On July 25, 2023, SQZ Biotechnologies Company (the "Company" or "SQZ") reported that F. Hoffmann-La Roche Ltd ("Roche Basel") and Hoffmann-La Roche Inc. ("Roche US", and together with Roche Basel, "Roche") determined that Roche will not exercise its option under the License and Collaboration Agreement, dated October 5, 2018, by and between the Company and Roche, to obtain an exclusive license to develop and commercialize the Company’s candidate targeting HPV 16 positive solid tumors under the Company’s SQZ-APC-HPV program (Press release, SQZ Biotech, JUL 25, 2023, View Source [SID1234633418]). The Company will regain full clinical development and future commercialization rights for its programs targeting HPV 16 positive tumors. The Company also announced that it intends to explore potential strategic alternatives to support the advancement of its oncology programs including HPV 16 positive tumors, in an effort to allow the Company to partner all its clinical and preclinical assets across all disease areas and indications. Potential strategic partnerships may include, but are not limited to, a partnership, acquisition, merger, business combination, or other transaction. There can be no assurance that this process will result in SQZ pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. SQZ has not set a timetable for completion of this process and does not intend to comment further unless or until the Board of Directors has approved a definitive course of action, the process is concluded, or it is determined that other disclosure is appropriate.

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On July 25, 2023 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has closed its previously announced registered direct offering for the purchase and sale of 1,301,923 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary shares, at a purchase price of $1.35 per ADS (or ADS equivalent) (Press release, RedHill Biopharma, JUL 25, 2023, View Source [SID1234633417]).

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The Company also announced the completion of the previously announced exercise of its existing Class A warrants exercisable for 1,500,000 ADSs, in the aggregate, at a reduced exercise price of $1.35 per ADS, in exchange for new warrants and the reduction in the exercise price of its existing Class B warrants as described below.

H.C. Wainwright & Co. acted as the exclusive placement agent for the transactions.

The gross proceeds to the Company from the transactions were approximately $3.8 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from these transactions for general working capital, acquisitions, research and development, and general corporate purposes.

The securities described above other than the new warrants were offered by the Company and the ADSs issuable upon exercise of the Class A warrants are registered, pursuant to a "shelf" registration statement on Form F-3 (File No. 333-258259) previously filed with the Securities and Exchange Commission (the "SEC") on July 29, 2021, and declared effective by the SEC on August 9, 2021. The offering of the securities in the registered direct offering was 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 was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained 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].

In connection with the exercise of its Class A warrants, the exercising holder (i) received new warrants to purchase ADSs in a private placement and (ii) had the exercise price of its existing Class B warrants exercisable for 1,500,000 ADSs, in the aggregate, reduced to $1.80 per ADS. The new warrants are exercisable for up to an aggregate of 1,500,000 ADSs, at an exercise price of $1.80 per ADS and shall be exercisable until April 3, 2028. The new warrants described above were 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 warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the new warrants and the ADSs underlying the 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. As part of the transaction, the Company has agreed to file a resale registration statement on Form F-3 with the SEC within 15 days of the closing to register the resale of the ADSs underlying the new warrants issued in the private placement.

In connection with the registered direct offering, the Company also agreed that (i) certain existing warrants to purchase an aggregate of 330,106 ADSs at an exercise price of $4.75 per ADS and (ii) certain existing warrants to purchase an aggregate of 971,817 ADSs at an exercise price of $4.6305 per ADS, were amended to have a reduced exercise price of $1.80 per ADS.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities, 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 July 25, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, reported that an abstract detailing immune response data from the VERSATILE-002 Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer has been accepted for presentation at the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) (Press release, PDS Biotechnology, JUL 25, 2023, View Source [SID1234633416]). ESMO (Free ESMO Whitepaper) Congress 2023 is being held October 20-24, 2023 in Madrid.

