On May 19, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported it has treated the first patients in its Phase 1b randomized, controlled clinical trial evaluating ALRN-6924 to protect against chemotherapy-induced neutropenia and other bone marrow toxicities, as well as toxicities outside of the bone marrow in patients with p53-mutated breast cancer who are being treated with doxorubicin plus cyclophosphamide and docetaxel (AC+D) (Press release, Aileron Therapeutics, MAY 19, 2022, View Source [SID1234614851]).

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Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US. Aileron is pioneering a precision medicine-based approach that is designed to enable the selective chemoprotection of healthy, normal cells in patients with p53-mutated cancers who are receiving chemotherapy without protecting their cancer cells from chemotherapy.

"Dosing of the first patients in our Phase 1b trial in patients with p53-mutated neoadjuvant breast cancer is an important step in advancing our vision to bring chemoprotection to all patients with p53-mutated cancer regardless of the type of cancer or chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron Therapeutics. "The severe toxicity profile of AC+D will enable us to evaluate ALRN-6924’s protective effect against multiple chemotherapy-induced toxicities. Moreover, this breast cancer trial may potentially open an additional regulatory opportunity with established precedents for supportive care drug approvals."

AC+D, a standard of care for patients with neoadjuvant breast cancer, is a highly effective but also highly toxic chemotherapy regimen. It causes severe neutropenia in up to 75% of patients and alopecia in approximately 90% of patients.

Aileron has previously presented non-clinical proof of mechanism data demonstrating ALRN-6924’s ability to arrest cell cycling and protect against chemotherapy-induced toxicities in bone marrow stem cells (in vitro), epithelial gut mucosa cells (in vivo), and hair follicles and their stem cells (ex vivo). The company has also presented proof of mechanism data for cell cycle arrest in bone marrow stem cells and hair follicle cells in healthy human volunteers, and proof of concept data for reduced multilineage bone marrow toxicities in patients with small cell lung cancer (SCLC) treated with topotecan.

About the ALRN-6924 Breast Cancer Trial Design

The Phase 1b clinical trial will evaluate the safety, tolerability and protective effect of ALRN-6924 against hematologic toxicities and other toxicities in patients with neoadjuvant breast cancer. Anticipated to enroll 30 patients, the trial involves a parallel group design with a dose expansion cohort. Patients will receive doxorubicin plus cyclophosphamide (AC) on Day 1 of each 3-week cycle for 4 cycles, and then docetaxel (D) on Day 1 of each 3-week cycle for 4 cycles. In part 1 (Dose Evaluation), a control group of 8 patients with p53-wild type breast cancer (i.e., non-p53-mutated) will receive AC+D without ALRN-6924. Patients with p53-mutated breast cancer on the same AC+D regimen will be randomized to concurrently receive ALRN-6924 at 0.3 mg/kg ALRN-6924 (n=6) or at 0.6 mg/kg ALRN-6924 (n=6). ALRN-6924 is given as IV infusion on study days 0, 1 (day of chemotherapy) and 2. In Part 2 (Dose Expansion), 10 patients will receive the same AC+D regimen and the ALRN-6924 dose selected in Part 1.

Upcoming ALRN-6924 Data Readouts

In 4Q2022, Aileron anticipates reporting initial interim results from patients treated with AC in Part 1 of the breast cancer trial. In addition, the company anticipates reporting interim results from its ongoing Phase 1b randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 in patients with non-small cell lung cancer undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors in June 2022 and topline results from that trial in 4Q2022.

Virtual KOL Event Today

Aileron will host a KOL investor event today, May 19, 2022, at 4 pm ET to highlight ALRN-6924’s revolutionary potential as the first precision medicine-based supportive care drug, the landscape and unmet need of chemotherapy-induced toxicities, and the company’s clinical development program and planned data readouts in 2022. For more details and to register, visit View Source

On May 19, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, reported data from three presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on its scalable, off-the-shelf in vivo lentiviral vector-based platform, termed VivoVec, that has the potential to achieve efficient T cell transduction upon direct administration to patients (Press release, Umoja Biopharma, MAY 19, 2022, View Source [SID1234614868]).

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"At this year’s ASGCT (Free ASGCT Whitepaper) conference we’re excited to share for the very first time preclinical data showing our efforts to engineer lentiviral surface particles to structurally mimic the immune synapse. The immune synapse is the space formed between antigen presenting cells and T cells during T cell activation and we show that optimization of this synapse can enhance the efficiency of our in vivo CAR T cell platform, VivoVec, to create therapeutic T cells," said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. "Our research team is also sharing updates on improvements made to our proprietary manufacturing process for VivoVec particles that supports scalable cGMP production for clinical trials. Altogether these studies continue to provide additional evidence that our multi-component in vivo CAR T cell therapeutics platform, which also includes universal TumorTag small molecules and the RACR/CAR for natural expansion and proliferation of therapeutic CAR T cells, has great potential to overcome critical obstacles facing the cell therapy industry."

