On July 19, 2022 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January to June 2022 (Press release, Hansa Biopharma, JUL 19, 2022, View Source [SID1234616782]).

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Highlights for the second quarter 2022

Continued solid sales in the second quarter with SEK 19.5m in product sales; total revenue amounted to SEK 26.4m.
On June 16, 2022, the National Institute for Health and Care Excellence (NICE) recommended Idefirix for desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. NICE considers Idefirix to be a clinically and cost-effective treatment Market access has now been secured in 7 European countries and procedures are ongoing in 11 countries, including Spain and Italy.
On May 13, 2022, Hansa announced that the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary marketing authorization for Idefirix in adult patients with a positive crossmatch against an available organ from a diseased donor.
On April 20, 2022, Idefirix was granted ASMR 3 rating by the Transparency Commission (TC) of the French National Authority for Health (HAS) following the reimbursed AP2 early access program in France, which potentially can enable a faster commercial access process. In addition to ASMR 3 status, Idefirix also received designation as SMR Important (Service Médical Rendu), reflecting the actual medical benefit.
Annual General Meeting held on June 30, 2022, where all resolutions proposed by the board of directors were approved by shareholders, including the appointment of Peter Nicklin as the new Chairman of the Board of Directors. Peter Nicklin is currently chairman of the boards of Versantis AG (CH), Sciensus Ltd (U.K.), and Tunstall Group Ltd (U.K.). Peter Nicklin was recently the CEO at Amann Girrbach. He has also held senior executive positions at Baxter, Bayer Healthcare, Novartis and Bristol Myers Squibb, amongst others.
Clinical pipeline update

U.S. ConfIdeS: 22 patients have been enrolled for randomization in our pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplant with the aim of completing enrollment by the end of this year, as previously guided.
AMR: On-time completion of enrollment in the Antibody Mediated Rejection (AMR) Phase 2 trial; A first data read out is expected in the second half of 2022, as previously guided.
GBS: In the Guillain Barré Syndrome (GBS) Phase 2 trial, 18 out of a target of 30 patients have been enrolled. Hansa expects to complete enrollment of GBS patients in the second half of 2022 based on several initiatives taken to support enrollment including measures such as simplifying the protocol and increasing capacity.
Anti-GBM: Preparations to commence Phase 3 study later this year as previously guided are on track.
Events after the closing period

On July 11, 2022, the first patient was treated in Hansa’s post approval efficacy study (PAES). The PAES is an obligation under the European conditional marketing authorization and will be used to further investigate the long-term graft survival in 50 highly sensitized kidney transplant patients treated with Idefirix.
On July 18, 2022 Hansa concluded a USD 70 million non-dilutive financing transaction with NovaQuest Capital Management to support the continued development of the Company’s antibody-cleaving enzyme technology platform across multiple therapeutic areas while extending the expected cash runway through 2024.
Financial summary

SEKm, unless otherwise stated – unaudited

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa’s commercial launch activities and market access efforts for Idefirix in Europe continue to progress as planned. During the second quarter of 2022, we have seen continued solid sales and achievement of the important milestone of becoming the first and only product recommended by NICE for the desensitization of highly sensitized patients waiting for a kidney transplant from a deceased donor in England, Wales and Northern Ireland. Additionally, NICE also highlighted Idefirix as a clinically and cost-effective treatment, which is rare for orphan drugs. This recommendation is an important step forward for Hansa’s commercialization efforts and for patients in England, Wales and Northern Ireland, who have been struggling to find a donor match and in most cases had no other alternative but to remain on long-term dialysis.

Beyond the U.K., we are also pleased that Idefirix was granted ASMR 3 rating by the Transparency Commission (TC) of the French National Authority for Health (HAS). Less than 6% of all new medicines are granted ASMR 3, and so the achievement of this status is a testament to the importance and medical benefit of Idefirix as a new transformative therapy. Moreover, we are also pleased that the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary marketing authorization in Switzerland for Idefirix in kidney transplantation in addition to the already received marketing authorizations in the EU, the U.K. and Israel.

