On February 11, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its second quarter ended December 31, 2019 (Press release, Palatin Technologies, FEB 11, 2020, View Source [SID1234554147]).

"The June 2019 FDA approval of Vyleesi was meaningful on two fronts," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "For premenopausal women, it provides a safe and effective, as-needed treatment option for those with HSDD. For Palatin, we now have an enhanced cash position of $92 million at December 31, 2019, which puts us in an excellent position to advance our pipeline programs. We have two Phase 2 clinical studies starting in the first half of calendar year 2020: a dry eye disease study with data expected in the fourth quarter of calendar year 2020 and an ulcerative colitis trial with data expected in mid-calendar year 2021."

"AMAG’s planned divestiture of Vyleesi is based on its change in strategy, and is not a result of the Vyleesi launch performance to date," continued Spana. "As the licensor, we maintain certain rights and will take appropriate steps to ensure that the value of Vyleesi remains intact and continues to grow. We will also continue to be opportunistic and flexible as the divestiture process advances, with the objective that the ultimate licensee of the North American rights to Vylessi is committed to the robust commercialization of the product."

Recent Business Highlights

Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi (bremelanotide injection)
On January 9, 2020 AMAG Pharmaceuticals, Inc. ("AMAG") announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America, and another female healthcare product, Intrarosa. AMAG stated that it has received preliminary expressions of interest in these assets.

Under the Vyleesi license agreement, AMAG has a contractual obligation to use commercially reasonable efforts to commercialize Vyleesi. If AMAG materially breaches this obligation and fails to cure such breach, Palatin could potentially have the right to terminate the license agreement and have Vyleesi returned to Palatin. In the event AMAG assigns its Vyleesi license, the assignee must expressly agree to be bound by the Vyleesi license agreement between AMAG and Palatin.

Palatin is advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during calendar year 2020. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Both companies are advancing Vyleesi through the regulatory process in their respective territories, which includes the conduct of certain clinical studies in those territories prior to filing for market approval.

Vyleesi is the first as-needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG Pharmaceuticals, Palatin’s North American licensee, launched Vyleesi nationally in September 2019 through select specialty pharmacies with its established women’s health sales force of approximately 125 sales representatives. While AMAG has not yet released prescription numbers for the quarter ended December 31, 2019, AMAG has stated publicly that the "Vyleesi launch is off to a strong start."

Anti-Inflammatory / Autoimmune Programs
Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).

An investigational new drug application (IND) for PL9643 in dry eye disease was filed with the US Food and Drug Administration (FDA) in December 2019. A Phase 2 clinical study is expected to commence in the first quarter of calendar year 2020, with data readout anticipated in the fourth quarter of calendar year 2020.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is anticipated to start mid-calendar year 2020, with data readout mid-calendar year 2021.

Palatin continues its assessment and development work related to the treatment of patients with diabetic retinopathy and non-infectious uveitis (NIU), an indication which FDA granted orphan drug designation, with the objective of commencing clinical trials in calendar year 2021.

Natriuretic Peptide Receptor (NPR) System Program
Palatin has designed and is developing potential drug candidates that are selective agonists for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A (NPR-A), natriuretic peptide receptor B (NPR-B), and natriuretic peptide receptor C (NPR-C).

PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is anticipated to start patient enrollment in 2020.

PL3994 has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A. PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, has potential for reducing cardiac hypertrophy and fibrosis, among other indications.

Genetic Obesity Program
Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

Second Quarter Fiscal Year 2020 Financial Results

Revenue
For the quarter ended December 31, 2019, Palatin recognized as revenue $20,610 in reimbursement of shared Vyleesi costs related to our license agreement with AMAG. There were no revenues recorded in the quarter ended December 31, 2018.

Operating Expenses
Total operating expenses for the quarter ended December 31, 2019 were $5.7 million compared to $5.1 million for the comparable quarter of 2018. The increase in operating expenses was mainly due to the final payment of $625,000 made in connection with the mutually agreed upon termination of our engagement agreement on Vyleesi with Greenhill & Co.

Other Income/Expense, net
Total other income was $397,480 for the quarter ended December 31, 2019 compared to total other income $7,871 for the quarter ended December 31, 2018. The difference is related primarily to the increase in investment income.

Net Loss
Palatin reported a net loss of $(5.2) million, or $(0.02) per basic and diluted share, for the quarter ended December 31, 2019, compared to a net loss of $(5.0) million, or $(0.02) per basic and diluted share, for the same period in 2018.

