Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

Start Date05 Aug 2022

Sponsor / Collaborator

Epividian, Inc.

[+1]

NCT05383456

/ CompletedNot Applicable

The Visceral Adiposity Measurement and Observation Study

Start Date18 Apr 2022

Sponsor / Collaborator

Theratechnologies, Inc.

[+3]

NCT05388474

/ RecruitingNot Applicable

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States

The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end.
Primary Objective:
To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab.
Secondary Objective:
To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment.
To assess the long-term safety and tolerability of ibalizumab.
Other Objectives:
To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll.

Start Date22 Mar 2022

Sponsor / Collaborator

Theratechnologies, Inc.

[+2]

100 Clinical Results associated with Theratechnologies, Inc.

0 Patents (Medical) associated with Theratechnologies, Inc.

Literatures (Medical) associated with Theratechnologies, Inc.

15 Dec 2024·JAIDS Journal of Acquired Immune Deficiency Syndromes

Efficacy and Safety of 2 Fixed Doses of Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced HIV-Positive Individuals

Article

Author: Towner, William J. ; Anstett, Kaitlin ; Gathe, Joseph C ; Cash, R. Brandon ; DeJesus, Edwin

Background:Sustained viral suppression in patients with multidrug-resistant (MDR) HIV infection remains difficult; accordingly, agents targeting different steps in the HIV life cycle are needed. Ibalizumab, a humanized immunoglobulin G4 monoclonal antibody, is a cluster of differentiation (CD4)-directed postattachment inhibitor.Methods:In this phase 2b study, 113 patients with MDR HIV-1 and limited treatment options were assigned an optimized background regimen (OBR) and randomized to either 800 mg ibalizumab every 2 weeks (q2wk; n = 59) or 2000 mg ibalizumab every 4 weeks (q4wk; n = 54) up to week 24.Results:Viral loads (VL) below the detection limit were achieved in 44% and 28% of patients in the 800 mg q2wk and 2000 mg q4wk groups, respectively, at week 24. Mean (SD) VL (log10 copies/mL) decreased from Baseline [4.6 (0.8), 800 mg q2wk; 4.7 (0.7), 2000 mg q4wk] to week 2, with the reduction maintained through week 24 [2.9 (1.5), 800 mg q2wk; 3.2 (1.4), 2000 mg q4wk]. Baseline CD4+ counts were 80.5 and 54.0 cells/μL in the 800 mg q2wk and 2000 mg q4wk groups, respectively. Mean CD4+ T-cell count was increased at week 24 in both groups. No serious adverse events were related to ibalizumab.Conclusions:In heavily treatment-experienced patients with HIV (PWH) at a more advanced baseline disease severity, clinically significant response rates at week 24 were achieved with ibalizumab plus OBR. Ibalizumab's unique mechanism of action and lack of cross-resistance to other antiretroviral agents make it an important component of combination treatment regimens for PWH with limited treatment options.

27 Nov 2023·Open Forum Infectious Diseases

1499. Tesamorelin Reduces Visceral Adipose Tissue and Liver Fat in INSTI-Treated Persons with HIV

Author: Fourman, Lindsay ; Grinspoon, Steven K ; McLaughlin, Taryn ; Stanley, Takara

AbstractBackgroundSignificant attention surrounds the recent observation of weight gain in persons with HIV (PWH) initiating integrase inhibitors (INSTIs). Given the finding that visceral adipose tissue (VAT) is a critical component of this weight gain, the clinical implications of this weight gain are a growing concern, since VAT has been associated with downstream comorbidities including non-alcoholic fatty liver disease (NAFLD). Tesamorelin, a growth hormone releasing hormone analogue, has been shown to reduce VAT by over 15% in 6 months in PWH with lipohypertrophy. Therefore, we sought to investigate if tesamorelin could reduce VAT and liver fat in PWH on INSTI-containing regimens.MethodsTo do this, we leveraged data from a previous placebo-controlled trial of 61 participants with HIV-associated NAFLD. Measurements of body composition and hepatic fat fraction (HFF) were taken at baseline and after 12 months of treatment. Post-hoc analyses were performed to evaluate changes in body composition amongst individuals receiving INSTIs.ResultsAmongst participants, 39 (64%) were on INSTI containing regimens, the most common of which was dolutegravir (41%). These individuals were largely similar at baseline to those on regimens without INSTIs. Interestingly, although anthropometric measurements at baseline did not differ between the two groups, at 12 months, there were marked changes in VAT amongst the INSTI group. After 12 months, there was a significant difference in VAT change between the placebo and tesamorelin treated groups (p=0.0034). The placebo group had an increase in VAT of 10.8% whereas the Tesamorelin treated group had an overall reduction in VAT of 8.3%. Furthermore, the tesamorelin treated group saw a 31% relative reduction in HFF compared to baseline (p=0.006) which was significantly higher than in the placebo treated group (T:-4.9%, P:-0.1% absolute change p=0.015).ConclusionThese data reinforce the impact of INSTIs on VAT, body composition, and concomitant organs in PWH. It also demonstrates the potential for tesamorelin as a strategy to reduce VAT and HFF amongst individuals with INSTI-associated VAT accumulation.DisclosuresTaryn McLaughlin, PhD, Theratechnologies, Inc: Employee Steven K. Grinspoon, MD, Theratechnologies: Grant/Research Support Takara Stanley, MD, Pfizer, Inc: Grant/Research Support Lindsay Fourman, MD, Amryt Pharmaceuticals: Advisor/Consultant|Amryt Pharmaceuticals: Grant/Research Support

