On May 6, 2024 Guangzhou-Israel Biotechnology Fund (GIBF) reported that it has invested $10 million in Nectin Therapeutics Ltd (Press release, Nectin Therapeutics, MAY 6, 2024, View Source [SID1234642701]). Nectin is a biotechnology company developing novel targeted immunotherapies that address resistance to approved immune oncology treatments. The funds will be used to continue the development of Nectin’s portfolio of novel immuno-oncology products, including the advancement of Nectin’s ongoing NTX1088 global Phase 1 clinical trial targeting PVR and the preclinical development of its anti-drug conjugate (ADC) portfolio.

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Nectin is a clinical stage biotechnology company devoted to transforming the lives of cancer patients by leveraging unique insights into the nectin pathways to develop the next generation of immune oncology (IO) therapies. The company’s differentiated therapies have the potential to set new standards for efficacy and patient response rates across various difficult-to-treat cancers. Nectin’s technology addresses major escape mechanisms of current IO therapies through a diverse pipeline of novel monoclonal antibodies and antibody-drug-conjugates. It has a world-class scientific and management team with deep experience in oncology drug development and a successful track record in building biotechnology companies and developing innovative therapies. Nectin is a venture-backed, privately held company, funded by aMoon Fund, Peregrine Ventures, IBF, Integra Holdings, Myeloma Investment Fund (MIF), and Cancer Focus Fund.

NTX1088 is Nectin’s First-in-Class lead candidate – a highly potent monoclonal antibody directed against PVR (CD155), a transmembrane protein expressed on cancer cells and associated with resistance to PD1 and PDL1 immune checkpoint inhibitors. PVR blockade by NTX1088 is the first and only therapeutic approach aiming at restoring the antitumor immune activity of DNAM1 (CD226). DNAM1 is a cell surface glycoprotein, central to the function of T and NK cells, that is suppressed by PVR on tumor cells. Restoring the expression and activation of DNAM1 by blocking PVR results in increased antitumor activity from T and NK cells. PVR blockade by NTX1088 further stimulates an antitumor immune response by preventing the suppressing signaling of several immune checkpoint receptors, including TIGIT and CD96.

PVR is overexpressed in many solid tumors across different cancer indications, including lung, colorectal, liver, ovarian, breast, adrenal, pancreatic, uterine, head and neck, gastric and esophageal cancers. High PVR expression is associated with poor prognosis and with resistance to PD1 and PDL1 blockade, making PVR an attractive target for both monotherapy and in combination with PD1 blockers, as is currently being clinically evaluated in the combination of NTX1088 and KEYTRUDA (pembrolizumab).

"Nectin is working to usher in a new era of innovative immune-mediated cancer medicines and we are excited to back this important mission and team," said Professor Shlomo Noy, Managing Partner and Chief Medical Officer of GIBF. "We have been following the company closely as it continues to make meaningful progress across its portfolio as it develops transformational therapies that can improve the lives of many cancer patients and their treatment outcomes."

"We are grateful for the support from GIBF which reflects the rapid advancement of our anti-PVR clinical program as well as the progress in our development of several ADC candidates," said Fabian Tenenbaum, CEO of Nectin Therapeutics. "With this new investment we are looking forward to completing both the dose-escalation and dose-expansion trials for NTX1088 and continue our IND-enabling activities of our ADC assets. We value GIBF’s commitment to our mission of developing life-saving therapies and look forward to advancing innovative medicines to improve the lives of cancer patients."

On May 6, 2024 AbbVie (NYSE: ABBV) reported that it will participate in the Bank of America Securities Healthcare Conference on Wednesday, May 15, 2024. Robert A. Michael, president and chief operating officer, Scott T. Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, will present at 12:40 p.m. Central time (Press release, AbbVie, MAY 6, 2024, View Source [SID1234642700]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On May 6, 2024 Vyriad, Inc., a clinical-stage biotechnology company developing the next generation of targeted genetic therapies, reported that its abstract, In Vivo Generation of αCD19-CAR T Cells Using a Novel LV-based Platform Successfully Clears Advanced NALM-6 Tumor without Noticeable Toxicity, has been selected for an oral presentation at the 27th American Society of Gene & Cell Therapy Annual Meeting to be held May 7-11, 2024, in Baltimore, Maryland (Press release, Vyriad, MAY 6, 2024, View Source;cell-therapy-annual-meeting-302137235.html [SID1234642699]). Vyriad’s presentation will discuss progress in developing its highly targeted, efficient, serum-stable and durable lentiviral vector technology to deliver genetic payloads directly and specifically to CD3+ T cells in vivo.

