On May 23, 2022 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported new data from Cohort 2 of the ongoing Phase 1 study evaluating JK07, the Company’s lead drug candidate, for the treatment of heart failure with reduced ejection fraction (HFrEF) (Press release, Salarius Pharmaceuticals, MAY 23, 2022, View Source [SID1234614954]). The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.

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"Our study of JK07 in heart failure with reduced ejection fraction continues to demonstrate favorable safety and promising signals of clinical activity, and we look forward to gaining further insights as we enter Cohort 3," said Sam Murphy, Chief Executive Officer of SalubrisBio. "In addition, we’re thrilled to announce that the first CTA has been filed in Europe for JK08, to evaluate this novel CTLA-4/IL-15 antibody fusion protein in the treatment of solid tumors. We have made considerable progress this year across our pipeline and remain laser-focused on advancing these important programs to bring differentiated complex biologics to patients with unmet needs," concluded Murphy.

New Cohort 2 Data for JK07 Shows Favorable Safety and Further Promising Activity in Patients with HFrEF

In this ongoing randomized, double-blind, placebo-controlled, dose-escalation Phase 1b study evaluating JK07, patients treated in Cohort 2 (n=5) demonstrated a favorable safety profile and encouraging signals of clinical activity. In addition, dose-dependent increases in biomarker surrogates of target engagement have been observed across the two completed cohorts. Enrollment in Cohort 3, of five planned cohorts, has commenced in this Phase 1b study and SalubrisBio plans to report additional data from this study at future medical meetings.

CTA for JK08 Submitted in Europe

The first CTA has been filed in Europe seeking approval to initiate a Phase 1/2 study evaluating JK08 monotherapy for the treatment of advanced solid tumors. JK08 augments the T-regulatory cell targeting of a CTLA-4-specific antibody with an IL-15/sushi domain fusion peptide, which locally induces NK cell activation and antibody-dependent cellular cytotoxicity (ADCC), two biological hallmarks predictive of response to CTLA-4 targeted therapy. The study will assess the safety, pharmacokinetics, and anti-tumor activity of JK08 at multiple dose levels and will include multiple expansion cohorts following selection of the optimal biologic dose. Upon obtaining regulatory approvals, the Company plans to initiate recruitment during the third quarter of 2022.

Appointment of Arian Pano, MD as Chief Medical Officer

Dr. Pano comes to SalubrisBio from Kiniksa Pharmaceuticals, where he served as SVP of Clinical Development, overseeing all functional groups, including medical, research, clinical operations, regulatory, safety, biometrics, and medical writing. Previously he served as SVP of Clinical Development for Galapagos NV, and concurrently served as the US country head and Global Head of Safety. Dr. Pano has an extensive background in research and development with a focus on cardiovascular, metabolic rare diseases, inflammation and fibrosis. He earned his MD degree from the University of Tirana, Albania, completing fellowships in invasive cardiology and pediatrics. In addition, he holds an MPH in Healthcare Management from Harvard’s School of Public Health.

"Since clinical data is the currency of our industry, and as we are now generating meaningful clinical results, the time was right to expand and strengthen the leadership team by bringing on Ari to build our clinical organization, chaperone our drugs through mid- and late-stage development, and ensure our data management and pharmacovigilance functions support future planned regulatory filings," added Murphy.

About JK07

JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in HFrEF and undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3 and HER4. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

About JK08

JK08 is a recombinant fusion protein consisting of a CTLA-4-specific antibody and an IL-15 fusion domain. The JK08 design builds upon a breadth of clinical studies with CTLA-4 antibodies and recombinant IL-15 molecules, which together portend synergistic effects in an antibody fusion construct. The CTLA-4-specific antibody ipilimumab validated CTLA-4 as a target for cancer therapy, but response rates are limited. Analysis of clinical samples demonstrated that NK cell activity signatures and ADCC biomarkers correlate with ipilimumab responses. Recombinant IL-15 has exhibited potent stimulation of NK cell expansion and enhancement of ADCC in pre-clinical and clinical studies. Through the incorporation of a CTLA-4 antibody and IL-15 into a single molecule, JK08 can channel the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards depletion of T-regulatory cells and targeted reversal of immunosuppression which may contribute to cancer progression.

