On April 6, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs in Moderna’s pipeline, at Catalent’s biologics facility in Bloomington, Indiana (Press release, Moderna Therapeutics, APR 6, 2021, View Source [SID1234577639]).

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In June 2020, Catalent and Moderna announced that Catalent would provide aseptic vial filling and packaging from its Bloomington site, including additional staffing required for 24×7 manufacturing to support production of an initial 100 million doses of Moderna’s vaccine. On March 29, Moderna announced that this significant milestone was achieved.

As part of this expanded agreement, Catalent will now dedicate to Moderna’s use a new high-speed filling line at the site through June 2023, which can be used to manufacture the COVID-19 vaccine and potentially additional investigational programs in Moderna’s large clinical pipeline. Catalent will also provide inspection, labeling, cartoning, and final packaging for these programs.

"We appreciate this expanded collaboration with Catalent and the dedication of their team," said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. "This additional fill-finish capacity will be important for not only our COVID-19 vaccine, but also potentially for other programs in our clinical development pipeline."

"Catalent’s partnership with Moderna began in 2016, when we had only glimpsed the potential applications of mRNA and could not have guessed how pivotal mRNA would become in the fight against COVID-19," commented Alessandro Maselli, Catalent’s President and Chief Operating Officer. "We are proud to announce this extension of our companies’ strategic collaboration, and we look forward to further demonstrating our commercial manufacturing expertise as we help supply more vaccine doses."

Catalent announced in September 2020 its $50 million investment into this third high-speed vial filling line at Bloomington. Due to the company’s considerable experience in facility and capacity expansion, it was able to accelerate the overall project from a typical 18-month timeframe to approximately 10 months, including construction, procurement, installation, and CGMP qualification of the line, which will be completed in April 2021. Furthermore, the ability to dedicate this new line to Moderna will enable the site to free-up capacity on existing lines for other important customer programs.

On April 6, 2021 Bridge Biotherapeutics Inc.(288330 KQ), a clinical-stage biotech company headquartered in Seongnam, Republic of Korea, reported that the company has initiated the Phase 1/2 clinical trial assessing safety, tolerability, and anti-tumor activity of BBT-176 in non-small cell lung cancer (NSCLC) patients who acquired osimertinib-resistant EGFR triple mutations (Press release, Bridge Biotherapeutics, APR 6, 2021, View Source [SID1234577641]).

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BBT-176, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arises due to osimertinib (Tagrisso)-resistant mutations in NSCLC. The mutation results in a cysteine to serine change on amino acid 797 within the kinase domain sequence of the EGFR. From the pre-clinical studies, BBT-176 exhibited anti-tumor efficacy in mouse xenograft models and anti-brain metastases in patient-derived orthotopic xenograft models.

The Phase 1/2 study, an open-label study to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of BBT-176 in patients with NSCLC who progressed following prior therapy with an EGFR TKI agent (NCT identifier: NCT04820023), is expected to enroll approximately 90 participants separated into two parts: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). In the first part of the study, which has been initiated in the Republic of Korea, the RP2D (Recommended Phase 2 Dose) will be identified based on the evaluation of drug safety and tolerability in the treatment group. In the subsequent part of the study, which will be conducted both in the U.S. and Korea this year, primary and secondary outcome measures will include assessments of overall anti-tumor activity with objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In addition, detailed mutation profiles collected through liquid and tumor biopsy procedures will be analyzed after the study.

"We are highly encouraged to be able to initiate the first-in-patient study of BBT-176, which is expected to address high unmet medical needs of advanced NSCLC patients with C797S mutations across the globe," and "our Business Development team will be exploring strategic partnership opportunities as the clinical study progresses," said James Lee, CEO of Bridge Biotherapeutics.

Additional information about the clinical trial may be found at ClinicalTrials.gov, using identifier NCT: 04820023.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. Lung cancer is classified into two main groups: non-small cell lung cancers (NSCLC) and small cell lung cancers (SCLC), where NSCLC accounts for approximately 85% of all lung cancer diagnoses. In 2019, there were a combined 0.79 million diagnosed cases of NSCLC in men and women, aged 18 years and older, across the US, France, Germany, Italy, Spain, the UK, Japan, and urban China. The incidence of NSCLC is expected to increase at an annual growth rate (AGR) of 3.01% from 2019 to 2029, reaching 1.03 million cases in 2029[1].