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Presentation Title: In Vivo Generation of αCD19-CAR T Cells Using a Novel LV-based Platform Successfully Clears Advanced NALM-6 Tumor without Noticeable Toxicity

Session Name: CAR T-cell Therapies

Presentation Date/Time: Thursday, May 9, at 5:15 p.m. EST

Presenting Speaker: Karina Krotova, Ph.D., Principal Scientist, Imanis Life Sciences

Full abstracts are available for online viewing via the ASGCT (Free ASGCT Whitepaper) Annual Meeting website at View Source

On May 6, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343 as monotherapy for the treatment of claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least 2 lines of prior systematic treatments (Press release, Innovent Biologics, MAY 6, 2024, View Source [SID1234642698]).

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The BTD for IBI343 was based on the data from an ongoing Phase 1 study (NCT05458219), in which favorable safety and tolerability and promising antitumor activity of IBI343 monotherapy in advanced GC patients were observed. The study results will be published at an upcoming medical conference later in 2024.

Innovent is preparing for a registrational Phase 3 multi-regional clinical trial (MRCT) of IBI343 in patients with claudin18.2-positive, HER2-negative GC (G-HOPE-001, NCT06238843) to be initiated soon.

Dr. Hui Zhou, Senior Vice President of Innovent, said, "GC patients tend to progress after second-line systematic therapies with poor prognosis and have only a half year of survival expectancy. They are in urgent need of effective third-line treatment options. We are glad to see the NMPA granted BTD for IBI343 monotherapy based on the PoC clinical results in GC, and we will continue to validate its efficacy and safety in the registrational MRCT trial. Innovent has a comprehensive and robust oncology pipeline, and, particularly in GC, we have PD-1 inhibitor (TYVYT) for first-line GC treatment and anti-angiogenic drug (CYRAMZA) for second-line GC treatment. We will further explore IBI343’s potential in combination therapy as well as in other solid tumors such as pancreatic cancer."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs that have been granted BTD by NMPA.

About Gastric/ Gastroesophageal Junction Adenocarcinoma

Gastric cancer is one of the most common malignant tumors in the world and is one of the leading causes of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[i]. China and Japan are countries with highest incidence of gastric cancer[ii]. Currently, chemotherapy combination of fluoropyrimidine and platinum and immune checkpoint inhibitor therapy are the standard-of-care treatments for patients with advanced metastatic gastric cancer. However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival times for these patients is only about 0.5 year[iii].

Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[iv]. CLDN18.2 is expressed in up to 80% of patients with gastric cancer.

About IBI343 (Claudin18.2 ADC)

IBI343 is an antibody-drug conjugate composed of an anti-claudin18.2 antibody, and a cytotoxic drug exatecan. As a topoisomerase I inhibitor, exatecan effectively kills tumor cells by inhibiting DNA synthesis. Binding of IBI343 to claudin18.2-expressing tumor cells results in claudin18.2-dependent internalization of IBI343. Degradation of the cleavable linker will release the drug that causes DNA damage, leading to apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring tumor cells, resulting in a strong "bystander killing effect" of IBI343.

On May 6, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), a leading artificial intelligence (AI) oncology drug discovery and development company, reported a strategic AI-driven collaboration with French biotechnology company, Oregon Therapeutics to optimize the development of its first-in-class protein disulfide isomerase (PDI)(1) inhibitor drug candidate XCE853 in novel and targeted cancer indications (Press release, Lantern Pharma, MAY 6, 2024, View Source [SID1234642697]). Lantern will be leveraging its proprietary RADR AI platform to uncover biomarkers and efficacy-associated signatures of XCE853 across solid tumors that can aid in precision development. Collaborative efforts are expected to identify biomarker signatures that can be used to stratify tumors most responsive to XCE853 and guide potential future clinical development and patient selection. Oregon Therapeutics is developing XCE853 in various cancer indications, including drug-resistant ovarian and pancreatic cancer, certain hematological cancers and several pediatric cancers including CNS cancers.

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PDIs are promising targets for cancer therapy raising clinical interest recently2 notably for their potential in cancers of poor prognosis like breast cancer3 or ovarian cancer. Up-regulated expression of PDIs was found to be associated with worse clinical outcome in numerous cancers such as hepatocellular carcinoma(4), as well as breast and ovarian cancers(5). PDIs are protein chaperones and are central to maintaining cancer cell metabolism, additionally PDI inhibitors can cause cancer cell death through the accumulation of impaired proteins and dysregulated cellular stress responses. A combination of these effects is known as proteotoxicity, a unique and promising therapeutic strategy that may be especially effective in targeting cancers that are resistant to therapy.