Turning to our clinical development programs, at the end of May we announced the completion of enrollment in our imlifidase Phase 2 study in antibody mediated rejection (AMR) episodes post kidney transplantation. 30 patients with active or chronic active AMR episodes post kidney transplantation have been enrolled across 14 centers in France, Germany, Austria, Australia, and the U.S. Acute AMR episodes post kidney transplantation occur in 5-7% of patients, with significant risk of patients losing graft function. There is no approved treatment for AMR. The on-time completion of enrollment marks an important milestone for Hansa as we explore the potential of imlifidase in the post transplantation setting. First data read out is expected in the second half of 2022, as previously guided.

In the U.S., our pivotal ConfIdeS trial in kidney transplantation is progressing with 22 out of a target of 64 patients now enrolled for randomization. The ConfIdeS study is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. We have now initiated enrollment at ten sites and expect participation by up to 15 leading transplantation centers across the U.S., with the aim of completing enrollment by the end of this year.

In anti-GBM, we expect to commence a pivotal Phase 3 study of imlifidase following FDA’s acceptance of Hansa’s Investigational New Drug (IND) application earlier this year. The new study is expected to enroll approximately 50 patients across the EU and U.S, with the first patient expected to be enrolled later this year, as previously guided.

With respect to our GBS Phase 2 program, which has been impacted by the pandemic, we have recently implemented several significant initiatives to increase the enrollment rate. As of July 19, 2022, 18 out of a target of 30 patients were enrolled and we expect to see a further acceleration in recruitment of patients during the second half of the year, which will help to complete enrollment towards the end of 2022, as previously guided.

Lastly, I am also pleased to see the appointment of Peter Nicklin as new Chairman of the Board of Directors. Peter Nicklin brings significant global experience from both non-executive and senior executive roles within the life-science industry at companies such as Baxter, Bayer Healthcare, Novartis and Bristol-Myers Squibb. Peter Nicklin is currently chairman of the boards of Versantis AG (CH), Sciensus Ltd (U.K.), and Tunstall Group Ltd (U.K.). Whilst having spent significant time living and working across the globe, Peter now lives in Europe.

I look forward to keeping you updated on our continued progress with several upcoming and important milestones to be achieved across our platform and franchises as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases."

Conference call details

Hansa Biopharma will host a telephone conference today Tuesday July 19, 2022, 14:00 CET / 8:00am EST.

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentation" and will also be made available online after the call.

On July 19, 2022 ViewRay, Inc. (Nasdaq: VRAY) reported that details relating to the release of its first quarter 2022 financial results (Press release, ViewRay, JUL 19, 2022, View Source [SID1234616781]).

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ViewRay will hold a conference call to discuss results on Tuesday, August 2, 2022 at 4:30 p.m. ET. The dial-in numbers are (646) 307-1952 for domestic callers and (888) 672-2415 for international callers. The confirmation number is 7750966. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until August 16, 2022. The replay dial-in numbers are (800) 770-2030 for domestic callers and (609) 800-9909 for international callers. Please use the conference ID number 7750966.

On July 19, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, and Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has accepted and granted Priority Review designation[1] (in a CDE’s public notice ended on July 18, 2022) to a New Drug Application (NDA) that will support the full approval of olverembatinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) who are resistant and/or intolerant of first- and second-generation tyrosine kinase inhibitors (TKIs) (Press release, Ascentage Pharma, JUL 19, 2022, View Source [SID1234616780]). Following the conditional NDA approval in November 2021, the acceptance for the latest application marks another milestone and will potentially bring olverembatinib to benefit a broader population of patients with CML. Innovent and Ascentage are mutually committed to the commercialization of olverembatinib in the China market.

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In November 2021, the NMPA granted a conditional approval to olverembatinib for the treatment of adult patients with TKI-resistant CML-CP or CML-AP harboring the T315I mutation as confirmed by a validated diagnostic test, thus filling an urgent treatment gap that has long hindered the clinical outcome in Chinese patients with TKI-resistant CML harboring the T315I mutation.

The acceptance and Priority Review designation for this application are based on the results from an open-label, randomized, controlled, confirmatory Phase II pivotal study (study code: HQP1351CC203) which previously served as the basis for a Breakthrough Therapy designation to olverembatinib by the CDE in March 2021. The study is designed to evaluate the efficacy and safety of olverembatinib in patients with CML-CP who are resistant and/or intolerant to first- and second-generation TKIs, with the event-free survival (EFS) as its primary endpoint. A total of 144 patients were enrolled and randomized to either receive olverembatinib or the control group to receive the current best available treatment (BAT). Results show that olverembatinib significantly improved the EFS compared to the control group and has met the pre-specified superiority criteria. Detailed results from this study will be released at an upcoming academic conference.

CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs has significantly improved the clinical practice and management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance and there is an urgent unmet medical need for a safe and effective treatment. Olverembatinib is a potentially global best-in-class drug that has been developed by Ascentage Pharma and supported by the National Major New Drug Discovery and Manufacturing Program in China. As the first and only third-generation BCR-ABL inhibitor approved for the treatment of drug-resistant CML in China, olverembatinib is able to effectively target a spectrum of BCR-ABL mutants, including T315I.

The leading principal investigator of olverembatinib in China, Prof. Xiaojun Huang, MD, Director of the Institute of Hematology, Peking University, Director of the Hematology Department at Peking University People’s Hospital, commented: "The approval for olverembatinib last year has brought a breakthrough therapy for patients with drug-resistant CML harboring the T315I mutation. Meanwhile, many patients who are resistant to first- and second-generation TKIs still lack effective treatment and drug resistance to TKIs and this remains a major clinical challenge in the treatment of CML. In recent years, results from multiple clinical studies have validated olverembatinib’s therapeutic efficacy in CML patients. We hope that the second Priority Review designation granted to olverembatinib will allow more patients with CML to soon benefit from this novel drug."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased about the acceptance and Priority Review designation for the application for olverembatinib, as it will potentially allow a broader population of patients with TKI-resistant CML to benefit from this novel therapeutic. Innovent has established a robust pipeline and franchise in hematology and we are fully committed to bringing forth more ‘high-quality biopharmaceutical products that are affordable to ordinary people’ and serve the unmet medical needs from Chinese patients as early as possible."

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "As an innovative biopharmaceutical company dedicated to addressing the unmet medical needs of patients in China and around the world, Ascentage Pharma is forging ahead with its clinical development programs to allow more patients to benefit from our innovative drugs. Having this application for olverembatinib accepted and granted the Priority Review designation by the CDE highlights the authority’s commitment to filling the treatment gap in patients with drug-resistant CML and its strong recognition of olverembatinib’s therapeutic efficacy. We will work closely with the CDE to bring this innovative therapeutic to more patients as soon as possible."

About Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) is a malignancy caused by the clonal proliferation of hematopoietic stem cell in the bone marrow. Also referred to as chronic myelocytic leukemia, CML is one of the most common subtypes of chronic leukemia, accounting for 15% of all leukemia cases in adults. According to epidemiology data, the onset of CML in Chinese patients happens at a younger age than that in the West; the median age of onset of CML in China is around 45 – 50 years old, while it is 67 years old in the west.

BCR-ABL TKIs have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML, while BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance.

About Olverembatinib

Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China, the orally active, third-generation BCR-ABL inhibitor olverembatinib is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant CML. Olverembatinib can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.

In November 2021, olverembatinib was approved by the NMPA of China for the treatment of adult patients with TKI-resistant CML-CP or CML-AP harboring the T315I mutation as confirmed by a validated diagnostic test. In March 2021, it was granted the Breakthrough Therapy designation by the CDE for the treatment of patients with CML-CP who are resistant and/or intolerant of first- and second-generation TKIs.

In overseas, olverembatinib was cleared by the US FDA in July 2019 to directly enter a Phase Ib study. Since 2018, the clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings for four consecutive years, and was nominated for "Best of ASH (Free ASH Whitepaper)" in 2019. To date, olverembatinib has been granted one Fast Track designation and three Orphan Drug designations from the US FDA for the treatment of CML, acute lymphoblastic leukemia (ALL), and acute myeloid leukemia (AML); and one Orphan Designation from the European Medicines Agency (EMA) of the European Union for the treatment of CML.

In July 2021, Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

*Olverembatinib has not been approved for any indication in the U.S.

