On July 13, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor, a first-in-class XPO1 inhibitor, for three indications: in combination with bortezomib and dexamethasone (XVd), or in combination with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM); and as monotherapy in adult patients with relapsed and/or refractory diffuse large B-cell lymphoma (rrDLBCL), including DLBCL arising from follicular lymphoma, who have received at least two lines of systemic therapy (Press release, Antengene, JUL 13, 2021, View Source [SID1234584826]).

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Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore, and was granted Priority Review status by China’s National Medical Products Administration (NMPA) and Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS). This NDA submitted in Taiwan marks another milestone in Antengene’s expansion in the APAC markets and the company’s effort to address the unmet clinical needs of patients with hematologic malignancies.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "Within just nine months, we have submitted NDAs in six APAC markets, demonstrating our commitment to addressing the unmet needs of patients in the APAC region. Our seasoned team has a wealth of experience and depth of insight in product registration and commercialization in the Asia Pacific markets. I am confident that Antengene will deliver on our promise to bring our portfolio of innovative therapies to patients in the APAC markets."

"Selinexor is an anti-tumor drug with a highly novel mechanism of action. It has been approved by the FDA for three indications in two tumor types (MM and DLBCL) in less than two years, demonstrating its broad anti-tumor effects," said Kevin Lynch, Chief Medical Officer of Antengene. "Selinexor treatment in combination with dexamethasone still has 25.3% overall response rate (ORR) in patients who have failed five established therapies (penta-refractory) myeloma; and for patients with multiple myeloma who received at least one prior line of treatment, the median progression-free survival (PFS) is 13.9 months, which is significantly higher than that of the control group receiving bortezomib-based standard of care. In the subgroup analysis, patients who are 65 years or older, with renal insufficiency or high-risk cytogenetics can still achieve significant benefits from the XVd regimen. These are patients who are otherwise very difficult to treat. Finally, selinexor monotherapy can enable patients with rrDLBCL to obtain deep and durable responses with a median duration of response of 23.0 months for patients with complete response. We are therefore very optimistic about the potential efficacy benefits of selinexor combination regimens in DLBCL."

Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI) have entered into an exclusive collaboration and license agreement for the development and commercialization of selinexor and other two XPO1 inhibitors, and a PAK4/NAMPT inhibitor in 17 APAC markets including Mainland China.

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm, is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of RRMM and in June 2020 approved selinexor as a single-agent for the treatment of rrDLBCL. In December 2020, selinexor also received FDA approval as a combination treatment (XVd) for MM after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five late-stage clinical trials of selinexor in China for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma.

On July 13, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it has received approval from the Bioethics Committee of the Medical University of Karol Marcinkiewicz in Poznań (Ethics Committee) as well as an allowance from the Polish Department of Registration of Medicinal Products (URPL) for a protocol amendment for its Phase 1/2 evaluating Annamycin for the treatment of subjects with acute myeloid leukemia (AML) that is refractory to or relapsed after induction therapy (Press release, Moleculin, JUL 13, 2021, View Source [SID1234584811]).

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Annamycin is the Company’s next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML. Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. The Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.

"Based on the preliminary data seen demonstrating clinical benefit for patients receiving a full course of treatment in the 240 mg/m2 cohort and the recommendation from our medical advisors on the dose limiting toxicity criteria, we are pleased to have Ethics Committee approval and the allowance from the URPL to amend the protocol for future patients. This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study. Our team is committed to advancing this important clinical program forward and to potentially address the limitations with current treatment options for AML patients," commented Walter Klemp, Chairman and CEO of Moleculin.

The Phase 1/2 AML trial in Poland remains ongoing and is currently dosing patients at 240 mg/m2. Under the previous protocol transient elevated liver enzymes (AST and ALT) observed in two patients were considered a dose limiting toxicity (DLT), which investigators believe would inappropriately limit the potential for continued dose escalation. The amendment to the Annamycin clinical trial protocol allows for a change in the DLT criteria as it relates to transient grade 3 elevations and allows dosing of three additional patients in the 240 mg/m2 cohort. If no DLT (as defined by the new criteria) is experienced with these next three patients, the Company plans to escalate dosing in new cohorts by 30 mg/m2 instead of the 60 mg/m2 previously planned, and with a de-escalation of 15 mg/m2 at the DLT dose if future patients experience a DLT.

The results from the Phase 1 portion of the Company’s U.S. Phase 1/2 clinical trial of Annamycin for the treatment of AML met its primary endpoint and demonstrated a clean safety profile with no evidence of cardiotoxicity when delivered to patients at or below the lifetime maximum anthracycline dose established by the FDA. To date, an independent expert assessment of the absence of cardiotoxicity in the first 19 patients treated with Annamycin in both the Company’s U.S. and European Phase 1 clinical trials in which an independent expert concluded that he "does not see evidence of cardiotoxicity."

