On February 16, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported an update on the plan to amend and optimize the protocol of its Phase 1 oncology clinical trial with the goal of a timely re-submission to the United States Food and Drug Administration (FDA) (Press release, Theratechnologies, FEB 16, 2023, View Source [SID1234627335]).

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Following a voluntary pause in the study’s enrollment on December 1, 2022, the Company formed a Scientific Advisory Committee (SAC) to help determine the best developmental path forward for TH1902. In addition to the study’s principal investigator, the SAC includes several medical oncologists from across the U.S., who are leading experts in the end-to-end lifecycle of oncology drug development:

Erika Hamilton, MD, director of Breast Cancer and Gynecologic Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology;
Daniel Petrylak, MD, professor of medicine in Medical Oncology and Urology and chief, Genitourinary Oncology at Yale School of Medicine; and
Anthony Tolcher, MD, medical oncologist at Texas Oncology-San Antonio Medical Center.
The Company will continue to seek advice and input from Mace Rothenberg, MD, who is currently a scientific advisor to Theratechnologies.

"We are eager to resume patient enrollment with a revised protocol for TH1902 and have pulled together some of the best scientists in the field of oncology drug development to ensure an optimal amendment," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. "Their expert advice will be critical to examining different dosing strategies and patient selection to ultimately improve the chances of success of TH1902."

Theratechnologies is currently analyzing data and preparing responses to questions received from the FDA. This work is well underway and will be considered by the SAC as part of their meeting, which is scheduled for the latter half of March when the analyses are expected to be ready. Once expert advice is considered, the Company intends to promptly amend the protocol and re-submit to the FDA.

Consistent with the Company’s 2023 objective of generating positive adjusted EBITDA1 by fiscal year end, any new investments in TH1902 will be stage gated. Once the Phase 1 clinical trial has resumed, Theratechnologies will also evaluate potential partnerships for TH1902.

1 This is a non-IFRS measure. See "Non-IFRS and Non-U.S. GAAP Measure" below.

About SORT1+ Technology and TH1902

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

TH1902 is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. TH1902 is currently being evaluated in a Phase 1 clinical trial, although patient recruitment has recently been voluntarily paused.

On February 16, 2023 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, reported that it has agreed the terms and conditions for a convertible bond facility with Atlas Special Opportunities ("Atlas") which will secure financing of up to gross NOK 300 million over three years (Press release, Targovax, FEB 16, 2023, View Source [SID1234627334]). The agreement will be subject to approval by an extraordinary general meeting (EGM) of Targovax to be held in March 2023.

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The financing will enable Targovax to drive long-term shareholder value by supporting progress for its three R&D pillars, including:

Dosing the first patients in the ONCOS-102 phase 2 trial in PD-1 resistant melanoma at prestigious cancer centers in the USA and Europe
Generation of in vivo proof-of-concept data in multiple settings for Targovax´s unique circRNA program, an area of rapidly growing interest among big pharma and biotech
Supporting two clinical trials with the enhanced mutant RAS vaccine TG01 led by major academic centers in Norway and the USA
"This convertible bond financing from Atlas will provide secured access to significant capital to drive our portfolio of innovative R&D programs forward over the next three years. In a challenging funding climate for the global life sciences sector, the flexible structure allows us to control the amount and timing of financing, enabling us to generate data and build shareholder value as we progress. We evaluated a range of financing alternatives and credit facility solutions, and selected Atlas as a creative and experienced partner, committed to helping us achieve our goals. In parallel we are pursuing additional strategic opportunities to fully unlock the value and potential of our circRNA platform, which we are rapidly advancing at the Karolinska Institute in Stockholm" said Erik Digman Wiklund, CEO of Targovax.

"We have selected to partner with Targovax as we have recognized the strong potential of its lead clinical candidate ONCOS-102, complemented by the cutting edge circRNA pipeline program where we see significant future platform potential. Atlas has a long track record of supporting European biotech companies with innovative financing solutions during periods of high capital need. Our aim is to be a reliable long-term supporter for our biotech partners to deliver important scientific progress, and we always seek to align our interests with the development needs of the company, as well as the interests of existing shareholders" said Mustapha Raddi, Founder, Managing Partner of Atlas Capital Markets.

