On May 17, 2021 Kiromic reported the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs (Press release, Kiromic, MAY 17, 2021, View Source;Gamma-Delta-T-cell-Therapy [SID1234580162]).

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The clinical trial title: ALEXIS-PRO-1: A Phase 1, Open-label, Dose Escalation Study of KB-PD1, an Allogeneic Gamma Delta T-Cell Expressing a Chimeric PD1 Switch Receptor, in Subjects with PD‑L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies.

The FDA feedback is expected within 30 days from this IND submission.

Kiromic’s preclinical studies show rapid and complete tumor elimination with no toxicity as per results presented at the American Association Cancer Research 2021 poster LB148.

Unlike in the case of autologous CAR-T cell therapy products, which are derived from pretreated cancer patients, Kiromic’s proprietary PD1 Gamma-delta switch receptor therapy is derived from healthy donors.

Key features of the IND:

Product Name

KB-PD1

Product Type

Chimeric PD1 T-Cell live cell therapy

Cancer Type

All solid tumors

Targeting

Chimeric PD-L1

Patient Type

Patients with solid tumor positive for PD‑L1

Projected No. of Patients

30

Dosing

Dose escalation

Primary Completion of Trial

18 months

First-in-human dosing

3Q 2021 pending FDA authorization

First data from Trial

4Q 2021

How Our KB-PD1 Live T-Cell Therapy Improves CAR-T Market:

Marketed and traditional CAR-T

Kiromic KB-PD1

Malignancies
(Cancer Type)

Hematologic

Solid Tumors

Live Cell Origin

Autologous
Live Cells from pre-treatment patients

Allogeneic
Live Cells from healthy donors

Live Cell Cloning
(Manufacturing)

Single batch
Single dose

Single batch
Multi dose
(aka. Off-The-Shelf)

Mass Manufacturing
on-demand
a single patient

— Will be manufactured like a traditional drug
— Kiromic proprietary manufacturing
— Kiromic proprietary cryopreservation processing techniques

Kiromic was able to respect the expectations and meet the timeline 45 days before the end of the second quarter. Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of Q3 2021. Kiromic, an organization that is driven to achieve scientific breakthroughs, dedicated significant resources to the IND submission in an effort to achieve the optimal clinical trial design.

Historically, checkpoint inhibitors have been successful in solid malignancies, but KB-PD1 takes it one step further by not just blocking the PD1/PD-L1 interaction ("cutting the brakes") like a checkpoint inhibitor does, but rather, KB-PD1 rewires the brake into an accelerator.

In this way, Kiromic is optimistic that any cancer cell that expresses the PD-L1 marker will effectively activate and accelerate the ability of KB-PD1 to traffic through the tumor microenvironment (TME), which thus far has proven to be an imposing barrier to effective T-cell treatments in solid cancers.

IQVIA (CRO, Clinical Research Organization)

View Source

IQVIA is an industry driver in data technology and advanced analytics, designed to produce and develop optimal clinical trial outcomes.

IQVIA will be managing our clinical trail sites CRO (Clinical Research Organization).

Leading global sites are lining up to be the first to dose our KB-PD1 live cell therapies for solid tumors.

Site announcements are coming within weeks.

CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs

"I’m thrilled to see our technology go into the clinic, and it was due to the dedication of our team, and our strong preclinical results which helped propel Kiromic to be able to file this IND submission to the FDA on May 14, 2021," stated Dr. Maurizio Chiriva-Internati, DBSc, PhDs, CEO of Kiromic.

"Our people and vendors have been working tirelessly. They are excited and ready to launch the first-in-human dosing by 3Q 2021 pending FDA authorization.

Our KB-PD1 will be the first in the world to deliver this T-cell therapy to solid tumors with key features demanded by the T-cell therapy market. We aim to deliver KB-PD1 which will have:

— Higher efficacy

— Higher safety

— Lower manufacturing costs

— Lower distribution costs."

CFO of Kiromic, Mr. Tony Tontat

"This IND filing is an awaited news for the markets and will open up advantageous financing options to the company as we look to extend cash runway into 2022."

