On November 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the third quarter ended September 30, 2023 (Press release, 2seventy bio, NOV 14, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-third-quarter-financial-results-and-1" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-third-quarter-financial-results-and-1" rel="nofollow">View Source [SID1234637615]).

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"This quarter, 2seventy completed a significant reshaping of our organization, enabling us to advance our pipeline in an efficient and more cost-effective manner. We are also supporting BMS’ efforts to return Abecma to growth through a variety of commercial and medical affairs initiatives, including adding more treatment sites and boots on the ground," said Nick Leschly, chief kairos officer. "Collectively, we believe these measures will give us the ability to continue our mission of delivering time to patients, operate within a more disciplined cost structure and deliver value for our shareholders."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

Third quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $69 million. The decline in third quarter sales was due to increased competition from other BCMA-targeted therapies in addition to the planned manufacturing maintenance in June. The Company anticipates that competitive dynamics will continue to impact Abecma sales in the fourth quarter. Based on year-to-date results and current expectations for the fourth quarter, 2seventy bio does not expect to achieve the original revenue guidance of $470-570 million for 2023.
In order to restore growth in Abecma, BMS and 2seventy bio are focused on rapidly expanding the treating site footprint, competitively differentiating Abecma’s real-world data and safety profile, and educating on treatment sequencing and the emerging data supporting the use of Abecma before T cell engagers and antibody drug conjugates, including those targeting BCMA.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the United States. 2seventy bio reported collaborative arrangement revenue of $0.5 million and $48.0 million for the three months and nine months ended September 30, 2023, respectively.
In September, the Company announced a restructuring of its business operations and research and development model to significantly reduce costs while supporting the execution of a prioritized plan for the long-term growth of the Company. This restructuring is expected to achieve $130+ million savings in 2024-2025 period.
The Company anticipates staying within the previously-guided net cash spend range of $180-220 million for 2023.
2seventy bio ended the third quarter of 2023 with cash, cash equivalents and marketable securities of $284.3 million. While the Company has sufficient cash to fund current planned operations for at least 12 months, we are no longer providing specific cash runway guidance.
"While Abecma performance was impacted due to the evolving competitive landscape, we and our partners at BMS believe in the long-term potential of Abecma to meaningfully impact the lives of multiple myeloma patients. We support BMS’ efforts to improve the commercial performance for the product," said Chip Baird, chief operating officer. "As we gain more visibility to the commercial trajectory for Abecma, we will continue to carefully manage our cash to preserve our financial runway."

SELECTED ABECMA DATA TO BE PRESENTED AT ASH (Free ASH Whitepaper)

Oral Presentation: Idecabtagene Vicleucel (ide-cel) Versus Standard Regimens in Patients (pts) with Triple-Class Exposed (TCE) Relapsed and Refractory Multiple Myeloma (RRMM): Updated Analysis from KarMMa-3
Presenter: Paula Rodriguez-Otero
Date & Time: Monday, December 11, 4:45pm PT

In the final progression-free survival (PFS) analysis from the Phase 3 KarMMa-3 study in patients with RRMM who received 2-4 prior regimens, significantly longer PFS was maintained with ide-cel versus standard regimens. In pts who received ide-cel (n = 225) or a standard regimen (n = 126), median PFS (95% CI) was 15.7 (12.5–18.9) vs 4.4 (3.4–5.8) months, respectively. The ide-cel safety profile was consistent with previous reports, with no parkinsonism or Guillain–Barré syndrome reported. Ide-cel continued to demonstrate durable, clinically meaningful improvements in pt-reported outcomes, including symptoms, functioning, and quality of life (QOL) vs standard regimens. Interim overall survival (OS) will be included in the presentation.

Poster Presentation: Efficacy and Safety of Idecabtagene Vicleucel (ide-cel) in Patients with Clinical High-Risk Newly Diagnosed Multiple Myeloma (MM) with an Inadequate Response to Frontline Autologous Stem Cell Transplantation (ASCT): KarMMa-2 Cohort 2c Extended Follow-up
Presenters: Madhav Dhodapkar; Melissa Alsina
Date & Time: Saturday, December 9, 5:30 – 7:30pm PT

In updated data from the KarMMa-2 cohort 2c study, ide-cel continued to demonstrate deep, durable responses in patients with an inadequate response to frontline ASCT. No new safety signals were observed with extended follow-up, and no deaths were reported. No patients who received lenalidomide maintenance post ide-cel experienced disease progression.

