On June 30, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Ildong Pharmaceutical, reported an agreement under which Ildong will license a suite of Twist VHH antibody libraries to use to discover and develop antibodies for applications in immuno-oncology (Press release, Twist Bioscience, JUN 30, 2022, View Source [SID1234616416]).

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!

"This collaboration with Twist moves us closer to our vision of becoming a fully global healthcare company while also continuing to drive novel therapies in South Korea through the expansion of our pipeline," said Hongseok Ban, Ph.D. of Ildong Pharmaceutical. "Access to a selection of Twist’s VHH libraries will enable us to complete discovery efforts to select antibody candidates for development as novel immuno-oncology therapies."

"We believe our VHH libraries are extremely versatile in their applications developing novel and next generation therapies. Because they are significantly smaller than a traditional human antibody, they can be combined with other technologies, or used on their own for development of effective therapies," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This VHH library licensing agreement with Ildong is our first collaboration with a South Korea-based company and broadens our presence in the Asia-Pacific region."

Under the terms of the agreement, Ildong will license a suite of Twist’s VHH libraries for a period of three years and will use the libraries to conduct research and development activities. Twist will receive an upfront payment, annual maintenance fees and additional payments for success-based clinical and regulatory milestones as well as royalties on product sales.

VHH Antibody Libraries

Antibodies contain two variable domains, the heavy and the light chains. A VHH antibody, also known as a single domain antibody, is the antigen binding domain of the heavy chain, with three complementary determining regions (CDRs), or areas where antigens bind to the antibody. Twist’s VHH libraries use novel methods that combine synthetic and natural approaches to maximize diversity in the 10 billion antibody library, creating high quality VHH libraries for use against any protein target. The small size of the VHH antibodies allow them to access targets that traditional antibodies cannot, with tight binding affinity. The modular nature of VHH antibodies supports creation of bi- or multi-specific antibodies ideal for developing next generation therapies specific to oncology, autoimmune disease and virology.

About Ildong Pharmaceutical

Ildong Pharmaceutical
Health Research Center for sharing happier lives

As a leading pharmaceutical company in South Korea, Ildong Pharmaceutical has been dedicated and committed to the development and supply of superior pharmaceutical products that contribute to the health and well-being of people around the world. Ildong Pharmaceutical is steadfast in its vision of continuously growing with its customers as a leading global company by providing solutions for disease prevention and developing new solutions for healthier and happier lives.

Ildong Pharmaceutical has earned the trust of our customers with ethical drugs franchise for chronic disease and cancer therapies, antibiotics, and digestive and circulatory drugs, in addition to well-known OTC brands such as Biovita(probiotics product) and Aronamin(multivitamin). Ildong Pharmaceutical is on the road to reaching its vision of becoming a global total healthcare company with various new drug pipelines including Besivo(hepatitis B therapy), which is the 28th novel drug in South Korea, as well as new innovative drug pipelines and new businesses for health functional foods, medical devices, cosmetics, and beverages.

On June 30, 2022 Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that LG Chem Life Sciences (LG Chem), the life sciences division of the South Korean LG Group, has exercised its renewal option as part of the ongoing collaboration with Avacta, triggering a license renewal fee payment to Avacta of $2 million (Press release, LG Chem, JUN 30, 2022, View Source [SID1234616415]).

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!

Under the terms of the agreement, LG Chem has the exclusive rights to develop and commercialise, on a global basis, Avacta’s Affimer PD-L1 inhibitor with Affimer XT serum half-life extension for a range of indications. LG Chem has exercised its license renewal option and will progress the PD-L1/XT candidate by commencing pre-clinical studies which are intended to form the basis of an Investigational New Drug (IND) submission.

In December 2018, Avacta and LG Chem entered into a multi-target development agreement to develop Affimer therapeutics in several disease areas. In 2020 the companies agreed to expand this drug development partnership to include Avacta’s Affimer XT technology, which can be used to control the time a drug spends in the blood.

Dr Alastair Smith, Chief Executive Officer of Avacta, commented: "I am very pleased with the progress being made by our partners LG Chem with the Affimer PD-L1 checkpoint inhibitor programme, which includes the Affimer XT serum half-life extension technology. The initiation of IND enabling studies represents a significant step towards first-in-human clinical trials of the Affimer platform, which is a key value driver for the technology and for Avacta."

On June 30, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it has achieved key business objectives in the first half of 2022 and provided a review of progress with its two clinical stage drug candidates (Press release, Cyclacel, JUN 30, 2022, View Source [SID1234616414]).