CSIO of Kiromic, Mr. Gianluca Rotino

"This IND filing is supported by strong IP portfolio including new IP in areas such as:

— Gene editing

— Live cell harvesting

— Live cell expansion (manufacturing clones from small batches)

— Live cell logistics (manufacturing, tissue preservation, and transfers)

As we continue to grow our DIAMOND derived targets and our related clinical programs, our IP portfolio is continually being fortified in all major geographies, and we look forward to updating our investors in upcoming presentations and filings.

This is a key milestone, not only for Kiromic, positioning Kiromic as a pioneer in T-Cell therapy for solid tumors, but also for immunotherapy in general.

With the support of Kiromic’s innovations in AI, the clinical trial R&D process will now be faster bringing cellular therapies to patients with more expediency than previously achievable."

CMO of Kiromic, Dr. Scott Dalhbeck

"Patients and clinicians alike have been waiting for a T-Cell therapy which could deliver a safe, effective, and lower cost solution for solid tumors. We are on the brink of making this vision a reality when we dose the first solid tumor patients."

About Metastatic Solid Malignancies

The ALEXIS-PRO-1 clinical trial will enroll patients with metastatic or progressive locally advanced solid malignancies that express the PD-L1 marker on their tumor.

These late-stage patients typically have a survival of only a few months, and so effective treatments that are non-toxic and rapidly effective, are desperately needed.

Since most solid malignancies express PD-L1, the dose escalation phase of the trial will be open to a wide range of tumor types such as prostate, breast, pancreas, lung, colon, renal, bladder, ovarian, and others.

Once the optimal biologic dose (OBD) has been determined, the OBD will then be given to an expanded number of patients for the most promising indications.

Since Kiromic’s preclinical animal studies have shown a fast and brisk anti-tumor response, expectations are high that this product will be able to achieve what has thus far proven to be elusive with late-stage cancer patients – a significant and long-lasting improvement in the quality and quantity of life.

On May 17, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported the receipt of the $50 million second tranche under its convertible credit facility with Deerfield Partners, L.P. and certain of its affiliates (collectively, Deerfield) (Press release, ADC Therapeutics, MAY 17, 2021, View Source [SID1234580161]). Under the terms of the Facility Agreement dated April 24, 2020, Deerfield agreed to provide to the Company up to $115 million in financing consisting of two separate tranches. The first $65 million was received upon completion of the Company’s initial public offering in May 2020, and the second tranche of $50 million has now been received following the recent U.S. Food and Drug Administration (FDA) accelerated approval of ZYNLONTA (loncastuximab tesirine-lpyl).

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"Following the recent approval of ZYNLONTA, we are pleased to further strengthen our balance sheet with the $50 million second tranche draw down," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "These funds will support the continued execution of our launch and advancement of our deep pipeline of next-generation ADCs."

Pursuant to a related Registration Rights Agreement with Deerfield, the Company will file a registration statement on Form F-3 with the U.S. Securities and Exchange Commission within 15 days. In the event that in the future Deerfield elects to exercise its conversion option with respect to the convertible notes issued under the Facility Agreement, this registration statement will allow Deerfield to sell the resulting shares. ADC Therapeutics will not sell any securities under this registration statement.

For more information about the Facility Agreement, see the Company’s Annual Report on Form 20-F.

On May 17, 2021 Nanology Labs, an IND-stage company developing next generation nanomedicines to conquer cancer, reported that its seed capital raise was oversubscribed at $3M (Press release, NanOlogy, MAY 17, 2021, View Source [SID1234580160]). The round was led by FACIT with co-investors Creative Destruction Lab Angels, Ontario Brain Institute, Ontario Center of Innovation, and MEDTEQ. The capital will advance development of T-MX (aka Manganescan), a smart nanomedicine designed to overcome tumor hypoxia, a common cause of resistance in cancer treatment. The financing is timely as T-MX completes GLP-toxicology and GMP-manufacturing in readiness for a Ph1/2 study in patients with oligometastatic brain cancer, planned to start at the Princess Margaret Cancer Center, recognized internationally for expertise in tumor hypoxia.