"The updated clinical data to be presented on Abecma reinforces the potential of this therapy to play an important role in earlier lines," said Steve Bernstein, chief medical officer. "In the extended follow-up from the KarMMa-3 study, we saw responses from some patients continue to deepen. The additional data from the KarMMa-2, cohort 2c study is supportive of our registrational KarMMa-9 study in a similar patient population which is now open and enrolling. We look forward to presenting these data at ASH (Free ASH Whitepaper) along with additional sub-analyses that reinforce the impact of Abecma on patient-reported outcomes, quality of life and clinical use."

RECENT UPDATES

MUC16 DATA PRESENTED AT SITC (Free SITC Whitepaper) – In November, 2seventy bio presented new pre-clinical data on its MUC16-targeted CAR T-cell therapy in ovarian cancer, being developed as part of our expanded collaboration with Regeneron, in a poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). These preclinical data support the IND submission for MUC16, which is on track for end of year. The Company recently completed 270-MPH, an in-house clinical drug product manufacturing site, to more effectively support growing U.S. clinical needs. MUC16 will be the first program to be manufactured in this facility.
EXPANSION OF PARTNERSHIP WITH JW THERAPEUTICS – In September, 2seventy bio and JW Therapeutics announced their intention to expand their strategic alliance. The expansion, based on the partnership that was established last year, builds upon the companies’ translational and clinical cell therapy development platform originally designed to more rapidly explore T cell-based immunotherapy therapy products in Greater China. Specifically, the companies intend to add up to two additional candidates from the 2seventy bio portfolio, one in solid tumor indications using T-cell receptor (TCR) based technology and a second in autoimmune disease using a CAR T cell approach.
UPCOMING ANTICIPATED PIPELINE MILESTONES

Submission of an Investigational New Drug (IND) application for MUC16 program in ovarian cancer, being developed in partnership with Regeneron, anticipated by end of 2023.
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023.
SELECT THIRD QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $12.0 million for the three months ended September 30, 2023, compared to $13.4 million for the three months ended September 30, 2022. Total revenues were $89.7 million for the nine months ended September 30, 2023, compared to $35.3 million for the nine months ended September 30, 2022.
Research and development expenses were $51.3 million for the three months ended September 30, 2023, compared to $58.2 million for the three months ended September 30, 2022. Research and development expenses were $179.5 million for the nine months ended September 30, 2023, compared to $188.6 million for the nine months ended September 30, 2022.
Selling, general and administrative expenses were $13.0 million for the three months ended September 30, 2023, compared to $19.6 million for the three months ended September 30, 2022. Selling, general and administrative expenses were $53.2 million for the nine months ended September 30, 2023, compared to $60.7 million for the nine months ended September 30, 2022.
Net loss was $71.6 million for the three months ended September 30, 2023, compared to $67.9 million for the three months ended September 30, 2022. Net loss was $160.7 million for the nine months ended September 30, 2023, compared to $231.0 million for the nine months ended September 30, 2022.

Conference Call Information

2seventy bio will host a conference call and live webcast today, November 14, at 8:00 a.m. ET to discuss 3Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BI2148ebda1eeb4055a857a3dbe4e61710. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.

On November 14, 2023 Astrazeneca reported that PACIFIC-2 Phase III trial for Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival (PFS) versus CRT alone for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, NOV 14, 2023, View Source [SID1234637578]).

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Imfinzi sequentially administered after platinum-based CRT is the established, global standard of care for the treatment of unresectable, Stage III NSCLC based on the results of the PACIFIC Phase III trial. The PACIFIC-2 trial was initiated to evaluate concurrent Imfinzi administration with CRT, with the aim of addressing patients who progress or discontinue treatment during CRT and are therefore ineligible for the PACIFIC regimen.

Initial analysis of the safety and tolerability for Imfinzi and CRT in this patient population showed that the profiles were broadly consistent with the known profiles of these treatments, although there was an increased rate of infection observed during the concurrent treatment period in the experimental arm.

Jeffrey D. Bradley, MD, Vice Chair of Proton Therapy & Technology Development, Penn Medicine, Philadelphia and principal investigator for the trial said: "While the PACIFIC-2 trial results did not show what we hoped, the PACIFIC regimen remains the standard of care for patients with unresectable, Stage III non-small cell lung cancer. As a community, we will take insights from these results to advance future research."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Our goal with the PACIFIC-2 trial was to address a remaining unmet need for patients in this setting by introducing immunotherapy even earlier and concurrently administering Imfinzi with chemoradiotherapy. While today’s results did not reach statistical significance, we will learn from this trial and we remain committed to improving patient outcomes by expanding the benefit of immunotherapy to lung cancer patients across treatment settings."

