On March 28, 2023 PDS Biotechnology Corporation (NASDAQ: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported a business update and announced its financial results for the year ended December 31, 2022 (Press release, PDS Biotechnology, MAR 28, 2023, View Source [SID1234629408]).

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Fourth Quarter 2022 and Recent Business Highlights:

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PDS0101 Lead Drug Candidate

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VERSATILE-002 Phase 2 combination trial with Merck & Co. Inc.’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer.

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Completed first stage of enrollment in checkpoint inhibitor refractory arm

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Presented initial data on methods for investigating efficacy of PDS0101 in combination with KEYTRUDA (pembrolizumab) with respect to T cell activation and functionality at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2023

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National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers.

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Successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)

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Reported median overall survival (OS) of 21 months in advanced, ICI refractory cancer HPV-positive patients (N=29) having few remaining treatment options

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IMMUNOCERV Phase 2 clinical trial of PDS0101 with chemoradiotherapy (CRT) in patients with locally advanced cervical cancer.

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100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation), and 89% (8/9) complete response based on preliminary data

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Study demonstrated strong infiltration of T cells into the tumors, elimination of circulating tumor DNA

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PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)

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Signed exclusive global license agreement for PDS0301, a novel, investigational, proprietary investigational tumor targeting, antibody-conjugated IL-12, developed by Merck KGaA, Darmstadt, Germany

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Publication of PDS0301 monotherapy study linking PDS0301-induced immune responses with clinical outcomes in International Immunopharmacology

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Infectimune Platform

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Publication of preclinical Infectimune study in the peer-reviewed journal Viruses showing complete protection in animal studies with PDS0202, a novel investigational recombinant protein-based Universal flu vaccine

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A second preclinical Infectimune publication in the peer-reviewed journal Viruses showing unique induction of higher levels of multifunctional CD4 T cells compared to leading commercial vaccine technologies

"This past quarter and year have been exciting for PDS Biotech as we have made significant progress on our strategic initiatives and substantial advances in the clinic, including key data and development milestones involving our lead oncology candidate, PDS0101," stated Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "We received FDA guidance on the regulatory pathway for the VERSATILE-002 Phase 2 trial and, most recently, the triple combination Phase 2 trial. We look forward to progressing PDS0101 into a registrational trial in 2023."

Dr. Bedu-Addo continued, "Additionally, we were pleased to have signed an exclusive global agreement with Merck KGaA, Darmstadt, Germany to advance the development of PDS0301, a novel, investigational, proprietary antibody-conjugated IL-12. We also continued progressing our Infectimune platform as well as our preclinical oncology candidates."

Full-Year 2022 Financial Results
Net loss for the year ended December 31, 2022 was approximately $40.9 million, or $1.43 per basic share and diluted share, compared to a net loss of approximately $16.9 million, or $0.66 per basic share and diluted share for the year ended December 31, 2021. The higher net loss was primarily the result of investment in research and development, including the clinical programs and the acquisition of PDS0301.

Research and development expenses for the year ended December 31, 2022, increased to approximately $29.4 million compared to approximately $11.3 million for the year ended December 31, 2021. The increase of $18.2 million was primarily attributable to an increase in personnel costs of $2.3 million, clinical costs of $2.3 million, quality and manufacturing costs of $3.6 million and $10 million for the rights to PDS0301 from Merck KGaA, Darmstadt Germany. Of the $10 million paid to Merck KGaA, Darmstadt Germany, $5 million was in cash and the balance in shares of the Company’s common stock.

General and administrative expenses for the year ended December 31, 2022 increased to approximately $12.2 million compared to approximately $10.2 million for the year ended December 31, 2021. The $2.0 million increase was primarily attributable to an increase in personnel costs of $1.3 million and an increase in professional fees of $0.7 million.

Total operating expenses for the year ended December 31, 2022, were approximately $41.7 million, an increase of approximately 94% compared to total operating expenses of approximately $21.4 million for the year ended December 31, 2021.

The Company’s cash balance as of December 31, 2022 was $73.8 million. Based on the Company’s available cash resources and cash flow projections, the Company believes that with the anticipated initiation of one registrational trial in 2023, this balance is sufficient to fund Company operations and research and development programs into the third quarter of 2024.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 28, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13736455. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

On March 28, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that Chandler Robinson, MD, Monopar’s Chief Executive Officer, will present at the Jefferies Radiopharma Innovation Summit next week (Press release, Monopar Therapeutics, MAR 28, 2023, View Source [SID1234629407]).

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Presentation Details:

Date: April 3, 2023
Time: 1:00 – 1:30 pm
Location: Jefferies Conference Center, NYC, New York

On March 28, 2023 Herantis Pharma Plc ("Herantis"), a company developing disease-modifying therapies for Parkinson’s disease, reported its annual report for 2022 (Press release, Herantis Pharma, MAR 28, 2023, View Source,c3741784 [SID1234629406]). The Annual Report contains financial statements and the report of the Board of Directors. The Annual Report is available in PDF format as appendix to this release and on Herantis Pharma’s website: View Source

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For more information, please contact:

Julie Silber/Gabriela Urquilla

Tel: +46 (0)7 93 486 277/+46 (0)72-396 72 19

Email: [email protected]

Certified Advisor: UB Securities Ltd, Finland: +358 9 25 380 225

Company website: www.herantis.com

On March 27, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported that GSK has shared interim results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial investigating Jemperli (dostarlimab-gxly) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly alone compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer (Press release, AnaptysBio, MAR 28, 2023, View Source [SID1234629368]). These data from GSK’s RUBY clinical trial are being shared in a European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary, presented at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (25-28 March) in Tampa, Florida and published simultaneously in The New England Journal of Medicine.

