On February 15, 2023 Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for live-attenuated viral vaccines and immuno-oncology therapeutics, reported the completion of a $25 million Series B extension financing, with participation from a new investor, the Serum Institute of India Pvt. Ltd., along with existing investors Euclidean Capital and Adjuvant Capital (Press release, Codagenix, FEB 15, 2023, View Source [SID1234627253]).

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Proceeds from the financing will support the clinical development of CodaVax-RSV, an intranasal, live-attenuated vaccine candidate, for the prevention of respiratory syncytial virus (RSV) disease. Codagenix is set to begin dosing in a Phase 1 trial in healthy infants and toddlers in early 2023. The primary disease burden and hospitalizations during the previous 2022 RSV season were in the pediatric population, not older adults, and Codagenix has been granted Fast-Track designation by the U.S. Food and Drug Administration (FDA) to help solve this urgent unmet need. CodaVax-RSV is highly differentiated as it does not utilize a backbone virus, nor does it have genetic deletions to support induction of an immune response to the complete antigenic composition of the virus in children.

The funding will also support additional cohorts in an ongoing Phase 1 study for CodaVax-H1N1, a universal, live-attenuated influenza vaccine in 1H23 and expansion of the company’s oncology program to new indications, utilizing its platform for rational, indication-focused virotherapeutics.

The advanced development of the company’s intranasal COVID-19 vaccine candidate CoviLiv is currently being evaluated in the Solidarity Trial Vaccines (STV) which is supported by the World Health Organization (WHO) and the Serum Institute of India. STV is a placebo-controlled, Phase 3 safety and efficacy study with the primary endpoint of prevention of confirmed COVID-19 clinical disease. With completion of the STV study, Codagenix may be able to demonstrate primary efficacy of their COVID-19 vaccine platform potentially enabling CoviLiv to be developed as a future seasonal-COVID-19 vaccine.

"It is exciting to now have the Serum Institute of India as a direct investor, building upon our successful partnership in the development of CoviLiv and, of course, we thank Euclidean Capital and Adjuvant Capital for their continued support and belief in our differentiated platform," said J. Robert Coleman, Ph.D., M.B.A., Co-Founder and Chief Executive Officer of Codagenix. "This financing positions us well to advance our deep clinical pipeline, including live-attenuated vaccine candidates in RSV, that has the potential to meet a critical unmet need as well as further demonstrate our platform’s ability to design custom virotherapeutics for solid-tumors."

On February 15, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported topline data from BGBC008, a phase 2 trial evaluating its lead compound bemcentinibin combination with MSD’s anti-PD-1 therapy pembrolizumab in 2L+ Non-Small Cell Lung Cancer (NSCLC) patients (Press release, BerGenBio, FEB 15, 2023, View Source [SID1234627251]).

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BGBC008 Topline Data

The open-label, multi-center, single arm, multi-cohort, international phase 2 trial conducted in collaboration with MSD (Merck and Co., Inc. Rahway, NJ, USA), enrolled 90 evaluable patients with disease progression at study entry, who had received at least one prior line of chemotherapy, immunotherapy, or the combination. Enrolled patients received the combination of bemcentiniband pembrolizumab until disease progression as assessed by investigators. Topline results from the total evaluable population:

A clinically meaningful survival benefit and evidence of disease control was demonstrated with bemcentinibin combination with pembrolizumab regardless of prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI: 10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6, 9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).
A significant (p-value < 0.05) and clinically meaningful improvement in mOS based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS > 5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6) compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI: 6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months (95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.
The observed mOS was similar regardless of patient PD-L1 status.
Treatment with bemcentinib in combination with pembrolizumab was well-tolerated.
"We are very encouraged by the topline data" said Martin Olin, Chief Executive Officer of BerGenBio. "Treatment with bemcentinib in combination with pembrolizumab demonstrated long survival benefit and sustained disease control, particularly in patients with AXL TPS > 5, substantiating the relevance of AXL as a target and bemcentinib’s selective inhibition capabilities in NSCLC. Notably, the survival benefit was observed regardless of PD-L1 status. The data support our ongoing phase 1b/2a trial in 1L STK11m NSCLC patients, of whom approximately 80% have AXL expression. This subgroup of NSCLC represents more than 30,000 patients in the US and five largest European countries, for whom there is currently no effective targeted therapy available."

James Spicer, PhD, FRCP, Professor of Experimental Cancer Medicine at King’s College London and Principal Investigator of the BGBC008 trial, remarked, "The reported data shows that the combination of bemcentinib and pembrolizumab is well-tolerated in patients with NSCLC, and is particularly active in patients with tumour AXL expression. Other evidence suggests that current therapies are less effective in NSCLC with loss of the tumour suppressor gene STK11, and that AXL inhibition can restore susceptibility. Further investigation is warranted to confirm the role of AXL inhibition in STK11-mutated NSCLC patients, who are under-served by currently available therapeutic options."