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The abstract, titled, "Polyfunctional HPV16-Specific T cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC)," reports on the ability of PDS0101 in combination with KEYTRUDA to induce the right type of HPV16-specific multifunctional T cell responses in the treatment of advanced HPV16-positive head and neck cancer. PDS0101 is designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. The immunological clinical data demonstrates the immunotherapy’s potential to generate clinically-relevant multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity in advanced head and neck cancer patients.

"We are pleased to present biomarker data from the VERSATILE-002 clinical trial among a gathering of the world’s leading members of the clinical and scientific oncology community at ESMO (Free ESMO Whitepaper) Congress 2023," stated Lauren V. Wood, M.D., PDS Biotech’s Chief Medical Officer and a co-author of the study. "The incidence of HPV-positive head and neck cancers is growing rapidly, and there is currently a lack of effective targeted therapies to address this population. To date, multiple studies in early-stage and advanced cancer patients have demonstrated the ability of PDS0101 to induce high levels of active and potent HPV16-specific CD4 and CD8 multifunctional T cells, as well as long-lasting memory CD8 T cells, substantiating the potential for PDS0101 combined with KEYTRUDA to expand the range of treatments addressing HPV16-positive head and neck cancers."

Abstract Title: Polyfunctional HPV16-Specific T cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC)
Abstract Number: 6982
Presenting Author: Dr. Kevin Harrington, Ph.D., Professor of Biological Cancer Therapies, The Royal Marsden
Authors: K. Harrington, J. Weiss, K. Price, J. Kaczmar, D. Schaaf, N. Riebel, S. Jones, A. Cotty, S. McCarthy, L. Wood

For patients interested in enrolling in this clinical trial, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source and/or [email protected].

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

Interim efficacy and safety data will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for ICI-naïve patients. Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed.

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.

On July 25, 2023 Nymox Pharmaceutical Corporation [OTC: NYMXF] (the "Company") reported important new long-term clinical trial results from the Company’s 146 patient NX03-0040 NYMOZARFEX (TM) U.S. study for low grade localized prostate cancer (Press release, Nymox, JUL 25, 2023, View Source [SID1234633414]). New long-term follow-up data from the prospective randomized clinical trial of NYMOZARFEX (TM) for low grade early prostate cancer has indicated that there is strong statistically significant benefit from the treatment compared to controls when all available patient outcomes were included from 18 months to as long as up to >10 years after treatment.

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These additional 5 to 10-year data points add to the 5-year data that was published in the peer review World Journal of Urology in 2020 (World J Urol 38, 3101–3111 (2020). View Source). All clinical trial sites that were still open were contacted for follow-up data on the prostate cancer status of all available patients. A full effort was made to reach all possible subjects. The outcome comparisons showed greatly reduced percentages of subjects treated with NYMOZARFEX (TM) who had progressed by either cancer grade worsening or by prostate cancer surgery, radiotherapy, or chemotherapy; and which remained overall strongly statistically significant compared to the study’s randomized controls (p<.01).

This unique and successful study is the world’s first and only long-term prospective randomized controlled study of an intraprostatic molecular injectable treatment for low-grade localized prostate cancer to have been accomplished. The new data represents the longest term data available from this major study.

Study NX03-0040 was undertaken starting in 2012 at investigational sites across the U.S. with 146 men with the biopsy confirmed diagnosis of Grade Group1 prostate cancer. NYMOZARFEX (TM) was administered by a single painless injection directly into the prostate in a relatively simple procedure requiring several minutes or less in an office setting without sedation or anesthesia, and guided by routine ultrasound. NYMOZARFEX (TM) was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040. The patients were then biopsied after 6 weeks and then every 18 months, along with serial PSA measurements and long-term follow-up.

All subjects with 18 months or more follow-up were compared with the inclusion of follow-up data from up to 10 years or more after a single injection of NYMOZARFEX (TM). For the patients where investigational sites were closed or where patients for unrelated reasons were no longer available, the last known status reports were included if they were 18 months or longer. For any subject with a worsening (increase) in grade of prostate cancer on biopsy; or with prostate cancer surgery, or radiotherapy or chemotherapy, they were included regardless of time after study treatment, and were counted in the calculation as treatment failures. The data shows that the number of patients with one focal injection of NYMOZARFEX (TM) 15 mg directed at the tumor had significantly less progression to more advanced cancer or to major cancer treatments, than the randomized control subjects followed in the study.

