On February 14, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) ("Isofol"), reported that it will publish the company’s year-end report 2021 on Thursday, February 24, 2022 (Press release, Isofol Medical, FEB 14, 2022, View Source [SID1234608063]). On the same day, Isofol invites investors, analysts, and media to an audiocast with a subsequent question time.

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In conjunction with the publication of the year-end report 2021, Isofol invites investors, analysts, and media to an audiocast on February 24, at 11:00 a.m. CET. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.

On February 14, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that its Chief Executive Officer, Michael Engsig, and Chief Innovation and Strategy Officer, Agnete Fredriksen, will present and provide a corporate update at the SVB Leerink 2022 Global Healthcare Conference on February 18, 2022 at 2.00 p.m. CET/ 8.00 a.m. EST and are available for 1:1 investor meetings (Press release, Nykode Therapeutics, FEB 14, 2022, View Source [SID1234608062]).

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An updated corporate presentation will be available in the Investors section of the Company’s website at 7:00 a.m. CET on February 18, 2022 at www.nykode.com/investors. The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website here.

On February 14, 2022 Taiho Pharmaceutical Co., Ltd. reported that it has submitted to the Japanese Ministry of Health, Labour and Welfare, an application for the additional indication of "postoperative adjuvant chemotherapy in breast cancer" for its oral anticancer agent TS-1 (Press release, Taiho, FEB 14, 2022, View Source [SID1234608061]).

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This application is based on the results of an investigator-initiated study, Postoperative Therapy with TS-1 for oestrogen receptor-positive, HER2-negative breast cancer (POTENT study). According to the results of the POTENT study, the combination of TS-1 with endocrine therapy showed a clinically significant extension of invasive disease-free survival (iDFS) among patients with oestrogen receptor-positive, HER2-negative breast cancer with an intermediate or higher risk of recurrence. The safety profile was similar to that of TS-1 reported in the past, and no new concerns were identified in the POTENT study.

Taiho Pharmaceutical will continue to prepare for the delivery of this treatment option to patients with breast cancer, aiming to obtain approval as quickly as possible.

About the POTENT Study
POTENT is an investigator-initiated study conducted since March 25, 2011, under the designation of advanced medical care (Specific Clinical Research jRCTs051180057，UMIN000003969). The principal investigator, Masakazu Toi, M.D., Ph.D., Professor of Breast Surgery at Kyoto University’s Graduate School of Medicine and Faculty of Medicine, had submitted a study application to the Japanese Ministry of Health, Labour and Welfare under the former Advanced Medical Care Program. On January 25, 2011, the Advanced Medical Care Assessment Council approved the study with the advanced medical care name, "Postoperative Therapy with TS-1 for oestrogen receptor-positive, HER2-negative breast cancer."

The purpose of the study was to verify any increase in the effect on prevention of recurrence through a randomized comparative Phase III study in postoperative adjuvant therapy for oestrogen receptor-positive, HER2-negative breast cancer. The control group was treated with endocrine therapy (5 years), the standard treatment method, with the study group treated with endocrine therapy (5 years) in combination with TS-1 (1 year). The study endpoints included invasive disease-free survival, overall survival, safety, etc. The study enrolled 1,959 women from 139 breast cancer facilities across Japan during the registration period from February 2012 to February 2016.1

Public Health Research Center, contracted to serve as the study management office, received funding from Taiho Pharmaceutical and this study was conducted with such funding.
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1 Toi M et al., Lancet Oncol 2021; 22: 74–84.

For more information of the POTENT study, please refer to
View Source
View Source (in Japanese only)

About Primary Breast Cancer
According to the Japan Breast Cancer Society’s Annual Report of the Japanese Breast Cancer Registry for 2017,2 94,612 women in Japan are affected by breast cancer annually. It is reported that 75.3% of these cases are oestrogen receptor-positive, HER2-negative breast cancer. In cases of early-stage breast cancer, perioperative chemotherapy and postoperative endocrine therapy are given as standard treatments in addition to surgery, considering the risk of recurrence.

2 Hayashi N et al., Breast Cancer 2020; 27:803–809.

About TS-1
A member of the fluoropyrimidine class of anticancer agents, TS-1 is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anticancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU in the liver; and oteracil (Oxo), which decreases 5-FU phosphorylation in the gastrointestinal tract. Developed as a gastric cancer treatment, TS-1 was first approved in Japan in 1999 and has become a standard of care for the treatment of gastric cancer. TS-1 has been approved in Japan for the treatment of gastric, colorectal, head and neck, non-small cell lung, inoperable or recurrent breast, pancreatic, and biliary tract cancers.

On February 14, 2022 Biodesix, Inc. (NASDAQ: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the Company expects to report fourth quarter and record full-year 2021 preliminary unaudited total revenue of $7.2 million and $54.5 million, respectively (Press release, Biodesix, FEB 14, 2022, View Source [SID1234608060]). The strength in the full-year 2021 total revenue of $54.5 million compared to $45.6 million in 2020 was a result of growth in the Company’s core lung diagnostic testing and first half 2021 COVID-19 testing. The financial results included in this release pertaining to the fourth quarter and year ended December 31, 2021 are preliminary and unaudited and subject to final review and adjustments.