On May 23, 2022 Modra Pharmaceuticals ("Modra") reported that the company will present new data from its Phase 2b trial evaluating ModraDoc006/r, a boosted oral taxane therapeutic versus the standard-of-care IV chemotherapy docetaxel, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) at the upcoming ASCO (Free ASCO Whitepaper) General Annual Meeting held from June 3 – 7, 2022 virtually and in-person in Chicago, IL, USA (Press release, Modra Pharmaceuticals, MAY 23, 2022, View Source [SID1234614953]).

Please see below for details on the poster abstract.

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Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Poster Title: A phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Presenter: Ulka N. Vaishampayan, MD | University of Michigan

Location: In-Person & Live Stream | Arie Crown Theater

Session Date and Time: June 6, 2022 from 16:30 CDT – 18:00 CDT

Abstract Number: 5016

Poster Number: 200

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane therapy based on docetaxel, an intravenously administered therapy, that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile, as compared to standard IV docetaxel.

On May 23, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic", "We" or the "Company") (OTCQB:OTLC) reported financial results for the three months ended March 31, 2022 ("Q1 2022") as compared to the three months ended March 31, 2021 ("Q1 2021"), an update on its product and therapeutic development initiatives and other corporate updates (Press release, Oncotelic, MAY 23, 2022, View Source [SID1234614952]). The financial results were based on the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 23, 2022.

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Highlights for Q1 2022 and thereafter:

As previously reported, on March 31, 2022, we entered into a joint venture, or JV, with Dragon Overseas Capital Ltd. (Dragon Overseas) and GMP Biotechnology Ltd. (GMP Bio). Dragon Overseas and GMP Bio are affiliated with GMP. The intent is to develop and ultimately market OT-101, individually and in combination with other products, along with our JV partners.

Highlights of the transaction include:

Oncotelic to receive up to $50 million on sale of the RPD voucher following marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG.
Dragon Overseas has agreed to invest cash and other assets with a value of approximately $27.6 million for 55% ownership of the JV.
Oncotelic has licensed OT-101 to the JV for a 45% ownership in the JV.
The JV to be headquartered in Hong Kong.
Initial focus on the further development and commercialization of OT-101, including for DIPG as well as pancreatic cancers and glioblastoma.
The JV is planned to be taken into an IPO at a future point in time.
"With the JV transaction, clinical trial cost and payroll cost related to OT-101 has effectively been transferred to the JV, greatly reducing the operational cost of Oncotelic making up listing a strong possibility," commented Amit Shah, CFO.

"This week, we filed the patent application entitled TGF-beta therapeutics for age disease codifying the treatment of age-related disease such as cancers and infectious diseases as intervention on aging.," said Dr. Trieu, CEO and Chairman "we see a robust future for Oncotelic and the JV as the leaders in this new era of medicine".

When compared between Q1 2022 and Q1 2021, our research and development ("R&D") expenses decreased by approximately $1.0 million. The lower R&D expenses were primarily related to lower clinical trial activity in Q1 2022 as compared to Q1 2021 of approximately $0.9 million and approximately $0.1 million of other operational costs.

When compared between Q1 2022 and Q1 2021, our general and administrative ("G&A") expenses increased by approximately $3.3 million. This was primarily due to the increase of approximately $3.2 million in non-cash stock compensation expense, incurred in connection with issuance of new warrants of approximately $2.9 million and approximately $0.3 million on stock options. Excluding the non-cash stock compensation expense recorded during Q1 2022, our G&A expenses was almost the same as in Q1 2021.