The difference in financial results between the three months ended December 31, 2019 and 2018 was attributable to the increase in operating expenses of $0.6 million offset by the increase of $0.4 million in other income.

Cash Position
Palatin’s cash, cash equivalents, and accounts receivable total $91.6 million as of December 31, 2019, compared to cash, cash equivalents, and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.4 million as of December 31, 2019, compared to $4.2 million as of June 30, 2019.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on February 11, 2020 at 11:00 a.m. Eastern Time to discuss the results of operations for the quarter ended December 31, 2019 in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 7551093. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 7551093. The webcast and telephone replay will be available through February 18, 2020.

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On February 11, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the enrollment of the first patient in an investigator-sponsored clinical trial of its Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, GPS, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with MPM (Press release, Sellas Life Sciences, FEB 11, 2020, View Source [SID1234554145]).

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The Phase 1 open-label clinical study is being conducted by Memorial Sloan Kettering Cancer Center (MSK) and is enrolling patients with MPM who harbor relapsed or refractory disease after having received frontline, standard-of-care multimodality therapy. The principal investigator for the study is Marjorie G. Zauderer, MD, Co-Director, Mesothelioma Program and Associate Attending Physician in the Thoracic Oncology Service, Department of Medicine at MSK.

"We are pleased to be collaborating with Memorial Sloan Kettering on this Phase 1 trial and excited to have expanded the clinical evaluation of GPS in combination with nivolumab to patients with advanced MPM," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "There are few effective therapies for mesothelioma, a disease which is characterized by high expression of the WT1 antigen, and we believe that the combination of GPS and nivolumab could be promising for patients with MPM, due to the combination’s potential synergistic immune-based mechanisms for anti-tumor activity. We look forward to gaining further insights on the safety and clinical outcomes of this combination in MPM."

The trial is investigating the potential of GPS in combination with nivolumab to demonstrate anti-tumor immune responses and meaningful clinical activity in the presence of macroscopic disease in MPM patients and gauging the degree of clinical benefit by assessment of the overall response rate with the combination in comparison with that reported with nivolumab alone in historical comparable patient populations.

"There is significant preclinical and translational science evidence that PD-1 inhibitors may enhance the anti-cancer activity of cancer vaccines, with immuno-biologic and pharmacodynamic synergy from the combination of two such agents," said Dr. Zauderer. "By mitigating the negative effects of tumor microenvironment factors on immune response, PD-1 inhibitors, such as nivolumab, potentially allow for a patient’s immune cells to destroy cancerous growths that may be sensitized by GPS against WT1. I believe that WT1 serves as an ideal target for directly immunizing therapies in MPM, and I look forward to evaluating the combination of GPS and nivolumab in the clinic."

In a previous randomized, controlled, blinded Phase 2 clinical trial in MPM patients, GPS monotherapy, given as maintenance after first line tumor-debulking multimodality treatment, demonstrated meaningful clinical activity with median survival of 22.8 months vs. 18.3 months in the control group (N=41) and with associated sustained immune responses (both CD4+ and CD8+) against the WT1 antigen with the most common adverse events mild (grade 1 and 2) and self-limited injection site reactions.

On February 11, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at NobleCon16 – Noble Capital Markets’ 16th Annual Investor Conference on Tuesday, February 18, 2020 at 2:30 p.m. ET in Hollywood, Florida (Press release, Xenetic Biosciences, FEB 11, 2020, View Source [SID1234554144]).

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As part of his presentation, Mr. Eisenberg will provide a Company overview and discuss the Company’s novel CAR T platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. Xenetic is currently advancing the development program for XCART to confirm the positive preclinical results shown to date and to demonstrate a more attractive safety profile than existing therapies.

In addition to the presentation, management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. To request a meeting, please contact the NobleCon16 one-on-one desk.

On February 11, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the SVB Leerink 9th Annual Global Healthcare Conference on Tuesday, February 25 (Press release, AbbVie, FEB 11, 2020, View Source [SID1234554143]). Michael Severino, M.D., vice chairman and president and Robert A. Michael, executive vice president and chief financial officer, will present at 9:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 11, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, and Promedico, a member of the Neopharm Group, reported their entry into an exclusive distribution agreement for the commercialization of XPOVIO (selinexor), Karyopharm’s lead SINE compound, in Israel and the Palestinian Authority (Press release, Karyopharm, FEB 11, 2020, View Source [SID1234554142]).