Umoja’s one oral and two poster presentations demonstrate progress in UB-VV100 IND-enabling studies, manufacturing platform development, and next generation VivoVec surface engineering. Preclinical data provides early evidence of the anti-tumor activity and preliminary preclinical safety of UB-VV100, Umoja’s preclinical candidate for the treatment of B cell malignancies. Preclinical safety studies completed to-date demonstrate the overall low risk for off target transduction after in vivo administration of UB-VV100 in two animal models, including a model of intranodal delivery. Additional development of next generation VivoVec particle surface engineering with costimulatory ligands to promote T cell binding, activation, and transduction by replicating immune synapse formation will enable efficient in vivo CAR T cell generation and subsequent anti-tumor immune activity. Umoja further describes a scalable, suspension cell culture-based manufacturing process capable of producing cGMP-grade lentiviral vector product for in vivo CAR T cell therapy.

Presentation highlights:

Abstract #: 1242

Title: Preclinical Activity and Safety of UB-VV100, A Novel Lentiviral Vector Product Designed for Selective and Effective In Vivo Engineering of Therapeutic Anti-CD19 CAR T Cells for B cell Malignancies

Presenter: Alissa Brandes, Ph.D., Principal Scientist, Umoja Biopharma
Key Highlights:

Presentation describes the preclinical activity and safety of UB-VV100, a VivoVec particle containing a payload encoding an anti-CD19 4-1BBz CAR and a novel synthetic receptor, rapamycin-activated cytokine receptor (RACR).
Administration of UB-VV100 in a humanized mouse model of B cell malignancies results in the activation and transduction of T cells resulting in CAR expression, RACR enhanced CAR T cell expansion, and anti-tumor activity
UB-VV100 preliminary toxicology studies demonstrate a favorable safety and biodistribution profile in two preclinical animal models: intranodal administration to canines and systemic administration to humanized mice
Intranodal administration in canines, the proposed clinical route of administration, resulted in transduction that was largely restricted to the injected lymph nodes and no quantifiable transduction of non-immune tissues
Abstract #: 879

Title: A Lentiviral-Based In Vivo CAR T Cell Generation Platform with Viral Particle Surface Engineering Incorporating Anti-CD3 Single Chain Variable Fragment and T Cell Costimulatory Molecules

Presenter: Christopher Nicolai, Ph.D., Senior Scientist, Umoja Biopharma
Key Highlights:

Investigation of multiple novel surface particle engineering approaches for VivoVec lentiviral vectors to replicate immune synapse formation, resulting in enhanced particle-T cell binding, T cell activation, transduction, and transduced T cell quality.
VivoVec particles pseudotyped with the Cocal fusion glycoprotein and engineered to express T cell costimulatory ligands exhibited enhanced activation and transduction efficiency
CAR T cells generated with next generation VivoVec particles demonstrate enhanced anti-tumor activity and persistence in preclinical models of hematologic malignancy
Abstract #: 1166

Title: Development of a Scalable, Suspension Cell Culture-Based Manufacturing Process for VivoVec, a Lentiviral Vector Platform for In Vivo CAR-T Cell Generation

Presenter: Jeff Plomer, Ph.D., Senior Director Process Development, Umoja Biopharma
Key Highlights:

Poster describes the development of a scalable, suspension cell culture-based manufacturing process capable of producing lentiviral vector product with quality characteristics suitable for direct injection
The VivoVec platform is built on 3rd generation lentiviral vector gene delivery technology
Establishes a Quality Target Product Profile (QTPP) providing lentiviral vector product design that forms the basis for development
Utilizes well established biopharmaceutical manufacturing methods to control lentiviral vector production and reduce process-related impurities
Results will be used to identify critical process parameters and establish the operating ranges for the clinical and commercial manufacturing control strategy
Presentations can be accessed from the ASGCT (Free ASGCT Whitepaper) website at View Source

On May 19, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the company has established two wholly-owned subsidiaries in Romania and Australia to broaden and accelerate its global development plan for THIO, a telomere-targeting agent currently in development to evaluate its activity in multiple cancer indications (Press release, MAIA Biotechnology, MAY 19, 2022, View Source [SID1234614884]).