We recorded interest expense, including amortization of debt costs, of approximately $0.3 million for Q1 2022 in connection with debt raised from various convertible notes, including the JH Darbie Financing, as compared to $0.5 million for Q1 2021, due to debt raised from convertible notes in 2021 and the JH Darbie Financing.

During Q1 2022, we recorded a change in the value of the derivative of $0.2 million. We recorded approximately $0.5 million change in value of the derivatives on conversion of the debt to liabilities on the convertible notes issued to our CEO and a bridge investor (collectively, the "Convertible Notes").

During Q1 2022, we recorded a loss on extinguishment of debt of approximately $0.3 million on our JH Darbie Financing, upon granting approximately 33 million warrants to our investors. Correspondingly, we recorded a loss on conversion of debt of $28 thousand million during Q1 2021.

Recent Product Development Highlights

AL-101 CNS Program

AL-101 (intranasal apomorphine) – We had acquired AL-101 in September 2021. AL-101 is our lead fast-to-market 505(b)2 regulatory pathway drug candidate for Parkinson Disease ("PD") and Erectile Dysfunction ("ED"), especially phosphodiesterase 5 ("PDE5") non-responders. Oncotelic also plans to develop AL-101 as a new class of drug against Female Sexual Dysfunction ("FSD"), including Hypoactive Sexual Desire Disorder ("HSDD"). Through targeting the dopamine receptors in the brain AL-101 has multiple central nervous system effects that will be leveraged in its development – mirroring the successes we have had previously with Abraxane and Cynviloq via the 505(b)2 pathway. AL-101 has shown a favorable safety and efficacy profile and is phase 3 ready with six clinical trials completed and over 200 patients (2,200 doses) treated.

With over 60,000 new patients annually being diagnosed with PD in the United States. Currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. View Source As reported by Pharmaceutical Technology by GlobalData Healthcare on May 26, 2020, KYNMOBI (apomorphine HCI) sublingual film was approved through the 505(b)2 pathway for acute, intermittent treatment of OFF episodes in patients with PD. KYNMOBI dissolves under the tongue. Per GlobalData Healthcare, KYNMOBI is expected to generate $219 million annually. View Source We anticipate AL-101 to be a superior product based on rapid and preferential accumulation in the brain.

ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3).

FSD is a prevalent problem, afflicting approximately 40% of women and there are few available treatment options. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized HSDD in premenopausal women. Currently, this is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD – however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for an effective therapy against FSD and HSDD.

OT-101/PD-1 Oncology Program

The OT-101/PD-1 program is designed to assess the impact of OT-101 across multiple cancer indications, where local tumoral secretion of transforming growth factor-beta ("TGF-β") suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccines. Multiple phase 2 trials combination of OT-101, with a PD-1 inhibitor, in collaboration with large pharmaceutical company, and leading KOLs around the world, are being planned and developed. These trials span mesothelioma, glioblastoma, lung, and colorectal cancers where AI driven transcriptome analyses will be used to derive the predictive and prognostic biomarker for TGF-β therapeutics, including OT-101.

TGF- β promotes immune evasion. The different components surrounding a tumor are collectively known as the tumor microenvironment (TME). The TGF-β signaling pathway is activated in the TME and the tumor, leading to alteration in the composition of the TME that favors tumor growth and aggressiveness. A major component of the TME, called Cancer-Associated Fibroblasts. help the tumor grow and escape destruction by the host immune system. As such even if an immune cell is sitting next to the tumor cells, it would not do anything because the tumor is making so much TGF, essentially cloaking the tumors. OT-101 inhibits the making TGF- β protein.

A PD-1 inhibitor, such as pembroluzimab, is not chemotherapy or radiation therapy – it is an immunotherapy and it works with our immune system to help fight cancer. Immunotherapy is spectacularly effective. These agents mobilize the immune system to attack the tumor and achieve cure (not just slowing down of the tumor/remission). However, it will work in only about 10% of patients. The rest have too much TGF- β for PD-1 immunotherapy to be effective. Knocking down TGF with OT-101 should improve the cure rate above the 10%. We are hoping that cure rate can reach 100% in the future.

