On May 31, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that positive data from its Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in refractory solid tumors (TACTIC-2/NCT04727151), will be presented at the 2023 American Society Of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6 in Chicago (Press release, Triumvira Immunologics, MAY 31, 2023, View Source [SID1234632294]). Benjamin L. Schlechter, MD, from Harvard Medical School, and a Senior Physician in Gastrointestinal Oncology at Dana-Farber Cancer Institute, will highlight updated clinical data demonstrating the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2-targeted therapies.

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"We are encouraged by the promising results from the TACTIC-2 trial, which demonstrate the safety and compelling clinical activity of autologous TAC01-HER2 in refractory solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "These findings suggest that TAC technology has the potential to transform the treatment landscape for patients with HER2-positive gastric and esophageal cancers, offering a novel approach that harnesses the natural biology of T cells. We look forward to further exploring the therapeutic benefits of TAC01-HER2 in the phase 2 component of the trial and advancing its development towards improving patient outcomes in this population that has been deprived of significant therapeutic progress over the last 40 years."

"The interim results from the Phase I TACTIC-02 study are very promising, demonstrating a favorable safety profile for TAC01-HER2 treatment and early signals of clinical activity," stated Dr. Benjamin Schlechter, Principal Investigator of the study. "The observed disease control rate of 83% at 3 months and impressive partial responses in advanced gastric and GEJ cancer patients highlight the therapeutic potential of TAC01-HER2. These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with HER2-positive gastric and esophageal cancers."

Key Findings

Interim results from the Phase I TACTIC-02 study suggest a highly favorable safety profile for TAC-01 HER2 treatment with the potential of being an outpatient procedure.
One DLT (dose limiting toxicities) of Grade 3 pneumonitis and one Grade 3 CRS were observed at the highest dose level, both resolved with standard of care measures, without the need for ICU admission. No neurotoxicities reported to date across all cohorts.
TAC01-HER2 demonstrated early signals of clinical activity, highlighting two partial responses (in a stage IVb gastric cancer patient and a stage IV GEJ patient, at DL 2 and 4, respectively) and a disease control rate of 67% across DL2-4.
In gastric/GEJ/esophageal cancer patients, the DCR is 83%, while the ORR is 33% across DL 2-4.
Presentation Details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)
Authors: Benjamin L. Schlechter, MD, Senior Physician, Instructor in Medicine, Harvard Medical School and Attending Physician, Medical Oncology, Dana-Farber Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Poster Session Display Date and Time: 6/3/2023, 8:00 AM-11:00 AM
Poster Discussion Session Date and Time: 6/3/2023, 3:00 PM-4:30 PM
Abstract Number: 2519

Abstract titles are currently available on the ASCO (Free ASCO Whitepaper) website. A copy of the presentations will be available after the closure of the meeting, under the Presentations & Publications tab of the News & Resources section of the Company’s website.

On May 31, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the Jefferies Global Healthcare Conference on Wednesday, June 7, 2023 at 2:00 p.m. ET (Press release, Tempest Therapeutics, MAY 31, 2023, View Source [SID1234632292]).

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To access the live or archived recording of the company presentation, please visit the investor section of the Tempest website at View Source

On May 31, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Bill Newell, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Wednesday, June 7, 2023, at 4:30 p.m. ET/1:30 p.m. PT in New York City (Press release, Sutro Biopharma, MAY 31, 2023, View Source [SID1234632291]).

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A webcast of the fireside chat will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

On May 31, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported that John Celebi, President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference, being held in New York, NY, on Wednesday, June 7, 2023 at 9:30 a.m. ET (Press release, Sensei Biotherapeutics, MAY 31, 2023, View Source [SID1234632290]).

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A webcast of Sensei’s presentation will be available in the Investors section of the Sensei website. A replay of the webcast will be on the website for approximately 90 days following the event. Registration for the webcast is available here.

On May 31, 2023 Selvita S.A. [WSE: SLV], one of the largest contract research organization companies in Europe, reported its financial report for Q1 2023 (Press release, Selvita, MAY 31, 2023, View Source [SID1234632289]). The Group is growing despite the demanding market, taking on numerous actions to strengthen sales and optimize the business.

