On May 10, 2023 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update, including its financial position as of March 31, 2023 (Press release, Transgene, MAY 10, 2023, View Source [SID1234631412]).

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Key events and upcoming milestones

Since the beginning of the year, all of Transgene’s clinical and preclinical assets have progressed in line with expectations. Promising data were presented on all clinical-stage immunotherapies at the AACR (Free AACR Whitepaper) 2023 conference (April 2023). New data will be communicated in Q2 2023 on TG4001, TG4050 and BT-001.

Therapeutic cancer vaccines

TG4001: New data to be presented at the ASCO (Free ASCO Whitepaper) 2023 conference — Preparing for a planned potentially registrational trial in an HPV-positive indication

Transgene anticipates that the last patient will be randomized in the current Phase II clinical study in the first half of 2024. This study is comparing TG4001 in combination with avelumab vs avelumab alone in patients with HPV16-positive anogenital tumors. Final results will be communicated in 2024.

A trial-in-progress poster was presented at the AACR (Free AACR Whitepaper) conference in April 2023. New translational data from TG4001 will be presented in another poster at the upcoming ASCO (Free ASCO Whitepaper) conference (June 2–6, 2023). Transgene is working on the design of a potentially registrational trial to further confirm the benefit of this novel therapeutic cancer vaccine.

TG4050: Strong clinical potential confirmed by initial data from the two ongoing Phase I trials — Transgene is preparing a Phase II trial in head and neck cancers

New data were presented on TG4050 at AACR (Free AACR Whitepaper) 2023. These data show that this individualized neoantigen cancer vaccine is able to induce strong immune responses, which are expected to result in longer remission periods for patients.

All evaluable patients developed a specific immune response against multiple cancer neoantigens after treatment with TG4050 and remained disease-free in the head and neck cancer trial. These data suggest that TG4050 can boost the immune system of patients in the absence of pre-existing response and despite a challenging tumor micro-environment at baseline.

Transgene hosted a key opinion leader (KOL) event with the participation of Professor Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology) who highlighted the medical need in head and neck cancer and the potential of a virus-based immunotherapy such as TG4050.

Transgene expects the last patient to be treated in the Phase I study in head and neck cancer in the coming weeks. Final results from this trial are expected mid-2024.

Transgene and NEC are preparing for a Phase II trial in head and neck cancers which could be initiated in H2 2023.

Transgene will present new data from TG4050 at the upcoming ASCO (Free ASCO Whitepaper) conference in June.

Oncolytic Viruses

TG6002: New data presented at AACR (Free AACR Whitepaper) support the potential of intravenous administration (IV) of Invir.IO-based oncolytic viruses, which offers a competitive advantage

Clinical data presented at AACR (Free AACR Whitepaper) 2023 confirmed the mechanism of action and the safety of our Invir.IO based oncolytic viruses, which offers a key competitive advantage.

These findings support the potential of Invir.IO-based oncolytic viruses to be given by IV administration. This extends their potential use to a much broader range of solid tumors. At present, the use of oncolytic viruses is limited by their intratumoral administration.

BT-001: Ongoing Phase I trial — Monotherapy data expected in H1 2023

Transgene and BioInvent intend to communicate data from the Part A (monotherapy) of the ongoing Phase I trial in H1 2023. The Part B of the Phase I trial (in combination with pembrolizumab) is expected to start in the second half of 2023. KEYTRUDA (pembrolizumab) will be provided to the trial by MSD (Merck & Co).

TG6050: First patient treated with novel Invir.IO candidate designed to express IL-12 and be administered intravenously

In early 2023, Transgene announced the regulatory approval to initiate a clinical trial of TG6050, a novel oncolytic virus from its Invir.IO platform. This innovative candidate has been designed to express human IL-12, a cytokine known to trigger a potent antitumor immune response, and an anti-CTLA4 antibody.