01 Jun 2023·Journal of Clinical Oncology

Sudocetaxel zendusortide (TH1902), a novel sortilin-receptor (SORT1)-targeting peptide-drug-conjugate (PDC) in patients (pts) with advanced solid tumors: Results from part 1 (dose-escalation) of a phase 1, open-label study.

Author: Winer, Ira Seth ; Shah, Satish ; Sharma, Manish ; Douglas, Lynn Marie ; Meric-Bernstam, Funda ; Metcalfe, Annick ; Roy, Guylaine ; Marsolais, Christian

3089 Background: SORT1 is expressed in a variety of tumors when compared to most healthy tissue. TH1902 is a first-in-class PDC targeting SORT1, that consists of 2 molecules of docetaxel attached to the TH19P01 peptide via a cleavable succinyl linker. Conjugating the short peptide with various anti-cancer agents allows for targeted delivery of payloads to the tumor. Here we report results from Part 1 of a FIH, multicenter, phase 1 study, designed to explore the safety, pharmacokinetics (PK) and efficacy of TH1902 in advanced solid tumors. Methods: Part 1 used a modified rapid intrapatient dose escalation design. A starting dose of 30 mg/m2 Q3W of TH1902 was used for the study based on the available pre-clinical data of TH1902 and the known safety profile of docetaxel. Eligibility criteria included pts with advanced solid tumors (all-comers) that have relapsed or are refractory to standard anticancer treatment. Pts had no limit on previous lines of therapy, and were required to have measurable disease by RECIST, expected survival of ≥3 months, ECOG 0-1, and adequate organ function. Pts were not required to be tested for SORT1 at entry. The primary objective of the study was to characterize the safety and tolerability of TH1902. The primary objective of Part 1 was to identify the maximum tolerated dose and the recommended dose for Part 2 (dose expansion). Additional objectives included the examination of the PK of TH1902 and free docetaxel, and outcomes as related to SORT1 expression. Results: As of April 2022, 18 pts were enrolled in Part 1 and included 6 ovarian, 1 endometrial, 1 cervical, 3 prostate, 3 ER+/Her2+ BC, 3 melanoma and 1 NSCLC. Pts received an average of 8 prior regimens (range: 3-20). All pts received at least 1 dose of study drug and were evaluated after the 1st cycle for a DLT. Dose levels between 30-420 mg/m2 Q3W were studied. Following safety observations among the 6 patients enrolled at the 420 mg/m2 dose level (Gr 3 neuropathy [n=2], Gr 4 neutropenia [n=2], Gr 3 ocular [n=1] and Gr 2 skin toxicities), the dose was reduced to 300 mg/m2. At the at 300 mg/m2 cohort, seven pts received a mean of 2.9 cycles. AEs (regardless of relatedness) occurred in all 7 (100%) pts, mostly Gr 1-2. One pt had Gr 3 worsening anemia (probably related) and Gr 3 abdominal pain/fistula (unrelated). AEs of interest were all Gr 1-2, and included: ocular (keratitis/dryness)=2 pts; GI (nausea/vomiting/diarrhea)=2 pts; neuropathy=2 pts; MSK (arthralgia/myalgia/extremity pain)=2 pts. In 15 evaluable pts in Part 1 clinical benefit was observed in 10 pts: 1 PR (prostate with 53% decrease in target lesion) and 9 SD. PK and SORT1 expression analyses are ongoing. Conclusions: Although biological activity has been observed, the optimal dosing regimen of TH1902 is currently under evaluation. Clinical trial information: NCT04706962 .