On April 6, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported initial clinical data from the ongoing Phase 1/2 SWORD-1 study of its RET inhibitor drug candidate, TPX-0046 (Press release, Turning Point Therapeutics, APR 6, 2021, View Source [SID1234577625]).

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The initial data from the Phase 1 dose finding portion of the study showed preliminary clinical activity, including objective responses and a generally well-tolerated safety profile. Turning Point continues to evaluate doses and schedules to determine a recommended Phase 2 dose, and plans to revise the study protocol to include Phase 1 expansion cohorts at the recommended Phase 2 dose.

"RET-driven cancers affect nearly 10,000 patients annually in the U.S. and E.U., and patients who progress following treatment with a selective RET inhibitor remain particularly underserved," said Alexander Drilon, M.D., chief, Early Drug Development Service, Memorial Sloan Kettering Cancer Center. "While we continue to evaluate TPX-0046, the initial preliminary data are encouraging, with a generally tolerable safety profile and early signals of activity."

TPX-0046 Initial Clinical Data
Twenty-one patients enrolled in the study including 10 with non-small cell lung cancer (NSCLC) and 11 with medullary thyroid carcinoma (MTC) who were treated from December 2019 to the data cut-off date of March 10, 2021. Patients included those with RET-altered TKI-naïve NSCLC (n=3; all previously treated with platinum-based chemotherapy and immunotherapy) and MTC (n=2), and TKI-pretreated NSCLC (n=7) and MTC (n=9).

All 16 TKI-pretreated patients were previously treated with a selective RET TKI and 9 patients (56%) were treated with more than 1 prior TKI. Ninety-one percent of patients (19/21) had a baseline ECOG performance score of 1, and nearly half (10/21) received 3 or more prior therapies.

Preliminary efficacy data by investigator assessment was available for 14 evaluable patients with baseline measurable disease and at least one post-baseline assessment per RECIST v1.1, including TKI-naïve NSCLC (n=3) and MTC (n=2), and TKI-pretreated NSCLC (n=4) and MTC (n=5).

As of the March 10, 2021 data cut-off date:

Preliminary Safety and Pharmacokinetic Results

A total of 21 patients with RET-altered NSCLC or MTC were treated with TPX-0046 across multiple doses and schedules from 10mg once daily (QD) to 30mg QD
TPX-0046 was generally well tolerated, with the most frequent treatment emergent adverse event (TEAE) being Grade 1 or 2 dizziness
The maximum tolerated dose had not been determined, with 1 dose-limiting toxicity of treatment-related Grade 2 gait disturbance at 30 mg QD
TEAEs reported in greater than 20 percent of patients were dizziness (43%); fatigue (38%); alkaline phosphatase increase, constipation, decreased appetite, dry mouth, hyperphosphataemia, lipase increase (29% each); and alanine aminotransferase increase, dehydration, and muscular weakness (24% each)
There were infrequent dose reductions or drug discontinuations due to TEAEs
The majority of treatment related adverse events (TRAEs) were Grade 1 or 2 and there were no Grade 4 or 5 TRAEs
There were no treatment related Grade 3 or greater ALT/AST elevations, any grade of hypertension, hemorrhagic events or QT prolongation, and no interstitial lung disease or pneumonitis
Preliminary pharmacokinetic data indicates exposure increases in a dose dependent manner
Preliminary Efficacy Results

Of 5 RET TKI-naïve patients, 4 showed tumor regressions of -42%, -37%, -23%, and -3%, including 2 patients dosed at 30 mg QD who achieved confirmed partial responses with duration of responses of 5.6 and 5.8+ months, respectively. Three of the 4 patients with regressions remained on treatment awaiting their next scan
Of 9 TKI-pretreated patients, 3 patients (2 treated with only 1 prior selective RET TKI) achieved tumor regressions of -44%, -27% and -17%. All 3 patients remained on treatment awaiting their next scan
Of the 14 evaluable patients, 7 (50%) remained on treatment with duration of treatment ranging from 5.1 to 51+ weeks
"Given the encouraging data we have seen, we plan to modify the SWORD-1 study to include a dose expansion portion utilizing additional clinical sites," said Mohammad Hirmand, M.D., executive vice president and chief medical officer of Turning Point Therapeutics. "We look forward to advancing our development of TPX-0046 in both the RET-positive TKI-naïve and less heavily pretreated TKI-pretreated settings."

