On April 20, 2023 Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable, precision radiopharmaceuticals for cancer, reported that it has raised $142 million in combined Series A and B financing (Press release, Abdera Therapeutics, APR 20, 2023, View Source [SID1234630376]). Versant Ventures and Amplitude Ventures led the Series A round, with participation from Northview Ventures as well as founding partners of Abdera, adMare BioInnovations and AbCellera. The Series B round was led by venBio Partners with participation from existing investors as well as new investors including Viking Global Investors, Qiming Venture Partners USA and RTW Investments.

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"Radiopharmaceuticals hold the potential to transform the treatment of cancer, but the ability to finely tune radioisotope delivery to the tumor, while sparing healthy tissue, remains a major challenge for this class of drugs," said Lori Lyons-Williams, president and chief executive officer. "Abdera’s ROVEr platform enables the design of antibody-based radiopharmaceuticals that are ideally suited to specific cancer targets with optimized PK properties to pair with a radioisotope of choice and maximize therapeutic impact. Our goal is to leverage the power and flexibility of our platform to pursue a variety of oncology targets, advance potential best-in-class new cancer medicines and build Abdera into a leading radiopharmaceutical company."

Engineering the Future of Precision Radiopharmaceuticals

Current radiopharmaceutical targeting approaches leverage either small ligands or large proteins. While small ligands may lead to rapid tumor penetration and elimination, they are often associated with low total tumor accumulation, high renal uptake, and kidney toxicity. Large formats, often using existing antibodies not designed specifically for radiopharmaceutical therapy, may avoid renal uptake, but their large size and long half-life in circulation may limit tumor penetration and cause systemic irradiation potentially leading to bone marrow toxicities. The therapeutic index is not ideal with either approach.

Abdera’s Radio Optimized Vector Engineering (ROVEr) platform allows the company to design novel antibody-based radiopharmaceuticals with high affinity antigen binding domains to cancer targets and an engineered Fc domain that fine tunes the antibodies’ PK to best suit the delivery of therapeutic isotopes. Abdera aims to optimize the therapeutic index of potent radioisotopes emitting alpha or beta particles to selectively destroy tumor cells while sparing healthy cells, providing patients with potentially transformative new cancer treatments.

"We design our targeting molecules as heavy-chain-only antibodies, which we believe are the optimal size to achieve an ideal balance of target specificity, tumor penetration and accumulation of the radioisotope while avoiding high renal uptake," said Adam Judge, Ph.D., co-founder and senior vice president, research. "Our modular format offers the ability to fuse novel antigen binding domains designed for any cancer target of interest to an engineered Fc domain, rapidly creating antibodies with appropriate PK for radiopharmaceutical development. Abdera has generated promising proof-of-concept data in a variety of tumor models, leveraging a platform that provides an excellent foundation upon which to build a differentiated pipeline of potential best-in-class programs."

"Versant has been an early mover in the emerging radiopharmaceutical field, and we believe that Abdera’s approach represents a new wave of innovation in this space to address important cancer targets that may be intractable to other approaches," said Joel Drewry, Ph.D., principal at Versant Ventures. "We’re excited to be working with an exceptional management team and investor syndicate to advance the company’s cutting-edge technology."

Lead Program Targeting DLL3 Advancing Toward Clinic

Abdera’s lead program targets delta-like ligand 3 (DLL3), a protein in the Notch pathway that is upregulated and specifically expressed in small cell lung cancer (SCLC) and other solid tumors, with very rare expression on nonmalignant cells. The company’s DLL3 program is advancing through preclinical development, and Abdera expects to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2024. In addition, Abdera is advancing a robust pipeline for other undisclosed cancer targets.

"DLL3 is a well-validated target for SCLC, a cancer with few treatment options," said Yvonne Yamanaka, Ph.D., principal, venBio Partners. "Radiopharmaceuticals from Abdera’s ROVEr platform have the potential to address DLL3 and other tumor antigens that have been challenging to optimally target with conventional modalities due to low levels of expression. We look forward to working with Abdera to advance the company’s DLL3 program into the clinic and develop new radiopharmaceuticals for other cancers with high unmet need."

Purpose-Built Team

Abdera is led by an exceptional team of scientists and company builders with demonstrated track records in drug development spanning oncology, radiopharmaceuticals and biologics.

"Abdera is curating an ideal team to build a leading radiopharmaceutical company, spanning members with deep expertise in biologics and radiochemistry and experience developing one of the most commercially successful radiopharmaceuticals to launch in recent years," said Nancy Harrison, venture partner at Amplitude Ventures. "We are pleased to have worked with the company’s talented co-founders to grow Abdera and we look forward to what this team can achieve.

Abdera’s executive team includes:

Lori Lyons-Williams, president and chief executive officer
Adam Judge, Ph.D., co-founder and senior vice president, research
Lana Janes, Ph.D., co-founder and senior vice president, operations and innovation
Michael Abrams, Ph.D., co-founder and senior advisor
Kawa Chiu, chief technical officer
Jennifer McNealey, chief financial officer
Alison Armour, M.D., FRCR, FRCP, interim chief medical officer
Kelly Parker, senior vice president, human resources
Abdera’s board of directors includes:

Garry Nicholson, independent director and chairman of the board
Joel Drewry, Ph.D., principal, Versant Ventures
Nancy Harrison, venture partner, Amplitude Ventures
Maria Koehler, M.D., Ph.D., chief medical officer, Repare Therapeutics
Colin Walsh, Ph.D., partner, Qiming Venture Partners USA
Yvonne Yamanaka, Ph.D., principal, venBio Partners
Lori Lyons-Williams, president and chief executive officer

On April 20, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported preliminary survival data in the Part A safety lead-in of its ongoing phase 2 trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, APR 20, 2023, View Source [SID1234630375]).