140

News (Medical) associated with Theratechnologies, Inc.

10 Jan 2025

·www.globenewswire.com

World Orphan Drug Alliance expands to Canada and full LATAM region, completing the first truly global commercialization offering

By adding Canada and the entire Latin America region, including Mexico, WODA completes its full global commercialization offering for rare and specialty therapies.With two new members - Innovative Medicines Group and Theratechnologies - WODA now provides access to over 210 million rare disease patients. MONTREAL and MONTEVIDEO, Uruguay, Jan. 10, 2025 (GLOBE NEWSWIRE) -- The World Orphan Drug Alliance (WODA), a global alliance of commercial distributors dedicated to providing access to treatments for rare diseases and specialty medicines in complex markets worldwide, has expanded its reach to include Canada and all of Latin America (LATAM). The addition of two new members - Theratechnologies Inc. for Canada and Innovative Medicines Group (IMG) for LATAM - brings the total number of countries covered by WODA to 158 and extends its reach to 210 million rare disease patients. The alliance now consists of 12 members, each being expert for the region covered. This expansion effectively completes WODA's ambition to provide global access to rare disease treatments. “With a new partner in LATAM and the addition of Canada, we are thrilled to become the only truly global-for-local platform," said Patrick Jordan, Chairman of WODA. "Canada not only gives our partners a footprint in North America, but with Theratechnologies’ operations in the U.S., they can be a U.S. solution as well. With IMG, we have a broader coverage of LATAM, including Mexico." Headquartered in Montreal, Theratechnologies was one of WODA’s first partners with the distribution of EGRIFTA SV® globally. They have recently broadened their portfolio, announcing an exclusive licensing deal with Ionis Pharmaceuticals for two assets in Canada. With a strong history of collaboration, Theratechnologies is a natural partner for WODA in Canada. WODA has also gained a strong new member in IMG, introducing a new platform for LATAM. IMG allows for a turnkey solution in the stalwart markets of Brazil, Argentina, and Colombia, and with a strong regional footprint ensures coverage across the rest of Latin America, including Mexico. Based in Montevideo, Uruguay, the team has a proven track record of serving rare disease patients throughout the region. The Alliance now provides a broad outreach with a local focus through thirteen separate entities: Specialised Therapeutics (Australia, New Zealand and Southeast Asia), Medis (Central and Eastern Europe & Nordics), Path Pharma (Greece, Cyprus, Malta), CTS (Israel), Innovative Medicines Group (Latin America), Vector Pharma (Middle East, North Africa, and Turkey), Orpharm (Russia and the CIS region), EffRx (Switzerland), Veld (Africa), Nxera (Japan, South Korea), Theratechnologies (Canada) and its boutique consultancy partner Decisive Consulting. About WODAThe World Orphan Drug Alliance (WODA) is a global alliance of commercial distributors focused on providing access to treatments for rare diseases and specialty medicines in complex markets around the world. WODA aims to provide comprehensive support to pharmaceutical and biotech companies with rare disease, oncology, and highly specialized therapeutics portfolio, starting from Named Patient Programs through to full commercialization. More about WODA: www.woda-alliance.com Media contact: Tina Vojnovic, tina.vojnovic@woda-alliance.com+386 41 744 735

