On June 24, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that encouraging updated clinical data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo) in patients with macroscopic (measurable) deposits of malignant pleural mesothelioma (MPM).

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The study details are as follows:

Four evaluable male patients, aged approximately 67.3 + 4.1 (standard deviation), received GPS plus nivolumab for at least one month. Initial tumor stages were II (one patient), IIB (one patient) and IV (two patients).
All patients had the MPM epithelioid and/or sarcomatoid variant, a tumor which is universally expressing Wilms Tumor 1 (WT1), one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy.
Patients have received and progressed with, or are refractory to, frontline pemetrexed-based chemotherapy.
Average overall survival (OS) was 35.3 + 24.0 weeks with a median OS of 35.4 weeks, while average progression-free survival (PFS) was 8.8 + 4.2 weeks with a median PFS of seven weeks, both at a median follow-up of 35.4 weeks.
The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site, consistent with previously performed clinical studies with GPS.
With approximately 3,300 cases in the United States each year, accompanied by a rising incidence in developing countries, MPM is notoriously difficult to treat and can lead to poor clinical outcomes with respect to both overall survival and progression-free survival, especially for those patients with the sarcomatoid variant who show a median overall survival of approximately 4.0 to 5.0 months. In relapsed and refractory patients who progressed after the first line standard of care pemetrexed, a similar patient population to that in the GPS nivolumab combination trial, the common treatment regimen is vinorelbine and overall survival in those patients is reported to be between 4.5 and 6.2 months. In patients treated with other chemotherapy regimens, such as carboplatin and irinotecan, median overall survival is reported to be approximately 7.0 months.

"Considering the overall poor prognosis in this particular clinical setting, these preliminary data suggest that the combination of GPS with the PD1 inhibitor nivolumab may provide meaningful clinical benefit to patients with MPM. Surprisingly, the only sarcomatoid mesothelioma patient enrolled, who was diagnosed with Stage IV cancer, experienced a survival of 25 months and is still alive," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS. "Patients treated with GPS plus nivolumab combination therapy appear to be surviving significantly longer than expected. We believe that this could potentially be due to the persistence of a residual cellular immunity-mediated antitumor effect with this immunotherapy combination. Studying additional patients along with longer follow-up of existing patients will hopefully provide further clarity on these data, which we expect to review over the next six months as the study progresses."

SELLAS expects to report additional clinical and immune response data in Q4 2021, including an assessment of CD8+ and CD4+ T-cell responses to the WT1 peptide pool in the GPS mixture, as well as epitope spreading (ES) by testing for antibody presence (IgG’s) directed specifically against the full-length WT1 protein (intra-antigenic ES) and IgG’s presence against other key oncofetal antigens expressed in MPM (inter-antigenic epitope spreading).

On June 24, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported that it has priced its previously announced underwritten public offering of 1,000,000 ordinary shares (Press release, Portage Biotech, JUN 24, 2021, View Source [SID1234584322]).

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The public offering price of each ordinary share is $23.00. In addition, Portage has granted the underwriters a 30-day option to purchase up to an additional 150,000 ordinary shares at the public offering price, less underwriting discounts and commissions. This offering is expected to close on or about June 28, 2021, subject to satisfaction of customary closing conditions.

Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. are acting as book-running managers for the offering. B.Riley Securities, Inc. is acting as the lead manager for the offering. Portage intends to use the gross proceeds of $23,000,000 before deducting underwriting discounts and offering expenses (without giving effect to any exercise of the underwriters’ option to purchase additional ordinary shares, if any), for the acceleration of its PORT-2 and PORT-3 clinical programs, to prepare the next products to enter the clinic, and for working capital and other general corporate purposes. The ordinary shares are offered pursuant to a shelf registration statement on Form F-3 (File No. 333-253468), including a base prospectus, filed by Portage on February 24, 2021 and declared effective by the Securities and Exchange Commission, or the SEC, on March 8, 2021.