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Fourth Quarter and Full-Year 2021 Financial Highlights

•Total quarterly revenue of $6.8 million, excluding COVID-19 testing revenue, increased $1.2 million or 22% for the fourth quarter 2021 compared to the same period in 2020 and $0.8 million or 13% for the fourth quarter 2021 compared to the third quarter 2021; and
•Total annual revenue of $24.3 million, excluding COVID-19 testing revenue, increased $7.1 million or 41% for the year ended December 31, 2021 compared to the same period in 2020.
•Cash and cash equivalents as of December 31, 2021 of $32.7 million.
"We are pleased to see the continued growth in our core lung diagnostic business throughout 2021 despite the challenges created by the ongoing pandemic," stated Scott Hutton, Chief Executive Officer. "With the launch of our new IQLung Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS test and provides for both early and advanced stage lung cancer testing results, our Nodify Lung testing for lung nodule risk assessment, as well as the broad array of tests that we perform on behalf of our biopharmaceutical partners, we are very well positioned to continue to drive growth in our core business in 2022. As we said in our third quarter earnings call, given our current financial position, including covenants under our current debt facility, we will continue to explore paths to greater liquidity, including raising capital through additional equity and/or debt as the markets continue to evolve, and through partnering opportunities."

On February 14, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported preliminary results supporting the successful conclusion of its second Phase 1 trial (MB-105) in Poland evaluating Annamycin for the treatment of relapsed and refractory acute myeloid leukemia (AML), where Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D), subject to final approval of the Safety Review Committee, and indicated no signs of cardiotoxicity (a common problem with currently prescribed anthracyclines) (Press release, Moleculin, FEB 14, 2022, View Source [SID1234608059]). Based on preclinical animal data from sponsored research conducted simultaneous with its clinical trials, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. Based on this data, the Company plans to advance its AML clinical development program in a Phase 1/2 clinical trial in Europe evaluating the combination of Annamycin and Cytarabine utilizing the clinical data from its two prior Phase 1 clinical trials.

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"This important study conclusion now allows us to combine the safety and efficacy data from our MB-104 and MB-105 AML clinical trials using Annamycin as a single agent, along with the recent findings from preclinical studies showing that the combination of Annamycin with Cytarabine (AnnAraC) has the ability to synergistically improve activity against AML and move directly into a new AML clinical trial to study AnnAraC in humans," Dr. J. Paul Waymack, Senior Chief Medical Officer of the Company, commented. He continued, "The support of local physicians in Poland for an AML trial utilizing AnnAraC is encouraging, and we believe this will translate into a faster pace of recruitment than we experienced in our MB-105 clinical trial. As such, our Annamycin AML program is now positioned to progress to a Phase 1/2 combination clinical trial in Europe as soon as possible. We expect to begin this trial in the first half of this year."

"The RP2D will assist in setting the initial dosage in the AnnAraC clinical trial but imposes no limit on Annamycin as the new clinical study will have its own Phase 1 dose escalation portion setting a new RP2D for the combination. The successful outcome of our second Phase 1 study combined with the data we have seen to-date represents a major milestone in the AML program as we believe successful Phase 2 data from the combination trial could position AnnAraC for late-stage development and faster approval in AML versus Annamycin as a single agent," added Mr. Walter Klemp, Chairman and CEO of Moleculin Biotech.

In January, the Company reported that it had received an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting AML (MB-104 and MB-105) and the metastases of soft tissue sarcoma to the lungs (STS Lung) or MB-107, which concluded there was no evidence of cardiotoxicity. Specifically, the trial Moleculin is concluding (MB-105), began its first cohort with an initial dose of 120 mg/m2 for three consecutive days. Each cohort contained three patients receiving a full course of Annamycin. In the fifth and final cohort, patients’ daily dose was 240 mg/m2 with five patients receiving a full course of Annamycin. The overall response rate (ORR) was 60% in the last cohort. This included two partial responses (PR’s) and one complete response with incomplete recovery of neutrophils and/or platelets (CRi). Upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company has concluded recruitment for the trial. The data from MB-104 and MB-105 trials will be used to design and support the new proposed combination trial.

The clinical data presented above are preliminary and subject to changes as the final clinical study report will be prepared in the near term.

The Company reported in November of 2020 new animal data from its sponsored research program showing highly improved activity against acute myeloid leukemia when Annamycin was used in combination with the commonly used antileukemic drug Cytarabine (Ara-C) versus single agent. The data was presented at the 62nd Annual Meeting & Exposition of the American Society for Hematology ("ASH") under the title: "High Efficacy of Liposomal Annamycin (L-ANN or Annamycin) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model."1 This study demonstrated vastly higher efficacy of the L-ANN/ARA-C combination (AnnAraC) over that of the single agents in an immune-competent setting of an aggressive, p53-null AML model. The study summarily demonstrated a 68% improvement in median OS of the animals in the study compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone.

1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga R, Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W, High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136 (Supplement 1): 6–7. View Source

About Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia. For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.