On November 15, 2021 PACT Pharma, Inc., a clinical-stage company developing transformational personalized neoTCR-T cell therapies for the eradication of solid tumors, reported that new data related to its PACTImmune Database were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, PACT Pharma, NOV 15, 2021, View Source [SID1234595650]). The results were featured in a poster presentation (#820) entitled, "Machine learning significantly improves neoantigen-HLA predictions utilizing > 26,000 data points from the PACTImmune Database," at the SITC (Free SITC Whitepaper) conference, which was held November 10-14, 2021.

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The presented results reported findings from a study in which PACT applied machine learning to more than 26,000 manufactured polypeptides consisting of the initially predicted neoE peptide together with Beta-2-Microglobulin and the HLA heavy chain for 62 different HLA alleles. Data demonstrated that PACT’s approach significantly improved neoE-HLA predictions, resulting in a 22% improvement in success rates on prospective data as compared to the widely used netMHCpan4.1 predictions. Additionally, the presentation outlined key elements of PACT’s strategy for continued enhancements to its approach to further improve its predictive power.

"The PACTImmune Database enables us to tune and continue to learn from our platform and its growing data assets. Based on retrospective analysis we know that higher predicted neoE-HLA success corelates with more TCRs captured per patient. Ultimately, these improved predictions should give us more actionable neoTCR options for patients in our clinical trial," said Eric Stawiski, Vice President of Bioinformatics at PACT and presenter of the SITC (Free SITC Whitepaper) poster.

The abstract related to this presentation is available on the SITC (Free SITC Whitepaper) website and can be accessed at: View Source

About PACTImmune Database
PACT has developed a proprietary approach to validate predicted neoepitopes (neoEs) and their cognate T cell receptors (neoTCRs) by capturing neoepitope-specific T cells from peripheral blood. This neoTCR discovery and validation process is being applied in a clinical trial (NCT03970382) evaluating personalized neoTCR-T cell therapy to treat patients across eight solid tumor types. Extensive pre-, on- and post-treatment data related to this trial has been accumulated in the PACTImmune Database (PIDB) which represents a growing data asset for patient-specific tumor immunogenicity in solid tumors.

On November 15, 2021, Codiak BioSciences, Inc. (the "Company") and Lonza Rockland, Inc. ("Lonza") reported that closed (the "Closing") the transactions contemplated by that certain Asset Purchase Agreement dated as of November 1, 2021 by and between the Company and Lonza (the "APA"), pursuant to which to Lonza acquired Codiak’s exosome manufacturing facility and related assets, and subleased the premises, located at 4 Hartwell Place, Lexington, MA 02421 as reported on that certain Current Report on Form 8-K filed by the Company on November 2, 2021 (Filing, 8-K, Codiak Biosciences, NOV 15, 2021, View Source [SID1234595700]).

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In connection with the Closing, and as consideration for the APA, on November 15, 2021, the Company and Lonza entered into a Manufacturing Services Agreement (the "MSA"). Pursuant to the MSA, Lonza will become the exclusive manufacturing partner for future clinical and commercial manufacturing of the Company’s exosome products pipeline, subject to limited exceptions. Under the MSA, the Company shall receive approximately $65.0 million worth of exosome manufacturing services for its clinical programs during the next four years. Pursuant to the MSA, commencing in 2026, the Company shall purchase from Lonza a contractually agreed minimum amount of exosome manufacturing services per year for 10 years, or if earlier, until the fifth (5th) anniversary of the first commercial sale of a Company exosome product, subject to limited exceptions.

In connection with the Closing, on November 15, 2021, the Company and Lonza entered into a Licensing and Collaboration Agreement (the "License"). Pursuant to the License, the Company granted Lonza a worldwide, exclusive and sub-licensable license to the Company’s high-throughput exosome manufacturing intellectual property in the contract development and manufacturing field, and a worldwide, non-exclusive and sub-licensable license to such intellectual property for non-therapeutical uses outside the contract development and manufacturing field. Pursuant to the License, the Company is eligible to receive from Lonza a double-digit percentage of future sublicensing revenues. The Company shall retain its pipeline of therapeutic candidates and core exosome engineering, drug-loading expertise and related intellectual property. The companies will collaborate to establish a joint Center of Excellence for further development of exosome manufacturing technology, with a shared oversight committee. The Center of Excellence will leverage the strengths of both companies to pursue developments in exosome production, purification and analytics.

The foregoing summaries of certain terms of the APA, MSA and License do not purport to be complete and are subject to, and qualified in their entirety by, the text of the APA, MSA and License, which the Company plans to file as exhibits to its Annual Report on Form 10-K for the year ending December 31, 2021 and are incorporated by reference herein.