Dr. Paul Averback, CEO of Nymox said, "We are very excited about this major step forward for NYMOZARFEX (TM) which represents a first in class painless and well tolerated treatment approach for the very important condition of low grade localized prostate cancer. NYMOZARFEX (TM) treatment has shown persistent long-term benefit in this large study, where there was statistically significant less progression of the cancer in men who received the drug injection. The Company will soon be taking steps for meetings with regulatory authorities concerning marketing goals for NYMOZARFEX (TM). There is a global unmet medical need for more effective low-grade prostate cancer treatments that produce minimal collateral tissue damage and undesirable risks and often permanent unintended sexual, urinary, and bowel function side effects."

Nymox CEO added, "We further emphasize that NYMOZARFEX (TM) has also been shown to be associated with a significant reduction in the incidence of new prostate cancer in men suffering from BPH (benign prostatic hyperplasia). That other evidence which was initially unexpected came from patients who received NYMOZARFEX (TM) for their BPH in Nymox’s long-term studies of 977 men with BPH in the U.S. as part of Nymox’s pivotal Phase 3 BPH clinical program. Both 1) the long-term data reported here today involving prospective planned treatment of biopsy established low grade localized cancers, and 2) the unexpected long-term prevention of new onset confirmed cancer in BPH patients reported previously, together indicate that NYMOZARFEX (TM) has shown significant efficacy in men for the treatment and prevention of prostate cancer, without the risks and undesirable side effects generally associated with treatment of these conditions."

Low grade localized prostate cancer (Gleason 3+3; T1c) is a very common treatment problem. The Nymox study reported today involves patients with initially Gleason grade 3+3 or lower. These patients are found to have these tumors by biopsy which is usually instituted after finding abnormalities in PSA levels, and/or after abnormal digital rectal examination of the prostate, and/or after the patient has experienced lower urinary tract symptoms or other changes. Low grade localized prostate cancer represents a therapeutic challenge. Because of its slow growth and low initial level of malignancy, urologists and patients can be reluctant to proceed to invasive surgical treatments or radiotherapy due to the unpleasant and often permanent side effects these treatments cause in the genitourinary tract, such as sexual functional issues and/ or urinary issues. Eventually if and when the tumor progresses, invasive surgical and/or radiotherapeutic procedures become necessary, with greater risk due to the progression. Occasionally the tumors become highly malignant after variable lengths of time. These risks cause understandable anxieties and distress and many men prefer to advance to invasive therapy before running these risks of higher grade cancers. It is widely acknowledged that a treatment like NYMOZARFEX (TM) that can destroy or ablate the low grade cancers of the prostate without the dreaded side effects and morbidities, would be an important benefit for these patients.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of prostate cancers are initially considered low risk. One of the major problems with the main current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, brachytherapy) is the relatively high incidence of serious sexual and other problems post- treatment. In 9 studies, NYMOZARFEX (TM) treatment has been shown to have a negligible significant adverse effect profile post-treatment and no significant adverse effects on sexual or other functions or testosterone levels.

Leading urologists have long recognized the unmet need for prostate cancer treatments that can contribute to improved outcomes for their patients together with reduced side effects and stresses that may have significantly impact on quality of life. The goal of NYMOZARFEX (TM) injectable is to allow for an initial and less toxic treatment for low-risk prostate cancer patients, achieving the benefits of molecular ablation with minimal risk of side effects. For many patients, this treatment combined with surveillance would be extremely helpful for the unpleasant and persistent uncertainties, anxieties, and psychological/emotional burdens associated with only selecting active surveillance.

About NYMOZARFEX (TM) (Fexapotide)

NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 patients with over 1600 injections administered including over 1200 Fexapotide administrations. Fexapotide has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments.