The Delivir trial is evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options. The first patient has been dosed. Completion of the trial is expected in H2 2024.

AstraZeneca collaboration update

As previously announced on 5 May 2023, the Company was informed by AstraZeneca of its decision to terminate its oncolytic virus research and development collaboration with Transgene that was signed in 2019. The decision was made by AstraZeneca following a strategic review of its pipeline. Following termination, Transgene will regain the global rights to the oncolytic virus drug candidate that was in-licensed by AstraZeneca in December 2021. This intravenous drug candidate has been granted a US IND.

Operating revenue

Q1

In millions of euros

2023

2022

Revenue from collaborative and licensing agreements

0.1

0.4

Government financing for research expenditures

1.5

1.7

Other income

–

0.1

Operating revenue

1.6

2.2

During the first quarter of 2023, revenue from collaborative and licensing agreements was mainly composed of revenue from the collaboration with AstraZeneca.

As of March 31, 2023, government financing for research expenditures mainly consisted of accrual of 25% of the research tax credit expected for 2023 (€1.5 million in the first quarter of 2023 compared to €1.7 million for the same period in 2022).

Cash, cash equivalents and other financial assets

Cash, cash equivalents and other financial assets stood at €17.0 million as of March 31, 2023, compared to €26.8 million as of December 31, 2022. In the first quarter of 2023, Transgene’s net cash burn was €9.8 million, compared to €2.8 million for the same period in 2022. In Q1 2022, cash burn was reduced due to an $8 million payment from AstraZeneca following the exercise of a license option for an oncolytic virus developed by Transgene.

The Company holds shares of Tasly BioPharmaceuticals valued at €14.3 million at the end of December 2022. The Company is expecting to sell its shareholding in Tasly BioPharmaceuticals in mid-2023.

As a result, the Company confirms its financial visibility until early 2024.

New leadership structure appointed to accelerate the development of Transgene’s innovative immunotherapy portfolio

On May 5, 2023, Transgene announced its Board of Directors’ decision to appoint Dr. Alessandro Riva, MD, as the Company’s new Chairman and CEO to accelerate the development of Transgene’s innovative immunotherapy portfolio. Alessandro Riva has been the Chairman of the Company’s Board of Directors since May 2022. Dr. Riva has an outstanding track record in the pharmaceutical and biotechnology industry, leading to the approval of innovative oncology treatments in the US and in Europe. Dr. Riva’s appointment will be effective on June 1st, 2023. Hedi Ben Brahim will retire from the CEO position and will stay n as a strategic advisor until the transition is complete.

In addition, on May 5, 2023, the Combined General Meeting adopted all resolutions recommended by the Board of Directors, including the appointment of Ms. Carol Stuckley, MBA, as an independent Director of the Company. Ms. Carol Stuckley brings more than 35 years of experience as a strategic and international financial executive, with proven success leading finance teams and creating shareholder value for healthcare companies.

In March 2023, Transgene appointed Dr. John C. Bell and Dr. Pedro Romero as key scientific advisors. These key opinion leaders in cancer immunotherapy bring considerable expertise to Transgene.

On May 10, 2023 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will participate in the RBC Capital Markets Global Healthcare Conference (Press release, Avid Bioservices, MAY 10, 2023, View Source [SID1234631411]). Nick Green, president and chief executive officer, will be the featured speaker in a fireside chat at the conference, which will take place May 16-17, 2023.

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Details of the company’s participation are as follows:

RBC Capital Markets Global Healthcare Conference
Conference Date: May 16-17, 2023
Fireside Chat Time/Date: 8:30 – 8:55 a.m. Eastern on Wednesday, May 17, 2023

On May 10, 2023 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the first quarter ended March 31, 2023 and provided business updates on belrestotug, its anti-TIGIT antibody; inupadenant, its adenosine A2A receptor antagonist; and EOS-984, a first-in-class small molecule program targeting a novel mechanism in the adenosine pathway (Press release, iTeos Therapeutics, MAY 10, 2023, View Source [SID1234631410]).