On November 15, 2021 Scandion Oncology A/S reported that it will publish its Q3 interim report on Thursday, November 18, 2021 before 09:00 CET (Press release, Scandion Oncology, NOV 15, 2021, View Source;2021,c3454064 [SID1234595589]).

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Scandion Oncology’s executive management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

On November 15, 2021 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as non-alcoholic steatohepatitis (NASH), reported financial results for the third quarter ended September 30, 2021 and corporate highlights (Press release, Terns Pharmaceuticals, NOV 15, 2021, View Source [SID1234595605]).

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"Recent positive clinical data for TERN-101 and TERN-501 presented at AASLD validate part one of Terns’ strategy, which is demonstrating monotherapy proof of concept. Notably, TERN-501 produced significant and dose-dependent changes in sex hormone binding globulin (SHBG), a marker of target engagement linked to NASH efficacy, suggesting that it has potential to be a best-in-class THR-β agonist. We look forward to the top-line data readout from the AVIATION Trial of TERN-201 in the first quarter of 2022, which could mark our third clinical candidate with promising monotherapy data," said Senthil Sundaram, chief executive officer at Terns. "I am proud of the quality of execution at Terns and the momentum with which we are advancing our pipeline towards the second part of our strategy: achieving compelling and differentiated efficacy results in studies involving multiple clinically validated mechanisms of action. With this goal in mind, we are excited to move towards the planned initiation in the first half of 2022 of Terns’ first clinical trial in NASH patients including both monotherapy and combination arms of TERN-101 and TERN-501."

Recent Developments and Anticipated Milestones

TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Fully enrolled Part 1 of Phase 1b AVIATION Trial in NASH in September 2021
Top-line data from AVIATION Part 1 expected in 1Q 2022, including:
Key efficacy readout in corrected T1 (cT1) levels, an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
Safety, tolerability and plasma VAP-1 activity
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Reported positive top-line data from Phase 1 proof of concept clinical trial in November 2021, including a presentation at AASLD 2021 demonstrating:
Significant, dose-dependent effects on SHBG, a key pharmacodynamic marker of THR-β engagement linked to NASH histologic efficacy
TERN-501 was generally safe and well-tolerated with a predictable pharmacokinetic (PK) profile with low variability
Significant, dose-dependent reductions in atherogenic lipids including low-density lipoprotein (LDL) cholesterol and apolipoprotein B (Apo-B) in all TERN-501 dose groups compared to placebo
The safety, PK and PD results support continued development of TERN-501 and indicate that it is well-suited for co-formulation with other small molecule NASH agents as an oral, once-daily fixed dose combination

Data support plans to initiate in 1H 2022 Terns’ first NASH trial of a THR-β agonist (TERN-501) alone and in combination with a farnesoid X receptor (FXR) agonist (TERN-101)
TERN-101: Liver-distributed FXR agonist

Presented positive data from Phase 2a LIFT clinical trial in NASH at AASLD’s The Liver Meeting Digital Experience 2021, which demonstrated:
cT1 declined significantly as early as Week 6 with persistent decreases through Week 12 in all TERN-101 groups compared to placebo, with cT1 changes at Week 6 strongly correlated with changes at Week 12
TERN-101 treatment led to study population shifts to cT1 categories associated with lower risk of clinical events in chronic liver disease patients
In 10 and 15 mg groups of TERN-101, numerical reductions in alanine aminotransferase (ALT) and MRI protein density fat fraction (MRI-PDFF) were observed, with significant reductions in gamma glutamyl transferase (GGT) in all dose groups
TERN-101 was overall safe and well-tolerated at all doses studied with no discontinuations due to adverse events, including pruritus
In 5 and 10 mg groups of TERN-101, no differences from placebo in LDL cholesterol and high-density lipoprotein (HDL) cholesterol percentage change from baseline to Week 12 were observed
GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1) receptor agonist

Driven by computational interaction mapping, chemical synthesis and in vitro characterization of approximately 100 GLP-1R agonist compounds; lead candidates currently undergoing higher species in vivo profiling
Synthetic GLP-1 peptides have been approved for indication such as diabetes and obesity, which are conditions often accompanying NASH
Development candidate anticipated to be designated as TERN-601 in 4Q 2021
Key Appointments

Ann E. Taylor, M.D. joined the Board of Directors in September 2021, bringing more than 35 years of experience in drug development, having served most recently as chief medical officer of AstraZeneca plc
Pamela Danagher joined Terns as vice president and head of regulatory affairs in August 2021, bringing more than 20 years of experience in the pharmaceutical and biotechnology sectors
Third Quarter Financial Results

Cash Position: As of September 30, 2021, cash, cash equivalents and marketable securities were $177.2 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $7.2 million for the quarter ended September 30, 2021, as compared with $5.4 million for the quarter ended September 30, 2020
General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the quarter ended September 30, 2021, as compared with $3.3 million for the quarter ended September 30, 2020
Net Loss: Net loss was $11.8 million for the quarter ended September 30, 2021, as compared with $11.6 million for the quarter ended September 30, 2020

On November 15, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the third quarter of 2021 (Press release, Molecular Templates, NOV 15, 2021, View Source [SID1234595621]).