OT-101/IL-2 Oncology Program

Our OT-101/IL-2 combination trial (the "Trial"), has now successfully completed the safety evaluation of its safety cohort, allowing for further expansion of its clinical program into phase 2 and higher doses.

The Trial – A Multi-center, Open label, Phase Ib clinical study to evaluate the safety, tolerance, and efficacy of TASO-001 ("OT-101"), a TGF-β targeting anti-sense oligonucleotide, in combination with recombinant interleukin-2 (Aldesleukin, "IL-2"), in patients with advanced or metastatic solid tumor cancer. ClinicalTrials.gov Identifier: NCT04862767. The Trial is being conducted by Autotelic BIO, a partner of Oncotelic on the OT-101/IL-2 combination.

In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was shown to be the optimal dose for OT-101 in a prior trial targeting pancreatic cancer, melanoma, and colorectal cancer ("P001"). In the P001 trial, the maximum tolerated dose was not reached even at 330 mg/m2. Therefore, the Company believes that increasing the dose above 140 mg/m2 should further enhance the clinical activity of OT-101.

OT-101 COVID-19 program

On October 18, the data lock of the Study Data and Analysis Data Models (SDTMs & ADaMS Databases) were generated for the Company’s C001 trial for COVID-19. The trial compares OT-101 plus standard of care ("SOC") versus Placebo plus SOC, the SOC which includes dexamethasone (N= 32 pts at 2:1 randomization ratio). Dexamethasone is the only known drug to improve outcome for severe COVID-19. The top line data as previously disclosedare:

Safety endpoints met. OT-101 as a TGF-β inhibitor was safe to administer to COVID-19 patients including severe/critical COVID-19 patients.

Efficacy signals were obtained. End of treatment- Day 7-mortality for the entire study population was 4.5% OT-101 versus 20% Placebo.

Incidence of >96% viral load knockdown on End of Treatment- Day 7- was 89% for OT-101 versus 67% for placebo.

Overall survival improved significantly improved from 4 day for placebo to 14 day OT-101 among critically ill COVID-19 patients.
The data form the basis for us to further develop this as a drug to treat severe respiratory viral infections including flu and COVID. Both tumor cells and the SARS-CovCoV-2 viruses induce TGF-β as part of their immune evasion mechanism. Consequently, inhibiting TGF-β by OT-101 is expected to impact both cancer and COVID. By targeting the host protein, OT-101 is expected to work against multiple respiratory viruses agnostic of the emerging variants, unlike traditional antiviral drugs and vaccines.

Artemisinin COVID-19 Program

We deployed Artemisinin as herbal supplement in India under the name PulmoHealTM together with Chopra Foundation and Heart Care Foundation of India (HCFI) and Parmarth Niketan Ashram to combat COVID during the deadly surge in COVID-19 in summer of 2021 as a humanitarian effort. As we build our patent portfolio around Artemisinin and its analogs for COVID-19 and other respiratory viral infections we are positioning Artemisinin and its analog artesunate as pharmaceutics.

On May 23, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has initiated the first in a series of studies to test the ability of its pancreatic cancer therapy to treat malignant ascites (Press release, PharmaCyte Biotech, MAY 23, 2022, View Source [SID1234614951]). The initiation of this first study was made possible after PharmaCyte’s successful production of a Master Cell Bank as well as the demonstration that the Master Cell Bank is adventitious agent free.

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In PharmaCyte’s initial study, it aims to establish a mouse model of malignant ascites to serve as a basis for further CypCaps plus ifosfamide efficacy studies. This study involves inoculating the peritoneal space of genetically susceptible mice with radiolabelled mouse colon carcinoma cells. Study parameters include survival, clinical signs, body weight, assessment of tumor spread using fluorescence imaging and indexing of total tumor volume.