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"Nanoparticles derived from our platform technology are actively transported into cells and across the blood-brain barrier. Our lead product, T-MX, accumulates in cancer cells, where it becomes detectable by MR-imaging and generates oxygen molecules that reprogram hypoxic tumors from cold to hot. This, in turn, boosts immunogenic cell death and greatly sensitizes solid tumors to destruction by radio, chemo and immunotherapy." says Dr. Mohammad Amini, CEO and co-founder of Nanology Labs, "Extensive safety, efficacy, and manufacturing studies have de‑risked T-MX to the extent that we are confident it could provide greater therapeutic efficacy and longer patient survival, offering healthcare professionals a potentially curative therapy across a broad range of cancers."

On May 17, 2021 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s scientific researchers, together with its joint research partners, Universities of Jaén and Granada, published key data in a peer reviewed journal, Expert Opinion on Biological Therapy, confirming the anti-tumor potential of a mixture of two pancreatic proenzymes trypsinogen and chymotrypsinogen (Press release, Propanc, MAY 17, 2021, View Source [SID1234580159]). Treatment with proenzymes sensitizes cancer stem cells (CSCs) which may allow standard treatment approaches, like chemotherapy and radiotherapy to be more effective. Expert Opinion on Biological Therapy is a peer-reviewed medical journal covering research on all aspects of biological therapies. The article is entitled "Trypinsogen and chymotrypsinogen: potent anti-tumor agents," and can be accessed via the link: View Source

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The article is the fifth scientific publication published on the effects of proenzymes in cancer and fourth published in a peer reviewed journal. The current research demonstrates that novel pancreatic proenzyme formulations exert the following effects on CSCs:

Decreases cell proliferation and migration;
Induces cell differentiation on CSCs to become benign;
Impairs angiogenesis (tumor blood vessel formation); and
Reduces the metastatic potential of CSCs.
"We continue to publish compelling scientific data confirming the effects of proenzymes against CSCs and its potential as a targeted therapy," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer, "There is currently significant interest in therapies that are not only more effective and less toxic, but critically, also support the immune function of patients. Given the current global pandemic situation, the risk of secondary infection in people afflicted with cancer undergoing chemotherapy of radiation is life threatening. This is yet another significant potential clinical application of proenzymes as a cancer treatment regimen."

"It has been accepted in the medical community that pancreatic proenzymes exert significant effects on tissue repair inflammation and the immune system, but less understood in its role as an anti-cancer therapy, despite both phenomena being closely linked," said Professor Macarena Perán, Department of Health Sciences, University of Jaén and Propanc’s Scientific Advisor. "Our research concludes that proenzymes as an adjuvant therapy in cancer has proved to be a successful strategy for reducing tumor size and improving the survival rate. These observations have tremendous potential clinical applications for late-stage cancer patients suffering from solid tumors. My team and I remain determined to assist the Propanc Team introducing this new approach to the medical and scientific community."

About the University of Jaén:

The University of Jaén is among the Top 50 of the best young universities in the world according to THE (Times Higher Education). Likewise, the University of Jaén received the EFQM 500+ European Seal of Excellence, the highest level of recognition awarded by the Excellence in Management Club, as the official representative of the European Foundation for Quality Management (EFQM) in Spain. It also stands out in the field of computing, since the University of Jaén is among the 75 best universities in the world, according to Academic Ranking of World Universities (ARWU) 2017. The University of Jaén is repeatedly in the top 4% of universities worldwide, according to the Ranking Center for World University Rankings (CWUR), which annually collects the thousand best and most valued among the more than 25,000 existing universities. In addition, it is the fourth Spanish university that has obtained the highest score in the ranking of international student satisfaction, published by the STEXX International Studyportals Organization, in its 2016 version.

