On October 16, 2023 Synaffix B.V., a Lonza company (SIX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported to have entered into a licensing agreement with SOTIO Biotech (SOTIO), a clinical stage immuno-oncology company owned by PPF Group (Press release, Synaffix, OCT 16, 2023, View Source [SID1234636016]).

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SOTIO will gain access to Synaffix’s ADC technologies, GlycoConnect, HydraSpace and toxSYN linker-payloads, in an initial ADC program with the option to expand research and commercial licenses into two additional programs at a later date.

Under the terms of the agreement, Synaffix will be eligible to receive up to $740 million in payments spanning signature, target nomination and milestone payments plus additional royalties on commercial sales. SOTIO will be responsible for the research, development, and commercialization of the ADCs. Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary technologies.

Peter van de Sande, Head of Synaffix, said: "The selection of our ADC technologies by a seasoned ADC player like SOTIO is a strong recognition of the potential of these technologies to maximize the therapeutic index of ADCs. We look forward to partnering with SOTIO, and believe that with their singular focus on cancer immunotherapies and robust clinical pipeline, this partnership can deliver innovative medicines for patients in areas of high unmet medical need."

Radek Spisek, Chief Executive Officer of SOTIO, said: "At SOTIO, we are building a broad pipeline of next-generation ADCs to address the challenges of solid tumors – and access to Synaffix’s ADC platform technologies will ensure we remain at the leading edge of this space. This collaboration combining SOTIO’s deep expertise in solid tumor drug development with Synaffix’s clinical-stage platform technology will drive important new innovations for the benefit of patients."

Synaffix was fully acquired by Lonza in June 2023 and represents a newly formed ‘Center of Excellence’ for bioconjugation. As a Lonza company, Synaffix will continue to operate under the Synaffix name and further expand its operations in Oss (NL) to cater for further innovation and growth.

On October 16, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the company will have five presentations and one poster at the 14th Annual World ADC Conference, taking place in San Diego, October 16-19, 2023 (Press release, Sutro Biopharma, OCT 16, 2023, View Source [SID1234636015]).

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Presentation Details:
Development of Next Generation ADCs Using Novel Expression Platforms & Precise Conjugation
Presenter: Gang Yin
Date/Time: October 17, 2023, 12:00pm PT

Discovery of Novel Linker Payloads for Site-Specific ADCs with Improved Efficacy & Therapeutic Index
Presenter: Krishna Bajjuri
Date/Time: October 17, 2023, 2:00pm PT

Precision Engineering for Enhanced Therapeutic Index: Designing STRO-004, a Tissue Factor Targeted ADC for Broadened Efficacy & Safety
Presenter: Alice Yam
Date/Time: October 17, 2023, 5:30pm PT

Stress Free ADC Production with Cell-Free Technology
Presenter: Ganesh Vissvesvaran
Date/Time: October 18, 2023, 12:00pm PT

Preclinical Development of STRO-003, a ROR1 Targeting Antibody-Drug Conjugate for Treatment of Hematologic & Solid Cancers
Presenter: Helena Kiefel
Date/Time: October 18, 2023, 2:00pm PT

Poster Details:
Site-specific Dual Conjugation Enabled by an Integrated in vivo / in vitro Antibody Production Platform
Presenter: Miao Wen
Date/Time: October 17, 2023, 6:00pm PT

Following the event, the content will be made available in the Clinical/Scientific Presentation and Publication Highlights section of Sutro Biopharma’s website at www.sutrobio.com.

On October 16, 2023 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that the Company will deliver a corporate presentation at the upcoming ThinkEquity Conference (Press release, Soligenix, OCT 16, 2023, View Source [SID1234636014]). The conference will be held October 19, 2023 with presentations, one-on-one meetings, and networking. For more information about The ThinkEquity Conference, please refer to the conference website at View Source

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Key members of Soligenix management will hold one-on-one meetings throughout the conference. Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling platform.

If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected].

On October 16, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported positive initial topline data at the 45 mg (safety) dose level from its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies (Press release, Sellas Life Sciences, OCT 16, 2023, View Source [SID1234636013]). Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.

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A total of five patients with r/r AML who failed venetoclax-based therapies have been enrolled to date at the 45 mg dose level. The first patient enrolled in the study achieved a complete response, remains alive and is currently in the fifth month of treatment after relapsing on venetoclax, and the second patient is alive and in the fourth month of treatment. All patients enrolled were alive at the time of their last follow-up and four continue treatment. Anti-leukemic effects have been observed in all patients without any significant safety issues to date. Patients with AML that fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival (mOS) of approximately 2.5 months.

"This outcome may represent a long-awaited breakthrough in treating patients refractory to venetoclax combination therapies after multiple lines of treatment," said Dr. Omer Jamy, a principal investigator in the study and Assistant Professor of Medicine at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) and Associate Director of the Bone Marrow Transplant Program at UAB. "Almost all older AML patients in the United States are treated with venetoclax combinations at some point during their course of treatment and, unfortunately, the majority of them become resistant to venetoclax with limited options thereafter. Survival of those patients with currently available treatment options is approximately 2.5 to 3 months. Based on what we have seen to date in this Phase 2a study of SLS009, we have managed to reverse this resistance to therapy and, equally important, extend survival in addition to a very good safety profile and quality of life. I hope to see continuation of this pattern in other patients enrolled later."

