On June 2, 2022 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the Jefferies Healthcare Conference on Thursday, June 9, 2022, at 8:00 a.m. ET (Press release, Scholar Rock, JUN 2, 2022, View Source [SID1234615469]).

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A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On June 2, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies for the treatment of hard to treat cancers, reported that it will participate in the Virtual Investor Innovation in Oncology Event on Thursday, June 9, 2022 at 11:00 AM ET (Press release, Xenetic Biosciences, JUN 2, 2022, View Source [SID1234615488]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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For the roundtable discussion, Jeffrey F. Eisenberg, Chief Executive Officer and Curtis A. Lockshin, PhD, Chief Scientific Officer of Xenetic Biosciences will be joined by Allan Tsung, MD, Scientific Advisor to the Company, Director of Surgical Oncology at the Ohio State James Comprehensive Cancer Center and Co-Director of the Gastrointestinal Clinical Trials portfolio, and recently appointed Chair of the Department of Surgery at the University of Virginia School of Medicine and Director of the Cancer Therapeutics program at the UVA Comprehensive Cancer Center. As part of the event, the Company and Dr. Tsung will discuss the Company‘s recently licensed DNase-based oncology platform, the role of Neutrophil Extracellular Traps ("NETs") in cancer and the use of DNase in targeting NETs, and the potential broad utility of the platform for the treatment of high-value oncology indications where there remains significant unmet need.

In addition to the moderated portion of the event, investors and interested parties will have the opportunity to submit questions live during the event. The Company will answer as many questions as possible during the event.

A live video webcast of the Virtual Investor Innovation in Oncology Event will be available on the Events page in the Investors section of the Company’s website (xeneticbio.com) and archived for 90 days.

On June 2, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that the Company will participate in the following upcoming investor conferences taking place in New York (Press release, Arbutus Biopharma, JUN 2, 2022, View Source [SID1234615404]):

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Jefferies Healthcare Conference (June 8 – 10, 2022)

Fireside Chat: 3:00 pm ET on Thursday, June 9, 2022
Presenters: Michael McElhaugh, Chief Business Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer
JMP Securities Life Sciences Conference (June 15 – 16, 2022)

Fireside Chat: 9:00 am ET on Wednesday, June 15, 2022
Presenters: Michael McElhaugh, Chief Business Officer; Dr. Michael Sofia; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer
Live webcasts of the fireside chats can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com. An archived replay of the webcast will be available on the Arbutus website after the event.

On June 2, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported completion of its Phase 1b CIMON trial evaluating the safety and tolerability of MaaT033, the Company’s high-richness, high-diversity MET for oral administration, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HRMS) having received intensive chemotherapy (Press release, MaaT Pharma, JUN 2, 2022, View Source [SID1234615420]). In this study, performed in an immuno-compromised patient population, MaaT033 presented a good safety and tolerability profile, evaluated as the primary endpoint. The topline results also show rapid and persistent engraftment of MaaT033 in the patients’ gut. The study data support the Company’s preparation to initiate a Phase 2/3 trial later this year to evaluate MaaT033’s ability to improve survival and prevent complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with blood cancers. Every year, approximately 22,000 patients require allo-HSCT in the seven major markets. MaaT033’s oral formulation is designed to support long-term, ambulatory use, opening up new potential development opportunities for the Company. Today’s announcement confirms previously-announced promising interim results of the trial, which allowed early completion of the study.

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"Parallel to the clinical successes of our lead candidate MaaT013, we developed MaaT033 as our first oral formulation, and the strength of the engraftment we have seen in these cohorts exceeds our expectations. Together with a good safety profile, this solid evidence for our first oral candiate is a crucial milestone for MaaT Pharma," commented Hervé Affagard, CEO and co-founder of MaaT Pharma. "Allo-HSCT is a curative treatment of liquid tumors, that is unfortunately negatively impacted by two primary complications, graft-versus-host disease and severe infections, which hinder overall survival. We view the prevention of these adverse effects as the key to a better prognosis for these patients."

MaaT033 is designed to restore and maintain a healthy gut microbiome in patients with severe dysbiosis as a result of intensive chemotherapy and antibiotic treatment. Developed as an oral formulation in lyophilized capsules, its proprietary targeted-delivery design is conceived to optimize the product’s engraftment in the patient’s gut and its interaction with the immune system. Thanks to its high bacterial richness and ButycoreTM content, the product aims to reorient the gut microbial network towards immune homeostasis and restore the microbiome’s intestinal barrier function against infections.

