On June 20, 2024 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing targeted immunotherapeutic drugs, reported the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,828,500 shares of common stock, issued by Sonnet in October 2023 (the "Existing Warrants"), at a reduced exercise price of $1.20 per share (Press release, Sonnet BioTherapeutics, JUN 20, 2024, View Source [SID1234644455]). The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to an effective registration statement on Form S-1 (File No. 333-274581). The closing of the offering is expected to occur on or about June 21, 2024, subject to satisfaction of customary closing conditions.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the Existing Warrants for cash, Sonnet will issue new unregistered warrants to purchase up to 5,657,000 shares of common stock (the "New Warrants"). The New Warrants will have an exercise price of $1.55 per share (priced at-the-market under the rules of the Nasdaq Stock Market), will be exercisable upon issuance, and have a term equal to five years from the date of issuance. In connection with the transaction, Sonnet also (i) reduced the exercise price of the Existing Warrants to purchase an aggregate of 2,824,000 shares of common stock for all holders not participating in the transaction to $1.20 per share for the remaining term of the Existing Warrants, (ii) reduced the exercise price of certain outstanding warrants to purchase up to an aggregate of 227,272 shares of common stock issued by Sonnet in June 2023 (the "June Warrants") to $1.55 per share and (iii) extended the term of the June Warrants to the term of the New Warrants.

The gross proceeds to Sonnet from the exercise of the Existing Warrants are expected to be approximately $3.4 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for research and development, including clinical trials, working capital, the repayment of all or a portion of liabilities, and general corporate purposes.

The New Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the shares of common stock issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Sonnet has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the New Warrants.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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 June 20, 2024 4 Redx Pharma (JPJ:REDX), the clinical-stage, small molecule biotechnology company,
reported that Phase 2 data from zamaporvint (RXC004), a Porcupine inhibitor targeting Wnt-ligand dependent GI cancers, will be presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI), 26-29th June, Munich, Germany (Press release, Redx Pharma, JUN 20, 2024, View Source [SID1234644454]).

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Zamaporvint is a potent, selective, orally-active Porcupine inhibitor in development for hard-to-treat GI cancers. The principal efficacy hypothesis for zamaporvint is for use in combination, which has been investigated in Phase 2 signal searching patient cohorts with anti-PD-1 therapy. Monotherapy for single agent activity has also been investigated. The PORCUPINE study was in genetically-selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) as monotherapy and immuno-oncology combination (clinicaltrials.gov NCT04907539). The PORUPINE2 study was in all-comers biliary tract cancer as monotherapy and immuno-oncology combination, and in genetically selected pancreatic cancer as monotherapy (clinicaltrials.gov NCT04907851).

The data will be presented in two posters, one on the PORCUPINE study and one on the PORCUPINE2 study. Notably, these data demonstrate that zamaporvint, in combination with an anti-PD-1 agent in genetically-selected patient populations has the potential to improve upon efficacy outcomes achieved with standard of care alone.
Details of the poster presentations are as follows:

1)
Abstract Title: Phase 2 results of the Porcupine (PORCN) inhibitor zamaporvint
(RXC004) in genetically selected microsatellite stable colorectal
cancer patients
Session Title: Poster Session
Date/Time: Thursday 27 June 3:35 – 4:30pm CEST
Poster Number: 37P

2)
Abstract Title: Phase 2 results of the porcupine (PORCN) inhibitor zamaporvint
(RXC004) in patients with pancreatic and biliary tract cancer
Session Title: Poster Session
Date/Time: Thursday 27 June 3:35 – 4:30pm CEST
Poster Number: 391P
A copy of the posters will be made available on Company’s website following the presentation at:
View Source

On June 20, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients (Press release, Oncolytics Biotech, JUN 20, 2024, View Source [SID1234644453]). The co-primary endpoints of the cohort are objective response rate (ORR) and safety. It is supported by the US$5M Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award, an innovative program established to accelerate the development of new treatments for pancreatic cancer patients. It will be conducted in collaboration with AIO-Studien-gGmbH (AIO), a clinical trial group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers.

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"Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we’re excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration. I want to highlight PanCAN’s important support for this program with gratitude. The US$5M Therapeutic Accelerator Award has made it possible for us to broaden our evaluation of potential therapies that have the potential to improve outcomes for pancreatic cancer patients."

Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN said, "Working toward our vision to create a world in which all patients with pancreatic cancer will thrive, PanCAN launched the Therapeutic Accelerator Award to speed the drug development process and bring new options to patients faster. Dosing the first patient in this new cohort of the GOBLET study is an important step toward further evaluation of this investigational immunotherapeutic approach."