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"iTeos is entering 2023 from a position of strength. We are thoughtfully and methodologically advancing both our lead programs through clinical development to fully unlock their potential. Notably, we’re focused on progressing our multiple clinical studies with belrestotug and GSK’s Jemperli (dostarlimab), with continuing clinical development with both doublet and novel triplets. This includes the ongoing preparations for our first Phase 3 study in first line non-small cell lung cancer with the doublet of belrestotug and dostarlimab, which we are targeting for study initiation by the end of the year. For our adenosine pathway programs, we also remain on track with our first-in-class small molecule program EOS-984, as it enters the clinic in the near term. These advancements follow recently presented biomarker data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting, which have expanded our understanding of the mechanisms of adenosine-mediated immunosuppression, opening up avenues to new patient selection strategies," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Looking ahead, we will continue to leverage our expertise in tumor biology alongside our ability to evaluate novel combinations with our therapeutic candidates, as we continue to execute on our mission to bring a new generation of treatment options to those living with cancer."

Program Highlights:

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, late-stage development of belrestotug as a potential next-generation immuno-oncology agent through multiple combination studies is on track. Highlights include:
Ongoing randomized Phase 2 trial assessing the doublet of dostarlimab with belrestotug in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Ongoing Phase 2 expansion study assessing the doublet of dostarlimab with belrestotug in first line advanced or metastatic head and neck squamous cell carcinoma.
Phase 1b trials ongoing exploring two novel triplets in selected advanced solid tumors: belrestotug with dostarlimab and GSK’s investigational anti-CD96 antibody, and belrestotug with dostarlimab and GSK’s investigational anti-PVRIG antibody.
Continued advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating belrestotug as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
Adenosine Pathway
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on multiple immune cells found in the tumor microenvironment. Highlights include:

Progression of the ongoing two-part Phase 2 trial in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
Data describing a novel mechanism of action of inupadenant in tumor tissue was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2023. Translational analysis of tumor material from inupadenant clinical trials demonstrated that the predominant cell type in tumor tissue expressing high levels of the target A2A receptor were in fact antibody secreting cells. Additionally, these cells were shown in vitro to be suppressed by adenosine and that such suppression could be reversed by inupadenant.
EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway.

This complementary clinical development program has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells. EOS-984’s effects have been shown preclinically to be enhanced by combining with inupadenant and other standards of care.
The company completed Investigational New Drug / Clinical Trials Application-enabling activities, including toxicity studies, and anticipates initiating clinical studies for EOS-984 mid-year 2023.
First Quarter 2023 Financial Results

Cash and Investment Position: The company’s cash, cash equivalents, and investments position was $706.6 million as of March 31, 2023, as compared to $824.0 million as of March 31, 2022. The company continues to expect its cash balance to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $25.6 million for the quarter ended March 31, 2023, as compared to $21.1 million for the same quarter of 2022. The increase was primarily due to an increase in activities related to belrestotug and inupadenant clinical trials.
General and Administrative (G&A) Expenses: G&A expenses were $11.9 million for the quarter ended March 31, 2023, as compared to $10.6 million for the same quarter of 2022. The increase was primarily due to an increase in headcount and related costs compared to the same quarter last year.
Net Income/Loss: Net loss attributable to common shareholders was $15.6 million, or net loss of $0.44 per basic and diluted share, for the quarter ended March 31, 2023, as compared to a net income of $69.6 million, or a net income of $1.96 per basic share and $1.82 per diluted share, for the same quarter of 2022.

On May 10, 2023 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that the first patient has been dosed in Delivir, a Phase I clinical trial evaluating TG6050 (Press release, Transgene, MAY 10, 2023, View Source;First-Patient-Dosed-in-Phase-I-Trial-Evaluating-TG6050-a-Novel-IL-12-Armed-Oncolytic-Virus-Administered-Intravenously-in-Non-Small-Cell-Lung-Cancer [SID1234631409]). This multi-mechanism oncolytic immunotherapy is administered intravenously in patients with recurrent metastatic advanced non-small cell lung cancer (NSCLC).