On July 19, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that shared news of the publication of two independent, retrospective studies evaluating the use of Axumin (fluciclovine F 18) PET imaging in men with biochemical recurrence of prostate cancer who were undergoing androgen deprivation therapy (ADT) (Press release, Blue Earth Diagnostics, JUL 19, 2022, View Source [SID1234616779]). The first study of 320 men, 68 of whom were on ADT, was published in Urologic Oncology. It showed that there was no difference in the performance of Axumin PET imaging between the patients receiving ADT and the 252 patients not receiving ADT. Both populations had a whole body Axumin positivity rate of 82%, consistent with the patient population and positivity rates of data presented to the U.S. Food and Drug Administration (FDA) for approval of Axumin. The second study, published in Tomography, assessed 71 patients with biochemical recurrence of prostate cancer on ADT for three or more months. It found that there was no difference in Axumin performance and that the length of time on ADT did not influence Axumin detection rates. Axumin, a novel amino acid-based radiopharmaceutical, is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

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"Physicians face challenges in localizing recurrent disease in patients with prostate cancer who experience biochemical failure while on ADT," said Bital Savir-Baruch, MD, Chief of Nuclear Medicine, University of Arizona College of Medicine, Tucson, Ariz. and affiliated with Loyola University, Chicago, Ill. "ADT is known to affect the expression of prostate-specific membrane antigen (PSMA) receptors, and can inhibit the uptake of choline-based agents in patients with androgen-sensitive prostate cancer. The effect of ADT on 18F-fluciclovine imaging has not been well documented in clinical practice. The large retrospective study at Loyola explored its influence on the performance of 18F-fluciclovine in patients with recurrent prostate cancer. These results from the study at Loyola showed that patients with biochemical recurrence of prostate cancer undergoing treatment with ADT have similar 18F-fluciclovine positivity rates as those not on ADT, and the positivity rate increases with increasing PSA levels in both groups."

"We are pleased to note the publication of these clinically relevant studies that illustrate the ongoing interest of the physician community in the role that Axumin molecular imaging can have in guiding informed patient care for men with biochemical recurrence of prostate cancer," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "Blue Earth is the recognized leader in diagnostic PET prostate cancer imaging, and we continue to advance scientific knowledge about the proven clinical utility of Axumin (see Axumin full Indication and Important Information). Our prospective FALCON and LOCATE studies demonstrated that Axumin PET/CT located recurrent disease in the majority of men in the study, which frequently resulted in significant changes to their management plans for biochemical disease recurrence. Notably, Emory University’s independent EMPIRE-1 study (NCT01666808), published in The Lancet, demonstrated that treatment informed by Axumin PET imaging significantly improved event-free-survival for men with recurrent prostate cancer at three and four years. Those results included 30 (38%) patients with recurrent prostate cancer who were on ADT in the Axumin arm."

Dr. Gauden continued, "Axumin PET imaging has informed healthcare decisions for more than 165,000 men with recurrent prostate cancer across the United States, where it is available at more than 1,350 imaging centers and widely reimbursed. Blue Earth Diagnostics is committed to helping patients through innovative diagnostic solutions that empower the evolution of care for men with recurrent prostate cancer, and we look forward to helping even more patients in the future."

Highlights of the publications

"Effect of Hormonal Therapy on 18F-Fluciclovine PET/CT in the Detection of Prostate Cancer Recurrence, Localization of Metastatic Disease and Correlation with Prostate-specific Antigen"
(DOI: View Source)

The study was designed to explore the impact of androgen deprivation therapy (ADT) on the performance of 18F-fluciclovine. A retrospective analysis was conducted to compare the 18F-fluciclovine PET/CT positivity rate in 320 patients with biochemical recurrence of prostate cancer receiving ADT at the time of the scan with the rate achieved in those not receiving ADT. For each group, the number of positive 18F-fluciclovine PET/CT scans (positivity rate) was evaluated for the whole body, prostate/bed, and extraprostatic regions, and rates were correlated with PSA. The 18F-fluciclovine positivity rate was analyzed at the patient level, in the prostate/bed region and at each extraprostatic site (pelvic lymph nodes, extrapelvic lymph nodes, bone and soft tissue or other metastatic sites). Positivity rates were stratified according to whether or not the patient was receiving ADT at the time of scan.

