Tyra Biosciences to Participate at 2023 Cantor Global Healthcare Conference

On September 12, 2023 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that management will participate at the 2023 Cantor Global Healthcare Conference, taking place September 26-28, 2023, in New York, NY (Press release, Tyra Biosciences, SEP 12, 2023, View Source [SID1234635116]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Todd Harris, CEO of TYRA, will participate in a fireside chat on Wednesday, September 27, 2023, at 10:20 am ET.

A live and archived webcast of the fireside chat will be available via the For Investors page on the Investor section of the TYRA website.

European Medicines Agency Validates Type II Variation for Astellas’ XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

On September 12, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy (Press release, Astellas Pharma, SEP 12, 2023, View Source [SID1234635115]).

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas
"As the most commonly diagnosed cancer in men in Europe, prostate cancer impacts hundreds of thousands of patients across the continent, and for those who have received initial curative treatment, a risk remains that their cancer may return in the form of biochemical recurrence. These patients, particularly those with rapidly rising PSA levels, need new therapeutic approaches. The validation of the Type II variation by the EMA marks an important step toward potentially making XTANDI, an existing standard of care for advanced prostate cancer in the E.U., available to patients with earlier stages of the disease who are at risk of their cancer spreading."

Submission to the EMA was supported by data from the international Phase 3 EMBARK trial, which evaluated the safety and efficacy of XTANDI in patients with nmHSPC with high-risk BCR across three study arms: XTANDI plus leuprolide (n=355), placebo plus leuprolide (n=358), or XTANDI monotherapy (n=355).

The EMBARK study met its primary endpoint of metastasis-free survival (MFS) for the XTANDI plus leuprolide arm, demonstrating a statistically significant reduction in the risk of metastasis or death over placebo plus leuprolide. Detailed results from the trial were presented as a plenary session during the 2023 American Urological Association Annual Meeting on April 29.

The overall safety profile was consistent with the known safety profile of each of the medicines. XTANDI, either in combination with leuprolide or as a monotherapy, has not been approved by any regulatory agency for the treatment of patients with nmHSPC with high-risk BCR.

The EMBARK data are being discussed with other regulatory authorities around the world, including the U.S. Food and Drug Administration (FDA), to support additional license applications for XTANDI in this indication in 2023 and beyond.

Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2024.

About EMBARK
The Astellas- and Pfizer-led Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with nmHSPC with high-risk BCR at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered to experience high-risk BCR had a prostate-specific antigen doubling time (PSA-DT) ≤ 9 months; serum testosterone ≥ 150 ng/dL (5.2 nmol/L); and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer, or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide (n=355), enzalutamide 160 mg as a monotherapy (n=355), or placebo plus leuprolide (n=358). Leuprolide 22.5 mg was administered every 12 weeks.

The primary endpoint of the trial was MFS for enzalutamide plus leuprolide versus placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death due to any cause, whichever occurred first. For more information on the EMBARK trial (NCT02319837), go to www.clinicaltrials.gov.

XTANDI, either in combination with leuprolide or as a monotherapy, has not been approved by any regulatory agency for the treatment of patients with nmHSPC with high-risk BCR.

About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
In non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC), no evidence of the cancer spreading to distant parts of the body (metastases) is detectable with conventional radiological methods (CT/MRI), and the cancer still responds to medical or surgical treatment designed to lower testosterone levels.1,2 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a BCR within 10 years.3 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence.4 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC and high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA-DT ≤ 9 months. High-risk BCR patients with a PSA-DT of ≤ 9 months have a higher risk of metastases and death.5

About XTANDI (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC; also known as metastatic castration-sensitive prostate cancer or mCSPC), metastatic castration-resistant prostate cancer (mCRPC), and non-metastatic castration-resistant prostate cancer (nmCRPC). XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the U.S., European Union, and Japan. Over one million patients have been treated with XTANDI globally.[6]