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TG6050 seeks to overcome tumor resistance by initiating an antitumor response through multiple mechanisms of action that include oncolysis, the induction of an immune response together with high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody.

The Delivir trial will enroll up to 36 patients with advanced NSCLC who have failed standard therapeutic options, including immune checkpoint inhibitors. The IV route is considered the most appropriate route of administration for this patient population with disseminated disease and multiple overt and occult metastases. Completion of the trial is expected in H2 2024.

The potential for IV administration of Transgene’s patented Invir.IO platform has been seen in the data presented for TG6002. TG6050 will build on the safety profile of Transgene’s backbone while enhancing the therapeutic potential of its two highly immunogenic payloads – IL-12 and a full length anti-CTLA-4 antibody – while limiting exposure to their systemic toxicity.

"We are pleased to initiate this first-in-human trial of TG6050 administered intravenously in patients with recurrent/metastatic advanced non-small cell lung cancer in great need for effective new therapeutic options," said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. "Intravenous administration of TG6050 aims at significantly enhance the therapeutic potential of this promising oncolytic virus as it allows a targeted approach to many internal cancer lesions and metastases inaccessible by intratumoral injection. With its multiple mechanisms of action – including oncolysis, the induction of an immune response together with high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody – and its ability to be administered intravenously, TG6050 has several competitive advantages. We look forward to progressing this trial and delivering clinical results for this promising new oncolytic virus."

Efficacy and safety of TG6050 were demonstrated in preclinical and toxicology studies in non-human animal models. Initial data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14 -19, 2023 and can be accessed here.

About the Delivir trial (NCT: NCT05788926)

The Delivir trial is a multicenter, open label, dose-escalation Phase I trial evaluating TG6050 as a single agent. The trial will enroll up to 36 patients with metastatic/advanced non-small cell lung cancer (NSCLC), who have failed standard therapeutic options including immunotherapies such as immune checkpoint inhibitors. Patients will receive single and repeated escalating doses of TG6050 administered intravenously, to determine the recommended dose and best schedule of administration for subsequent clinical development.

About TG6050

TG6050 is an oncolytic virus developed with Transgene’s Invir.IO platform for intravenous administration. Invir.IO’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR- (VVCOPTK-RR-). TG6050 has been engineered to encode human IL-12, a cytokine that triggers a powerful antitumor immune response and a full length anti-CTLA4 antibody. It has also been optimized with the deletion of the gene encoding for the M2L viral protein that targets CD80 and CD86, two ligands of CTLA4 [source: Kleinpeter et al., J Virol. 2019 Jun 1; 93(11): e00207-19]. The use of an oncolytic virus to deliver these immunotherapies locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both therapeutic proteins eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows to increase the safety and tolerability profile of IL-12 and the anti-CTLA4 antibody.
It is evaluated in the Delivir trial, a Phase I trial conducted in advanced NSCLC patients.
A short video detailing TG6050’s mechanism of action can be found here.

On May 10, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a leading T-cell receptor (TCR) cell therapy company advancing a clinical-stage pipeline of therapeutics for solid tumors, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Alaunos Therapeutics, MAY 10, 2023, View Source [SID1234631408]).

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"Our TCR-T Library Phase 1/2 trial continues to garner significant interest among patients, physicians and investigators," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We’ve been actively enrolling patients and manufacturing cryopreserved products, and we expect to report interim clinical data in the third quarter of this year. As we work to fully realize the long-term potential of our TCR-T platform, we have simplified our corporate structure with the full prepayment of our loan with SVB and the recent agreement with Precigen. We are now moving forward unencumbered by debt or these potential royalties as we seek to transform the treatment of solid tumors."