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The first 2 patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therapy respectively after previously failing treatment with an immune checkpoint inhibitor.

As previously reported, the first 6 evaluable patients in Part A of THIO-101 cleared the THIO high dose (THIO 360 mg per cycle (120 mg on Days 1-3 Q3W) followed by the standard 350 mg dose of cemiplimab on Day 5) with no dose limiting toxicities. Treatment has been generally well tolerated and enrollment is underway in Part B. As of now, the first 2 patients continue to be progression free following their last dose, 7 and 6 months respectively, with no new treatment.

"The current treatment options in patients with advanced relapsed or refractory NSCLC who failed two or more therapy regimens are limited and show minimal benefit. Furthermore, discontinuation of treatment is rapidly followed by physical decline and death, therefore seeing patients with such survival and no disease progression in this clinical setting, is noteworthy," says MAIA’s Chief Medical Officer Mihail Obrocea.

"This observation may correlate well with the evidence of induction of innate and adaptive immune responses seen in the preclinical models of lung cancer, where only three doses of THIO followed by an immune checkpoint inhibitor resulted in long-lasting complete tumor regression with no recurrence," says MAIA’s Chief Scientific Officer, Sergei Gryaznov.

"In real-world clinical practice, observed survival in such heavily pretreated patients is 3-4 months. These preliminary survival results are very encouraging for patients with lung cancer," added Vlad Vitoc, MAIA’s Chief Executive Officer.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab). Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On April 20, 2023 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a collaboration with Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura., "Astellas"), by which Astellas will license a suite of Twist’s VHH antibody libraries to be used by Astellas for drug discovery and development (Press release, Twist Bioscience, APR 20, 2023, View Source [SID1234630374]).

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"We are pleased to extend our collaboration with Astellas to three agreements across two groups within the company, showcasing our ability to meet the varying needs of our customers and support their success," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This latest collaboration with Astellas demonstrates how Twist can enable our customers to grow their pipelines both externally with our antibody discovery services and by supporting their internal discovery with our highly specific and potent antibody libraries."

Under the terms of the agreement, Astellas will license a suite of Twist’s VHH libraries for a period of five years and will use the libraries to conduct research and development activities. Twist will receive an upfront payment and will be eligible to receive annual maintenance fees and fees per product through payments associated with specific clinical and commercial milestones. Twist will also be eligible to receive royalty payments on product sales.

Twist 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 up to 10 billion for each 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. During the pandemic, Twist published on the use of these libraries to neutralize SARS-CoV-2 (MAbs. 2022; 14(1): 2002236).

On April 20, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported the first patient has been dosed at City of Hope in a Phase 1 clinical trial of JANX008 in subjects with advanced or metastatic solid tumors including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma (Press release, Janux Therapeutics, APR 20, 2023, View Source [SID1234630373]). JANX008 is an epidermal growth factor receptor (EGFR) directed T cell engager (TCE) and is the second product candidate utilizing Janux’s TRACTr platform to be administered in humans.

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"We are excited to initiate the clinical evaluation of our second product candidate from our TRACTr platform. JANX008 is designed to achieve tumor-selective T-cell activation and tumor killing while sparing healthy tissues," said Wayne Godfrey, M.D., Chief Medical Officer at Janux. "Our preclinical data with JANX008 demonstrated tumor growth inhibition and lower toxicity levels, when compared to an unmasked T cell engager."

Marwan Fakih, M.D., Professor, Medical Oncology and Therapeutics Research, Judy and Bernard Briskin Distinguished Director in Clinical Research and the principal investigator from City of Hope, notes, "EGFR is a validated therapeutic target in several tumor types and highly expressed in many other tumor types, so the opportunity to target EGFR from the T-cell engager axis would be meaningful to address unmet medical needs in various disease types in oncology. We look forward to clinically exploring the safety and activity of JANX008."

"JANX008 is the second therapeutic from our TRACTr platform to enter a first-in-human clinical trial, demonstrating the potential of our platform and the commitment of our team to address critical and urgent unmet needs for patients with advanced or metastatic solid tumors," said David Campbell, Ph.D., President and CEO of Janux. "We are grateful to our team and clinical investigators for their support in bringing another new therapeutic with a novel mechanism of action into the clinic."

About the JANX008 Phase 1 Clinical Trial

The Phase 1 clinical trial is a first-in-human, Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05783622.

Janux’s TRACTr and TRACIr Pipeline

JANX008 is a TRACTr that targets EGFR and is being studied in a Phase 1 trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s lead candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

On April 20, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 4, 2023, following the release of its first quarter 2023 financial results (Press release, Puma Biotechnology, APR 20, 2023, View Source [SID1234630372]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.