On October 26, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the Credit Suisse 30th Annual Healthcare Conference on Tuesday, Nov. 9 at 8:00 a.m. ET (Press release, PTC Therapeutics, OCT 26, 2021, View Source [SID1234591958]).

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The presentation will be webcast live on the Events and Presentations page on the Investor section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

On October 26, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that the independent Data and Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 has recommended that the trial advance into the combination stage with checkpoint inhibitors. In June, the company presented initial results from the first three monotherapy cohorts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting demonstrating that the investigational cell therapy is safe and well-tolerated and can stimulate immune responses in certain patients with advanced or metastatic human papillomavirus positive (HPV16+) tumors (Press release, SQZ Biotech, OCT 26, 2021, View Source [SID1234591976]). Data from the highest dose monotherapy cohort has been accepted for oral presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress being held December 8-11, 2021.

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"We are encouraged by our initial SQZ-PBMC-HPV-101 Phase 1/2 trial data and pleased to advance the highest dose of our SQZ APC clinical candidate into the combination stage of the trial," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "Based on our preclinical studies and available clinical trial data, we believe SQZ APCs could work synergistically with checkpoint inhibitors to provide additional clinical benefit to patients. Our clinical team and trial sites are ready to begin this important phase of the study."

The combination stage of the trial is now open for enrollment and will include checkpoint inhibitors targeting the PD-(L)1 and CTLA-4 pathways. In parallel, the company plans to continue to enroll in the highest dose monotherapy cohort.

The DSMB recommendation and initiation of the combination cohorts will trigger a Roche collaboration agreement milestone payment. The company’s most recently reported cash runway projections anticipated these proceeds.

New data from the monotherapy portion of the SQZ-PBMC-HPV-101 trial will be part of an oral presentation at ESMO (Free ESMO Whitepaper)-IO on December 9 in Geneva, Switzerland. Full presentation details can be found below.

ESMO-IO Presentation Details

Oral Presentation: Thursday, December 9 at 12:10 pm CET
Presentation Number: 48MO
Abstract Title: SQZ-PBMC-HPV-101: Preliminary results of a first-in-human, dose-escalation study of a cell-based vaccine in HLA-A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors

Lead Author: Jong Chul Park, MD, Massachusetts General Hospital; Developmental Therapeutics Member, Dana-Farber/Harvard Cancer Center

ESMO-IO will publish full abstracts on their website on Thursday, December 2 at 12:00 pm CET. SQZ will post its oral presentation on the company website on December 9 at 11:00 am CET.

SQZ-PBMC-HPV-101 Trial Design

SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and the definition of a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On October 26, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has reached an agreement with the Italian Medicines Agency, AIFA, for the reimbursement of Trogarzo for eligible people aged 18 and older living with multi-drug resistant (MDR) HIV-1 (Press release, Theratechnologies, OCT 26, 2021, View Source [SID1234596237]).

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"This agreement is an important milestone for Trogarzo and for HIV-1 patients in Italy," said Conor Walshe, General Manager, Europe. "Italy is the first country with a universal healthcare plan that has approved the formal reimbursement of Trogarzo for all patients in need. We expect to launch Trogarzo in Italy during the current quarter and look forward to its wider commercial availability in Europe over the coming months."

Trogarzo was first approved by the U.S. Food and Drug Administration (FDA) in March 2018 and was the first long-acting agent approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with MDR HIV-1 infection failing their current antiretroviral regimen. Trogarzo was approved by the European Medical Agency (EMA) in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen and is also commercially available in Germany. A number of patients are also being treated with Trogarzo in other European countries through early access programs. Theratechnologies plans to launch Trogarzo on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company received regulatory approval in Israel for Trogarzo and is working to secure pricing and reimbursement.

About Trogarzo1
Trogarzo a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.

Trogarzo blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with the post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. Trogarzo is administered every 2 weeks via intravenous infusion.

The most frequently reported adverse reactions were rash (9.2%), diarrhea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).

On October 26, 2021 Alkermes plc (Nasdaq: ALKS) reported the initiation of ARTISTRY-7, a global phase 3, open-label, randomized trial evaluating the anti-tumor activity and safety of intravenously administered (IV) nemvaleukin alfa (nemvaleukin), in combination with pembrolizumab, compared to investigator’s choice chemotherapy, in patients with platinum-resistant ovarian cancer. Nemvaleukin, Alkermes’ lead immuno-oncology candidate, is a novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy (Press release, Alkermes, OCT 26, 2021, View Source [SID1234591943]). As previously announced, ARTISTRY-7 is being conducted in collaboration with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA), which is providing KEYTRUDA (pembrolizumab) for the study. In addition, Alkermes is working with The GOG Foundation, Inc. (GOG) and the European Network of Gynaecological Oncological Trial groups (ENGOT) to conduct the study. The U.S. Food and Drug Administration recently granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.