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"We are focused on execution across our growing portfolio of wholly owned next-generation ETBs," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Third quarter highlights included the initiation of clinical development of MT-6402 (targeting PD-L1 via dual mechanisms), the initiation of the HER2-positive breast cancer expansion cohort for MT-5111 as well as continued enrollment of patients in our MT-0169 clinical program. These programs demonstrate the depth and versatility of our ETB platform and the potential to develop innovative treatments for a broad array of solid and hematological tumors with high unmet medical need."

Company Highlights and Upcoming Milestones

Corporate

In July 2021, MTEM dosed its first subject in a Phase 1 study of MT-6402. MT-6402 is the first of MTEM’s 3rd generation ETBs incorporating Antigen Seeding Technology to enter the clinic and represents a new approach to immuno-oncology.
On August 4, 2021, MTEM assumed full rights to TAK-169, now known as MT-0169, from its former co-development partner, Takeda, including full control of MT-0169 clinical development.
Enrollment in the MT-0169 Phase 1 study in relapsed/refractory multiple myeloma has resumed after the transfer of the IND to MTEM.
MTEM expects to provide an update on MT-5111, MT-0169 and MT-6402 by the end of this year and expects to provide periodic updates throughout 2022.
MT-0169 (CD38 ETB)

On August 4, 2021, MTEM assumed full rights to MT-0169 from its former co-development partner, Takeda, including full control of MT-0169 clinical development, per the terms of the terminated collaboration agreement with Takeda. MTEM will continue conducting the ongoing Phase 1 study for MT-0169 in relapsed/refractory multiple myeloma and non-Hodgkin’s lymphoma.
Patient enrollment in the 50 mcg/kg cohort is currently ongoing. MTEM continues to see pharmacodynamic activity with MT-0169. Data on the first four patients treated in the Phase 1 study evaluating MT-0169 was presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 12.
MT-6402 (PD-L1 ETB with Antigen Seeding Technology)

MTEM is enrolling patients in the Phase 1 study of MT-6402 which initiated in July 2021. MT-6402 is the first of MTEM’s 3rd generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of PD-L1 antibody therapies.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment are eligible for enrollment.
Patient enrollment in the 16 mcg/kg cohort (the starting dose) is currently ongoing. There have been no dose limiting toxicities and no signs of capillary leak syndrome observed to date.
Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
The HER2-positive breast cancer expansion cohort initiated as of November 2021 at a dose of 10 mcg/kg (anticipated to be a therapeutic dose level). Dose escalation will continue to determine the recommended Phase 2 dose while the breast cancer expansion cohort collects efficacy and safety data.
Research

MTEM continues to advance its pipeline of next-generation ETBs targeting CTLA-4, TIGIT, TROP2, SLAMF-7, CD20, and CD45.
A poster on ETB mediated depletion of TIGIT expressing immune cells for cancer immunotherapy was presented at the SITC (Free SITC Whitepaper) annual meeting on November 13.
Through 2021 and in 2022, MTEM expects to present preclinical data on ETB candidates at medical and scientific conferences.
Upcoming Investor Events

Stifel Healthcare Conference (November 15-17, 2021)
Evercore ISI 4th Annual HealthCONx (November 30 – December 2, 2021)
Financial Results

The net loss attributable to common shareholders for the third quarter of 2021 was $30.4 million, or $0.54 per basic and diluted share. This compares with a net loss attributable to common shareholders of $23.2 million, or $0.47 per basic and diluted share, for the same period in 2020.

Revenues for the third quarter of 2021 were $2.4 million, compared to $4.3 million for the same period in 2020. Revenues for the third quarter of 2021 were comprised of revenues from collaborative research and development agreements with Vertex and Bristol Myers Squibb. Total research and development expenses for the third quarter of 2021 were $22.9 million, compared with $19.6 million for the same period in 2020. Total general and administrative expenses for the third quarter of 2021 were $9.0 million, compared with $7.5 million for the same period in 2020.

As of September 30, 2021, MTEM’s cash and investments totaled $175.4 million. MTEM’s current cash and investments are expected to fund operations into the second half of 2023.