On May 18, 2021 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that notification was given to its partner and exclusive distributor, Genotests SpA by the Instituto de Salud Pública de Chile that the Marketing Authorization Application ("MAA") for Hexvix has been accepted for regulatory review (Press release, PhotoCure, MAY 18, 2021, View Source [SID1234580234]).

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During the regulatory review process, Genotests will begin to prepare for the commercial launch of Hexvix in Chile. In August 2020, Photocure entered into an agreement with Genotests, a privately held company specializing in the marketing of genetic tests for cancer and targeting cancer specialists, to exclusively market and distribute Hexvix in Chile. Under the terms of the agreement, Genotests will fund all costs to secure regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product and support Genotests with regulatory activities, training, and promotional materials.

"Acceptance of the Hexvix MAA with Fast Track designation by the Chilean regulatory authority is a milestone for both Photocure and Genotests as we move closer to bringing this important solution to bladder cancer patients in the region," said Dan Schneider, President and CEO of Photocure. "With Genotests’ dedication and strong execution on this initiative, we are hopeful that Hexvix will become accessible to patients in Chile in the fourth quarter of this year. This partnership represents Photocure’s first step into the South American continent, and supports our strategy of expanding the availability of Hexvix into new territories to ensure that patients and urologists have access to the benefits of using blue light cystoscopy (BLC). The procedure with Hexvix, or Cysview, is recommended in consensus treatment guidelines for the management of bladder cancer around the world."

"It is a privilege to bring this fantastic product to Chile" said Oscar Varas, founder and owner of Genotests. "There are approximately 1,500 new bladder cancer cases annually in our country, an estimated 5,000 TURBT* procedures and nearly 11,000 surveillance cystoscopies. We look forward to building on our established network and the successful demonstration of Hexvix Blue Light Cystoscopy, conducted in collaboration with Karl Storz, at the Chilean Urology Conferences in 2018 and 2019, to launch blue light cystoscopy with Hexvix into the Chilean urology community as soon as possible."

*TURBT: trans-urethral resection of bladder tumors

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Bladder Cancer

Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe, and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia and New Zealand. Please refer to View Source for further information on our commercial partners.

On May 18, 2021 Coeptis Pharmaceuticals, Inc., a wholly-owned subsidiary of Vinings Holdings Inc. (OTC PINK: NDYN), reported entry into two separate exclusive option agreements with VyGen-Bio, Inc., a majority-owned subsidiary of Vycellix, Inc., involving technologies being studied to potentially improve the treatment of CD38-related cancers (Press release, Coeptis Pharmaceuticals, MAY 18, 2021, View Source [SID1234580233]). The technologies are CD38-GEAR-NK, a cell therapy product being developed to protect CD38+ natural killer (NK) cells from destruction by anti-CD38 monoclonal antibodies (mAbs), and CD38-Diagnostic, an in vitro diagnostic tool being developed to analyze if cancer patients might be appropriate candidates for anti-CD38 mAb therapy. Both technologies are being developed from VyGen-Bio’s Gene-Edited Antibody Resistant NK (GEAR-NK) platform, which was discovered by scientists at the Karolinska Institutet in Sweden.

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The first option agreement involves co-development rights to CD38-GEAR-NK, which is an autologous, NK cell-based investigational therapeutic derived from a patient’s own cells and gene-edited to enable combination therapy with anti-CD38 mAbs, potentially minimizing the risks and side effects from CD38-positive NK cell fratricide. The first indication is expected to be multiple myeloma, an incurable cancer of plasma cells. Per the option agreement, Coeptis has paid VyGen-Bio a non-refundable fee for the exclusive option to purchase the co-development rights to the technology. Coeptis has until December 31, 2021 to exercise the option and pay the specified exercise consideration.

The second option agreement involves co-development rights to CD38-Diagnostic, which is an investigational in vitro screening tool to potentially pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. Per the option agreement, Coeptis has paid VyGen-Bio a non-refundable fee for the exclusive option to purchase the co-development rights to the technology. Coeptis has until December 31, 2021 to exercise the option and pay the specified exercise consideration.

"At Coeptis, we are focused on identifying and advancing technologies that have the potential to disrupt conventional treatment paradigms and improve patient outcomes," said Dave Mehalick, President and CEO of Coeptis Pharmaceuticals. "The option agreements with VyGen-Bio epitomize this business strategy as each technology may offer the potential to vastly improve the treatment of CD38-related cancers, including multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia, by identifying those patients who are most likely to benefit from anti-CD38 mAbs and then potentially ‘super charging’ a patient’s immune system by protecting CD38+ NK cells from destruction by anti-CD38 mAbs."

Mr. Mehalick continued, "We envision these agreements with VyGen-Bio to be an important step in support of our focus in cell and gene therapy."

On May 18, 2021 Innovent Biologics, Inc. (HKEX: 01801) and Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, MAY 18, 2021, View Source [SID1234580231]). This is the first U.S. regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly.

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"The acceptance of this application – the first for sintilimab in the U.S. and outside of China – is an important milestone in Innovent’s global commercialization strategy and in our collaboration with Lilly," said Dr. Yongjun Liu, president of Innovent. "We look forward to working closely with the FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the U.S., following the regimen’s regulatory approval in China earlier this year."

Sintilimab is currently being evaluated in a wide variety of cancer types under a broad clinical development program. To date, sintilimab has two indications approved in China, three regulatory submissions under review in China, and this regulatory application under review in U.S.. This regulatory application was submitted to the FDA in March 2021, primarily based on the results of the Phase 3 ORIENT-11 trial. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the sintilimab application is in March 2022. The FDA stated that it did not identify any potential review issues in its acceptance letter. It is currently planning to hold an Advisory Committee meeting to discuss this application.

