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PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

On June 14, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that the Company achieved the threshold for efficacy as per investigator assessment in Stage 2 of the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer (Press release, PDS Biotechnology, JUN 14, 2023, View Source [SID1234632704]). The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023. The threshold for efficacy, as defined in the clinical protocol, was achieved when 14 out of the 54 immune checkpoint inhibitor (ICI) naïve patients enrolled achieved a confirmed objective response. Additional patients in the trial have yet to undergo imaging evaluation.

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Per RECIST 1.1, the standard to classify oncologic imaging outcomes in clinical trials, patients are considered to have achieved an objective response when imaging studies document tumor shrinkage of 30% or more. In VERSATILE-002, the primary endpoint requires two consecutive scans 9 to 12 weeks apart, rather than one, to be considered a confirmed objective response. Confirmation with two consecutive scans is not required to achieve an objective response in every clinical trial per RECIST 1.1.

At the recent 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, we presented data showing 9 confirmed responses among 34 evaluable patients. Median progression free survival (PFS) of 10.4 months was also presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting along with a 12-month overall survival (OS) rate of 87.1% for patients with a CPS>1. Additional patients have been assessed since data was presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. With these additional data, a total of 14 patients have now achieved a confirmed response to date. The achievement of this endpoint suggests an additive effect of PDS0101 over published results with ICI monotherapy and is based on statistical calculations using the appropriate power and alpha.

The primary endpoint in the VERSATILE-002 study is the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1. The key secondary endpoints are progression free survival (PFS), OS at 12 and 24 months, safety, and tolerability. The study utilizes a Simon’s 2-stage optimum design.

"We are highly encouraged by the growing set of PDS0101 efficacy and safety data being generated in multiple independent trials by leading experts in the field," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "The consistency in PDS0101 induced HPV16-specific immune responses, the response rates and survival benefit observed in multiple types of HPV cancer and at different stages of disease, aligns with both the preclinical and Phase 1 monotherapy results. Multiple studies have demonstrated the induction of high levels of active and potent, HPV16-specific CD4 and CD8 T cells, as well as long-lasting memory CD8 T cells by PDS0101."

"Achieving the efficacy threshold in VERSATILE-002 is an important milestone for the Company, especially as it has been achieved ahead of the full efficacy evaluation for this cohort," stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "With our Phase 2 trial near completion, and our planned global Phase 3 confirmatory randomized, controlled trial, VERSATILE-003, actively advancing, we believe we are closer to our goal of providing a well-tolerated, safe and effective therapy for those who suffer from head and neck cancer, a critical unmet medical need."

PDS Biotech plans to initiate the VERSATILE-003 as a result of the successful completion of an End-of-Phase 2 meeting in the third quarter of 2022 with the FDA, during which PDS Biotech received guidance on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). The planned primary endpoints for VERSATILE-003 are OS and PFS. In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in the third quarter of 2023.

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 PDS0101 with 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 were presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for ICI-naïve patients (PR link). 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.

About VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus KEYTRUDA monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve 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.

About Versamune
Versamune is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability

NeuBase Announces 1-for-20 Reverse Stock Split

On June 14, 2023 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing Stealth Editors to perform in vivo gene editing without triggering the immune system, reported that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20, to be effective as of 5:00 p.m. Eastern Time today, June 14, 2023 (Press release, NeuBase Therapeutics, JUN 14, 2023, View Source [SID1234632703]).

The Company’s common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, June 15, 2023. Following the reverse stock split, the Company’s common stock will continue to trade on The Nasdaq Capital Market under the symbol "NBSE" with the new CUSIP number, 64132K201. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on The Nasdaq Capital Market.

The reverse stock split will not change the authorized number of shares of the Company’s common stock. No fractional shares will be issued in connection with the reverse stock split, and stockholders who would otherwise be entitled to receive a fractional share in connection with the reverse stock split will instead receive a cash payment in lieu thereof equal to such fraction multiplied by the closing sales price of the Company’s common stock as reported on The Nasdaq Capital Market on June 13, 2023. In addition, the reverse stock split will apply to the Company’s common stock issuable upon the exercise of the Company’s outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company’s equity incentive plans.

The reverse stock split will reduce the number of issued and outstanding shares of the Company’s common stock from approximately 33.8 million to approximately 1.7 million.

At the Company’s annual meeting of stockholders held on September 8, 2022, the Company’s stockholders approved the reverse stock split in connection with the Company’s common stock and gave the Company’s board of directors discretionary authority to select a ratio for the reverse stock split ranging from 1-for-5 shares to 1-for-20 shares. The Company’s board of directors approved the reverse stock split at a ratio of 1-for-20 on June 9, 2023.

