On April 11, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas ("head and neck cancers") (Press release, PureTech Health, APR 11, 2024, View Source [SID1234642015]).

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"In the U.S., there are approximately 66,000 people diagnosed with head and neck cancers each year, and the prognosis for metastatic disease is unfavorable, with a median survival rate of about ten months," said Eric Sherman, M.D., Memorial Sloan Kettering Cancer Center and an investigator in PureTech’s Phase 1/2 clinical trial. "There is an important need to explore promising new mechanisms and targets such as galectin-9 to bring therapeutic innovation to this patient population."

LYT-200 is an antibody against galectin-9, a potent cancer driver, and is the most advanced clinical program against this target. It is being evaluated in two ongoing clinical trials:

1. a Phase 1/2 adaptive design trial in advanced/metastatic solid tumors, including head and neck cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene’s tislelizumab, and shown disease control and suggestions of initial anti-tumor activity.

2. a Phase 1b clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome. LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of potential clinical activity.

"By granting Fast Track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "As galectin-9’s role in suppressing immune-mediated activity has been well-validated, it represents an important area of clinical research, especially in aggressive cancers with increased mortality."

Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need. The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting galectin-9 for the potential treatment of locally advanced/metastatic solid tumors that have poor survival rates, including head and neck cancers. It is also in development for the treatment of hematological malignancies, such as acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Galectin-9 is a potent oncogenic driver and immunosuppressor, and in AML it has been described to work via engagement with cytotoxic CD8 T cells and natural killer cells.

A wide variety of preclinical data underscores the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. These data demonstrate high expression of galectin-9 across various blood cancers and solid tumor types and show that galectin-9 levels correlate with poor survival in several cancers.

LYT-200 has demonstrated direct cytotoxic, anti-leukemic effects through multiple mechanisms, as well as synergy with standard of care chemotherapy and venetoclax in preclinical models. Consistent with its hub-and-spoke model, PureTech intends to advance LYT-200 via its Founded Entity Gallop Oncology.

On April 11, 2024 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, reported new data will be presented during the 50th Annual Meeting of the EBMT in Glasgow, United Kingdom (Press release, Orca Bio, APR 11, 2024, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-positive-clinical-data-on-orca-t-at-the-50th-annual-meeting-of-the-ebmt [SID1234642014]).

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Specifically, results from a single-center open-label Phase 1 clinical trial of an expanded group of older patients (n=20) treated with Orca Bio’s lead investigational high-precision cell therapy, Orca-T, and a reduced intensity conditioning (RIC) regimen will be presented. Preliminary data with Orca-T and RIC in patients with hematologic malignancies showed encouraging rates of relapse-free survival (77%). With a median follow-up of 9.65 months, no patients have experienced relapse to date (0%), demonstrating the curative potential for Orca-T in this historically challenging to treat patient group. An earlier dataset evaluating Orca-T and RIC in this population was presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

A second presentation will highlight findings from a non-randomized retrospective analysis comparing Orca-T plus single-agent tacrolimus with a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC). When compared to the historical PTCy cohort in this patient population, Orca-T offered potentially favorable rates of relapse-free survival, non-relapse mortality and overall survival. These data were previously presented at the 2024 Tandem Meetings, Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR).

"At Orca Bio, we continue to build clinical evidence to support the profile of Orca-T and its potential to expand life-saving treatment to patients while also reducing treatment-related risks," said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. "We look forward to joining top healthcare professionals from around the world at EBMT and sharing the latest findings that support the potential for Orca-T to offer a new curative solution for providers and their patients."

The EBMT abstracts are available at View Source

Details of the Orca Bio presentations follow:

Title: Phase 1 Trial Results for Patients with Advanced Hematologic Malignancies Treated with Orca-T Cell Therapy with Reduced Intensity Conditioning and Single Agent Tacrolimus

Poster Code: A121

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

Title: A Retrospective Analysis Comparing Orca-T to Post-Transplant Cyclophosphamide Based Allogeneic Hematopoietic Stem Cell Transplant in Patients with Matched Unrelated Donors Receiving Myeloablative Conditioning

Poster Code: A107

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

About Orca-T
Orca-T is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T includes infusions containing regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

On April 11, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported the submission of a Type C meeting request to the FDA (Press release, Oncolytics Biotech, APR 11, 2024, View Source [SID1234642013]). This meeting aims to discuss the Company’s planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).

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"A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment. We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep’s development and its registration. Ongoing discussions with our clinical collaborators and partners have helped us to prepare a robust, compelling briefing document," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We eagerly anticipate our discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in metastatic breast cancer, a critical step towards bringing this innovative treatment to patients. Having a well-defined plan for the registrational track study will also help advance our strategic partnering discussions. We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, added, "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control. Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients."