About the University of Granada:

The University of Granada is widely recognized internationally for its quality in higher education, teaching, research and outreach. National and international rankings reflect the University Granada’s position among the top universities in Spain and among the best in the world. In 2018, the University of Granada has further consolidated this dominant position – taking 278th place in the world and 3rd in Spain in the recently published Shanghai Academic Ranking of World Universities (ARWU 2018). Viewed from the perspective of its performance in specific academic subjects, the UGR has also set a new record, with a further 34 subjects taught at the University featuring in the 2018 ARWU — 12 more than in 2017. Furthermore, 5 of the University Granada’s subjects feature among the world top 100, marking another significant milestone.

On May 17, 2021 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the first quarter ended on March 31, 2021 and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAY 17, 2021, View Source [SID1234580158]).

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"Our team is executing on all cylinders as we approach our June 1, 2021 PDUFA for Brexafemme," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "So far this year, we have received a total of approximately $35 million in non-dilutive funding, which is adequate to support our Brexafemme U.S. launch in the second half of the year while further extending our cash runway into 2023. We are also advancing the development of ibrexafungerp in the hospital setting, including our new IV formulation currently in Phase 1. With ibrexafungerp poised to become the first new antifungal class approved in over 20 years, we believe that the approval of the VVC indication may represent just the first step in the larger build-out of our antifungal franchise."

Ibrexafungerp Update

Remain on track for anticipated June 1st approval of ibrexafungerp for the treatment of VVC and commercial launch in the second half of 2021. SCYNEXIS is currently in discussions with the FDA to finalize its recommended wording for different sections of the drug’s Prescribing Information to provide adequate information to prescribers.

Dosing is ongoing in Phase 1 testing of the liposomal IV formulation of ibrexafungerp. Based on promising pre-clinical data of our liposomal IV formulation of ibrexafungerp, SCYNEXIS is conducting a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the IV liposomal formulation of ibrexafungerp in healthy subjects. The study is being conducted in South Africa and dosing began in March 2021.
Enrollment is complete in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapy in the U.S. SCYNEXIS expects the last-patient / last-visit by the end of 2021 with top-line results and a supplemental NDA submission anticipated in the first half of 2022, resulting in a potential approval in late 2022.
Enrollment is ongoing in our refractory invasive fungal infections (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES). On March 2, 2021 SCYNEXIS presented positive data from its third interim analysis of the FURI study and first interim analysis of the CARES study, showing oral ibrexafungerp’s ability to treat severe fungal infections in the hospital setting. Consistent with two prior interim analyses, the FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains. In total, oral ibrexafungerp showed clinical benefits in 64 out of 74 patients (86.5%), with 46 patients achieving a complete or partial response. The first interim analysis of CARES study showed strong clinical activity of oral ibrexafungerp in patients with invasive candidiasis and candidemia due to Candida auris, a high-mortality infection classified by Centers for Disease Control and Prevention as an urgent threat to public health, with 8 out of 10 patients (80.0%) experiencing a complete response. The results support continued enrollment in both open-label Phase 3 studies, with potential future submissions under the LPAD regulatory pathway.
Ibrexafungerp Phase 3 data were presented at a key medical conference, reporting efficacy in non-albicans Candida (NAC) and severe patients with vulvovaginal candidiasis infections. On April 30, SCYNEXIS presented posters on two data sets from SCYNEXIS’s Phase 3 VANISH program demonstrating the therapeutic potential of ibrexafungerp at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting that took place virtually from April 30-May 2, 2021. The data highlighted ibrexafungerp efficacy in treating patients with NAC, which was comparable to that of the total patient population enrolled in the trial. Additionally, ibrexafungerp was shown to be efficacious in patients with severe VVC, and may provide a treatment alternative where currently available therapies may not be satisfactory.
Corporate Developments and Subsequent Events