Standard Registrar and Transfer Company is acting as the exchange agent and paying agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Standard Registrar and Transfer Company will provide instructions to any stockholders with certificates regarding the process in connection with the exchange of pre-reverse stock split stock certificates for ownership in book-entry form or stock certificates on a post-reverse stock split basis. Stockholders are encouraged to contact their bank, broker or custodian with any procedural questions.

Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

On June 14, 2023 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Ipsen, JUN 14, 2023, View Source [SID1234632702]). The review is based on positive results from the pivotal Phase III NAPOLI 3 trial, in which the Onivyde regimen demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), compared to nab-paclitaxel plus gemcitabine, with a safety profile consistent with the profiles of the treatment components. These results were presented at the January 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI).

"PDAC is a devastating disease in need of additional treatment options. The FDA’s decision to accept the sNDA for this Onivyde-based regimen in treatment-naïve patients with metastatic disease represents an important milestone in the potential treatment of this complex form of cancer," said Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. "We’re committed to developing therapies which have the potential to make a meaningful difference to the lives of people living with cancer and look forward to working with FDA as they review this application."

The FDA provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of Ipsen’s application. In 2020, the FDA granted Ipsen Fast Track designation for Onivyde as a first-line combination treatment for mPDAC. The FDA’s Fast Track program facilitates the development and expedites the review of medicines that treat serious conditions and have the potential to address an unmet medical need.

NAPOLI 3 data, as presented at ASCO (Free ASCO Whitepaper) GI 2023

Trial met its primary endpoint of OS, showing patients in the NALIRIFOX group had a statistically significant improvement in median OS of 11.1 months, versus 9.2 months in the nab-paclitaxel and gemcitabine group (HR 0.83 [95% CI 0.70–0.99]; p=0.04). At 12 months, the OS rate for the NALIRIFOX group was 45.6%, and for the nab-paclitaxel and gemcitabine group it was 39.5%. At 18 months, the OS rate was 26.2% for the NALIRIFOX group, and 19.3% for the nab-paclitaxel and gemcitabine group.1
Trial met its secondary endpoint showing patients treated with NALIRIFOX had a statistically significant improvement in median PFS of 7.4 months versus 5.6 months for nab-paclitaxel and gemcitabine (HR 0.69 [95% CI 0.58–0.83]; p=0.0001).1
The objective response rate was 41.8% (36.8%-46.9%; 95% CI) for patients treated with the NALIRIFOX regimen versus 36.2% (31.4%-41.2%; 95% CI) for patients treated with nab-paclitaxel and gemcitabine.1
The safety profile of NALIRIFOX was consistent with the profiles of the treatment components. The most common Grade 3/4 treatment-emergent adverse events with more than 10% frequency in patients receiving NALIRIFOX versus nab-paclitaxel and gemcitabine included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia (15.1% vs 4.0%), anemia (10.5% vs 17.4%) and neutropenia (14.1% vs 24.5%).1
– ENDS –

About the NAPOLI 3 trial
NAPOLI 3 is a randomized, open-label Phase III trial of an investigational Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for mPDAC. NAPOLI 3 enrolled 770 patients across 205 trial site locations in 18 countries. Patients were randomized to receive Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle).

About Onivyde
Onivyde is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In Onivyde, irinotecan is enclosed in tiny fat particles called liposomes, which accumulate in the tumor and release slowly over time.

Onivyde is currently approved in most major markets including the U.S., the E.U. and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with mPDAC after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with mPDAC.

Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent pharmaceutical company with an international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.

About PDAC
PDAC is the most common type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.2,3 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).4 Even in later stages, weight loss, abdominal pain and jaundice are the most common symptoms making PDAC difficult to detect.5 Despite significant advances in cancer treatments since the 1970s, no treatment options for PDAC significantly extend life.4 Currently, fewer than 20% of people diagnosed with PDAC survive longer than one year and, overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.2,3

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA

Fatal neutropenic sepsis occurred in 0.8% of patients receiving Onivyde. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving Onivyde in combination with 5-FU and LV. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.

Severe diarrhea occurred in 13% of patients receiving Onivyde in combination with 5-FU/LV. Do not administer Onivyde to patients with bowel obstruction. Withhold Onivyde for diarrhea of Grade 2–4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.

CONTRAINDICATION
Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to Onivyde or irinotecan hydrochloride.

Warnings and precautions

Severe neutropenia: see boxed WARNING. In patients receiving Onivyde/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients.