About XTANDI (enzalutamide) in the E.U.
Enzalutamide is an androgen receptor signaling inhibitor indicated in the E.U. for the treatment of adult men with:

Metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC) in combination with androgen deprivation therapy (ADT).
High-risk non-metastatic castration-resistant prostate cancer (CRPC).
Metastatic CRPC who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated. It is also indicated in adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Important Safety Information
For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: View Source

Important Safety Information
For Important Safety Information for enzalutamide please see the Package Insert.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


MorphoSys Receives U.S. FDA Fast Track Designation for Tulmimetostat in Endometrial Cancer

On September 12, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, the company’s investigational next-generation dual inhibitor of EZH2 and EZH1, for the treatment of patients with advanced, recurrent or metastatic endometrial cancer harboring AT-rich interacting domain containing protein 1A (ARID1A) mutations and who have progressed on at least one prior line of treatment (Press release, MorphoSys, SEP 12, 2023, View Source [SID1234635113]). The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines intended to treat serious conditions and potentially address an unmet medical need, with the goal of getting these important, new therapies to patients earlier.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tulmimetostat was designed to improve on first generation EZH2 inhibitors through increased potency, longer residence time on target and a longer half-life, offering the potential for enhanced anti-tumor activity. The Fast Track designation in endometrial cancer was granted based on preclinical results and preliminary clinical data from an ongoing Phase 1/2 study. This study is investigating tulmimetostat as a monotherapy in patients with advanced solid tumors or lymphomas, including ARID1A-mutated endometrial carcinoma and ovarian clear cell carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer. Updated results were presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.

"Receiving Fast Track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores this investigational therapy’s potential in a patient population with limited treatment options," said Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and Development Officer. "The preliminary results from our Phase 1/2 study of tulmimetostat are very promising. We will continue to generate data from this study across tumor types to inform our future development plans for tulmimetostat, both as a monotherapy and in combination with other treatments."

Tulmimetostat is MorphoSys’ third clinical program to receive Fast Track designation from the FDA. Pelabresib, an investigational BET inhibitor, received Fast Track designation for myelofibrosis in 2018, and tafasitamab, a CD19-targeting immunotherapy, received this designation for relapsed or refractory diffuse large B-cell lymphoma in 2014.

MOLECULAR PARTNERS PRESENTS NEW DATA ON ITS RADIO DARPIN THERAPY (RDT) PLATFORM AT THE EANM 2023 ANNUAL MEETING

On September 12, 2023 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biopharmaceutical company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported new data from its Radio-DARPin Therapy (RDT) platform pertaining to potential efficacy of the approach and building on prior engineering achievements that boosted its renal safety profile (Press release, Molecular Partners, SEP 12, 2023, View Source [SID1234635112]). These data will be presented at the European Association of Nuclear Medicine (EANM) Annual Meeting, held September 9–13 in Vienna, Austria and can be accessed here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The data show the ability of Molecular Partners to substantially increase tumor uptake of RDT candidates through an adjustment of systemic half-life, achieved by binding to the common blood protein serum albumin. These results build on preclinical data, previously reported at AACR (Free AACR Whitepaper) and SNNMI in 2023, demonstrating how DARPin engineering can achieve a marked reduction of candidate reabsorption by the kidney, addressing a key challenge for protein-based radionuclide delivery vectors.

"We have previously discussed what is required for the successful expansion of DARPins as a targeting moiety for radiotherapy, including protection of kidneys, tumor accumulation, and the ability to apply these learnings broadly across the platform. With today’s data we show that tuning of half-life can substantially impact the tumor uptake of our Radio DARPins," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Importantly, we are highly encouraged by the data showing that these techniques can be applied across the platform and utilized as we explore multiple targets in the field, including novel targets potentially less amenable to other approaches."