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"We continue to be encouraged in the differentiated outcomes delivered by immuno-oncology antibodies discovered at AnaptysBio as GSK advances their development to treat multiple advanced solid tumors. The positive results from the RUBY trial represent a potential breakthrough for patients with primary advanced or recurrent endometrial cancer," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "There is a potential significant royalty opportunity over time to AnaptysBio from Jemperli if this indication is approved, as well as from GSK’s ongoing Phase 3 trials, including of dostarlimab in first line ovarian cancer and, in combination with cobolimab, a TIM-3 antagonist, in second line NSCLC."

For specific details on the results of Part 1 of the RUBY trial, please reference the GSK stock-exchange announcement here. The safety and tolerability profile of dostarlimab-gxly in combination with carboplatin/paclitaxel in the RUBY phase 3 trial was generally consistent with the known safety profiles of the individual agents.

GSK stated in its press release that its "ambition is for dostarlimab to become the backbone of the Company’s ongoing immuno-oncology-based research and development program when used alone and in combination with standard of care and future novel cancer therapies, particularly for patients who currently have limited treatment options. Dostarlimab is being investigated in registrational enabling studies as monotherapy and as part of combination regimens, including in patients with recurrent or primary advanced endometrial cancer, patients with Stage III or IV non-mucinous epithelial ovarian cancer, and patients with other advanced solid tumors or metastatic cancers."

GSK also has advanced, in Q3 2022, both arms of the COSTAR Lung clinical trial to Phase 3, testing both doublet and triplet combinations of dostarlimab-gxly plus chemotherapy, and cobolimab (TIM-3 antagonist) plus dostarlimab-gxly plus chemotherapy in advanced non-small cell lung cancer.

Jemperli was discovered by AnaptysBio and licensed to TESARO, Inc., now a part of the GSK group of companies, under a Collaboration and Exclusive License Agreement signed in March 2014. GSK is responsible for the ongoing development and commercialization of Jemperli. AnaptysBio is entitled to receive milestones and tiered royalties of 8% for annual net sales of Jemperli below $1 billion and 12% up to 25% of annual net sales above $1 billion. In 2021, AnaptysBio monetized with Sagard Healthcare Royalty Partners certain commercial milestones and royalties for annual net sales of Jemperli below $1 billion up to a certain amount of receivables before such receivables revert back to AnaptysBio.

About Endometrial Cancer

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynecologic cancer globally, with approximately 417,000 new cases reported each year worldwide[i], and incidence rates are expected to rise by almost 40% by 2040.[ii][iii] Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[iv]

About RUBY

RUBY is a two-part global, randomized, double-blind, multicenter phase 3 trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. The primary endpoints in Part 1 are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumors v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and ITT populations and OS in the overall population. Pre-specified exploratory analyses of PFS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. Part 1 RUBY included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. In Part 2, the primary endpoint is investigator-assessed PFS. Secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

About Jemperli (dostarlimab-gxly)

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[v]

Jemperli is not approved anywhere in the world for use in combination with standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly for primary advanced or recurrent endometrial cancer. In the US, Jemperli is indicated for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumors, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication in solid tumors may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

On March 27, 2023 Allist Pharmaceuticals reported that its partner ArriVent Biopharma, Inc. (hereinafter referred to as "ArriVent" ) completed an oversubscription of US $ 155 million Series B financing (Press release, Allist Pharmaceuticals, MAR 27, 2023, https://www.allist.com.cn/newsd/101/2069.html [SID1234642122]). The proceeds will be used to support registration clinical trials and exploratory research for ArriVent ’s main product candidate, fumetinib mesylate (hereinafter referred to as " vometinib " ), as well as to expand its subsequent product pipeline.

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Fumetinib is a national Class I new drug independently developed by Ellis and has independent intellectual property rights. Currently, both first-line and second-line indications for lung cancer in China have been approved and included in the national medical insurance directory. On June 30 , 2021 , ArriVent and ArriVent announced an exclusive overseas licensing cooperation agreement. ArriVent has obtained the exclusive development and commercialization license rights for fumetinib in the world (except mainland China, Hong Kong, Macao and Taiwan), providing ArriVent with a global Scope-wide promotion of fumetinib and other treatments presents huge development opportunities. With the joint efforts of both parties, the overseas cooperation of fumetinib is progressing smoothly.

Deputy General Manager of Ellis

Hu Jie

ArriVent ‘s team has rich clinical development experience, and together with ArriVent, we have promoted the wider clinical application of fumetinib around the world, helping patients around the world obtain safe and effective treatment and improve their quality of life.

This financing has been recognized by many senior investors, laying a solid financial guarantee for ArriVent’s subsequent clinical development and pipeline expansion, which is of great significance. The excess fundraising fully demonstrates the investors ‘ high recognition of the ArriVent team, the efficacy, clinical advancement and market potential of the fumetinib product, and the high recognition of the cooperation between ArriVent and ArriVent . Ellis will continue to work closely with ArriVent to jointly commit to the global clinical development of fumetinib and jointly build new product pipelines. Here, on behalf of ArriVent, I would like to congratulate ArriVent on its successful Series B excess financing and the company’s smooth development.