On December 29, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the company has completed submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for FAP-2286, the lead compound in its peptide-targeted radionuclide therapy (PTRT) development program (Press release, Clovis Oncology, DEC 29, 2020, View Source [SID1234573309]). Following clearance of the INDs by FDA, Clovis plans to initiate a Phase 1/2 clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to determine the dose and tolerability of the FAP-targeting therapeutic agent (Phase 1), with expansion cohorts planned in multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) will be utilized as a diagnostic to identify patients with fibroblast activation protein (FAP)-positive tumors appropriate for treatment with the therapeutic agent.

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"Submission of these INDs is a very important milestone in the development of FAP-2286, the first clinical candidate from our PTRT platform," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Targeted radiopharmaceuticals represent an emerging therapeutic class and an area of significant interest to the clinical community, and FAP is considered a target of particular interest given its high, selective expression in multiple solid tumors. We are enthusiastic about the opportunity to become a leader in the rapidly evolving field of PTRT, and the first to begin clinical development of a peptide-targeted radionuclide therapy targeting FAP."

Fibroblast activation protein (FAP) is a cell-surface protein that is expressed in limited amounts by normal tissues, but highly expressed in cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.i,ii,iii Preclinical data demonstrate that 177Lu-FAP-2286 potently and selectively binds FAP on the surface of CAFs and tumor cells to deliver the beta-particle emitting radioisotope 177Lu, resulting in DNA damage and cell death.vi,iv Compelling anti-tumor efficacy of 177Lu-FAP-2286 has been demonstrated in FAP-expressing preclinical tumor models.v

Following clearance of the INDs by FDA, the Phase 1/2 study LuMIERE is planned to start in the first half of 2021 to determine the dose of 177Lu-FAP-2286 to be used in Phase 2 development. The FAP-targeting imaging agent, 68Ga-FAP-2286, will be used to identify patients with FAP-positive tumors eligible for treatment with 177Lu-FAP-2286 in the study. Once the Phase 2 dose is determined, expansion cohorts will evaluate 177Lu-FAP-2286 and 68Ga-FAP-2286 in multiple tumor types.

About Peptide-Targeted Radionuclide Therapy

Peptide-targeted radionuclide therapy (PTRT) is a form of targeted radiotherapy that is emerging as a new treatment option for patients with cancervi.These therapies consist of a small amount of a radioactive isotope, known as a radionuclide, linked to cell-targeting peptide that binds to a cancer specific protein which selectively directs the radionuclide to tumors.v Following binding, the radionuclide warhead emits ionizing radiation causing DNA damage and cell death to neighboring tumor cells.vii

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.iii Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey and Israel. FAP-2286 is an unlicensed medical product.

On December 29, 2020 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 the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas (Press release, Moleculin, DEC 29, 2020, View Source [SID1234573308]).

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Moleculin recently announced that the FDA had allowed its request for Investigational New Drug (IND) status for Annamycin, allowing Moleculin to begin a Phase 1B/2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease. The rationale for this clinical trial includes recent animal data, including data presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held June 22nd- 24th, 2020, and data from an independent laboratory announced on October 21, 2020, which demonstrated that Annamycin is capable of reaching 6 to 34-fold higher levels of accumulation in the lungs than that of doxorubicin, the primary first-line chemotherapy for STS. Additionally, clinical data show no cardiotoxicity associated with the use of Annamycin, as well as the ability to avoid multidrug resistance mechanisms, both of which are often treatment-limiting effects of anthracyclines (which includes doxorubicin) in this setting. Taken together, these factors suggest that Annamycin could represent an important treatment to help address a significant unmet need in patients with STS lung metastases.

"This is now the second Orphan Drug designation for Annamycin, as Annamycin previously received ODD for the treatment of relapsed or refractory acute myeloid leukemia," commented Walter Klemp, Chairman and CEO of Moleculin. "We believe this continues to show how the breadth of our pipeline affords us ‘multiple shots on goal’ and therefore multiple opportunities to create shareholder value."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

On December 29, 2020 AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, reported that it has closed its Series B-2 financing round for up to $25 million (Press release, AIVITA Biomedical, DEC 29, 2020, View Source [SID1234573307]). Financing was provided by several life sciences investment firms.

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Proceeds will support clinical development of AIVITA’s personalized immunotherapy programs, including Phase 2 studies in glioblastoma and ovarian cancer, as well as AIVITA’s application for commercial approval of its melanoma immunotherapy via Japan’s expedited regenerative medicine regulatory pathway. Proceeds will also support AIVITA’s ongoing development of a personalized vaccine for COVID-19 prevention, which is currently in a Phase 2/3 study.

