On February 5, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that members of Immunome management will present at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Thursday, February 8 at 9:30 a.m. ET (Press release, Immunome, FEB 5, 2024, View Source [SID1234639856]).

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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

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

On February 5, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in Gynecologic Oncology validating its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in endometrial cancer (Press release, Natera, FEB 5, 2024, View Source [SID1234639855]). The full study can be found here.

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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

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Endometrial cancer (EC) is the most common gynecologic malignancy in the United States. Disease incidence has been rising, but mortality has been rising even faster, potentially due to a higher frequency of aggressive high-risk subtypes of the disease.1-4 More accurate risk stratification is needed to identify those patients who will benefit from therapeutic interventions with curative intent. Current guidelines rely on clinicopathological risk factors to define risk groups and aid in adjuvant treatment decision-making.5,6 However, the decision to administer adjuvant therapy for patients with high-risk and high-intermediate-risk EC remains unclear, creating the need for better diagnostic tools to help determine who is most likely to benefit from treatment.7-10

This real-world study analyzed 267 plasma samples drawn after surgery from 101 patients with EC. The patient cohort was composed of multiple histological subtypes, with patients stratified based on clinicopathological risk factors into high-risk (52%), high-intermediate (22%), low-risk (15%), and other (12%). Key findings include:

Patients who tested Signatera MRD-positive at either a single time point or longitudinally experienced significantly higher rates of recurrence than those who remained Signatera-negative (58% and 52%, vs. 6% and 0%, respectively), regardless of mismatch repair (MMR) or p53 status.
Signatera MRD status was the only significant risk factor for recurrence when adjusted for clinicopathological risk groups and molecular subgroups such as MMR and p53 status (HR=18.9, p=.001).
"This study provides clinical validation of Signatera as a powerful post-surgical biomarker of recurrence risk for patients with endometrial cancer," said Minetta Liu, MD, chief medical officer of oncology at Natera. "Use of Signatera in clinical workflows may help physicians and patients tailor their adjuvant treatment decisions based on direct evidence of molecular residual disease."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.

On February 5, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference being held from February 7-8, 2024 in New York (Press release, Adicet Bio, FEB 5, 2024, View Source [SID1234639853]).

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

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Details of the event are as follows:

Date: Thursday, February 8, 2024
Time: 3:00 p.m. ET

The live audio webcast of the presentation can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On February 5, 2024 Incyte (Nasdaq:INCY) reported that it has entered into an asset purchase agreement with MorphoSys AG (FSE: MOR; NASDAQ: MOR) which gives Incyte exclusive global rights for tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi (tafasitamab-cxix) and outside of the U.S. as Minjuvi (tafasitamab) (Press release, Incyte, FEB 5, 2024, View Source [SID1234639852]).

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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

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"This new agreement with MorphoSys provides Incyte with exclusive global rights to tafasitamab and full control over its development and commercialization, allowing us to realize significant operating efficiencies and cost synergies," said Hervé Hoppenot, Chief Executive Officer, Incyte.

In the previous agreement, MorphoSys and Incyte were collaborating and sharing costs for the clinical development and commercialization of tafasitamab in the U.S.; Incyte had exclusive rights outside of the U.S. Under the terms of the new agreement, MorphoSys will receive a payment of $25 million from Incyte and Incyte will gain global development and commercialization rights for tafasitamab. Incyte will now recognize revenue and cost for all U.S. commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. The agreement is effective immediately.

In addition to its approved indication, tafasitamab is being evaluated as a therapeutic option in ongoing pivotal trials for first-line DLBCL, relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL).

About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19-targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Please see the U.S. full Prescribing Information for Monjuvi for important safety information.

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational uses have not been established in pivotal trials.

Monjuvi and Minjuvi are registered trademarks of Incyte. Tafasitamab is marketed by under the brand name Monjuvi in the U.S., and under the brand name Minjuvi in the EU and Canada.

XmAb is a registered trademark of Xencor, Inc.

On February 5, 2024 Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on February 7, 2024 (View Source) (Press release, Regen BioPharma, FEB 5, 2024, View Source [SID1234639850]).

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

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This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to get through as many of them as possible.

"We plan to use this time to continue to update our shareholders on our fiscal and scientific goals for the upcoming year, introduce a new scientific consultant with public biotech experience who is joining our team, and discuss our continuing progress on our DuraCAR program," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting at 2:20-2:50 Eastern time on Wednesday February 7, 2024. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=d1cd45a6dc&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

About the Emerging Growth Conference
The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.