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!

"We are highly encouraged by clinical safety and anticancer activity observed with oral fadraciclib monotherapy to date," said Spiro Rombotis, President and Chief Executive Officer. "Based on available information we believe that a favorable tolerability profile, daily dosing and target engagement against CDK2 and CDK9 differentiates fadraciclib as potentially best-in-class. Data collected to date in fifteen patients suggest that fadraciclib may have activity across a range of solid tumors and lymphomas. With respect to our second strategic priority, we are actively advancing development of CYC140, our oral PLK1 inhibitor, and enrolling patients in a registration-directed Phase 1/2 study in solid tumors and lymphomas. We look forward to reporting additional data at our R&D Day in the fall of 2022."

"It is exciting to observe dose-related efficacy signals in certain solid tumors and lymphomas, and in particular endometrial cancer and T-cell lymphoma," noted Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer. "Based on the absence of dose-limiting toxicities at all dose levels, we are adding two dose levels in a protocol amendment to test higher doses of oral fadraciclib before determining the recommended Phase 2 dose which we anticipate in the second half of 2022."

1H 2022 Key Achievements and Corporate Updates

Fadraciclib

Fifteen patients with advanced solid tumors and lymphomas treated with oral fadraciclib at all five dose levels as per protocol in the 065-101 dose escalation study.
Demonstrated evidence of target engagement for CDK2 and CDK9 in cell assay system and patient PK data suggested that these targets are potentially inhibited at 100mg twice daily levels.
A cutaneous T cell lymphoma (CTCL) patient achieved partial response (PR) in the first oral treatment cycle.
A peripheral T cell lymphoma (PTCL) patient achieved 38% reduction in target lesions by PET scan in the first oral treatment cycle.
An endometrial cancer patient achieved stable disease with 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after two and a half years of treatment.
A pancreatic cancer patient achieved stable disease by confirmatory scan for five oral treatment cycles.
As no dose limiting toxicities have been observed, the Company has submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) to escalate to two additional dose levels before determining recommended Phase 2 dose (RP2D).
Based on good tolerability in 065-101, a protocol amendment in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes has enabled acceleration of the study by omitting dose levels two and three and now enrolling at dose level 4.
CYC140

No dose limiting toxicities observed to date in 140-101, a Phase 1/2 study of oral CYC140 in solid tumors.
An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle.
Corporate Updates

The Company is planning an R&D Day in the fall of 2022 to present updated data from the 065-101 and 140-101 clinical trials.
The Company has also submitted an abstract to potentially present fadraciclib data from 065-101 at a cancer conference in the fall of 2022.

On June 30, 2022 Novartis reported that results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status (Press release, Novartis, JUN 30, 2022, View Source [SID1234616413]). Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in patients receiving chemotherapy plus placebo and reduced the risk of death by 34% (hazard ratio=0.66; CI, 0.54-0.80, p<0.0001).1 In collaboration with BeiGene, these data were presented today during a late-breaking oral session at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer (Abstract #LBA-1).

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!

"These data, which show tislelizumab plus chemotherapy extended patients’ lives by a median of more than six months, are a promising outcome in the treatment of this aggressive cancer," said Dr. Ken Kato, Chief of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. "Importantly, the significant overall survival benefit was observed across all patient subgroups in the trial, indicating that tislelizumab plus chemotherapy may be a viable treatment option for patients regardless of their PD-L1 score."

In patients with PD-L1 score ≥10% (secondary endpoint), tislelizumab plus chemotherapy showed a median OS of 16.6 months (CI, 15.3-24.4 months) versus 10.0 months (CI, 8.6-13.0 months) in patients receiving chemotherapy plus placebo and reduced risk of death by 38% (HR=0.62; CI, 0.44-0.86, p=0.0020). In those with PD-L1 score <10% (exploratory analysis), median OS with tislelizumab plus chemotherapy was 16.7 months (CI, 13.0-20.1 months) versus 10.4 months (CI, 9.1-13.0 months; HR=0.72; CI, 0.55-0.94). Survival benefit was consistent across all other subgroups, including race, geographical region and investigator choice of chemotherapy. Tislelizumab plus chemotherapy also significantly improved progression-free survival (7.3 months vs 5.6 months; HR=0.62; CI, 0.52-0.75, p<0.0001) and objective response rate (63.5% vs 42.4%; odds ratio=2.38, p<0.0001).1

"The prognosis for ESCC remains poor, with a five-year survival rate of just five percent, and patients are in need of more treatment options, especially in earlier lines of therapy," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "These results add to the growing body of evidence demonstrating the potential for tislelizumab to help patients with esophageal cancer, and reinforce our commitment to studying tislelizumab alone and in synergistic combinations across additional tumor types that may benefit from an immunotherapy."

