On October 17, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that previously announced interim data from the SB101 clinical trial of the company’s proprietary Fully Human AlbuminBinding (FHAB) candidate, SON-1010 (IL12- FHAB), will be presented by Dr. Sant Chawla, a key opinion leader in the field of sarcoma research, at the upcoming Connective Tissue Oncology Society Annual Meeting 2023, which will be held November 1‑4, in Dublin, Ireland (Press release, Sonnet BioTherapeutics, OCT 17, 2023, View Source [SID1234636075]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"We are excited to be part of Sonnet’s first-in-human use of SON-1010 in the cancer setting that is being studied in the SB101 trial," said Sant Chawla, MD, Principal Investigator and Director of the Sarcoma Center in Santa Monica, California. "We believe using an albumin-binding domain to extend the PK and target IL-12 to the tumor microenvironment is an excellent way to modify the local immune response. We also believe the increased amount of the SPARC protein in sarcoma and other solid tumors provides an excellent mechanism for retention of SON-1010 where it can have the most impact."

Details of the abstractand poster presentation are as follows:

Title: Interim Analysis of a Phase 1 Study using IL12-FHAB with Optimized Pharmacokinetics

Abstract Number: 1566754

Session: Immunology-Immunotherapy

Presentation Type: Poster

Time: Posters to be displayed during the entire conference. A poster reception will be held on November 2 from 5:30-6:30pm.

Location: The Convention Center, Dublin, Ireland

On October 17, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the topline clinical data from the final analysis of the Phase 1/2 clinical trial of galinpepimut-S (GPS) in combination with pembrolizumab (Keytruda) in Wilms’ tumor-1 (WT1)-positive platinum-resistant ovarian cancer (NCT03761914) will be presented at an e-Poster session at the 2023 International Gynecologic Cancer Society (IGCS) Annual Global Meeting taking place November 5-7, 2023, in Seoul, South Korea (Press release, Sellas Life Sciences, OCT 17, 2023, View Source [SID1234636073]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The multicenter study was sponsored by SELLAS and conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside the United States and Canada). Based on data in this e-Poster presentation, SELLAS is planning the submission of a full-length manuscript to a peer-reviewed journal during the first half of 2024.

Abstract Publication and Poster presentation details:

Title: Phase 1/2 study of galinpepimut-S plus pembrolizumab combination in patients with WT1+ platinum-resistant ovarian cancer in 2nd/3rd line of therapy.

Galinpepimut-S (GPS) is an HLA-unrestricted heteroclitic peptide vaccine against WT1, an antigen highly expressed in ovarian cancer. GPS has previously shown promising activity as maintenance therapy in combination with checkpoint blockade in patients with advanced ovarian cancer in 2nd/3rd remission. The clinical trial investigated the effects of GPS plus pembrolizumab in patients with measurable WT1+ platinum-resistant ovarian cancer relapsed after or refractory to 1st/2nd -or later- line of therapy.

Abstract Embargo Release Date and Time: The abstract reporting the key results of this study will become public today at 5 pm Korean Standard Time (4 am EDT US) and available for access via the IGCS 2023 website: View Source The abstract does not include follow-up assessments performed and further key outcomes which have been included in the e-Poster.

E-Poster Session Date and Time: The e-Poster for this study (# EP294) will be available for viewing to all registered delegates via the IGCS 2023 mobile application, IGCS 360 Educational Portal, and onsite (at the congress venue) at the e-Poster stations on November 5, 2023, at 8:30 am Korean Standard Time (November 4, 2023 at 7:30 pm EDT US) and throughout the duration of the meeting. The e-Poster is accompanied by a brief audio review of the data by the lead author.

Lead (Presenting) Author: Roisin E. O’Cearbhaill, M.D., Research Director, Gynecologic Medical Oncology Service; Clinical Director, Solid Tumor, Cellular Therapy Service; and Associate Attending Physician Memorial Sloan Kettering Cancer Center, New York, NY, USA.

On October 17, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it has entered into a definitive agreement for the purchase and sale of 4,347,827 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing 10 ordinary shares, at a purchase price of $1.15 per ADS (or ADS equivalent), in a registered direct offering (Press release, Purple Biotech, OCT 17, 2023, View Source [SID1234636072]). In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 4,347,827 ADSs. The warrants will have an exercise price of $1.25 per ADS and will be immediately exercisable upon issuance for a period of five and one-half years. The closing of the offering is expected to occur on or about October 19, 2023, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. Purple Biotech intends to use the net proceeds from the offering to fund the development of its oncology therapeutic candidates and for general working capital and corporate purposes.