AstraZeneca has several ongoing registrational trials focused on testing Imfinzi in early stages of lung cancer, including in resectable NSCLC (ADJUVANT BR.31), medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable, Stage III NSCLC (PACIFIC-5, 8 and 9), and in limited-stage small-cell lung cancer (SCLC) (ADRIATIC).

Notes:

Stage III NSCLC
Each year, an estimated 2.2 million people are diagnosed with lung cancer globally.1 Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC, making it the most common form of lung cancer.2-3 Approximately one in three patients with NSCLC are diagnosed at Stage III (locally advanced), where the majority of tumours are unresectable (cannot be removed with surgery).4-5

Stage III NSCLC is divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally.6 In contrast to Stage IV, when cancer has spread to other parts of the body (metastasised), the majority of Stage III patients are currently treated with curative intent.3,6

PACIFIC-2
The PACIFIC-2 trial was a Phase III, randomised, double-blind, placebo-controlled, multi-centre international study of Imfinzi concurrently administered with platinum-based CRT in patients with unresectable, Stage III NSCLC. In the trial, patients were randomised 2:1 to receive a 1,500mg fixed dose of Imfinzi or placebo every four weeks starting at the beginning of definitive CRT. Patients continued to receive Imfinzi or placebo as consolidation treatment after CRT until disease progression.

The trial was conducted at 88 centres across more than 20 countries involving 328 patients. The primary endpoint was PFS, and key secondary endpoints included overall survival, objective response rate and duration of response.

Imfinzi 
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial results which have been confirmed in the real-world setting in the PACIFIC-R study.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial. Additionally, Imfinzi is approved in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial.

In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma in the US, EU, Japan and several other countries based on the TOPAZ-1 and HIMALAYA Phase III trials, respectively. Imfinzi is also approved in previously treated patients with advanced bladder cancer in a small number of countries.

Since the first approval in May 2017, more than 200,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several gastrointestinal cancers and other solid tumours.

In 2023, AstraZeneca announced positive results for several Phase III trials evaluating Imfinzi in various combinations, including in ovarian (DUO-O) and endometrial (DUO-E) cancers with Lynparza (olaparib), gastric and gastroesophageal cancer (MATTERHORN) and resectable NSCLC (AEGEAN).

On November 14, 2023 Astrazeneca reported that Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin) (Press release, AstraZeneca, NOV 14, 2023, View Source [SID1234637577]).

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The approval by China’s National Medical Products Administration (NMPA) was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence, as well as a prespecified exploratory analysis of an additional cohort of patients in China.

BTC is a group of rare and aggressive cancers that occur in the bile ducts (cholangiocarcinoma) and gallbladder.1,2 An estimated 211,000 new patients are diagnosed with gallbladder and biliary tract cancer each year, and nearly one in five patients diagnosed is in China.3,4 These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years.5

Shukui Qin, MD, President of Nanjing Tianyinshan Hospital of China Pharmaceutical University and national leading principal investigator of the trial in China, said: "Over the past decade, there has been little progress in the treatment of advanced biliary tract cancer. However, the successful results of the TOPAZ-1 trial confirmed that durvalumab plus routine chemotherapy has statistically significant and clinically meaningful overall survival and progression-free survival benefits for these patients. This approval provides a new and better option for the treatment of these patients in China."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "With this approval for Imfinzi plus chemotherapy, physicians will now be able to offer this global standard-of-care treatment to patients in China, where nearly one in five patients with biliary tract cancer is diagnosed. This important milestone underscores our commitment to bring innovative medicines that transform survival outcomes to people across the globe living with aggressive gastrointestinal tumours such as biliary tract cancer."

In an interim analysis of the TOPAZ-1 Phase III trial, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021). Median OS was 12.8 months versus 11.5 for chemotherapy. Additionally, efficacy results from a prespecified exploratory analysis in an additional cohort of TOPAZ-1 patients enrolled in China were consistent with those in the overall global trial population, showing Imfinzi plus chemotherapy reduced the risk of death by 22% versus chemotherapy alone (HR of 0.78; 95% CI, 0.51-1.18).

In the TOPAZ-1 trial, Imfinzi plus chemotherapy was generally well tolerated, with no new safety signals observed. Safety results in the cohort of Chinese patients were consistent with results in the overall global trial population.