Recent Developments and Upcoming Milestones

TCR-T Library Phase 1/2 trial actively enrolling patients: Alaunos continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53 and EGFR driver mutations across six solid tumor indications. Early translational data from the first three patients treated in the program will be highlighted in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023. Alaunos currently expects to provide an interim data update on multiple new patients in the third quarter of this year as the Company advances the program towards Phase 2 readiness with a recommended Phase 2 dose anticipated by year end 2023.

Manufactured multiple cryopreserved products: In the first quarter of 2023, Alaunos enhanced its manufacturing process to move from fresh to cryopreserved cell product enabling greater flexibility for patient scheduling and treatment. To date, the Company has manufactured multiple cryopreserved products with viability, purity and TCR positivity comparable to our prior process.

Completed full prepayment of amended loan and security agreement with Silicon Valley Bank (SVB): In May 2023, Alaunos fully prepaid the remaining amounts owed under its term loan with SVB, which was $11.0 million as of March 31, 2023. With no remaining obligations due to SVB, the restricted cash balance of $13.9 million as of March 31, 2023, has also been released.

Amended exclusive license agreement with Precigen, Inc.; Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations: In April 2023, Alaunos amended its exclusive license agreement with Precigen. Under the terms of the amended agreement, Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations, while Precigen regains the rights to its CAR-T and IL-12 assets. The amended agreement eliminated all commercial sales-based royalties and milestone obligations, in alignment with Alaunos’ focus on its priority TCR-T programs.

Expanded infrastructure of hunTR TCR discovery platform to increase throughput; expect to add three new TCRs in 2023: In the first quarter of 2023, Alaunos significantly increased the throughput potential of its hunTR TCR discovery platform to further accelerate TCR discovery and validation. New lab equipment and advanced bioinformatics capabilities have multiplied the screening throughput while maintaining a high success rate of TCR discovery. The Company expects to add three new TCRs to its library, potentially bringing the total number of unique TCRs to 15 by the end of 2023.

Appointed Robert Hofmeister, PhD, MS, to Board of Directors: In March 2023, Alaunos appointed Robert J. Hofmeister, PhD, MS, to the Company’s board of directors. Dr. Hofmeister brings deep expertise in the discovery and development of engineered T-cell receptor therapies as well as a background in cellular immunology and translational science. He is currently Chief Scientific Officer of a stealth early-stage biotechnology company and was most recently Chief Scientific Officer at TCR2 Therapeutics.

First Quarter Ended March 31, 2023, Financial Results

Research and Development Expenses: Research and development expenses were $6.5 million for the first quarter of 2023, compared to $5.6 million for the first quarter of 2022, an increase of approximately 17%. The increase was primarily due to incremental manufacturing activities related to the TCR-T Library Phase 1/2 trial and hunTR research efforts of $1.7 million, partially offset by a $0.7 million decrease in employee-related expenses.

General and Administrative Expenses: General and administrative expenses were $3.2 million for the first quarter of 2023, compared to $3.5 million for the first quarter of 2022, a decrease of approximately 10%. The decrease was primarily due to lower professional fees of $0.2 million.

Net Loss: Net loss was $10.0 million, or $(0.04) per share, for the first quarter of 2023, compared to a net loss of $9.8 million, or $(0.05) per share, for the first quarter of 2022.

Cash, Cash Equivalents and Restricted Cash: As of March 31, 2023, Alaunos had approximately $37.4 million in cash balances, which included restricted cash of approximately $13.9 million. Based on current operating plans, the Company expects its operating outflows, excluding debt service costs, for 2023 to be between approximately $35 million and $40 million. The Company expects to have sufficient cash resources to fund research and development programs and operations into the fourth quarter of 2023.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, May 10, 2023, at 9:00 a.m. ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The event will be archived on the Company’s website for approximately 30 days after the call.