The financing will be made available to Targovax through an initial tranche of bonds in the total nominal value of NOK 37.5m upon EGM approval of the agreement, followed by a second tranche of NOK 30m and subsequent tranches of NOK 25m up to the total nominal value of NOK 300m, with at least three months between tranches. Targovax has full control over when and how many tranches are called upon over the 3-year agreement period, thereby ensuring flexible and predictable access to capital as required.

The convertible bonds will be issued at 92 percent of nominal value and thereby provide Targovax with a total of up to NOK 276 million in net capital. The bonds will not carry any interest and can be converted into shares at the discretion of Atlas, at a price determined as 100 percent of the average volume weighted share price (VWAP) of three of the last 15 trading days preceding the bond conversion request by Atlas. After conversion, Atlas may sell the Targovax shares in the market subject to certain pre-defined restrictions. Targovax retains the right to repurchase unconverted bonds at any time at 110 percent of nominal value.

Targovax will provide further information about the convertible bond financing in the company’s Q4 presentation on 16 February 2023, and welcome questions in the Q&A-session of the presentation. An EGM notice will be issued in due time with detailed information about the agreement, financial structure and commercial terms.

Atlas Capital Markets ("ACM") is an investment fund based in London, founded in 2012 by Mustapha Raddi. In 2016 Atlas Capital Markets created joint venture investment vehicles Atlas Special Opportunities LLC ("ASO") and Arena Structured Private Investment ("ASPI") with Arena Investors LP, a credit specialist asset manager based out of New York with $4 billion under management. Since 2022 ACM has signed a co-investment agreement with the international investment bank Macquarie IM.

ACM’s management has decades of experience and has executed more than 80 transactions across the world successfully.

Contact information, Atlas Capital Markets
[email protected]
www.atlascapitalmarkets.com

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: [email protected]

Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: [email protected]

Media enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Email: [email protected]

On February 16, 2023 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported the disclosure of MUC16 as the target of it’s latest immune-oncology program (Press release, iBioPharma, FEB 16, 2023, View Source [SID1234627333]).

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MUC16 is a well-known cancer target often overexpressed in several types of solid tumors, including ovarian, lung, and pancreas cancers. Specifically, MUC16 is a large extracellular protein expressed on more than 80% of ovarian tumors. Tumor cells can evade immune attack by shedding or glycosylating MUC16, making it difficult for traditional antibody therapies to effectively target and destroy the cancer cells.

Using its patented epitope steering AI platform, iBio’s innovative approach to this challenge allows its new monoclonal antibodies (mAbs) to bind to a specific region of MUC16 that is not shed or glycosylated, circumventing both tumor evasion mechanisms and potentially providing a powerful tool in the fight against cancer.

"The targeting of a very specific, patho-physiologically relevant, region of MUC16 is a testament to the versatility of our AI technology, as it successfully shows it can be applied to a broad range of targets," said iBio’s Interim Chief Executive Officer and Chief Scientific Officer, Martin Brenner. "This success adds to the growing list of target classes to which we have made differentiated antibodies using our patented epitope steering technology."

With the addition of the MUC16 program, iBio expands its Immuno-Oncology Portfolio complementing its Treg depleting programs IBIO-101 and CCR8, as well as its program targeting the tumor-specific EGFRvIII protein.

On February 16, 2023 Helocyte, Inc., ("Helocyte") a subsidiary company of Fortress Biotech, Inc. (Nasdaq: FBIO), reported that data from a Phase 1 pilot trial (see NCT03560752) evaluating the potential safety, immunological response and efficacy of the cytomegalovirus ("CMV") vaccine Triplex to enhance CMV protective immunity in immunosuppressed recipients of allogeneic hematopoietic cell transplants ("HCT") will be presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCTÔ and CIBMTRâ ("Tandem Meetings"), taking place February 15-19, 2023, in Orlando, Florida (Press release, Helocyte, FEB 16, 2023, View Source [SID1234627332]). Triplex was developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.

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City of Hope researchers led a pilot trial to explore the vaccination of immunocompetent HCT donors with Triplex to enhance CMV protective immunity in recipients of an allogeneic HCT. Triplex is a recombinant modified vaccinia Ankara ("MVA") viral vector expressing immunodominant CMV antigens, pp65, IE1 and IE2 that has previously been demonstrated to be safe, highly immunogenic and potentially efficacious in both healthy volunteers and HCT recipients. Triplex has been dosed safely in over 100 subjects.