The ADSs (or ADS equivalents) described above (but not the unregistered warrants and the ADSs issuable thereunder) are being offered by Purple Biotech pursuant to a "shelf" registration statement on Form F-3 (File No. 333-268710) previously filed with the Securities and Exchange Commission (the "SEC") on December 8, 2022 and declared effective by the SEC on May 22, 2023. The offering of the ADSs (or ADS equivalents) in the registered direct offering is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs representing ordinary shares underlying such unregistered warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the ADSs underlying the unregistered warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

In connection with the offering, the Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 631,556 of the Company’s ADSs that were previously issued in June 2020 and June 2018 at exercise prices of $9.00 to $28.00 per ADS, respectively, such that effective upon the closing of the offering the amended warrants will have a reduced exercise price of $1.25 per ADS and will expire five and one-half years from the closing of the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 17, 2023 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 members of the management team will participate in fireside chats at two upcoming investor conferences (Press release, PureTech Health, OCT 17, 2023, View Source [SID1234636071]). Webcasts of the presentations will be available at View Source

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Jefferies London Healthcare Conference

Presenters: Daphne Zohar, Founder and Chief Executive Officer, and Julie Krop, M.D., Chief Medical Officer

Date: Wednesday, November 15, 2023

Evercore ISI 6th Annual Healthcare Conference

Presenters: Daphne Zohar, Founder and Chief Executive Officer, and Julie Krop, M.D., Chief Medical Officer

Date: Wednesday, November 29, 2023

Commenting on the third quarter progress, Daphne Zohar, Founder and Chief Executive Officer of PureTech, said:

"It has been a very productive third quarter across our Wholly Owned Pipeline and Founded Entities, with multiple milestones reached as well as the continued progression toward several more major catalysts by the end of this year.

"Across our Wholly Owned Pipeline, we are looking forward to data from two clinical trials by the end of 2023, including data from the Phase 1b trial of LYT-200 in oncology, and the Phase 2a trial of LYT-300 in a validated clinical model of anxiety.

"Recently, we have been increasing our focus on our central nervous system (CNS) programs, including LYT-300 and LYT-310, that originated from our GlyphTM technology platform. Our increased focus reflects the historic success we’ve had in CNS by enabling drugs with proven human efficacy to realize their full therapeutic potential by applying an innovative solution to a previous limitation. As a result, we have now generated an additional two programs based on our Glyph platform, expanding our CNS pipeline to seven programs.

"Our increasing focus on this proven strategy for treating brain diseases builds on the success we had with KarXT and we are also pleased to note the important milestone of Karuna’s submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for KarXT for the treatment of schizophrenia. If approved, KarXT, invented at PureTech, will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.

"We plan to provide more guidance on our capital allocation and returns strategy in the fourth quarter. We look forward to another catalyst-rich quarter and continuing to deliver on our mission of changing the lives of patients with devastating diseases."

Key Highlights & Progress

Wholly Owned Programs

· LYT-100 (deupirfenidone), is currently in development for the treatment of conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis (IPF).

o Progressed Phase 2b dose-ranging trial of LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF). Topline results are expected in 2024. We plan to pursue a streamlined development program for LYT-100 in IPF and are using the same endpoints that have supported past approvals. Pending positive clinical and regulatory feedback, we intend to advance the program into a Phase 3 trial. We believe the results of the Phase 2b trial, together with a Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.

o Presented expanded data from a completed trial of LYT-100 in healthy older adults, which informed the two doses selected for the ongoing, global Phase 2b dose-ranging trial of LYT-100 (ELEVATE IPF) in patients with IPF. In addition to supporting the improved tolerability of LYT-100 versus the FDA-approved dose of pirfenidone, the new data presented supported the selection of a higher dose of LYT-100 with the potential for improved efficacy that is now being evaluated in ELEVATE IPF.