"We are pleased the sintilimab submission is progressing. Our pursuit of this proposed indication in the U.S. reinforces Lilly’s and Innovent’s joint commitment to offer additional therapeutic options for people living with lung cancer and the healthcare providers who treat them," said Anne White, president, Lilly Oncology. "This is an encouraging start for our collaborative efforts to make sintilimab available in countries beyond China, as we continue to pursue opportunities globally for this immuno-oncology medicine across various tumor types."

About the ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1., and secondary endpoints include overall survival (OS) and safety profile.

A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Conditional crossover was permitted. The results of the ORIENT-11 study were published in 2020.1

About Lung Cancer

Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year. In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype. Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

On May 18, 2021 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid (CBD) medicines to improve quality of life for cancer patients, reported its financial results for the three months ended March 31, 2021 (Press release, Enveric Biosciences, MAY 18, 2021, View Source [SID1234580230]).

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David Johnson, Chairman and Chief Executive Officer, said, "Thus far in 2021, we continued to focus on making progress on our pipeline of support care therapies, bolster our management team and Scientific Advisory Board with talented industry experts and maintain a healthy balance sheet, which as of March 31, 2021 had approximately $23 million in cash. As we approach the second half of this year, we expect to receive approval and initiate two critical Phase I/II trials in Glioblastoma Multiforme and Radiation Dermatitis. In parallel, we opportunistically continue to evaluate strategic investments similar to our Diverse Biotech license for five molecules, exclusive supply agreement with PureForm and other undervalued synergistic investments."

Corporate Updates:

Appointed Arash Asher M.D., Director of Cancer Rehabilitation and Survivorship to Cedars-Sinai Cancer Center, to Enveric’s Scientific Advisory Board. Enveric Biosciences held its first Scientific Advisory Board meeting on April 25, 2021, during which the Board discussed and reviewed Enveric’s radiodermatitis and glioblastoma clinical development plans in detail.
Appointed Carter Ward as Chief Financial Officer, effective May 15, 2021. Mr. Ward brings extensive public company leadership experience in life sciences, SEC reporting and the capital markets. Mr. Ward is replacing John Van Buiten, who is expected to remain in a consulting role with the company, supporting Mr. Ward both during the transition and moving forward.
Enhanced Board of Directors with the appointment of Dr. Douglas D. Lind. Dr. Lind’s extensive and diverse background, working in both healthcare and finance, will add tremendous value in helping Enveric bring better treatment options to cancer patients in need.
On March 10, 2021, the Company also received $3,267,245 from the exercise of warrants to purchase 851,099 shares of common stock.
Financial Results for the Three Months Ended March 31, 2021:

Net cash used in operating activities was $3,162,278 during the three months ended March 31, 2021, which consisted primarily of a net loss of $3,250,711, offset by amortization of intangibles of $136,640, other income from the change in fair value of warrant liability of $3,813,000, stock-based compensation expense of $3,591,565, inducement expense related to conversion of warrants of $298,714, increases in prepaid expenses and other current assets for $66,208, offset by increases in accounts payable and accrued liabilities of $59,278.

Enveric’s operating expenses increased to $6,764,997 for the quarter ending March 31, 2021 from $836,702 for the three months ended March 31, 2020. This change was primarily driven by an increase in general and administrative fees of $5,770,343 and an increase in research and development costs of $157,952. The increase in general and administrative fees was primarily driven by stock-based compensation of $3,591,565, stock option modification expense of $298,714, and an increase in public company compliance costs of $582,667.

Net cash provided by financing activities was $24,881,733 during the three months ended March 31, 2021, which included $21,614,488 in proceeds from the sale of common stock, net of offering costs, and $3,267,245 in proceeds from warrant exercises. Cash as of March 31, 2021 totaled $22,657,150 and the Company currently has no debt.

As of May 13, 2021, the Company had 21,390,290 shares of common stock outstanding.

On May 18, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the first patient has been dosed in an abbreviated combination clinical study (NCT04202003) of lemzoparlimab (also known as TJC4) with azacitidine (AZA) in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) in China (Press release, I-Mab Biopharma, MAY 18, 2021, View Source [SID1234580229]).

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Lemzoparlimab is a differentiated anti-CD47 monoclonal antibody designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity. AZA is a chemotherapeutic drug that may synergize with lemzoparlimab to treat hematologic malignancies.

This phase 2 combination cohort expansion study builds on the dose escalation monotherapy trial in China and will evaluate the safety, tolerability and efficacy of lemzoparlimab in combination with AZA in patients with newly diagnosed AML who are intolerant to intensive chemotherapy or treatment-naïve patients with intermediate and high-risk myelodysplastic syndrome. Patient enrollment is expected to be completed by Q4 2021.

"Lemzoparlimab has already shown promising and differentiated features as a novel therapy in phase 1 studies. We look forward to advancing lemzoparlimab as a combination treatment in patients with AML and MDS to further validate its safety and clinical efficacy. A pivotal trial towards registration is anticipated immediately after this," said Dr. Joan Shen, CEO of I-Mab.

The Company is on track with its accelerated clinical development plan for lemzoparlimab with the ambition for NDA approval as the first CD47 antibody drug for the treatment of hematologic malignancies in China while advancing two ongoing clinical trials of lemzoparlimab in combination with Rituxan in patients with NHL and Keytruda in advanced solid tumors in the U.S. The NHL combination study also included clinical sites in China as an international multi-center trial (IMCT) to potentially bridge to a registrational clinical trial in China if approved by the NMPA. Patient enrollment of both the NHL and solid tumor trials will be completed by Q4 2021 with the preliminary topline data expected thereafter.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China.