Imfinzi plus chemotherapy is approved in the US, EU (1st-line), Japan and other countries for the treatment of adults with locally advanced or metastatic BTC. Regulatory applications are also currently under review in several other countries based on the TOPAZ-1 results.

Notes

Biliary tract cancer
BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).1,2

Early-stage BTC affecting the bile ducts and gallbladder often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor.5-7 Cholangiocarcinoma is more common in China and Southeast Asia and is on the rise in Western countries.1,5

TOPAZ-1
TOPAZ-1 was a randomised, double-blind, placebo controlled, multicentre, global Phase III trial of Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st-line treatment in 685 patients with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer. Patients with ampullary carcinoma were excluded.

The primary endpoint was OS and key secondary endpoints included progression-free survival, objective response rate and safety. The trial was conducted in 105 centres across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan and China.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC) in the US, EU, Japan and many other countries based on the HIMALAYA Phase III trial.

In addition to its indications in gastrointestinal (GI) cancers, Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial results, which have been confirmed in the real-world setting in the PACIFIC-R study.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small-cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Additionally, Imfinzi is approved in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. Imfinzi is approved in previously treated patients with advanced bladder cancer in a small number of countries.

Since the first approval in May 2017, more than 200,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several GI cancers, and other solid tumours. In 2023, AstraZeneca announced positive results for Phase III trials including combinations with Imfinzi in ovarian (DUO-O) and endometrial (DUO-E) cancers with Lynparza (olaparib), as well as in resectable NSCLC (AEGEAN) and in liver cancer eligible for embolisation (EMERALD-1). In June 2023, Imfinzi added to standard-of-care neoadjuvant chemotherapy met a key secondary endpoint of pathologic complete responses in the MATTERHORN Phase III trial.

On November 14, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that it will present at the Bell Potter Healthcare Conference, a virtual investor conference that showcases Australia’s leading healthcare companies to institutional investors and Bell Potter’s retail network (Press release, Starpharma, NOV 14, 2023, View Source;mc_eid=bf52dd3418 [SID1234637576]).

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Starpharma will present an overview of the business, with a focus on recent milestones, including the positive clinical data reported for DEP cabazitaxel1 and DEP irinotecan2 in multiple cancers, as well as the positive preclinical data from the DEP radiotheranostics programs.

The Bell Potter Healthcare Conference presentation is appended.

On November 14, 2023 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it will present on several of its programs at the 15th Annual Protein & Antibody Engineering European Summit (PEGS Europe), which runs November 14-16 in Lisbon, Portugal (Press release, Molecular Partners, NOV 14, 2023, View Source [SID1234637575]). The presentation will focus on the multiple ways Molecular Partners has designed DARPins to activate the immune system against cancer only under certain conditions. This conditional activation is intended to focus immune attack more specifically against tumor cells and minimize damage to healthy cells, a major challenge for current oncology drugs and development efforts.

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The presentation consists of a review of several differentiated mechanisms of action that leverage the DARPin platform and conditional activation approaches/MoAs being advanced by Molecular Partners:

MP0317, a CD40 agonist, is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is highly expressed on tumor cells. Positive data from MP0317’s ongoing Phase 1 clinical study in patients with advanced solid tumors was recently presented at the 2023 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
MP0533, a novel tetra-specific DARPin for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (AML/MDS), engages CD3 on T cells and targets three tumor-associated antigens (TAAs) CD33, CD123, and CD70. MP0533 preferentially binds with higher avidity to cells expressing at least two of these three TAAs. This proposed MoA focuses on T cell-mediated preferential killing of AML cells while potentially sparing healthy cells. MP0533 is currently in Phase 1/2a clinical development and initial data will be presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
The SWITCH-DARPin platform, a versatile novel DARPin design for conditionally triggering an immune cell attack only in the presence of defined tumor antigens.
Details of the presentation can be found below. The presentation will be made available on Molecular Partners’ website after the conference.

Title: From Clustering Activated Agonists to SWITCH-DARPins
Presenter: Dr Daniel Steiner, Senior Vice President of Research, Molecular Partners
Agenda section: Engineering: Conditionally Activated Biologics
Timing: Tuesday November 14, 2023, 11:15am GMT

In addition to the conditionally activated DARPin designs referenced above, Molecular Partners continues to progress its Radio-DARPin Therapy (RDT) platform and portfolio of projects, both in-house and in partnership with Novartis. The portfolio of RDT candidates represent a unique delivery system for radioactive payloads to solid tumors and has significantly expanded the company’s work in oncology therapeutics.