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In Q1 2023, Selvita Group (excl. Ardigen) generated EUR 19.5 million in revenues, up by 9% y/y. The EBITDA profit in this period reached EUR 4.1 million, which translates into a margin of 20.8%. Thus, the Group has generated better results than the estimates published in March (revenues in the range of 4-7%, EBITDA margin in the range of 19-21%).
As previously announced, the Company is undertaking numerous business development activities, focusing on markets and clients with the largest potential and research budgets. Since the beginning of 2023, Selvita has been gradually strengthening its sales forces in the United States and Europe.
The Company opened its new Selvita Research Centre in Kraków. The new location will provide a workplace for approximately 250 scientists, thus significantly increasing Selvita’ capabilities to provide the highest quality services in the area of drug discovery. The investment is a significant milestone in the Company’s development and creates a foundation for further organic growth of the Company.
Selvita’s backlog for 2023 amounts to EUR 51.7 million (as of May 28, 2023) and is 2% higher than the value reported a year earlier (as of May 24, 2022). The Company observes increased caution among its clients, resulting in the orders being concluded for shorter periods, which has a significant impact on the presented backlog in the first half of the year.
The company continues to implement numerous optimizations and enforce its savings policy, which should have a positive impact on margins both in 2023 and in the longer term.
We are very glad that the first quarter turned out to be better than expected. We continue focusing on activities aimed at increasing the revenue base, while paying great attention to our expenses. Our priority remains to return to the revenue dynamics and margins levels to which our investors have become accustomed. We have a strong scientific team on board and infrastructure to support further development, – comments Bogusław Sieczkowski, co-founder and Chief Executive Officer at Selvita.
The market we operate in remains demanding, however, as already announced, we expect an increase in contracting dynamics in the second half of the year. Industry reports indicate that both pharma and biotech companies have high cash reserves and, statistically, increasing amount of research work is outsourced to subcontractors. However, there are many indications that due to the slowdown in financing the sector, they are more careful with their budgets, – comments Dr. Milosz Gruca, Executive Vice President, and Chief Commercial Officer at Selvita.
While in the pandemic years – 2020-2021 – financing of the global biopharmaceutical sector more than doubled, in 2022 it returned to the levels from 2019. Most of the capital dedicated to the drug discovery and development (over 70%) went to companies on the U.S. market. In Europe, the British market stands out positively. Selvita is very active on both of these markets, taking advantage of the local sales offices in the largest biotechnology hubs.

We have intensified sales activities and strengthened the BD team, acquiring several experienced specialists operating in the most promising markets – in particular in the United States. We strongly focus on Big Pharma companies. At the same time, in the coming quarters, we expect the extension of numerous orders which some customers contracted exceptionally for a shorter than usual period, – adds Dr. Gruca.
FINANCIAL RESULTS AND MARKET ENVIRONMENT

In 2023 the cost base will be higher than in 2022, mainly due to the increase in employment in 2022 and the costs related to the launch of the new building. Despite the pressure on margins, we maintain a very good financial position and low debt ratios. We focus on increasing revenues and optimizations that will have a positive impact on Selvita’s finances in both the short and long term, – adds Dariusz Kurdas, Chief Financial Officer at Selvita.
In Q1 2023, Selvita generated EUR 18.9 million in revenues from commercial services, up by 9% y/y and more than the preliminary estimates of 4-7% as published in March.

Drug discovery services provided by Selvita generated EUR 15.5 million (an increase of 5% y/y) and accounted for 82% of revenues from commercial services provided by the Company. Services provided in the area of regulatory research accounted for the remaining part of commercial revenues and amounted to EUR 3.4 million (up 29% y/y).

The EBITDA profit in Q1 2023 amounted to EUR 4.1 million compared to EUR 5.4 million a year earlier. The EBITDA margin reached 20.8%, i.e. in the upper range of the 19-21% estimations made by the Company in March.

There are many indications that in 2023 the dynamics of contracting between quarters will be different than usual. Selvita’s backlog for 2023 amounts to EUR 51.7 million (as of May 28, 2023) and is 2% higher than the value reported a year earlier (as of May 24, 2022), despite the demanding market and high base. The company expects contracting to accelerate in the second half of the year.

*The results do not include non-cash costs of the non-dilutive incentive program for employees. Backlog as of May 28, 2023.