On February 11, 2021, SCYNEXIS entered into a licensing and strategic partnership agreement for ibrexafungerp with Hansoh Pharmaceutical that covers the Greater China region. So far SCYNEXIS received $11 million in upfront and milestone payments and is eligible to receive additional development and commercial milestone payments of up to $111 million, plus double-digit royalties on net sales.
On February 23, 2021, SCYNEXIS announced that it has partnered with Amplity Health, a leading global contract commercialization organization, to support the anticipated U.S. commercialization of Brexafemme (the conditionally FDA-approved brand name for ibrexafungerp for vaginal yeast infections) in the second half of 2021. SCYNEXIS will utilize Amplity’s commercial execution expertise and resources for sales force, remote engagement, training, market access and select operations services.
In May 2021, SCYNEXIS entered into an agreement with a third party to sell a portion of its unused 2020 New Jersey NOLs for approximately $4.2 million.
On May 10, 2021, SCYNEXIS granted stock options to three new employees to purchase an aggregate of 15,000 shares of SCYNEXIS common stock at a per share exercise price of $6.50, the closing trading price on May 10, 2021. Each option has a ten-year term, with one-fourth of the shares subject to the option vesting on the one-year anniversary of the employee’s first date of employment and the remainder vesting in equal monthly installments for thirty-six months thereafter, provided the employee continues to provide service to SCYNEXIS. The stock options were granted pursuant to SCYNEXIS’s 2015 Inducement Award Plan, as amended in April 2021, which was adopted by the SCYNEXIS’s board of directors in March 2015 under Rule 5635(c)(4) for equity grants to induce new employees to enter into employment with SCYNEXIS.
On May 11, 2021, SCYNEXIS announced the appointment of Christine Coyne as its Chief Commercial Officer to lead the anticipated U.S launch and commercialization of Brexafemme. She brings to the team deep anti-infective commercial expertise across hospital and community settings.
On May 13, 2021, SCYNEXIS entered into a loan agreement with Hercules Capital, Inc. and Silicon Valley Bank for an aggregate principal amount of $60.0 million. Under the terms of the loan agreement, SCYNEXIS received an initial tranche of $20.0 million from the lenders on the Closing Date and is eligible to receive an additional $10.0 million upon FDA approval of ibrexafungerp for the treatment of vaginal yeast infections. Subsequent cash injections will be available upon achieving certain milestones.
First Quarter 2021 Financial Results

Cash and cash equivalents totaled $92.0 million on March 31, 2021, compared to $93.0 million in cash and cash equivalents on December 31, 2020.

Research and development expense for the three months ended March 31, 2021 decreased to $6.9 million from $9.9 million for the three months ended March 31, 2020. The decrease of $2.9 million, or 30%, for the three months ended March 31, 2021, was primarily driven by a decrease of $2.1 million in clinical development expense, a decrease of $0.9 million in chemistry, manufacturing, and controls (CMC) expense, and a decrease of $0.5 million in preclinical expense, offset in part by an increase in salary related costs of $0.3 million and a net increase in other research and development expense of $0.3 million.

Selling, general & administrative expense for the three months ended March 31, 2021 increased to $6.7 million from $2.6 million for the three months ended March 31, 2020. The increase of $4.1 million, or 156%, for the three months ended March 31, 2021 was primarily driven by a $1.7 million increase in commercial related expense, an increase of $1.0 million in business development expense, an increase of $0.5 million in expense associated with increased information technology costs, and an increase of $0.3 million salary related costs.

Total other expense was $2.0 million for the three months ended March 31, 2021, compared to total other income of $5.5 million for the three months ended March 31, 2020. During the three months ended March 31, 2021 and 2020, SCYNEXIS recognized non-cash income of $1.3 million and $4.8 million, respectively, on the fair value adjustment of the warrant liabilities and during the three months ended March 31, 2021 and 2020, recognized non-cash expense of $0.1 million and non-cash gains of $0.7 million on the fair value adjustment of the derivative liabilities, respectively.

Net loss for the three months ended March 31, 2021 was $4.7 million, or ($0.18) per basic and ($0.23) per diluted share, compared to a net loss of $7.0 million, or ($0.72) per basic and diluted share for the three months ended March 31, 2020.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently under regulatory review for the treatment of vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), and in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The FDA has accepted a New Drug Application for ibrexafungerp for the treatment of VVC and granted a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. It also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.