On May 17, 2023 NuCana plc (NASDAQ: NCNA) reported financial results for the first quarter ended March 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAY 17, 2023, View Source [SID1234631809]).

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!

As of March 31, 2023, NuCana had cash and cash equivalents of £31.0 million compared to £41.9 million at December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £7.9 million for the quarter ended March 31, 2023, as compared to a net loss of £8.4 million for the quarter ended March 31, 2022. Basic and diluted loss per share was £0.15 for the quarter ended March 31, 2023, as compared to £0.16 per share for the comparable quarter ended March 31, 2022.

"Building off of a productive 2022 and executing on a number of milestones that continued to demonstrate the potential of our ProTides, we entered 2023 with strong momentum," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We continue to advance NUC-3373 and plan to provide data updates in 2023 from each of the three ongoing studies evaluating this ProTide, which we believe has the potential to replace 5-FU across multiple tumor types. These studies are: the Phase 2 portion of the NuTide:302 study evaluating NUC-3373 combined with leucovorin and either irinotecan (NUFIRI) or oxaliplatin (NUFOX) plus bevacizumab in patients with second-line colorectal cancer; the randomized Phase 2 NuTide:323 study of NUFIRI plus bevacizumab compared to the standard of care FOLFIRI plus bevacizumab in patients with second-line colorectal cancer; and the Phase 1b/2 NuTide:303 modular study of NUC-3373 both in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer."

Mr. Griffith continued: "We recently presented data on NUC-7738 highlighting its multi-faceted mechanisms of action at the AACR (Free AACR Whitepaper) 2023 Annual Meeting, which continues to support our clinical development strategy. NUC-7738 is based on a novel nucleoside analogue, 3’-deoxyadenosine, and is being evaluated in the Phase 2 part of the NuTide:701 study both as a monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma. This study is progressing well and we anticipate sharing additional data later this year."

Mr. Griffith concluded: "With numerous upcoming value-driving milestones and a cash runway expected to fund operations into 2025, we are well positioned and look forward to an exciting year as we advance our mission of developing safer and more effective treatment options for patients with cancer."

2023 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2023, NuCana expects to:

Announce data from the Phase 2 (NuTide:302) study of NUC-3373 combined with irinotecan and bevacizumab (NUFIRI-bev) and in combination with oxaliplatin and bevacizumab (NUFOX-bev) in second-line patients with colorectal cancer;
Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI-bevacizumab versus the standard of care FOLFIRI-bevacizumab for the second-line treatment of patients with colorectal cancer; and
Announce data from the Phase 1b (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer to identify additional indications for development.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2023, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 both as monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma.

On May 17, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported an update on operational progress and reported financial results for the for the first quarter of 2023 (Press release, Nanobiotix, MAY 17, 2023, View Source [SID1234631808]).

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!

"2023 will be a foundational year for Nanobiotix, and we are energized to further advance late-stage development of our radioenhancer NBTXR3 in head and neck cancer. The recent operational efficiencies implemented last year are working, and we are seeing enrollment progress well in our pivotal Phase 3 study, NANORAY-312, with 122 sites activated in 24 countries to date," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "We remain focused on our near-term milestones including final data for Study 102, and a first look at NBTXR3 in pancreatic cancer as part of our MD Anderson collaboration. We are excited to welcome a new Chief Medical Officer in the third quarter of this year who will help further enhance our clinical development strategy. We believe that the clinical and corporate framework we are establishing will strongly position us for growth and successful execution across our programs in the years ahead."

Pipeline Status and Expected Upcoming Milestones

Chief Medical Officer (CMO) candidate with strategically aligned experience in oncology and immuno-oncology is expected to join the organization in Q3 2023
Locally Advanced Head and Neck: Priority Registration Pathway in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC), Local Control as Single Agent Activated by Radiotherapy (RT):

NANORAY-312 Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients with LA-HNSCC
Futility analysis to be conducted following 25% of planned PFS events expected in H1 2024
Initial Phase 3 interim efficacy and safety data expected after 67% of planned PFS events in H2 2024
Study 102 Phase 1 trial evaluating RT-activated NBTXR3 in LA-HNSCC
Final safety and efficacy data expected in H2 2023
Recurrent/Metastatic Head and Neck: Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma (R/M HNSCC), Priming Immune Response Followed by an Anti-PD-1 Treatment:

Study 1100 Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 in patients with advanced cancers
Phase 1 data update anticipated at a time to be determined
Phase 3 registrational program for patients with unresectable locoregional recurrent (LRR) or recurrent or metastatic HNSCC resistant to previous anti-PD-1/PD-L1 therapy
Company plans to consult with incoming CMO prior to continuing discussions with FDA on potential registration pathway for an NBTXR3-immunotherapy approach, and expects to provide an update in Q3 2023
Pancreatic, Lung and others: Expanding NBTXR3 Opportunity, Collaborating with a World-Class Partner to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:

Ongoing collaboration with The University of Texas MD Anderson Cancer Center
Preliminary Phase 1b dose escalation safety data in PDAC expected in H2 2023
Completion of enrollment in Phase 1b dose expansion trial for PDAC expected in H2 2023
Determination of RP2D for NBTXR3 in non-small cell lung cancer (NSCLC) expected in H2 2023
Initial Phase 1b/2 data for NBTXR3 in combination with chemotherapy in patients with esophageal cancer expected in 2024
First Quarter Financial Updates

Cash and Cash Equivalents:

Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €30.2 million as of March 31, 2023, will fund its operations into the third quarter of 2023, assuming no additional cash inflows, no business development transaction is consummated and assuming the European Investment Bank does in fact exercise the covenant requiring the Company to have a cash and cash equivalents balance at least equal to the principal of the loan balance currently at €25.3 million.