Severe diarrhea: see boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed.

Interstitial lung disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold Onivyde patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue Onivyde in patients with a confirmed diagnosis of ILD.

Severe hypersensitivity reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue Onivyde in patients who experience a severe hypersensitivity reaction.

Embryo-fetal toxicity: Onivyde can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after Onivyde treatment.

Adverse reactions

The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%).
Adverse reactions led to permanent discontinuation of Onivyde in 11% of patients receiving Onivyde/5- FU/LV; the most frequent adverse reactions resulting in discontinuation of Onivyde were diarrhea, vomiting, and sepsis.
Dose reductions of Onivyde for adverse reactions occurred in 33% of patients receiving Onivyde/5 FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia.
Onivyde was withheld or delayed for adverse reactions in 62% of patients receiving Onivyde/5-FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia.
The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%).
Drug interactions

Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of Onivyde.
Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy.
Special populations

Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after Onivyde treatment.
Lactation: Advise nursing women not to breastfeed during and for 1 month after Onivyde treatment.
Please see full U.S. Prescribing Information including Boxed WARNING for Onivyde.

IO Biotech Announces Achievement of Significant Phase 3 Clinical Trial Recruitment Milestone

On June 14, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, reported that it has randomized 225 patients in its global Phase 3 clinical trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma (Press release, IO Biotech, JUN 14, 2023, View Source [SID1234632700]). This clinical milestone is significant as the Phase 3 trial protocol calls for an interim analysis of overall response rate one year after 225 patients have been enrolled. Data obtained from this interim analysis, if positive, could allow for submission of a Biologics License Application for an accelerated approval in the United States.

Additionally, the company announced that it is increasing the number of patients to be enrolled in the Phase 3 trial to 380 patients, which could potentially accelerate the time to reach the primary end point of progression free survival. If the data are supportive, the PFS endpoint would serve as the basis for submitting marketing applications on a global basis.

"I am very proud to announce today that we have hit this critical enrollment milestone in our global Phase 3 clinical trial as planned," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "The enthusiasm for this trial in cancer care centers in Europe, Australia, South Africa, Israel, and the United States is a testament to the need for improved outcomes for patients with advanced melanoma. With the momentum of enrollment building in this trial, we are taking the opportunity to increase the target for full enrollment by 80 patients, which will potentially accelerate the timeline to the primary endpoint of PFS. Even with this increase in target enrollment to 380 patients, we continue to expect to reach full enrollment in this trial by the end of this year and we continue to expect our cash to support our activities through the third quarter of 2024."

Dr. Zocca continued, "Our full team continues to work diligently to develop novel vaccines that have the potential to significantly improve the current treatment paradigm for people with cancer. Should the interim analysis for this Phase 3 trial be positive, we have the potential to have our first vaccine candidate approved and available for patients in 2025 – this is an exciting time in the evolution of IO Biotech."

About IO102-IO103

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.

About the IOB-013/KN-D18 Phase 3 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Target enrollment is 380 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

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

Immix Biopharma Completes $5 Million At-The-Market Equity Offering Program

On June 14, 2023 Immix Biopharma, Inc., (Nasdaq:IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering CAR-T cell therapies and tissue specific therapeutics targeting oncology and immuno-dysregulated diseases, reported that it has completed its previously announced "at-the-market" equity offering program (the "ATM Offering") (Press release, Immix Biopharma, JUN 14, 2023, View Source [SID1234632699]).

"We are delighted to complete the $5 million common stock ATM offering. We believe the terms were favorable to investors in a turbulent market environment. Further, we would like to welcome Bridgewest to our institutional investor syndicate. We are focused on continued efficient execution of our clinical development plans: NEXICART-1 for NXC-201, which we believe is the world’s first out-patient CAR-T in multiple myeloma and AL amyloidosis, and our IMX-110 clinical trials including IMMINENT-01 combination trial with BeiGene’s anti-PD-1 antibody," said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma.

ImmixBio disclosed on March 22, 2023 that it filed a prospectus supplement with the U.S. Securities and Exchange Commission to offer and sell shares of the Company’s common stock having an aggregate offering price of up to $5,000,000 from time to time through the ATM Offering. The Company ultimately sold 2,263,868 shares of common stock and generated aggregate gross proceeds before commissions and offering expenses of approximately $5,000,000. ThinkEquity acted as agent for the ATM.

The Company intends to use net proceeds from the ATM Offering for its IMX-110 + tislelizumab Phase 1b combination clinical trial, its IMX-110 monotherapy clinical trial, and general corporate purposes.