After determination of the recommended Phase 2 dose, Turning Point plans to study TPX-0046 in multiple Phase 1 dose expansion cohorts in up to 75 patients with RET-altered malignancies prior to an end of Phase 1 meeting with the Food and Drug Administration.

Webcast and Conference Call
Turning Point will host a webcast and conference call accompanied by a slide presentation to discuss the results at 4:30 p.m. ET today. Athena Countouriotis, M.D., president and chief executive officer, will host the call, which will also include Dr. Hirmand.

The discussion will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 9939858. A replay will be available through the "Investors" section of www.tptherapeutics.com.

On April 6, 2021 Sapience Therapeutics, Inc., a clinical stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult to treat oncology indications, reported multiple poster presentations, including a late-breaker, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which is being held in a virtual format (Press release, Sapience Therapeutics, APR 6, 2021, View Source [SID1234577642]). The posters will be available on April 10, 2021.

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Details of the poster presentations are as follows:

Title: Tumor uptake and predictable PK of ST101 – a peptide antagonist of C/EBPβ – in patients with advanced unresectable and metastatic solid tumors
Abstract Control Number: 5106
Presentation Time: The e-poster will be available on the AACR (Free AACR Whitepaper) website on Saturday, April 10, 2021
Session Type: E-Poster Session (late-breaker)
Session Category: Experimental and Molecular Therapeutics
Session Title: New Targets
Permanent Abstract Number: LB114

Title: C/EBPβ antagonist peptide, ST101, as a therapeutic approach in breast cancer
Abstract Control Number: 3578
Presentation Time: The e-poster will be available on the AACR (Free AACR Whitepaper) website on Saturday, April 10, 2021
Session Type: E-Poster Session
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Permanent Abstract Number: 959

Title: β-catenin antagonist peptide attenuates Wnt-dependent oncogenic activity
Abstract Control Number: 3677
Presentation Time: The e-poster will be available on the AACR (Free AACR Whitepaper) website on Saturday, April 10, 2021
Session Type: E-Poster Session
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Permanent Abstract Number: 964

More details can be found at View Source

About ST101

ST101 is a peptide inhibitor of C/EBPβ, which is a transcription factor overexpressed in many cancers that regulate cellular differentiation and promote tumor survival and proliferation. ST101 significantly decreases the expression of C/EBPβ target genes/proteins involved in cell survival, proliferation and differentiation including BCL-2, MCL-1, BIRC5/survivin, cyclins and ID family of proteins. ST101 has been demonstrated to induce selective cancer cell cytotoxicity across a variety of tumor types, including but not limited to breast cancer, melanoma, prostate cancer, GBM, lung cancer, and AML. C/EBPβ is expressed and active in cancer cells but not active in normal cells (post-differentiation), providing a therapeutic opportunity.

On April 5, 2021 Outpace Bio, a spinout from Lyell Immunopharma, reported that the company has landed $30 million in Series A funding to design new proteins that solve problems in cell therapies (Press release, Outpace Bio, APR 5, 2021, View Source [SID1234637777]). Lyell’s focus is developing new T cell therapies to fight cancer. To get started, Outpace is collaborating with Lyell to develop molecular controls for T cells that could refine and strengthen targeted cell therapies. Beyond that, the company plans to establish a series of partnerships to develop a variety of next-generation cell therapies

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Outpace co-founders Marc Lajoie and Scott Boyken both trained in the Baker lab at the Institute for Protein Design at the University of Washington, which specializes in "de novo protein design." Rather than finding proteins that already exist and then trying to customize them, de novo protein design means building completely original proteins from basic building blocks, using advanced computer algorithms to predict the created protein’s final 3D shape.