MAA) and rolling review. The ILAP also provides opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development and regulatory plans, as well as reimbursement.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.

About Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. Many patients develop chronic anemia, the predominant clinical problem in lower risk MDS, and become dependent on red blood cell transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival. Approximately 70% of MDS patients are categorized in the lower risk groups at diagnosis, according to the International Prognostic Scoring System that assigns relative risk of progression to acute myelogenous leukemia and overall survival by taking into account the presence of a number of disease factors, such as cytopenias and cytogenetics.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.