"The completion of this financing round reflects strong asset development, an outstanding team and a focused strategy," said Hans S. Keirstead, Ph.D., chairman and chief executive officer of AIVITA. "AIVITA has clearly proven that personalized pan-antigenic vaccines are highly efficacious, safe and inexpensive to produce."

AIVITA’s cancer immunotherapy programs are designed to target the seed of all cancers – tumor-initiating cells – with a pan-antigenic approach that targets all neoantigens on those cells. Previous studies of these cancer immunotherapies have demonstrated promising safety and efficacy in multiple cancer types. AIVITA’s COVID-19 vaccine program uses the same autologous cell therapy platform, with patients’ own dendritic cells loaded with SARS-CoV-2 spike proteins and re-administered to potentially provide enhanced protection against viral mutations. The company has also leveraged its core technologies to create a skincare line launching in the US market in January 2021, known as Root of Skin MD, which dedicates net proceeds toward the treatment of cancer.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating, cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%) and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: View Source

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and completed treating 57 patients with the tumor-initiating cell-targeting immunotherapy, AV-GBM-1.

In a final analysis of progression-free survival, patients treated with AV-GBM-1 had a 38% increase in progression-free survival as compared to Stupp’s standard of care.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating, cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On December 29, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company,reported that it secures further valuable IP rights in Australia and Brazil (Press release, Oasmia, DEC 29, 2020, View Source [SID1234573306]).

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XMeNa platform patent granted in Australia – a major market within the Oceania region

The XMeNa patent protects an improved method for producing Oasmia’s nanotechnology platform XR-17, a drug-delivery system currently used with paclitaxel and other cancer drugs. The patent is important for Oasmia as it expands the territories for exclusivity of the key technology XR‑17 used in our lead product Apealea (paclitaxel micellar), which is being launched in key markets globally.

Francois Martelet, Chief Executive Officer of Oasmia commented "The XMeNa patent is already approved in several major pharmaceutical markets, including the US. With the XMeNa patent now approved in Australia, Oasmia has secured valuable IP protection for the major Oceania market with a significant pharmaceutical market."

"Water Soluble" patent granted in Brazil

The newly approved "Water soluble" patent is related to a novel nanoparticular formulation of a water soluble pharmaceutically active substances, such as doxorubicin, in combination with Oasmia’s patented technology XR-17. Doxorubicin is used to treat a variety of different forms of cancer such as acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma, amongst others.
The patent is also related to the product candidate Doxophos Vet which Oasmia developed for the treatment of lymphoma, the most common cancer in dogs.

Brazil is among the Top 10 Pharmaceutical Markets Worldwide and Oasmia is now positioned to secure market exclusivity in Brazil under its national patent law.

"Tax-dox-mix" patent receives notice of allowance in Brazil

The tax-dox-mix patent is related to the Oasmia project OAS-19 and focuses on the treatment of various cancers in humans. The patent covers a combination of a wide range of water soluble and water insoluble chemotherapeutic drugs in a single XR-17 containing solution. With an innovative dual chemotherapeutic agent encapsulation and release mechanism, this approach is intended to allow the administration of one single infusion containing two active pharmaceutical ingredients.

On December 29, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the company has appointed Dr Christina Reimer as Chief Medical Officer (Press release, Alligator Bioscience, DEC 29, 2020, View Source [SID1234573305]). She most recently comes from a position as Senior Medical Director at Ferring Pharmaceuticals in Copenhagen.

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Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. She will report to Head of R&D, EVP Malin Carlsson, and be part of the management team.

"I am very pleased with the successful recruitment of Christina Reimer to Alligator. Her international experience in leading clinical development and in building development organizations will significantly strengthen our clinical capacity. This is crucial in the phase we are in now, with two products on the way to Phase II and another product in clinical Phase I. We look forward to welcoming Christina to Lund and to our management team", said Per Norlén, CEO of Alligator Bioscience.

Christina Reimer is a medical doctor with specialist qualifications and a PhD in gastroenterology. She also has considerable experience from leading clinical programs within the industry. Christina Reimer will assume the role of Chief Medical Officer (CMO) at Alligator on February 1, 2021.

"Alligator’s solid science-based approach to discover new cancer treatments and the fact that they have several assets in clinical development is what makes this opportunity unique. I hope to be able to apply my many years of clinical experience with cancer patients and my clinical drug development skills to progress Alligator’s assets through the next important steps of development. I look very much forward to become part of the team at Alligator", said Christina Reimer.