At the time of the 18F-fluciclovine scan, 68/320 (21%) patients were on ADT, while 252/320 (79%) were not. The median Gleason score was 8 (range of 6–10) in the ADT group vs. 7 (range of 6–10) in the non-ADT group. Overall, positivity rates demonstrated no statistical significance between the ADT and non-ADT groups. Positivity rates (ADT vs. non-ADT) were 82% (56/68) vs. 82% (206/252) for the whole body, 57% (39/68) vs. 60% (152/252) for prostate/bed, and 60% (41/68) vs. 53% (133/252) for extraprostatic regions. No significant difference was observed between ADT and non-ADT groups at different PSA levels. The authors cited certain limitations to the study, among them its retrospective nature and lack of histopathological data, and unknown duration of ADT therapy. As stated in the abstract, the authors concluded that "detection of prostate cancer recurrence with 18F-fluciclovine PET/CT is not significantly influenced by ADT, suggesting that localization of disease in patients with detectable PSA who are receiving ADT is feasible with 18F-fluciclovine."1

The manuscript, "Effect of Hormonal Therapy on 18F-Fluciclovine PET/CT in the Detection of Prostate Cancer Recurrence, Localization of Metastatic Disease and Correlation with Prostate-specific Antigen" was published online on June 21, 2022, in Urologic Oncology. It will also appear in an upcoming print issue. Authors on the manuscript were: Jad El Bulbul, Abdulrahman Hashem, Damian Grybowski, Cara Joyce, Essam Rashad, Medhat S. Gabriel, Robert H. Wagner, and Bital Savir-Baruch. All authors are affiliated with Loyola University Medical Center or its Health Sciences Campus, Maywood, Ill. Dr. Savir-Baruch is now affiliated with the University of Arizona College of Medicine, Tucson, Ariz. as well as Loyola University.

"Effect of Androgen Deprivation Therapy on the Results of PET/CT with 18F-Fluciclovine in Patients with Metastatic Prostate Cancer"
(DOI: View Source).

The study was designed to investigate the impact of concurrent ADT on disease detection with 18F-fluciclovine PET in patients with metastatic prostate cancer following primary therapy. Data from 71 patients who had been receiving ADT for at least 3 months at the time of undergoing an 18F-fluciclovine PET/CT scan were retrospectively reviewed. The reasons for the PET/CT scan were rising PSA (n=58), staging of advanced disease (n=4) or therapeutic monitoring (n=9).

Malignant lesions with increased uptake of 18F-fluciclovine were detected in 60/73 (82%) of the scans; 33 (45%) had lesions in the prostate/bed and 46 (63%) in extraprostatic sites. Patients received ADT for a median of 2 years pre-scan. The time on ADT did not influence detection. The detection rates were 89% for patients who had received ADT for < 1 year, 63% for a period of 1 – <2 years, 83% for 2 – 4 years, 78% for > 4 – 10 years and 67% for a treatment period of >10 years. The authors cited certain limitations to the study, including its retrospective nature and lack of histopathological data, and the inability to compare 18F-fluciclovine scans while patients were on ADT and after withdrawal. As stated in the abstract, the authors concluded that "18F-fluciclovine detected recurrent or metastatic lesions in 82% of patients with prostate cancer receiving ADT. The rates achieved are consistent with widely reported data for 18F-fluciclovine PET/CT, suggesting that withdrawal of ADT before scanning is not necessary."2

The manuscript, "Effect of Androgen Deprivation Therapy on the Results of PET/CT with 18F-Fluciclovine in Patients with Metastatic Prostate Cancer" was published in Tomography on June 3, 2022. The manuscript will also appear in an upcoming print issue. Authors on the manuscript were: Tore Bach-Gansmo, Katrine Korsan and Trond Velde Bogsrud. Dr. Bach-Gansmo and Katrine Korsan are affiliated with Oslo University Hospital; Oslo, Norway. Dr. Bogsrud is affiliated with Oslo University Hospital and Aarhus University Hospital, Aarhus, Denmark.

Indication and Important Safety Information About Axumin

INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

On July 19, 2022 Medikine, Inc., a biopharmaceutical company developing transformative therapeutics for cancer, autoimmune disorders, and infectious diseases using its novel PEPTIKINE technology, reported it has initiated dosing of MDK-703, an extended half-life IL-7 mimetic (Press release, Medikine, JUL 19, 2022, View Source [SID1234616778]). The Phase 1 clinical trial, in healthy volunteers, will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single, ascending intramuscular doses of MDK-703 compared to placebo. Top-line results from the clinical trial are expected in the fourth quarter of 2022.

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MDK-703 is the First IL-7 Mimetic to be Studied in Humans

MDK-703 is an investigational biologic drug incorporating an IL-7 PEPTIKINE discovered using Medikine’s platform technology. Medikine’s PEPTIKINES are substantially smaller molecules than the cytokines they emulate, structurally unrelated to natural cytokines, engineered for low immunogenicity, and readily amenable to incorporating targeting and other pharmacological features.