The incidence of treatment-related adverse events (TRAEs) was similar in both arms. Most common TRAEs for tislelizumab plus chemotherapy versus chemotherapy were anemia (68% vs 61%), decreased neutrophils (78% vs 80%), decreased white blood cell count (55% vs 65%), decreased appetite (39% vs 38%), nausea (37% vs 42%) and peripheral sensory neuropathy (26% vs 21%).1

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020.2 In the United States, it is estimated there will be more than 20,000 new diagnoses and more than 16,000 deaths from esophageal cancers.3

RATIONALE 306 (NCT03783442) is a multi-regional Phase III, randomized, placebo-controlled, double-blind study of tislelizumab in combination with chemotherapy versus chemotherapy in patients with unresectable, locally advanced recurrent or metastatic ESCC. Approximately 649 study participants were randomized 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy plus placebo. The primary endpoint is OS in the all-comer intent-to-treat population. Secondary endpoints include OS in patients with PD-L1 score ≥10%, progression-free survival, objective response rate, duration of response, health-related quality of life measures and safety.

About Tislelizumab
Tislelizumab is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.

Tislelizumab is a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 17 pivotal clinical trials across a broad array of solid tumors, with more than 9,000 patients enrolled to date in 35 countries and regions. Novartis broad portfolio of advanced therapeutic approaches offer a unique opportunity to study tislelizumab in differentiated, potentially synergistic combinations.

Novartis has the rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene.

On June 30, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo to treat patients with solid and hematologic malignancies, reported that the company will participate in two Hanson Wade summits taking place in July in Boston (Press release, Umoja Biopharma, JUN 30, 2022, View Source [SID1234616411]). Details can be found below.

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!

In Vivo Engineering of Therapeutic Cells Summit held July 12-14, 2022

Umoja’s participation will begin on July 13:

Participation: Panel
Title: Applying In Vivo CAR-T Cell Therapy for Oncology and Beyond
Umoja Speaker: Shon Green, Ph.D., Senior Director, Translational R&D (In-Vivo)
Details: The panel will address how in vivo CAR T-cell therapy obviates current ex vivo bottlenecks including access, efficacy, and toxicity as well as achieving transient versus longer-term effects for different indications.
Time: 12:30 PM ET

Participation: Poster
Title: Preclinical development of UB-VV100, a novel platform for in vivo engineering of therapeutic anti-CD19 CAR T cells
Umoja Speaker: Susana Hernandez Lopez, Scientist
Time: 3:00 PM ET

Umoja’s participation will continue July 14:

Participation: Fireside Chat
Title: In Vivo Engineering of Therapeutic Cells as the Future of Cell and Gene Therapy
Umoja Speaker: Andy Scharenberg, M.D., Co-founder and CEO
Details: The fireside chat will evaluate what has inspired the industry to move from ex vivo to in vivo therapies, outline the advantages and opportunities that in vivo cell and gene therapies offer over current generations, and discuss the next steps to streamline pre-clinical development to fast-track in vivo therapies to the clinic.
Time: 9:15 AM ET

Participation: Oral Presentation
Title: In Vivo Approaches to Generate CAR T Cells Engineered to Mediate Durable Antitumor Responses
Umoja Speaker: Ryan Larson, Ph.D., Vice President, Head of Immunology
Details: The presentation will cover how manufacturing complexities limit patient access to autologous CAR T-cell products, the ability of Umoja’s VivoVec off-the-shelf lentiviral vector platform to enable efficient generation of functional CAR T-cells in vivo, and how the approach can be applied to target both hematological and solid tumor cancers.
Time: 11:30 AM ET

iPSC Manufacturing Summit from July 26-28, 2022

Umoja’s participation will begin on July 28:

Participation: Oral Presentation
Title: Engineering iPSCs with Synthetic Receptors to Drive Differentiation Compatible with Scale-Up
Umoja Speaker: Teisha Rowland, Ph.D., Principal Scientist, iPSC Team Lead
Details: The presentation will cover how iPSCs can more efficiently be differentiated into functional, persistent immune cell types by genetically engineering iPSCs to express a synthetic cytokine receptor, how differentiation can be performed in suspension to make it compatible with efficient scale-up production, and how the overall approach may be used in a manufacturing setting to drive high-purity immune cell production.
Time: 11:45 AM ET