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"We are pleased to expand our clinical development operations across three continents, which reinforces MAIA’s commitment to delivering our novel therapeutic THIO to cancer patients across the globe," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Currently, our efforts are focused on site initiation and patient enrollment across Eastern Europe and Australia."

The Romanian subsidiary, MAIA Biotechnology Romania S.R.L., and the Australian subsidiary, MAIA Biotechnology Australia, will be used to conduct various activities including site initiation and patient enrollment, related to THIO-101, a Phase 2 clinical study evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The primary objectives of the trial are to evaluate the safety of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration and to assess the clinical efficacy of THIO in patients.

"In Europe, we have identified 22 clinical trial sites across 5 countries. In Australia, we have 3 clinical trial sites, with more coming online soon. We are very pleased with this progress," said Mihail Obrocea, MD, Chief Medical Officer of MAIA.

Joseph F. McGuire, MAIA’s Chief Financial Officer, added, "The establishment of our subsidiaries in Europe and Australia is a critical step in the global expansion of our business."

About THIO-101, a Phase 2 Clinical Trial

This trial (THIO-101) will be the first to test THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will reverse resistance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety of THIO administered as an anticancer agent and a priming immune system agent prior to cemiplimab administration and (2) to assess the clinical efficacy of THIO followed by cemiplimab using Overall Response Rate (ORR) as the primary clinical endpoint. We expect the study to start initially in Australia and Europe followed by the United States. The company has received Ethics Committee approval to proceed with the THIO-101 trial in Australia.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On May 19, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Jefferies 2022 Healthcare Conference on Wednesday, June 8, 2022, at 9:30 a.m. EDT (Press release, Bio-Techne, MAY 19, 2022, View Source [SID1234614901]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On May 19, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported financial results for the fiscal fourth quarter and year ended March 31, 2022 and provided a business update (Press release, Replimune, MAY 19, 2022, View Source [SID1234614852]).

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"We have ended the fiscal year in a very strong position from which to execute on our vision to establish our products as a cornerstone of immuno-oncology regimens and we look forward with these firm foundations in place to a potentially transformative 12-month period ahead," said Philip Astley-Sparke CEO of Replimune. "Updated data in anti-PD1 naïve cutaneous squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma continue to support our two registration-directed clinical trials in these settings. We are maintaining guidance that we expect to complete enrollment into our registration directed CERPASS clinical trial in CSCC mid-year and to release top line data in early 2023. Further, we expect to release initial directional data from our registration directed IGNYTE clinical trial in anti-PD1 failed melanoma in late 2022. Launch scale manufacturing has been established and commercial planning to establish a major skin cancer franchise is advancing. With RP2/3 we have announced an exciting mid stage program in colorectal cancer (CRC), hepatocellular carcinoma (HCC) and head and neck cancer (SCCHN) where an expedited path to potential approval in some settings may be feasible. Finally, we have a strong cash position to drive value through multiple major data catalysts."

Corporate Updates

Provided data update for RP1 in its skin cancer programs at a virtual investor event in March 2022.
IGNYTE anti-PD1 naïve NMSC cohort of patients treated with RP1 combined with Opdivo (nivolumab) (n=32; recruitment complete): The overall response rate (ORR) in CSCC increased to 65%, compared to 60% at the June 2021 update with the complete response rate (CRR) unchanged at 47%. Updated response rates in BCC, MCC and angiosarcoma were 25%, 75% and 67% respectively with multiple complete responses documented, indicating the potential utility of RP1 in additional NMSCs beyond CSCC.
IGNYTE anti-PD1 failed and anti-PD1 naïve melanoma cohort of patients treated with RP1 combined with Opdivo (n=36; recruitment complete): The ORR in anti-PD1 naïve cutaneous melanoma remained at 62.5%. The ORR in cutaneous melanoma patients who had previously failed anti-PD1 or both anti-PD1 and anti-CTLA-4 (n=16) was reported to have risen to 37.5%, an improvement from the 31% ORR reported in the June 2021 update, including two complete responses.
IGNYTE anti-PD(L)-1 failed NMSC cohort of patients treated with RP1 combined with Opdivo (n=12; recruitment ongoing): The initial early ORR data in this group was 33.3% with responses having been observed in anti-PD(L)-1 failed CSCC, MCC and angiosarcoma, including one complete response as of the cutoff date. Other patients who remain on study with a shorter follow up also showed tumor shrinkage. The Company believes the clear activity of RP1 combined with Opdivo in anti-PD(L)-1 failed NMSC represents a new potential therapeutic option for these patients and supports the broader potential for RP1 in skin cancers, including those with anti-PD(L)-1 failed disease.
Phase 1b/2 ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancer (n=6; recruitment ongoing): Initial data with RP1 monotherapy in solid organ transplant patients demonstrated a similar safety profile to that observed in patients who are not immune suppressed, with initial clinical activity having been seen. Two of the first six patients enrolled (33%) had so far achieved a response, with one complete response and one partial response.
Provided detailed strategy and clinical development plan for RP2/3 at a virtual investor event in March 2022.
The Phase 2 development plan for RP2/3 is intended to target tumor types in large underserved markets, including where liver metastases are common, as well as patients with primary liver cancer, and patients with early disease where the objective of treatment would be to increase the rate of cure. This includes the development of RP2/3 in combination with current standards of care (SOC), including immunotherapy, chemotherapy and radiation, and in settings following the current SOC.
The following indications for signal finding single arm Phase 2 clinical trials were identified which meet these criteria:
Locally advanced (LA) and 1L recurrent SCCHN in combination with chemoradiation, or SOC chemotherapy and anti-PD1 therapy, respectively. The Company’s objective is to also expedite the initiation of a randomized controlled registration directed program in LA SCCHN.
1L and 2L hepatocellular carcinoma (HCC) in combination with SOC immunotherapy and anti-PD1/L1 therapy respectively.
3L micro-satellite stable colorectal cancer (CRC) in combination with anti-PD1 therapy.
Additional signal finding work is also intended in other indications.
The RP2/3 Phase 2 program is expected to initiate around the calendar year end.
The decision as to whether RP2 or RP3 will be used in these clinical trials will be made later in the calendar year, following generation and analysis of further clinical data with RP2 and RP3 in their respective ongoing Phase 1 clinical trials.
Upcoming Milestones