IL-7 is a cytokine critical for the development and maintenance of T cells, including enhancing generation, function, and survival of memory T cells. In oncology, treatments with these biological attributes, alone or in combination with other immune-based therapies, may enhance the rate, depth, and durability of clinical response. In addition to these anti-tumor properties, MDK-703 has the beneficial property that it will not generate anti-drug antibodies (ADAs) that neutralize native IL-7, an issue previously observed with IL-7 agents that have been studied in humans. The company plans to investigate MDK-703 in solid tumors following the completion of the Phase 1 clinical trial in healthy volunteers.

Medikine has shown that MDK-703 behaves similarly to IL-7 in human immune cell in vitro studies and in humanized mice and non-human primates in vivo studies. In addition to increasing the total number of CD8 T cells and CD4 T cells, MDK-703 increased the number of memory T cells, particularly T memory stem (TSCM) cells. TSCM cells are a subset of memory T cells that have the potential to self-renew and differentiate, thereby reconstituting the entire spectrum of memory and effector cell types.1 In addition, MDK-703 had negligible-to-no impact on the expansion of CD4 T regulatory and natural killer (NK) cell populations.

"Based on preclinical data, we believe that MDK-703 has best-in-class potential, with biology consistent with facilitating the differentiation, maintenance, and survival of the T cell subsets that are critical for durable anti-tumor activity in humans. The initial study of MDK-703 in healthy subjects is designed to provide important proof-of-pharmacology that is relevant to cancer treatment, including the impact on specific T-cell populations and the lack of neutralizing IL-7 ADAs," commented Dr. Joseph Leveque, president and chief medical officer of Medikine.

Medikine Applies Expertise in PEPTIKINE Technology to Next-Generation Cytokine Drug Development

Medikine’s founding team of Ronald W. Barrett, Ph.D. (chief executive officer and chairman of the Board), William J. Dower, Ph.D. (scientific advisor), and Michael C. Needels, Ph.D. (chief technology officer), have worked together since the 1990s. They are experts in peptide library technology and its application to the discovery of cytokine receptor agonists and antagonists. Their groundbreaking work at the Affymax Research Institute resulted in the discovery of peptide mimetics of erythropoietin and thrombopoietin. At Medikine, they have been taking this concept to a new level of sophistication and utility by engineering novel PEPTIKINES for multi-subunit cytokine receptors.

As Medikine moves from PEPTIKINE discovery research into clinical development, the company’s leadership team is well prepared with the recent addition of Joseph Leveque, M.D., as president and chief medical officer, and Marcos Milla, Ph.D., as interim chief scientific officer. Dr. Leveque previously has held senior executive and therapeutic area leadership roles at Mirati Therapeutics, Synthorx, ARMO BioSciences, Bristol Meyers Squibb, and Amgen. Dr. Milla is currently a venture partner at Samsara BioCapital and was previously chief scientific officer at Synthorx, head of Therapeutics Discovery at Adaptive Biotechnologies, and head of Emerging Science and Innovation of Janssen Discovery Sciences. Research by Drs. Leveque and Milla at Synthorx to discover and develop a "non-alpha" IL-2 derivative led to Synthorx’s acquisition by Sanofi for $2.5 billion in late 2019.

Dr. Milla commented, "With its versatile drug discovery platform, Medikine is well-positioned to develop transformative therapies for cancer and other serious diseases. I am particularly intrigued by the pharmacology of MDK-703, with its unique action on key T cell memory populations of great importance to find and destroy cancer cells―one that I believe could offer advantages over other cytokine-based therapies in development. I am thrilled to help realize the possibilities of this lead program and the rest of Medikine’s pipeline."

Medikine’s Pipeline of PEPTIKINE Therapeutics

In addition to its lead product candidate, MDK-703, Medikine also has identified novel PEPTIKINES that activate the IL-2/15βγ receptor complex. The company is exploring their use for engineering bispecific cytokine mimetics with differentiated profiles, including an IL-7 and IL-2/15βγ dual receptor agonist, and a cell-targeted IL-2/15βγ attenuated receptor agonist. Medikine also has identified multiple high-affinity peptide ligands for both subunits of the IL-18 receptor that do not bind to the IL-18 decoy soluble receptor. Medikine is exploring the use of these peptide ligands as part of IL-18 PEPTIKINES.