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"The initiation of our phase 3 study of nemvaleukin in platinum-resistant ovarian cancer is an important milestone for the nemvaleukin clinical development program and reflects our commitment to focusing on the high unmet need of patients living with difficult-to-treat cancers such as platinum-resistant ovarian cancer," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "ARTISTRY-7 is designed to build upon the durable and deepening responses observed in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study. We look forward to sharing updates from ARTISTRY-7 as the study progresses and as we advance toward potential registration."

ARTISTRY-7 is a global phase 3, open-label, randomized study designed to evaluate the anti-tumor activity and safety of IV nemvaleukin in combination with pembrolizumab compared to investigator’s choice chemotherapy, with additional nemvaleukin and pembrolizumab monotherapy arms, in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The primary endpoint of ARTISTRY-7 is progression-free survival as assessed by the investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Additional endpoints include objective response rate, overall survival, disease control rate, duration of response, time to response, cancer antigen-125 response, pharmacokinetics (PK)/ pharmacodynamics (PD) and safety. The study is expected to enroll approximately 376 patients. Patients will be randomized to one of four treatment arms to receive nemvaleukin and pembrolizumab combination therapy, pembrolizumab monotherapy, nemvaleukin monotherapy, or investigator’s choice chemotherapy.

More information can be found at www.clinicaltrials.gov (NCT05092360, GOG-3063, ENGOT-ov68)

About Nemvaleukin Alfa (nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

On October 26, 2021 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported the expansion of an existing research agreement, led by Menashe Bar-Eli, Ph.D., Professor, Department of Cancer Biology, at The University of Texas MD Anderson Cancer Center, and will evaluate the potential efficacy of the combination of NT219, a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3, and immuno-oncology drugs, such as anti-CTLA4 or anti-PD1/PDL1 antibodies (Press release, Purple Biotech, OCT 26, 2021, View Source [SID1234591959]).

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"Previously completed preclinical studies have shown that NT219 is able to overcome resistance to certain treatment approaches, with results demonstrating sensitization of various tumor types to the approved therapies," said Hadas Reuveni, Ph.D., VP Research and Development of Purple Biotech. "This new research leverages preclinical data depicting the interface of the lymphoid and myeloid systems within the biology, as well as a target in human cancer. It provides an opportunity to address the alterations of metabolism of both the tumor and the responsive human immune system, altering a "cold" tumor unresponsive to immune oncology approaches into a responsive "hot" one. This collaboration will also provide an opportunity to assess potential synergies mitigating anti-apoptotic mechanisms associated with TGFbeta and the canonical WNT pathway."

"Our prior preclinical studies with NT219 demonstrated its effect on the STAT3 and IRS pathways and the encouraging clinical data presented at ASCO (Free ASCO Whitepaper) 2021 supports the further evaluation of potentially combining NT219 with immunotherapy agents," said Dr. Reuveni. "We look forward to understanding the potential impact of such combinations through this expanded research collaboration. Based on the profile of NT219 and the data generated to date, we believe there are multiple potential benefits that can be derived by combining NT219 with certain immuno-oncology drugs."

"We are thrilled to expand this collaboration, and we believe that combining NT219 with immune-oncology backbone therapies is an important path forward for our NT219 clinical program," said Isaac Israel, Chief Executive Officer of Purple Biotech. "The collaboration is an important step in the translational work that could support the advancement of this potential treatment into the clinic. We recently presented promising initial clinical data for NT219 as a monotherapy treatment for advanced solid tumors and look forward to the availability of additional top-line data from the first part of this ongoing Phase 1/2 clinical trial."

Previous research conducted by Dr. Bar-Eli demonstrated that treatment of mice-bearing melanoma with early generation compounds of NT219 inhibited tumor growth and metastasis by blocking STAT3 and IGF1R/IRS signaling. The inhibition of downstream pro-angiogenic and pro-invasion factors in-vivo, such as VEGF, MMP-2 and IL-8, was shown, as well as the suppression of macrophage recruitment to the tumor microenvironment.