"CMV is still the most common infectious complication in allogeneic HCT and remains of fundamental clinical concern. While preemptive antiviral therapies have greatly reduced the risk of CMV end-organ disease and mortality, such therapies are often associated with significant toxicities, delayed immune reconstitution and even resistance," said Ryotaro Nakamura, M.D., Jan & Mace Siegel Professor in Hematology & Hematopoietic Cell Transplantation, City of Hope. "This novel approach represents a promising strategy to convey CMV protective immunity to HCT recipients early after transplant, and potentially reduce or eliminate the need for antiviral therapy."

The trial, the results of which were also recently published in the American Journal of Hematology, enrolled 17 CMV-seropositive patients who received an HCT from a CMV-seropositive (n=16) or CMV-seronegative (n=1) matched related donor ("MRD") vaccinated with Triplex prior to stem cell harvest.[i] Donor and recipient pairs who participated in the trial were observed to have adhered closely to the protocol. Triplex was generally well-tolerated in stem cell donors who participated in the study with no serious adverse events reported. All HCT recipients were fully engrafted with stem cells of donor origin without delay. On day 28 post-HCT, levels of functional CMV and vaccine-specific CD137+CD8+ T cells were observed to be significantly higher (p=0.017 and for pp65 alone, p<0.0001) in recipients of Triplex-vaccinated MRD compared to a control cohort of recipients of HCT from an unvaccinated MRD. CMV events requiring antiviral intervention in recipients with Triplex-vaccinated donors were observed to be lower (18%) than those in similar cohorts prophylactically treated with the antiviral, letermovir (37%).

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We are encouraged by the results of this pilot study that further demonstrate the potential safety, immunogenicity, and efficacy of Triplex. The donor vaccination paradigm deployed in the trial may be applicable to other (higher risk) HCT settings, including those involving haploidentical or mis-matched donors – thereby potentially reducing the need for antivirals, which have been associated with significant toxicities and delayed immune reconstitution. We look forward to advancing the development of Triplex, which is currently the subject of multiple ongoing and planned clinical trials in HCT, solid organ transplantation, Human Immunodeficiency Virus and in combination with CAR-T therapy, most of which are supported by funding from the National Institutes of Health."

Details of the presentation are as follows:

Abstract number: 82
Title: CMV-MVA Triplex Vaccination of Stem Cell Donors to Enhance CMV Specific Immunity and Prevent CMV Viremia in Recipients after Stem Cell Transplant
Date and Time: Saturday, February 18, 11:00 a.m. – 11:15 a.m. ET
Location: World Center Marriott – Crystal NPQ
Presenter: Ryotaro Nakamura, M.D., Jan & Mace Siegel Professor in Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, CA
For more information about the 2023 Tandem Meetings, please visit: View Source

About Triplex
Triplex is a universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara viral vector vaccine engineered to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins [UL83 (pp65), UL123 (IE1), UL122 (IE2)] linked to CMV complications in the post-transplant setting. In previous Phase 1 and Phase 2 studies, Triplex was found to be safe, well-tolerated and highly immunogenic. Triplex is currently the subject of multiple ongoing clinical trials, including: a Phase 2 trial for CMV control in HCT recipients with haploidentical donors (see NCT04060277); a Phase 1/2 trial for CMV control in pediatric recipients of HCT (see NCT03354728); a Phase 2 trial for reduction in viral load of Human Immunodeficiency Virus ("HIV") in adults co-infected with HIV and CMV (see NCT05099965); and a Phase 1 trial of Triplex in combination with a bi-specific CMV/CD-19 Chimeric Antigen Receptor T Cell for the treatment of Non-Hodgkin Lymphoma (see NCT05432635). Triplex is also the subject of several planned studies, including: a Phase 2 trial for CMV control in HCT recipients in which the donor is vaccinated with Triplex; a Phase 2 for CMV control in recipients of liver transplant; and a Phase 2 trial for CMV control in recipients of kidney transplant.

On February 16, 2023 Fresenius Kabi reported that its Biosimilar Stimufend (pegfilgrastim-fpgk) is now available from Fresenius Kabi in the United States (Press release, Fresenius, FEB 16, 2023, View Source [SID1234627331]). Stimufend was approved by the U.S. Food and Drug Administration (FDA) in September 2022 for use in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is Fresenius Kabi’s first U.S. biosimilar launch. The expansion of the company’s global biosimilars portfolio with a focus on oncology and immunology is an important milestone in its Vision 2026 growth strategy.

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