There is an important unmet need in the global middle aged and elderly male population for effective treatment for prostate enlargement (known as BPH, benign prostatic hyperplasia). BPH affects up to half the global male population after late middle age, and the vast majority of men have the condition when they reach their mid-70’s and older. Current medical treatments are intended for life-long treatment but are hindered by intolerable side effects that many or most men experience, and they stop treatment usually in the first year or two. These side effects can be sexual problems or a variety of other issues, some of which are more serious such as hypotension, depression, possible increased risk of prostate cancer, retrograde ejaculation, and many others. Surgical treatments are effective usually, but have the drawbacks of surgical pain, anesthesia, catheterizations, complications and other risks such as the frequent permanence of retrograde ejaculation, and occasional need for re-treatments.

For more information please contact [email protected] or 800-936-9669.

On July 25, 2023 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, reported second quarter 2023 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, JUL 25, 2023, View Source [SID1234633413]).

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"Kiniksa continues to make significant progress in bringing ARCALYST, the first and only FDA-approved therapy for recurrent pericarditis, to patients in need. As a result of increased call frequency and expanded reach with target prescribers, we are seeing increased prescriber adoption and patient enrollments. We are still in the early stages of building the recurrent pericarditis market and remain encouraged by the high level of patient satisfaction, payer approval rates, and duration of therapy. These key metrics provide conviction in raising our 2023 ARCALYST sales guidance to between $220 million and $230 million," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Within our pipeline, we continue to enroll patients in the KPL-404 Phase 2 trial in rheumatoid arthritis and expect data in the first half of 2024. Additionally, we have a strong financial position and our cash reserves, combined with our continued ARCALYST commercial execution and financial discipline, now provide cash runway into at least 2027."

Portfolio and Collaboration Execution

ARCALYST (IL-1α and IL-1β cytokine trap)

• ARCALYST net product revenue was $54.5 million for the second quarter of 2023.

• Since launch, more than 1,250 prescribers have written ARCALYST prescriptions for recurrent pericarditis.

• As of the end of the second quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 20 months.

- Average total duration of therapy includes the approximately 45% of patients who restarted ARCALYST, within an average of 8 weeks, after having discontinued therapy.

KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)

• Kiniksa is enrolling patients in the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. The company expects data from the trial in the first half of 2024.

Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

• Kiniksa is pursuing collaborative study agreements to evaluate the potential of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated.

Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

• In the second quarter of 2023, Kiniksa recognized a $15.0 million development milestone related to a new indication under its global license agreement with Genentech, a member of the Roche Group (Genentech).

Financial Results

• Total revenue for the second quarter of 2023 was $71.5 million, compared to $27.0 million for the second quarter of 2022.

- Total revenue for the second quarter of 2023 included $54.5 million in ARCALYST net product revenue and $17.0 million in license and collaboration revenue, compared to $27.0 million in ARCALYST net product revenue and $0.0 million in license and collaboration revenue for the second quarter of 2022.

• Total operating expenses for the second quarter of 2023 were $74.6 million, compared to $46.3 million for the second quarter of 2022.

- Total operating expenses for the second quarter of 2023 included $6.5 million in non-cash, share-based compensation expense, compared to $6.7 million for the second quarter of 2022.

• Net income for the second quarter of 2023 was $15.0 million, compared to a net loss of $20.0 million for the second quarter of 2022.

- Net income for the second quarter of 2023 included a $16.2 million tax benefit primarily due to the release of a valuation allowance on non-cash deferred tax assets.

• As of June 30, 2023, Kiniksa had $185.0 million of cash, cash equivalents, and short-term investments and no debt.

2

Financial Guidance

• Kiniksa now expects 2023 ARCALYST net product revenue of between $220 million and $230 million compared to prior guidance of between $200 million and $215 million.

• Kiniksa now expects that its cash and cash equivalents will fund its current operating plan into at least 2027.

Conference Call Information

• Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 25, 2023, to discuss second quarter 2023 financial results and recent portfolio execution.

• Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.