The planned series of studies will build on previous data obtained by Prof. Matthias Löhr of the Karolinska Institute in Stockholm, Sweden, and his colleagues that showed PharmaCyte’s treatment for pancreatic cancer can slow the production and accumulation of malignant ascites. Heidelberg Pharma Research, a leading German biotechnology company focused on cancer therapies, will conduct the study.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "The expansion of our oncology program is continuing with the pursuit of a treatment for malignant ascites. This patient population is dealing with advanced cancer, and malignant ascites only compounds the problems these patients must endure at a very difficult time. The establishment of a reliable malignant ascites animal model is a critical step on the path to create a first-ever treatment for malignant ascites and represents our desire to address unmet medical needs and the patient’s quality of life."

Ascitic fluid is normally produced in the peritoneum, a sheet of tissue that covers the organs in the abdomen; however, the presence of cancer can cause the peritoneum to produce too much ascitic fluid when cancer cells irritate the peritoneum, which causes the abdomen to swell as fluid accumulates. This is known as malignant ascites. It is more likely to develop in patients who have ovarian, uterine, cervical, colorectal, stomach, pancreatic, breast and liver cancers. In most patients, development of malignant ascites is a sign of advanced disease and poor prognosis.

Malignant ascites can result in impairment to the quality of life of a cancer patient. In addition to abdominal distention, pain and difficulty breathing, it may also cause nausea, vomiting, early satiety, lower extremity edema, weight gain and reduced mobility. These symptoms can interfere with a patient’s ability to eat, to walk and to perform daily activities. They also reduce a patient’s ability to withstand anti-cancer therapies, potentially reducing survival.

As a supportive or palliative measure, malignant ascites can be drained by paracentesis, percutaneously implanted catheters, peritoneal ports or peritoneovenous shunts. These treatments are invasive, can be painful and are expensive. PharmaCyte expects its treatment to offer cancer patients a therapy that slows down or eliminates the production and accumulation of malignant ascites fluid. There is currently no such treatment on the market.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On May 23, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec") reported that it is the recipient of the 2022 Vanguard Award presented by the Triple Negative Breast Cancer (TNBC) Foundation (Press release, OncoSec Medical, MAY 23, 2022, View Source [SID1234614949]). OncoSec’s Head of Patient Advocacy, Kimberly Irvine, will accept the award on behalf of the Company at the Foundation’s gala titled, "No One Fights Alone," on May 25, 2022.

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"On behalf of OncoSec, I want to thank the TNBC Foundation for this distinguished honor and recognition," said Kimberly Irvine, Head of Patient Advocacy. "Our efforts aiming to provide much needed therapies to patients with metastatic TNBC (mTNBC) is one key pillar of our mission to help patients with cancer who don’t respond to currently available treatments. As a two-time breast cancer survivor, myself, I understand the unmet need. We look forward to continuing our research and working with the TNBC patient community to learn about their experiences and how we can better meet their needs."

Hayley Dinerman, Executive Director at TNBC Foundation, added, "Triple negative breast cancer accounts for up to 15% of breast cancers in the U.S., but many patients have never heard of TNBC. As the leading advocacy group for the TNBC community, it’s our goal to educate and support patients battling this disease, and to recognize academic, pharmaceutical and biotech industry partners who work to improve patient outcomes. The TNBC Foundation is thrilled to recognize OncoSec as the 2022 Vanguard Award recipient for its unrelenting dedication to cancer research and to patients struggling with TNBC. We are excited to see new developments from the company as it progresses its TNBC program."

The Triple Negative Breast Cancer Foundation’s Vanguard Award for Excellence in Oncology Research was previously awarded to Immunomedics (acquired by Gilead Sciences, Inc.) in 2019, Eisai Co., Ltd. in 2018, and Hackensack University Medical Center in 2017.

To learn more about the Vanguard Award and the TNBC Foundation visit, tnbcfoundation.org.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.