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial commented, "I have been pleased to observe the strength of the clinical response data for pelareorep in multiple cohorts of the GOBLET gastrointestinal study, especially in pancreatic and anal cancer. mFOLFIRINOX is currently considered the best treatment option for many pancreatic cancer patients. Therefore, the evaluation of pelareorep and mFOLFIRINOX, with or without atezolizumab, presents an important opportunity to identify a novel therapeutic approach that may broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies."

"Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep’s potential as a backbone immunotherapy that can impact various tumor types. The collaboration with GCAR on a registration-enabling study for the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer, meeting with the FDA to align on next steps for our breast cancer program, expanded enrollment in the GOBLET anal cancer cohort, and now the initiation of dosing in the mFOLFIRINOX cohort of GOBLET, announced today, are all important elements of our corporate plan," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal."

About GOBLET cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On June 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 20, 2024, View Source [SID1234644452]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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The third and fourth patients showed stable disease at their four- and two-month follow-up visits, respectively. Both patients are doing well, and neither showed any dose-limiting toxicities. Patients three and four are being treated at the Beverly Hills Cancer Center (BHCC).

The second patient, also being treated at the BHCC, previously had stable disease and showed a complete response in their brain metastasis. At the four-month follow-up visit, while stable disease of previously treated sites and a clean brain MRI were confirmed, a new site of disease, a sub-cutaneous metastasis, was detected by CT and PET scans. This patient is in generally good condition and tolerated their initial treatment well. As such, the Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA) approved a single-use, single-patient protocol, and on June 19, the patient started a new course of treatment with low-dose radiation and gamma-delta T cells under a single patient IND.

"We are optimistic the latest targeted treatment with Deltacel will control the second patient’s new lesion, which is suspected to have originated from a micro-metastasis not detected and therefore not targeted with radiation during the first course of treatment. This new protocol might be applied to all patients who received or will receive the Deltacel treatment and could be instrumental in controlling any new tumor lesions or progressing lesions," said Pietro Bersani, CEO of Kiromic BioPharma.

Kiromic BioPharma also reports submitting a request for Fast Track designation for Deltacel to the FDA. Fast Track designation facilitates and expedites the development and review of drugs that treat serious conditions and address unmet medical needs. For further information on Fast Track designation, please visit the FDA’s website.

"We continue to be encouraged by the favorable results of the Deltacel-01 trial, which reinforce our confidence in the potential of Deltacel to provide meaningful clinical benefits to patients in need. This confidence underscores the recent open-market purchases of common stock by several Kiromic directors and executive officers, as reported on Form 4 filings," noted Mr. Bersani.

"Proceeding with a single-use, single-patient protocol of Deltacel supports our commitment to advancing innovative therapies that address unmet clinical needs in unique ways, which include the possibility for retreatment," he added. "We are also excited about the potential of expediting Deltacel clinical development through Fast Track designation."

The fifth patient in the trial completed their 30-day safety visit at the BHCC with no toxicities reported, and the sixth patient is expected to be enrolled in July.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On June 20, 2024 Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, reported that updated clinical data from the ALISON clinical trial with its lead product vididencel in ovarian cancer will be presented at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Annual Congress, being held from June 20-22, 2024 in Florence, Italy (Press release, mendus, JUN 20, 2024, View Source [SID1234644451]). The trial reached its primary objective of inducing tumor-directed immune responses in at least 10 patients treated with vididencel.

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Ovarian cancer is the deadliest gynaecological cancer, mainly due to its high recurrence rate. Improving disease free and overall survival in advanced high grade serous ovarian carcinoma (HGSC) after primary treatment remains challenging. The Phase 1 ALISON trial explores the potential of vididencel to induce clinically relevant immune responses in ovarian cancer. The trial is fully enrolled (17 participants) and all participants have completed the vididencel treatment phase per April 2024. Vididencel-induced immune responses against tumor antigens that are regularly upregulated in HGSC were observed in 10 out of 15 patients evaluated so far, with 3 patients not reaching a vaccine induced response (VIR) due to high baseline responses. Vididencel treatment only gave mild adverse reactions, predominantly at the site of injection. The observed immune responses following vididencel treatment may provide the basis for an effective anti-tumor response. At week 22, 10 patients had stable disease and 7 patients had imaging-confirmed recurrence. To further evaluate clinical benefit, long-term follow-up of patients is ongoing.

Mendus anticipates to report the primary read-out of the ALISON trial based on immune response evaluation of all treated patients in 2024Q4.

Please see below for abstract details:

Abstract Number: 50P (poster presentation)

Abstract Title: Vididencel, a cell-based cancer vaccine, induces tumor-directed immune responses in high-grade serous ovarian carcinoma patients

Authors: A. Vledder, H. van Zeeburg, K. Brummel, A.L. Eerkens, N. van Rooij, A. Plat, J. Rovers, M. de Bruyn, H. Nijman

Session Date & Time: Thursday, 20 June 2024 between 12:30 – 13:30 CEST

After presentation, the poster will be made available on the Mendus website.