"We know from previous studies that AML patients are highly dysbiotic as a result of intensive chemotherapy and antibiotic therapy. From the CIMON trial data, we can be confident that MaaT033 results in robust levels of engraftment in the gut of AML patients at the targeted dose," said Prof. Christian Recher, Professor of Hematology at the Toulouse University Hospital/IUCT-Oncopole (France) and Principal Investigator of the study. "This strong foundational data supports the launch of the next phase evaluating MaaT033 in preventing allo-HSCT complications in this patient population."

The CIMON Phase 1b trial (NCT04150393) was an open-label, dose-ranging study investigating the maximum tolerated dose of MaaT033 in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy. The trial enrolled 21 patients in four dose escalation cohorts (up to three capsules a day for 14 days) across six sites in France. The trial allowed to select the recommended dose for MaaT033, which remains confidential at this stage. MaaT033 showed rapid and persistent engraftment with the detection of more than 60% of the MaaT033 microbial communities (OTUs) in the patient’s gut post-exposure at the selected dose. Substantial engraftment was maintained during the treatment period and for at least three weeks after the end of treatment (last measure). Good tolerability of the candidate was also observed in this immunocompromised population, with only four serious adverse events (SAE) considered as unrelated to the treatment and one possibly related SAE (an infectious diarrhea event with no detection of the causal pathogen in the administered MaaT033 and patient recovery within four days). This is in line with the expected AE profile with standard of care treatments in this fragile population.

MaaT Pharma has performed a Scientific Advice procedure with the European Medicine Agency and will move forward with preparations for a Phase 2/3 randomized, double-blind, placebo-controlled study in 340 patients, that will assess safety and tolerability of MaaT033 before and after allo-HSCT, as well as the efficacy of the candidate in improving overall survival and prevention of allo-HSCT complications. The trial initiation is planned by end of 2022. This is in line with the program announced during the Company’s IPO in November 2021, and part of the funding raised during the IPO is allocated to the clinical development of MaaT033.

The Phase 1b CIMON topline data will be presented and discussed by Prof. Mohamad Mohty (Professor at Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department, Saint-Antoine Hospital, AP-HP, France) during the Company’s upcoming Virtual R&D Day, which will be held on Tuesday June 7, 2022 (register here).

Complete trial results will be submitted for presentation and/or publication in a peer-reviewed forum.

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem TherapyTM. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species.

On June 2, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported financial results and provided a business update for the quarter ended March 31, 2022 (Press release, Immatics, JUN 2, 2022, View Source [SID1234615438]).

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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "Immatics has continued to build positive momentum in the first quarter of 2022. We have started treatment in two of three Phase 1b cohorts advancing our IMA203 TCR-T studies targeting PRAME. We have reached a key milestone by entering the first-in-human trial with our first TCR Bispecifics candidate directed against MAGEA4/A8 and have set the stage for further advancing our TCER pipeline. We have also further strengthened our pipeline portfolio to address the needs of cancer patients by joining forces with Bristol Myers Squibb to develop multiple off-the-shelf TCR-T and/or CAR-T programs based on our allogeneic gamma-delta cell therapy platform ACTallo."

First Quarter 2022 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTallo and Autologous TCR-T – Immatics entered into a strategic multi-program collaboration with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs combining Immatics’ proprietary gamma-delta T cell-derived, allogeneic Adoptive Cell Therapy (ACT) platform ACTallo, with a suite of next-generation technologies developed by Bristol Myers Squibb. Immatics will receive an upfront payment of $60 million and is eligible for up to $700 million per Bristol Myers Squibb program through development, regulatory and commercial milestone payments and tiered royalty payments up to low double-digit percentages on net sales. The new collaboration covers development and commercialization of two programs for Bristol Myers Squibb. Both companies have an option to develop up to four additional programs each. In addition, Bristol Myers Squibb and Immatics will expand their autologous T cell receptor-based therapy (TCR-T) collaboration signed in 2019 by including one additional TCR-T target discovered by Immatics. Immatics will receive a payment of $20 million and eligibility for milestone payments as well as tiered royalties.