Dr. Heineman continued, "Our proposed study plans to evaluate pelareorep in patients with HR+/HER2- mBC who are eligible for chemotherapy after progressing on prior hormonal therapy, including a CDK 4/6 inhibitor. We also intend to evaluate potential biomarkers, including the expansion of tumor-infiltrating lymphocytes, using T cell receptor sequencing. We look forward to the opportunity to discuss our plans with the agency and align on the best approach to advance the development of pelareorep as a potential treatment option to improve outcomes for breast cancer patients."

On April 11, 2024 Novartis reported the offer document for the voluntary public takeover offer by its wholly owned subsidiary Novartis BidCo AG for all outstanding shares of MorphoSys AG ("MorphoSys"), including all shares represented by MorphoSys American Depositary Shares (the "Offer"), for an offer price of EUR 68.00 per share in cash (Press release, Novartis, APR 11, 2024, View Source [SID1234642012]). The offer price corresponds to a premium of 142% on the volume-weighted average price during the last three months, as of the unaffected January 25, 2024, close.

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The Offer is being made upon and subject to the terms and conditions set out in the offer document, including a 65% minimum acceptance threshold. The offer document is available in German and in the form of a non-binding English language translation, which, alongside other information in relation to the offer, are available on the following website: www.novartis.com/investors/morphosys-acquisition.The publication of the offer document has been approved by the German Federal Financial Supervisory Authority ("BaFin").

MorphoSys’ Management Board and Supervisory Board have declared that they intend to recommend to shareholders the acceptance of the offer in their joint reasoned statement subject to a careful review of the offer document.

The acceptance period for the Offer starts today and ends on 13 May 2024, at 24:00 hours CEST and 18:00 hours EDT (also on May 13, 2024) (the "Acceptance Period"). As all mandatory antitrust clearances have already been obtained, the payment of the offer price will be effected for the MorphoSys shares and ADS tendered during the Acceptance Period shortly after the publication of the tender results for that period, if the minimum acceptance threshold has been reached and the other offer conditions have been satisfied.

Georgeson is acting as information agent for Novartis in the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer.

From today until 30 May 2024, a takeover offer hotline for shareholders is available between 9:00-18:00 hours CEST from Monday through Friday under +49 89 3803 8187 (for German callers) and +44 20 3005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 EDT from Monday through Friday and 12:00-18:00 on Saturdays under +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S).

Additional Information and Where to Find it
This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Takeover Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the "Bidder"). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the "SEC"). The solicitation and offer to buy shares of MorphoSys will be made only pursuant the offer document. In connection with the Takeover Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the "Takeover Offer Documents"), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the "Recommendation Statements"). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TAKEOVER OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TAKEOVER OFFER. The Takeover Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944.

In addition to the Offer to Purchase, including the means to tender and certain other Takeover Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Takeover Offer in the manner described in the offer document.

Acceptance of the Takeover Offer by stockholders residing outside Germany and the United States of America may be subject to further legal requirements. With respect to the acceptance of the Takeover Offer outside Germany and the United States, no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction.

On April 11, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, reported that it has closed $5 million in second lien convertible loan funding with a term of 30 months, augmenting approximately $4.75 in gross cash proceeds from prior 2024 funding to date (Press release, NKGEN Biotech, APR 11, 2024, View Source [SID1234642011]). Outstanding or issuable securities that may deliver additional cash to the company over time, or on large share and volume moves, after their pending issue and/or registration, include over two million forward purchase shares and our expectation of over ten million warrants with a cash strike price set, or expected to be reset, at $2.00 per share.

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"This $5 million in funding is a statement of confidence and support for NKGen, our team, and our story in a challenging market. This provides breathing room for us to execute our plans, continue to pursue larger funding opportunities with both financial and strategic investors, and capitalize on our outstanding structured securities upon registration of the underlying shares. It will help fund our clinical trials and operations, filing of our annual report on Form 10-K, and filing of an amended registration statement on Form S-1 soon thereafter. This will help us to achieve additional value-creating milestones across both our neurodegenerative and oncology clinical programs and repay certain bridge funding liabilities," said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech.

Dr. Song continued, "We are intently focused on our upcoming Phase 2 Alzheimer’s clinical trial and recently submitted an IND for Parkinson’s disease while streamlining our resources for maximum efficiency. Accordingly, we have successfully reduced our monthly burn rate for operations and clinical trials by almost 50%. In addition, we have several catalysts expected this year including data readouts (both safety and cognitive) for the Phase 1 portion of our moderate Alzheimer’s trial and the initiation of Phase 2."