CERPASS – Registration-directed Phase 2 clinical trial in CSCC

RP1 in combination with Libtayo (cemiplimab-rwlc) in CSCC: The Company is actively enrolling patients in a registration-directed, global, randomized, controlled, 180-patient Phase 2 clinical trial (CERPASS) evaluating RP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment in mid-year 2022 with top line data expected to be available in Q1 2023.
IGNYTE – Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo

Anti-PD1 failed melanoma cohort: The Company continues to enroll patients in the 125-patient cohort of the IGNYTE Phase 2 clinical trial in patients with anti-PD1 failed melanoma. The Company continues to expect to report initial directional data from the first 75 patient with six months follow up in late 2022.
RP2 and RP3

RP2 alone and in combination with Opdivo in difficult-to-treat cancers: After fully enrolling patients in the RP2 monotherapy (n=9) and combination with Opdivo (n=30) cohorts in the Phase 1 clinical trial with RP2 (data presented in Nov 2020 and Nov 2021), a further cohort of Phase 1 patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer and uveal melanoma) was opened, with the first patients having been enrolled and from which initial data is expected towards the end of the year.
RP3 alone and in combination with Opdivo in difficult-to-treat cancers: The Company completed enrollment in the initial part of its Phase 1 clinical trial with RP3 alone. Following determination of the recommended Phase 2 dose (RP2D), enrollment into the cohort of patients dosed with RP3 combined with Opdivo has recently commenced. This cohort will focus on enrolling patients with GI cancers, breast cancer, lung cancer and head and neck cancer. Initial data for this combination cohort is expected towards the end of the year. Additional patients will also be dosed as monotherapy.
Financial Highlights

Cash Position: As of March 31, 2022, cash, cash equivalents and short-term investments were $395.7 million, as compared to $476.3 million as of March 31, 2021. The decrease was primarily related to cash utilized in operating activities in advancing the Company’s expanded clinical development plan.

Based on the current operating plan, Replimune believes that existing cash and cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body.

R&D Expenses: Research and development expenses were $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022, as compared to $16.2 million for the fourth quarter and $56.8 million for the fiscal year ended March 31, 2021. This increase was primarily due to clinical expenses driven by the Company’s lead programs, expansion into additional studies, operating our dedicated manufacturing facility and related increased personnel costs. Research and development expenses included $2.1 million in stock-based compensation expenses for the fourth quarter and $8.6 million in stock-based compensation expenses for the fiscal year ended March 31, 2022.

S,G&A Expenses: Selling, general and administrative expenses were $10.3 million for the fourth quarter and $38.8 million for the fiscal year ended March 31, 2022, as compared to $6.0 million for the fourth quarter and $23.2 million for the year ended March 31, 2021. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and the initial build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $3.7 million in stock-based compensation expenses for the fourth quarter and $15.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2022.

Net Loss: Net loss was $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022, as compared to a net loss of $21.5 million for the fourth quarter and $80.9 million for the fiscal year ended March 31, 2021.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo. alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.
Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.