The offering will be made only by means of a prospectus. A preliminary prospectus supplement related to the offering was filed with the SEC on June 23, 2021 and is available on the SEC’s website at www.sec.gov. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

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

On June 24, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, for the treatment of HER2-high and HER2-low expressing gastric cancers (Press release, Pieris Pharmaceuticals, JUN 24, 2021, View Source [SID1234584320]).

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"The granting of orphan drug designation to cinrebafusp alfa underscores the high unmet medical need that persists in the treatment of gastric cancer and reinforces our conviction in the importance of developing this program while setting a high bar for success to help patients with limited therapeutic options," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We look forward to beginning the phase 2 trial of cinrebafusp alfa later this summer."

FDA grants orphan drug designation to promote the development of a drug that targets a condition affecting 200,000 or fewer U.S. patients annually. Orphan drug designation provides qualifying therapies with development and commercial incentives, including FDA assistance in clinical trial design, tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years following FDA approval, in addition to other available regulatory exclusivities.

About Cinrebafusp Alfa:
Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. Based on encouraging phase 1 study results, which demonstrated clinical benefit as single agent and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of cinrebafusp alfa in combination with ramucirumab and paclitaxel for the treatment of HER2-high expressing gastric cancer and in combination with tucatinib for the treatment of HER2-low expressing gastric cancer.

On June 24, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported ahead of this morning’s Virtual Investor and Analyst Day that it anticipates exceeding its previously announced financial guidance for the second quarter ending July 4, 2021, driven by broad-based momentum across both COVID and non-COVID businesses (Press release, PerkinElmer, JUN 24, 2021, View Source [SID1234584319]).

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Presentations from company executives for this morning’s Investor and Analyst Day will begin at 8:30 a.m. ET and conclude at approximately to 11:30 a.m. ET. All participants are requested to register prior to the start of the event. The link can be accessed on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the webcast will be available on the PerkinElmer website following the presentation.

Additionally, PerkinElmer will release its second quarter 2021 financial results after market close on Wednesday, July 28, 2021. The Company will host a conference call the same day at 5:00 p.m. ET to discuss these results. Prahlad Singh, president and chief executive officer, and Jamey Mock, senior vice president and chief financial officer, will host the conference call.

To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 6596884. A live audio webcast of the call will also be available on the Investors section of the Company’s website.

A replay of the webcast will be available beginning at 7:00 p.m. ET, Wednesday, July 28, 2021 through the Investors section of the Company’s website.

On June 24, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients,reported that it will present its oropharyngeal cancer (OPC) patient population analysis of the Phase 2 Validive (clonidine HCl MBT) trial for the prevention of chemoradiotherapy-induced severe oral mucositis in head and neck cancer at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2021 annual meeting (Press release, Monopar Therapeutics, JUN 24, 2021, View Source [SID1234584318]). This analysis provided the rationale for the design of Monopar’s Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US.

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"We are excited to share the data from our analysis at this pre-eminent multidisciplinary conference dedicated to supportive care in cancer and for the opportunity to continue working towards providing a treatment for this debilitating condition," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

Session Title: Mucositis – New Dimensions in Research and Clinical Practice, Oral Proffered Paper 2

Presentation Title: Subgroup Analysis of Head and Neck Cancer Patients Treated with Clonidine Mucobuccal Tablet in a Randomized, Double-Blind Phase 2 Trial (Study BA2009-28-01) Supports Further Clinical Development in Patients with Oropharyngeal Cancer

Author: Andrew Mazar, PhD, Chief Scientific Officer of Monopar Therapeutics

Date and Time: The Company’s presentation will be available on demand for registered attendees starting Friday, June 25, 2021 at 8:00am EDT. For information on registration, visit: View Source

About Validive

Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation. The mucobuccal tablet provides for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient’s home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages’ expression of the destructive cytokines that are released in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence compared to placebo (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg, a safety profile similar to placebo, and a high rate of treatment compliance (over 90%).