ACTengine IMA203 (PRAME) – Update on Phase 1b expansion cohorts:

Cohort A – IMA203 as monotherapy: First patient treated at provisional Recommended Phase 2 Dose (RP2D) in March
Cohort B – IMA203 in combination with an immune checkpoint inhibitor: First patient treated at RP2D in May
Cohort C – IMA203CD8, a 2nd generation monotherapy where IMA203 is co-transduced with a CD8 co-receptor: IND granted by FDA, patient enrollment planned for Q2 2022
The next data read-out for the IMA203 monotherapy cohort is planned for 2H 2022. An initial data read-out for the IMA203/immune checkpoint inhibitor combination therapy cohort and the IMA203CD8 cohort is planned for YE2022.

ACTengine IMA201 (MAGEA4/A8) – Dose escalation is ongoing, target dose level to commence.

ACTengine IMA202 (MAGEA1) – A preliminary interim analysis from 16 patients treated in the dose escalation cohort demonstrated a favorable tolerability profile for IMA202. Signs of clinical and biological activity were observed, but were not reaching the threshold of objective responses as per RECIST1.1. Treatment-emergent adverse events for IMA202 were transient and manageable. No dose-limiting toxicities or signs of auto-immune toxicities were observed. 11 out of 16 patients (69%) showed disease control and 5 out of 16 patients (31%) showed tumor shrinkage. Maximum change of target lesion was minus 35%. Following final evaluation, Immatics plans to present the full data set at a later timepoint. Immatics management has decided not to further progress the IMA202 program into Phase 1b dose expansion and is evaluating development options and partnering opportunities for the program and the target MAGEA1.

TCR Bispecifics Programs

TCER IMA401 (MAGEA4/8) – Immatics initiated a Phase 1 clinical trial with its T cell engaging receptor (TCER) IMA401 for patients with recurrent and/or refractory solid tumors. IMA401 is the most advanced TCER candidate and targets an HLA-A*02-presented peptide derived from both MAGEA4 and/or MAGEA8. TCER IMA401 is being developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial with approximately 50 patients at up to 15 centers in Germany.
TCER IMA402 (PRAME) – Manufacturing of the clinical batch is on track for the 2H 2022 and initiation of the Phase 1 trial is planned in 2023.

Corporate Developments

Board of Directors Update

Nancy Valente, M.D., was appointed to Immatics’ Board of Directors in March 2022 and will be nominated for election at Immatics’ Annual General Meeting in June 2022. She brings over 20 years of experience in oncology and hematology drug development. Additional information on all members of Immatics’ Board of Directors can be found on the Immatics website.

First Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €252.7 million ($280.5 million1) as of March 31, 2022 compared to €145.1 million ($161.1 million1) as of December 31, 2021. The increase is mainly due to the receipt of the upfront payment in connection with the collaboration agreement with Bristol Myers Squibb on IMA401, partly offset by the financing of our ongoing research and development activities. This does not include $60 million cash to be received from the collaboration agreement signed with Bristol Myers Squibb in May 2022 or the $20 million cash to be received as a result of Bristol Myers Squibb’s decision to add one additional autologous TCR-T target as part of a 2019 collaboration agreement. With the addition of these upfront payments, the Company projects a cash runway into 2H 2024.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €102.9 million ($114.2 million1) for the three months ended March 31, 2022, compared to €7.4 million ($8.2 million1) for the three months ended March 31, 2021. The increase is mainly related to the recognition of revenue for the license portion of the collaboration agreement with Bristol Myers Squibb on IMA401.

Research and Development Expenses: R&D expenses were €25.1 million ($27.9 million1) for the three months ended March 31, 2022, compared to €23.0 million ($25.5 million1) for the three months ended March 31, 2021.

General and Administrative Expenses: G&A expenses were €9.3 million ($10.3 million1) for the three months ended March 31, 2022, compared to €8.4 million ($9.3 million1) for the three months ended March 31, 2021.

Net Income/Loss: Net income was €85.7 million ($95.1 million1) for the three months ended March 31, 2022, compared to a net loss of €22.8 million ($25.3 million1) for the three months ended March 31, 2021. The increase mainly resulted from a one-time revenue in connection with the partial recognition of the upfront payment from the collaboration with Bristol Myers Squibb on IMA401.

Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of March 31, 2022 (1 EUR = 1.1101 USD).

Upcoming Investor Conferences

Jefferies Global Healthcare Conference (in-person) New York, NY – June 8-10, 2022
Jefferies London Healthcare Conference, London, U.K. – November 15-17, 2022
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.