In the US, nearly 612,000 people(6) are projected to die from cancer in 2024 and, resistance to anticancer drugs will be implicated in 90% of those deaths(7). To date, no PDI inhibitor has reached the clinic due to the complexities related to selecting and mapping the molecules that will most accurately target the right PDI enzymes. There are more than 20 PDI enzymes, with each playing a slightly different and often biologically redundant role. Oregon Therapeutic’s lead drug-candidate XCE853 is known to target PDIs of specific interest for cancer. Lantern Pharma and Oregon Therapeutics believe that computational tools, including foundational models, machine learning and large-scale molecular analysis can offer an ideal and streamlined pathway for breaking through these data and decision complexities – making RADR the perfect platform for better informing the role XCE853 can play in effective cancer treatment. (8, 9)

"To date, our first-in-class metabolic inhibitor, XCE853, has exhibited robust preclinical efficacy in both in vitro and in vivo models across multiple cancer types," said Marc-Henry PITTY, MD, CEO of Oregon Therapeutics. "Lantern’s RADR AI platform will leverage the in vitro and in vivo data to potentially advance XCE853 development in a highly targeted manner and will help inform disease indications and biomarker signatures that can aid in the design of future clinical trials and in the pursuit of combination therapies with other approved cancer drugs. Our team is looking forward to efficiently selecting among the landscape of ideal development options and efficiently de-risking future clinical development decisions." Oregon Therapeutics has previously performed preclinical studies indicating that in addition to ovarian and pancreatic cancer, XCE853 may also be particularly active in renal, prostate, lung, breast, and head and neck cancers, and leukemia based on preclinical cell-line studies. Oregon project leader, Sandrine Courtès PhD, who has been developing the collaboration with Lantern Pharma, stated: "PDIs Inhibitors have a great potential, since this molecular target is highly expressed in several cancer types, supports tumor growth and is associated with clinical outcomes."

The collaboration focuses on the integration and interrogation of molecular, genetic and transcriptomic data pertaining to XCE853. This analysis will be powered by RADR and its growing library of over 60 billion data points from many diverse types of biological measurements and oncology experiments, as well as more than 200 ML algorithms focused on problems that are central to real-world cancer drug development. The initial objectives of the collaboration are to:

1) uncover biomarkers and efficacy-associated gene signatures to guide in the eventual stratification and selection of patients for future clinical trials,

2) identify tumor-based response and resistance mechanisms to XCE853 and strategies to overcome treatment resistance, and

3) expand the use of XCE853 in additional therapeutic cancer indications for XCE853.

"Drug development teams have found significant data and modeling challenges in regard to tackling the complexities associated with PDI inhibitors given the challenges with creating meaningful models, and accumulating and deciphering the data," said Panna Sharma, CEO and President of Lantern Pharma. "Our AI platform, RADR, can increase the confidence, insights, and comfort levels in developing data-driven development paths by modeling highly complex scenarios at a scale that only has become possible recently. It’s an ideal approach for Oregon Therapeutics, which has executed a series of highly targeted in vivo and in vitro experiments and is poised to make incredibly important and patient-centric decisions about the clinical future of the molecule. That’s where RADR can play a highly essential and market defining role."

Under the terms of the collaboration, Lantern Pharma is receiving equal IP co-ownership and drug development rights in newly discovered biomarkers, novel indications, and/or new pharmacological use strategies for XC853 and related analogues. Oregon Therapeutics is entitled to financial benefits resulting from the out licensing of the background IP to Lantern Pharma. Lantern Pharma and Oregon Therapeutics are both entitled to additional financial benefits resulting from the out licensing of any collaboration IP to a third party. No further financial details regarding the collaboration were disclosed.

About RADR

RADR is Lantern Pharma’s proprietary integrated AI platform for large-scale biomarker and drug-tumor interaction data analytics that leverages machine learning. It is used to provide mechanistic insights about drug-tumor interactions, predict the potential response of cancer types and subtypes to existing drugs and drug candidates, and uncover patient groups that may respond to potential therapies being developed by Lantern Pharma and its collaborators.

RADR uses an ensemble-based approach to apply its library of algorithms to statistical, correlative, and inferential problems in drug-tumor interactions. This allows the platform to rapidly analyze large amounts of complex data and predict how both patients and tumors will respond to therapeutic combinations. RADR also evolves as new datasets are added, which improves and sharpens the insights generated from the algorithms.

RADR’s highly scalable machine-learning methods are designed to guide drug development and yield new biological insights, while also having the potential to increase response rates and improve outcomes in clinical trials. The robustness and growing number of datasets powering RADR is anticipated to continue to improve machine-learning results, accelerate automation of other features and aid oncology drug development for Lantern and its partners with an ultimate focus on benefitting cancer patients.