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Under the terms of the agreement, Karyopharm will receive certain prespecified payments and is eligible to receive additional payments if prespecified regulatory and commercial milestones are achieved by Promedico, a fully-owned Neopharm LTD company. Karyopharm is also eligible to receive double-digit royalties on future net sales of XPOVIO in the covered territory. In exchange, Promedico will receive exclusive rights to commercialize XPOVIO in the covered territory and is responsible for all regulatory filings and obligations required for registering XPOVIO. Karyopharm has retained exclusive production rights and will supply finished product for commercial use in the covered territory.

"The addition of XPOVIO fits our portfolio of innovative oncology products designed to treat diseases with significant unmet need," said Avishay Zlotnik, Chief Executive Officer of Promedico Ltd. "We share Karyopharm’s commitment to cancer patients and believe our deep expertise as one of the largest healthcare distributor groups in Israeli will allow us to effectively bring XPOVIO to the Israeli market."

"Neopharm companies have a proven track record of successfully commercializing new therapeutics in Israel, making them an ideal partner to further expand the global reach of XPOVIO," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "We look forward to working with their world-class team to bring XPOVIO to cancer patients in need of novel therapies."

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. In addition to receiving accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor. A New Drug Application was recently submitted to the FDA seeking accelerated approval for selinexor as a new treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Selinexor has received Fast Track and Orphan designation from the FDA for the patient population evaluated in the SADAL study. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION

Thrombocytopenia

XPOVIO can cause thrombocytopenia, leading to potentially fatal hemorrhage. Thrombocytopenia was reported as an adverse reaction in 74% of patients, and severe (Grade 3-4) thrombocytopenia occurred in 61% of patients treated with XPOVIO. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia and fatal hemorrhage occurred in <1% of patients.

Monitor platelet counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia

XPOVIO can cause neutropenia, potentially increasing the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3-4) neutropenia occurred in 21% of patients treated with XPOVIO. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients.

Obtain neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G-CSF). Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Gastrointestinal Toxicity

Gastrointestinal toxicities occurred in patients treated with XPOVIO.

Nausea/Vomiting

Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patients treated with XPOVIO. The median time to onset of the first nausea event was 3 days.

Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4% of patients treated with XPOVIO. The median time to onset of the first vomiting event was 5 days.

Provide prophylactic 5-HT3 antagonists and/or other anti-nausea agents, prior to and during treatment with XPOVIO. Manage nausea/vomiting by dose interruption, reduction, and/or discontinuation. Administer intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use additional anti-nausea medications as clinically indicated.

Diarrhea

Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6% of patients treated with XPOVIO. The median time to onset of diarrhea was 15 days.

Manage diarrhea by dose modifications and/or standard anti-diarrheal agents; administer intravenous fluids to prevent dehydration in patients at risk.

Anorexia/Weight Loss

Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5% of patients treated with XPOVIO. The median time to onset of anorexia was 8 days.

Weight loss was reported as an adverse reaction in 47% of patients, and Grade 3 weight loss occurred in 1% of patients treated with XPOVIO. The median time to onset of weight loss was 15 days.

Monitor patient weight at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support.

Hyponatremia

XPOVIO can cause hyponatremia; 39% of patients treated with XPOVIO experienced hyponatremia, 22% of patients experienced Grade 3 or 4 hyponatremia. The median time to onset of the first event was 8 days.

Monitor sodium level at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Treat hyponatremia per clinical guidelines (intravenous saline and/or salt tablets), including dietary review. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Infections

In patients receiving XPOVIO, 52% of patients experienced any grade of infection. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. Grade ≥3 infections were reported in 25% of patients, and deaths resulting from an infection occurred in 4% of patients. The most commonly reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Most infections were not associated with neutropenia and were caused by non-opportunistic organisms.

Neurological Toxicity

Neurological toxicities occurred in patients treated with XPOVIO.

Neurological adverse reactions including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients, and severe events (Grade 3-4) occurred in 9% of patients treated with XPOVIO. Median time to the first event was 15 days.

Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes.

Embryo-Fetal Toxicity

Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥20%) are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65.3% had the dose of XPOVIO interrupted. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia. The rate of fatal adverse reactions was 8.9%.