In summary, the presented results highlight that a desirable tumor to kidney ratio can be achieved for RDTs while also keeping circulating blood levels low to further support a robust efficacy-to-safety profile. The engineering solutions applied to optimize the properties of the RDT platform are transferrable to different tumor-associated antigens. These results present a unique opportunity to explore new targets of interest and thereby potentially further expand the target space for radioligand therapy.

Molecular Partners continues to progress its RDT platform and portfolio of projects, both in-house and in partnership with Novartis. The tumor-associated protein Delta-like ligand 3 (DLL3) has been selected as one of the first targets of Molecular Partners’ proprietary RDT program.

The presentation details are as follows:

Title: DARPin platform for the development of powerful targeting agents for radioligand therapy
Session Title: M2M Track – TROP Session: New Therapeutic Radiopharmaceuticals
Session Number: 1804
Abstract Number: OP-897
Session Location & Timing: Hall E2; Sept 13, 2023; 9:45–11:15 am local time (CEST)
Order in Session: 3
Presentation Time: 10:05–10:15 am local time (CEST)

XENOTHERA granted orphan drug designation (ODD ) from the FDA for LIS1 in the treatment of T-lymphomas.

On September 12, 2023 XENOTHERA reported that R&D teams have demonstrated, in vitro and in vivo, the efficacy of LIS1 treatment on several T lymphomas (Press release, Xenothera, SEP 12, 2023, View Source [SID1234635110]). Given the heterogeneity of this disease, XENOTHERA’s researchers have explored the potential of LIS1 on different subtypes and shown that up to 90% of patients’ tumors are likely to be sensitive to LIS1. XENOTHERA’s antibody thus represents a new therapeutic hope for T lymphoma patients, whose prognosis is particularly unfavorable.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Orphan drug designation is a major step, as formal confirmation by a regulatory agency; by its decision, the FDA affirms the therapeutic interest of a future drug for patients for whom no treatment is available. In addition to this external confirmation of the biotech’s results and strategy, the ODD will enable XENOTHERA’s LIS1 to benefit from free and accelerated regulatory processes, tax advantages and a 7-year marketing exclusivity once the market authorization is obtained.

"Recognition of the quality and therapeutic value of a drug candidate is always an important milestone for a biotech. Here, the analysis of our data by the FDA confirms the soundness of our strategy in the field of cancer, onco-hematology for LIS1, and solid tumors for XON7. We are more than happy to bring new hope to T lymphoma patients, for whom the treatments available today are unfortunately of limited efficacy. LIS1 will be an additional weapon in the arsenal of treatments available to hematologists, who are keenly interested in innovative therapies such as XENOTHERA’s. The first clinical trial in T-lymphoma is scheduled early 2024; this ODD confirms the importance of moving forward, for the good of patients, and we will put all our energy into making the treatment available to patients as quickly as possible," comments Odile Duvaux, President and co-founder of XENOTHERA.

About T lymphomas:

T lymphomas are a heterogeneous group of pathologies, divided into several categories: primary cutaneous, peripheral lymph node, leukemic and extra-lymph node. Depending on their molecular structure, they are classified into several sub-categories, all belonging to the "non-Hodgkin’s lymphoma" class. Treatment approaches and prognosis vary according to subcategory. In the USA, they account for 15% of non-Hodgkin’s lymphomas, or around 12,000 new cases per year. In France, they are estimated to account for around 1% of all cancers. Their course is generally aggressive. About LIS1: LIS1 is a humanized polyclonal antibody (GH-pAb) from XENOTHERA’s platform, in development since 2014, targeting lymphocyte antigens. It is presented as a solution for intravenous administration. LIS1 was introduced in human in 2019, with a first exploratory clinical trial in kidney transplant patients in Europe, completed in 2022. This trial confirmed the product’s safety. LIS1 first indication is the prevention of acute rejection in solid organ transplantation, for which an ODD has already been granted by the FDA and EMA. T lymphomas represent a second indication for the product. The first LIS1 clinical trial in T lymphoma is scheduled early 2024.