The Company plans to present further details of the BCBG008 trial at an upcoming medical conference.

First-Line STK11m NSCLC Trial (BGBC016)

BerGenBio is studying bemcentinibin a global, open-label, phase 1b/2a trial evaluating bemcentinibin combination with the current standard of care of pembrolizumab and platinum doublet chemotherapy, for the treatment of 1L NSCLC patients with mutations in the STK11 gene. More than 30,000 NSCLC patients (US and EU5) harbor STK11 mutations which are associated with poor prognosis with currently available therapies. The Company believes that STK11 mutations create a severely immunosuppressed tumor microenvironment associated with AXL expression and activation, resulting in the development of drug resistance, immune evasion, and metastases.

On February 15, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported that it received an award notification from the National Cancer Institute (NCI) for the development of a first-in-class combination of DNA damage response inhibitors for the treatment of high-grade serous ovarian cancer (HGSOC) (Press release, Aprea, FEB 15, 2023, View Source [SID1234627250]). Total funding under the award is up to $1,996,571 over a period of two years, subject to the availability of funds and satisfactory progress of the project over such period.

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HGSOC is a devastating disease responsible for the deaths of about 125,000 women worldwide each year and has low survival rates. Approximately 50% of HGSOCs harbor genetic mutations in BRCA1, BRCA2, or other genes that cause defects in homologous recombination (HR). Another large fraction of HGSOCs exhibit amplification of the cell proliferation regulator Cyclin E1 (CCNE1). To develop a potential therapy for this disease, Aprea Therapeutics is initiating a first-in-human clinical trial of a new highly selective ataxia–telangiectasia and Rad3 related (ATR) inhibitor, ATRN-119. In addition, Aprea Therapeutics has also developed a highly potent and selective WEE1 inhibitor, ATRN-W1051, with a differentiated structure and potentially preferable pharmacokinetic properties. In pre-clinical studies, ATRN-W1051 has demonstrated anti-proliferative activity against a variety of cancer cell lines and shown the potential to inhibit the growth of genetically-defined HGSOC tumors in xenograft models. Notably, the combination of these two agents is a potential treatment for women with CCNE1-amplified HGSOC.

"We are honored and grateful to receive this competitive award to support our scientific approach and compelling opportunities within our pipeline. This award validates our efforts to bring new and effective therapies to cancer patients carrying genetically defined cancers with high unmet medical needs," said Oren Gilad, Ph.D., President, and Chief Executive Officer of Aprea Therapeutics. "A growing body of scientific evidence provides exciting development opportunities for our ATR and WEE1 inhibitors, and the studies proposed in this grant have the potential to provide additional support in validating our findings and progressing these studies towards a clinical trial."

A portion of the work will be carried out at the laboratories of University of Pennsylvania Perelman School of Medicine researchers Drs. Fiona Simpkins, Professor of Obstetrics and Gynecology, and Eric Brown, Associate Professor of Cancer Biology.

This grant will support an evaluation of the in vivo and in vitro activity and tolerability of ATRN-119 and ATRN-W1051 using a library of cell lines and patient-derived xenograft models of HGSOC that express varying levels of CCNE1. These studies could potentially identify mechanistically relevant biomarkers of sensitivity to ATRN-W1051 and may inform future clinical trial protocols using ATRN-119 combination and ATRN-W1051 for the treatment of HGSOC.

Disclosure:
Dr. Simpkins is a member of the Aprea Therapeutics Scientific Advisory Board and affiliated with the University of Pennsylvania. Dr. Brown is a Scientific Consultant for Aprea Therapeutics and owns equity interest in the company in addition to serving on the Scientific Advisory Board.

Research content supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA278078 is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

On February 15, 2023 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that management will participate in fireside chat at the SVB Securities Global Biopharma Conference today at 9:20 am ET (Press release, Celldex Therapeutics, FEB 15, 2023, View Source [SID1234627249]). A webcast of the presentation will be available on the "Events & Presentations(opens in a new tab)" page of the "Investors & Media(opens in a new tab)" section of the Celldex website. A replay will be available for 90 days following the event.

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On February 15, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its fourth quarter and full year 2022 financial results and operational highlights before open of U.S. markets on Tuesday, March 7, 2023 (Press release, Autolus, FEB 15, 2023, View Source [SID1234627248]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm GMT to discuss the company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.