"This initial outcome that includes a complete response, anti-leukemic activity in all patients, good safety profile across the patients and indications of extended survival for our enrolled patients still continuing treatment, we believe opens multiple registrational opportunities for SLS009. We will be exploring these options in the coming weeks as we treat patients with the recommended Phase 2 dose, 60 mg, in this study," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "While these results are early, they are extremely encouraging and consistent with the Phase 1 study results, and further strengthen our initial proposition that the addition of CDK9 inhibition in combination with BCL-2 inhibition and hypomethylating agents could provide patients with a triple hit to increase response rates and survival outcomes without sacrificing safety and tolerability due to the specificity of SLS009. We look forward to providing additional updates this quarter from this study."

The Phase 2a clinical trial of SLS009 is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels, 45 mg and 60 mg, in combination with aza/ven. In addition to safety and tolerability of SLS009 in combination with aza/ven, the primary endpoints are composite complete response rate (CRc) and duration of response (DOR). Additional endpoints include event free survival (EFS), overall survival (OS), and pharmacokinetic (PK) and pharmacodynamic (PD) assessments.

SLS009 was recently granted orphan drug designation by the U.S. Food and Drug Administration in AML supported by the data from the Phase 1 study of SLS009 as a monotherapy that met all key study objectives. In the Phase 1 study one patient with AML achieved a complete response, making SLS009 the first CDK9 inhibitor to achieve a complete response in r/r AML as a monotherapy and remained alive for 11 months as of the last follow up. Among the 31 Phase 1 AML patients, 29 out of 31 (94%) patients were alive as of their May 2023 follow-up.

On October 16, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported positive initial topline data at the 45 mg (safety) dose level from its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies (Press release, Sellas Life Sciences, OCT 16, 2023, View Source [SID1234636013]). Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.

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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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A total of five patients with r/r AML who failed venetoclax-based therapies have been enrolled to date at the 45 mg dose level. The first patient enrolled in the study achieved a complete response, remains alive and is currently in the fifth month of treatment after relapsing on venetoclax, and the second patient is alive and in the fourth month of treatment. All patients enrolled were alive at the time of their last follow-up and four continue treatment. Anti-leukemic effects have been observed in all patients without any significant safety issues to date. Patients with AML that fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival (mOS) of approximately 2.5 months.

"This outcome may represent a long-awaited breakthrough in treating patients refractory to venetoclax combination therapies after multiple lines of treatment," said Dr. Omer Jamy, a principal investigator in the study and Assistant Professor of Medicine at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) and Associate Director of the Bone Marrow Transplant Program at UAB. "Almost all older AML patients in the United States are treated with venetoclax combinations at some point during their course of treatment and, unfortunately, the majority of them become resistant to venetoclax with limited options thereafter. Survival of those patients with currently available treatment options is approximately 2.5 to 3 months. Based on what we have seen to date in this Phase 2a study of SLS009, we have managed to reverse this resistance to therapy and, equally important, extend survival in addition to a very good safety profile and quality of life. I hope to see continuation of this pattern in other patients enrolled later."

"This initial outcome that includes a complete response, anti-leukemic activity in all patients, good safety profile across the patients and indications of extended survival for our enrolled patients still continuing treatment, we believe opens multiple registrational opportunities for SLS009. We will be exploring these options in the coming weeks as we treat patients with the recommended Phase 2 dose, 60 mg, in this study," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "While these results are early, they are extremely encouraging and consistent with the Phase 1 study results, and further strengthen our initial proposition that the addition of CDK9 inhibition in combination with BCL-2 inhibition and hypomethylating agents could provide patients with a triple hit to increase response rates and survival outcomes without sacrificing safety and tolerability due to the specificity of SLS009. We look forward to providing additional updates this quarter from this study."

The Phase 2a clinical trial of SLS009 is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels, 45 mg and 60 mg, in combination with aza/ven. In addition to safety and tolerability of SLS009 in combination with aza/ven, the primary endpoints are composite complete response rate (CRc) and duration of response (DOR). Additional endpoints include event free survival (EFS), overall survival (OS), and pharmacokinetic (PK) and pharmacodynamic (PD) assessments.

SLS009 was recently granted orphan drug designation by the U.S. Food and Drug Administration in AML supported by the data from the Phase 1 study of SLS009 as a monotherapy that met all key study objectives. In the Phase 1 study one patient with AML achieved a complete response, making SLS009 the first CDK9 inhibitor to achieve a complete response in r/r AML as a monotherapy and remained alive for 11 months as of the last follow up. Among the 31 Phase 1 AML patients, 29 out of 31 (94%) patients were alive as of their May 2023 follow-up.