· LYT-300 (oral allopregnanolone) is an oral prodrug of allopregnanolone, enabled by our GlyphTM technology platform, that is currently in development for the treatment of a range of neurological and neuropsychological conditions, including anxiety, mood disorders and Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).

o Progressed a Phase 2a proof-of-concept trial of LYT-300 using a validated clinical model of anxiety in healthy volunteers. Results are expected by the end of 2023.

o Awarded up to $11.4 million from the U.S. Department of Defense to advance LYT-300 for Fragile X-associated Tremor/ Ataxia Syndrome (FXTAS). The Phase 2 trial of LYT-300 in FXTAS in collaboration with the University of California, Davis is expected to initiate in 2024.

· LYT-310 (oral cannabidiol [CBD]), is currently in development for the treatment of epilepsies and other neurological indications.

o A Phase 1 clinical trial of LYT-310 is expected to begin in the fourth quarter of 2023.

· LYT-200 (anti-galectin-9 mAb) is currently in development for the treatment of metastatic/locally advanced solid tumors, including urothelial and head and neck cancers, and hematological malignancies, such as acute myeloid leukemia (AML).

o Progressed a Phase 1b trial of LYT-200 in combination with tislelizumab in urothelial and head and neck cancers. Topline results are expected in 2024.

o Progressed a Phase 1b trial evaluating LYT-200 as a single agent for the treatment of AML. Initial results from a subset of patients are expected by the end of 2023.

Founded Entities

· Karuna Therapeutics (Nasdaq: KRTX) (Karuna) submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the potential approval of KarXT for the treatment of schizophrenia.

· Vedanta dosed the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 for the treatment of ulcerative colitis. The FDA also granted Fast Track designation to VE202. The phase 3 RestoratiVE303 pivotal study of VE303, designed for the prevention of recurrent Clostridioides difficile infection, is expected to initiate in the coming months.

· Akili, Inc. (Nasdaq: AKLI) (Akili) announced its strategic plan to transition from a prescription to a non-prescription business model. Akili is on track to submit its adult clinical trial data later this year to the FDA for over-the-counter (OTC) authorization of EndeavorOTC, and is planning to submit data to the FDA to convert its pediatric prescription product, EndeavorRxⓇ, to OTC in 2024.

· Sonde Health has partnered with Together, an AI-based health assistant, to provide enhanced mental health detection and monitoring through its new Mental Vitals feature. This collaboration integrates Sonde’s technology into the Together app, allowing users to access advanced voice analysis for early detection of symptoms related to depression and anxiety.

· PureTech will not move forward with the contemplated plan of merger with Gelesis and will instead focus on other strategic business initiatives.

On October 17, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that the company will present two poster presentations at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 taking place October 20-24, 2023, in Madrid, Spain (Press release, ORIC Pharmaceuticals, OCT 17, 2023, View Source [SID1234636070]). The presentations will highlight the initial Phase 1b clinical data for ORIC-114 in EGFR/HER2 exon 20 mutated cancers and new preclinical data for ORIC-114 demonstrating activity against additional atypical mutations in EGFR.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

In conjunction with the ESMO (Free ESMO Whitepaper) presentations, ORIC will host a conference call and webcast on Saturday, October 21, 2023, at 9:00 a.m. ET. Management will be joined by Dr. Alexander Spira, Clinical Director, NEXT Oncology-Virginia, who will share his perspective on the initial data from the Phase 1b study and the potential of ORIC-114 to treat EGFR/HER2 exon 20 mutated cancers.

Details of the ESMO (Free ESMO Whitepaper) poster presentations are as follows:

Title: A Global Phase 1b Study of ORIC-114, a Highly Selective, Brain Penetrant EGFR and HER2 Inhibitor, in Patients with Advanced Solid Tumors Harboring EGFR Exon 20 or HER2 Alterations
Poster #: 1333P
Poster Session: NSCLC, metastatic
Date & Time: Monday, October 23, 2023, at 9:00 a.m. CEST

Title: Preclinical Activity of ORIC-114, a Highly Selective, Brain Penetrant,
Irreversible Kinase Inhibitor, Against Atypical Mutations in EGFR
Poster #: 1345P
Poster Session: NSCLC, metastatic
Date & Time: Monday, October 23, 2023, at 9:00 a.m. CEST

Full abstracts are available for public viewing via the ESMO (Free ESMO Whitepaper) website. ePosters will be available Saturday, October 21, 2023, at 9:00 a.m. CEST.

Conference Call and Webcast Details

To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.