Moleculin Biotech expects to continue reporting cohort topline results from the ongoing Phase 1/2 study for treatment of AML and to report the study’s topline results in the second half of 2022. Annamycin has been granted Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.

On July 13, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will host a webcast on Tuesday, July 20, 2021 at 4:30 p.m. ET / 9:30 p.m. IST to provide an update on Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), which was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 (Press release, Jazz Pharmaceuticals, JUL 13, 2021, View Source [SID1234584827]).

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Jazz senior management will be joined by Dr. Luke Maese, associate professor of pediatrics, University of Utah – Huntsman Cancer Institute, Primary Children’s Hospital, to discuss the Rylaze FDA approval, commercial launch and an overview of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) and the need for recombinant, non-E. coli derived asparaginase treatments.

About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for Rylaze is available at: <View Source>

Important Safety Information

RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

On July 13, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that it has expanded its ongoing collaboration with IntoCell Inc., a biotechnology company based in South Korea (Press release, Cellectar Biosciences, JUL 13, 2021, View Source [SID1234612852]).

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The parties have been collaborating on combining IntoCell’s validated novel Ortho-Hydroxy Protected Aryl Sulfate (OHPAS) linker chemistry with Cellectar’s validated novel targeting platform, phospholipid ethers (PLEs) to develop new PDCs. IntoCell’s platform significantly enhances the utility of traditional antibody drug conjugate linkers by customizing the entire linker to a specific project. The collaboration has exceeded the necessary preclinical results to warrant further development and the initiation of Investigational New Drug (IND) enabling studies with multiple payloads. Cellectar will have the right to globally develop and commercialize any OHPAS containing PDC.

"Since initiating our multi-target collaboration, Cellectar has been able to advance various PDC candidates which leverage the differentiated advantages of IntoCell’s technology," said James Caruso, president and CEO of Cellectar. "Through this arrangement we are excited to broaden our research into next-generation targeted therapies and anticipate the development of additional candidates for Cellectar’s growing small molecule PDC pipeline."

"We have built a strong partnership with Cellectar through the multi-target PDC platform collaboration. Our partnership has validated the use of PLEs with our novel OHPAS linker platform technology and the competitive potential of these innovative PDCs. This validation has led to the expansion of our collaboration," said Tae Kyo Park, Founder and CEO of IntoCell. "We will continue to cooperate closely with Cellectar to accelerate the advancement of IntoCell-related PDC candidates into clinical trials."

About IntoCell and the OHPAS linker
IntoCell is a Korea-based biotechnology company dedicated to the development and commercialisation of novel antibody drug conjugate (ADC) platform technologies comprising scaffold moiety, ligands, toxins, linkers and conjugation methods. IntoCell has developed a novel self-immolative Ortho-Hydroxy Protected Aryl Sulfate (OHPAS) linker that works with a wide variety of functional groups, triggering groups, and both phenolic and non-phenolic payloads. The resulting ADCs have proven to be highly stable in chemical and biological environments and have demonstrated excellent potencies in-vitro and in-vivo. IntoCell has also developed proprietary benzodiazepine dimers and modified duocarmycinoids that show high potency with improved safety in preclinical models. IntoCell has created an OHPAS Linker-toxin Library containing a variety of toxins that can be optimized for the fast delivery of a pre-clinical candidate in novel ADC programs.

Using its novel chemistries, IntoCell is developing a pipeline of proprietary ADCs that includes a B7-H3 programme which is demonstrating excellent preclinical data.

For more information, please visit View Source

On July 8, 2021 (the "Amendment Effective Date"), Navidea Biopharmaceuticals, Inc. (the "Company") reported that it entered into an Amendment to Stock Purchase Agreement and Letter of Investment Intent (the "Amendment") with Keystone Capital Partners, LLC ("Investor") pursuant to which Investor agreed to purchase 22,077 shares of Series D Redeemable Convertible Preferred Stock ("Series D Preferred Stock") on or before July 9, 2021 at 5 p.m. Eastern Time for an aggregate purchase price of $2,207,700 (Filing, 8-K, Navidea Biopharmaceuticals, JUL 13, 2021, View Source [SID1234584812]). The Amendment amends that certain Stock Purchase Agreement and Letter of Investment Intent (the "Purchase Agreement") dated August 31, 2020 between the parties, pursuant to which Investor agreed to purchase 150,000 shares of Series D Preferred Stock for an aggregate purchase price of $15,000,000 before the end of the nine-month period following the date when the Company’s registration statement on Form S-1 filed pursuant to the Purchase Agreement was declared effective. Prior to the Amendment Effective Date, Investor had purchased 72,500 shares of Series D Preferred Stock pursuant to the Purchase Agreement, leaving a remaining balance of 77,500 shares of Series D Preferred Stock. After purchasing 22,077 of the remaining shares, Investor has no further right or obligation to purchase shares of Series D Preferred Stock pursuant to the Purchase Agreement. The Amendment also contains a customary mutual release provision.

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