License out/inOrphan Drug

09 Jan 2025

·www.globenewswire.com

Theratechnologies Provides Update on EGRIFTA SV® Supply

MONTREAL, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that a shortage of EGRIFTA SV® (tesamorelin for injection) will occur at the patient level in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024. While the Company is aware of remaining inventory of EGRIFTA SV® in certain pharmacies throughout the United States, several pharmacies have reported stockouts. Theratechnologies filed a required Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) on December 18, 2024. The Company subsequently submitted questions as part of a Type D meeting request concerning the status of two recently manufactured batches of EGRIFTA SV®, which are waiting to be released to pharmacies. The FDA confirmed that it would respond to the Company’s questions in writing no later than February 8, 2025. “We remain committed to people with HIV who rely on EGRIFTA SV®, as it is the only FDA-approved medicine of its kind, and we will continue to work with the FDA to expedite the release of the new batches for patients,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. The Company will update the market on any further material developments. EGRIFTA SV® is distributed in the United States only. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the time period related to the availability of EGRIFTA SV® to patients; (ii) the date by which the FDA will respond to the Company’s questions following its request to have a Type D meeting; and (iii) the timelines related to the potential release of the recently manufactured batches of EGRIFTA SV®. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the FDA will provide answers to the questions asked by the Company by February 8, 2025; (ii) the responses to the questions asked by the Company will confirm that the Company is able to release the recently manufactured batches of EGRIFTA SV® or will confirm that the review of the PAS will be completed prior to the expiry of a four-month period; (iii) current market demand for EGRIFTA SV® will remain unaffected; (iv) the shortage of EGRIFTA SV® will not adversely impact the financial conditions of the Company; and (v) the Company will be able to negotiate waivers of defaults with its secured creditors to the extent the drug shortage period results in defaults under its credit agreements. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to: (i) delays in responding to the Company’s questions beyond February 8, 2025; (ii) refusal by the FDA to release the recently manufactured batches of EGRIFTA SV® until the PAS review is completed; (iii) FDA’s review of the PAS not being completed before April 18, 2025; (iv) non-approval of the PAS; (v) issuance of questions as part of the PAS review by the FDA resulting in delays in completing the PAS review and resulting in delays beyond April 18, 2025 to release the recently manufactured batches of EGRIFTA SV®; (vi) issuance of a complete response letter following the filing of the PAS as a result of the manufacturing site being classified as Official Action Indicated preventing the Company from releasing the recently manufactured batches of EGRIFTA SV®; (vii) a decrease in demand for EGRIFTA SV® due to its shortage potentially adversely impacting the resumption of the commercialization of EGRIFTA SV®; (viii) losses of key employees due to the shortage; and (ix) defaults under the covenants of the credit agreements resulting from the shortage. The Company refers current and potential investors to the “Risk Factors” section of the Company’s Form 20-F dated February 21, 2024 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Investor inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@theratech.com1-551-261-0401 Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800

Drug ApprovalAccelerated Approval

18 Dec 2024

·www.globenewswire.com

Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment

MONTREAL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility where EGRIFTA SV® is produced. A PAS is reviewed by the FDA within four months of receipt and an approval is needed prior to the distribution of the recently manufactured batches of EGRIFTA SV®. Existing inventory levels of EGRIFTA SV® are expected to meet patient demand until mid-January 2025. Theratechnologies therefore continues discussions with the relevant FDA divisions in an effort to accelerate the release of EGRIFTA SV® and avoid a product shortage at the patient level. The Company will update the market on any further material developments. EGRIFTA SV® is distributed in the United States only. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the review period of the PAS by the FDA, the availability of EGRIFTA SV® to patients and the avoidance of an EGRIFTA SV® shortage at the patient level. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the PAS as filed will meet FDA’s regulatory requirements; (ii) the classification of the Company’s third party manufacturing site as official action indicated (OAI) will not result in the issuance of a complete response letter (CRL) following the submission of the PAS; (iii) the Company will be successful in its discussions with the various FDA divisions leading to the release of the recently manufactured batches of EGRIFTA SV® in order to avoid a drug shortage at the patient level; (iv) the FDA will review and approve the PAS before mid-January 2025; and (v) market demand for EGRIFTA SV® will remain unaffected despite the risk, or the occurrence, of a drug shortage. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to: (i) the occurrence of a drug shortage of EGRIFTA SV® due to various factors, including the inability of the Company to convince the FDA to accelerate the review timelines of the PAS or agree to alternative solutions allowing the release of the recently manufactured batches of EGRIFTA SV®, the rejection of the PAS for failure to meet regulatory requirements, the issuance of comments by the FDA on the PAS impacting its review timelines, the issuance of a CRL requiring the Company’s manufacturing site to be reinspected prior to any newly-manufactured batch of EGRIFTA SV® being released to the market; (ii) reduced revenues in the Company’s first quarter of its fiscal year 2025 in the event the PAS is not reviewed expeditiously or alternative solutions are not implemented allowing the Company to resume sales of EGRIFTA SV® before a four-month period; and (iii) patient attrition and lower demand for EGRIFTA SV® as a result of a drug shortage. The Company refers current and potential investors to the “Risk Factors” section of the Company’s annual information form filed under Form 20-F dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Investor inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@theratech.com1-551-261-0401 Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800

Drug ApprovalAccelerated Approval

100 Deals associated with Theratechnologies, Inc.

100 Translational Medicine associated with Theratechnologies, Inc.

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Pipeline Snapshot as of 02 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ibalizumab-UIYK ( CD4 x Viral fusion proteins )	HIV Infections More	Approved
Tesamorelin Acetate ( GHRH )	Lipodystrophy More	Approved
IV (Theratechnologies)	HIV Infections More	Phase 2
Tesamorlin F8	Nonalcoholic Steatohepatitis More	Phase 2
Sudocetaxel Zendusortide ( SORT1 x Tubulin )	Solid tumor More	Phase 1

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