Next Annual General Meeting of the Company

The Company announced that its next Annual General Meeting ("AGM") will be held on June 27, 2023, at its headquarters, 60 rue de Wattignies, 75012 Paris, France. The notice of meeting of this AGM will be published shortly in the French legal bulletin and will include the agenda, the proposed resolutions as well as instructions to participate and vote in this AGM. All documentation regarding this AGM will be published on the Company’s website.

On May 17, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported positive preclinical data underscoring the potential of its DeltEx Gamma-Delta T cells to target and kill ovarian cancer (Press release, In8bio, MAY 17, 2023, View Source [SID1234631807]). The data were featured in a poster presentation at the American Society of Cell & Gene Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting and showed that DeltEx Gamma-Delta T cells were able to target and kill ovarian cancer cells, even in platinum-resistant and treatment-resistant cell lines.

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 findings highlight the synergy of combining gamma-delta T cells with chemotherapy to target solid tumors, even outside the brain," said William Ho, CEO and co-founder of IN8bio. "We are encouraged by these data that suggest that a combination using DeltEx Gamma-Delta T cells may provide a promising new approach to treating patients with ovarian cancer."

IN8bio’s DeltEx Drug Resistance Immunotherapy, or DeltEx DRI, gamma-delta T cells are engineered to be more effective at killing cancer cells. These cells are designed to be resistant to the killing effects of chemotherapy, allowing them to remain functional and be used concurrently in combinations to create a strong synergistic tumor killing effect. The preclinical data demonstrates that temozolomide (TMZ), an alkylating agent that creates DNA double-stranded breaks, can work synergistically in combination with poly ADP-ribose polymerase inhibitors (PARPi) to significantly increase NKG2D ligand (NKG2D-L) expression. NKG2D-L are proteins that make cancer cells more visible to the immune system, particularly to gamma-delta T cells, and resulted in greater killing of ovarian cancer cells, even in platinum-resistant and treatment-resistant ovarian cell lines.

Lawrence Lamb, Ph.D., co-founder and Chief Scientific Officer of IN8bio, expressed great optimism about the broad implications of this research and approach, "These data serve as a compelling proof-of-concept, demonstrating how gamma-delta T cell biology could seek out and eradicate tumor cells across a broad range of challenging cancer indications." In addition, "We are encouraged by these results and look forward to evaluating the applicability of INB-400 in ovarian cancer and other solid tumor targets as soon as possible."

About INB-400

INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic drug resistant immunotherapy (DRI) technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI technology.

On May 17, 2023 ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA) ("ImmunoPrecise" or "IPA" or the "Company") an AI-driven biotherapeutic research and technology company reported that Dr. Jennifer Bath, the company’s Chief Executive Officer and President, will present at the Jefferies Healthcare Conference on Friday June 9, 2023, at 11:00 a.m. Eastern time (Press release, ImmunoPrecise Antibodies, MAY 17, 2023, View Source [SID1234631806]).

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!

The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On May 17, 2023 Elevar Therapeutics, Inc., a wholly owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC) (Press release, Elevar Therapeutics, MAY 17, 2023, View Source [SID1234631805]).

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!

Each year, liver cancer is the cause of more than 830,000 deaths worldwide1. HCC is the most common type of liver cancer and typically has a poor prognosis with a lack of treatment options.

"Elevar Therapeutics’ submission of a New Drug Application for the combination of rivoceranib and camrelizumab marks an important milestone in our effort to provide an improved treatment option for patients confronted with uHCC," said Saeho Chong, chief executive officer of Elevar. "We thank the many physicians, institutions and patients who have contributed to rivoceranib’s development, and we look forward to working closely with the FDA during its evaluation period."

The NDA is supported by positive clinical data from the Phase 3 CARES 310 study (NCT03764293), in which rivoceranib plus camrelizumab demonstrated statistically significant and clinically meaningful prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC.

Results from the randomized, open-label, international trial, which included 543 patients and was conducted at 95 study sites across 13 countries/regions, demonstrated median overall survival (OS) for camrelizumab + rivoceranib of 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5] for sorafenib; hazard ratio 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001. Median progression-free survival for camrelizumab + rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]); 1-sided p<0.0001, and confirmed objective response rate for camrelizumab + rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib.

With efficacy results generally consistent across all subgroups, the data suggested the combination confers a benefit in a global uHCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC cases2.

"The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for advanced hepatocellular carcinoma," said Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. "As an oncologist focused on evolving the standard of patient care in HCC, I am encouraged by Elevar’s NDA filing and look forward to the completion of the FDA’s review process."

In February 2023, the combination therapy of rivoceranib and camrelizumab was approved by the National Medical Products Administration (NMPA) as a first-line treatment for liver cancer in China.

Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

To learn more, visit ElevarTherapeutics.com.

1View Source 2Ghouri YA, Mian I, Rowe JH. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog. 2017 May 29;16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMCID: PMC5490340.

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.