On September 20, 2019 An Upstate Medical University professor is the lead investigator on a recently awarded National Institutes of Health grant to study how manipulating a gene could help people better tolerate and recover from chemotherapy (Press release, SUNY Upstate, SEP 20, 2019, View Source [SID1234551515]).

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William Kerr, PhD, is a professor of microbiology and immunology, biochemistry and molecular biology as well as pediatrics at Upstate. Kerr has spent much of his career studying the SHIP1 enzyme, which can affect how an immune cell detects and kills cancer cells. He is a co-founder of Alterna Therapeutics, a private biotechnology company. Kerr, Alterna Therapeutics and a Syracuse University professor are the recent beneficiaries of the one-year $225,000 NIH grant.

Kerr said research supported by the grant will be conducted at Upstate and at the Central New York Biotech Accelerator.

"This NIH grant at Upstate advances and showcases SUNY’s enduring commitment to medical discovery and innovation," said SUNY Chancellor Kristina Johnson. "This research has the potential to impact millions of people whose lives are upended by the devastating effects of chemotherapy. I applaud Dr. Kerr for his leadership on this work that may one day result in better therapeutics for people diagnosed with cancer."

The project is described this way: "While chemotherapy remains a mainstay in the treatment of cancer, some types of chemotherapy deplete bone marrow stem cells that are responsible for daily production of blood cells. The severely debilitating side effects of chemotherapy on daily blood cell production frequently result in hospitalization and treatment delays, and may compel dose reductions that compromise drug efficacy, with potentially fatal consequences. This project will develop a novel technology to significantly improve blood cell recovery following chemotherapy, thus reducing healthcare costs for cancer patients and saving lives."

Kerr’s initial study of this topic involved modulating the activity of the SHIP1 enzyme to enhance blood cell recovery after radiation exposure. Papers describing these findings have been cited in ongoing research more than 100 times and featured by the editors at the journal Science, he said. In 2015, Kerr received an investment from SUNY’s Technology Accelerator Fund (TAF) to systematically test more than 100 SHIP1 inhibitors to find the best candidates for a therapeutic product. TAF targets critical research and development milestones – such as feasibility studies, prototyping and testing – which demonstrate that an idea or innovation has commercial potential. Since its launch in 2011, TAF has invested over $2.6 million to successfully advance the commercial readiness of 49 SUNY-developed innovations.

This new study will apply modulating the activity of the SHIP1 enzyme but after chemotherapy rather than radiation, Kerr said.

"We’re very interested in exploring the potential to expand stem cell production to help promote recovery of blood cell populations," said Alterna Therapeutics co-founder and CEO Chris Meldrum. He noted that Kerr’s breakthrough could be especially helpful to patients who undergo chemotherapy or other treatments that severely deplete or suppress production of blood cells by the bone marrow. Some of those treatments cause severe deficiencies in neutrophil and platelet counts, which can make a patient very sick requiring hospitalization. That in turn can slow down or halt their treatments, which puts the patient at a higher risk for the cancer to return. The discovery from Dr. Kerr’s lab additionally has the potential to be a treatment used in improving blood cell recovery following bone marrow transplant procedures.

"It’s taken us about a year to get some of these grants and now that we have the first one we’ll be applying for others," Kerr said, noting this is a "phase one grant" to test the initial science and could lead to Phase 2 funding from the NIH for further clinical development and testing.

"I’m excited. This bodes well that the review committees of the NIH see research conducted by Alterna Therapeutics as valuable and thus something that the NIH should support because it could lead to next generation cancer therapies."

On September 20, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS) reported the closing of its initial public offering of 12,578,125 shares of its common stock at a price to the public of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,640,625 additional shares (Press release, IGM Biosciences, SEP 20, 2019, View Source [SID1234539668]). The shares began trading on The Nasdaq Global Select Market on September 18, 2019 under the symbol "IGMS." IGM received gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, of approximately $201.3 million.

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Jefferies, Piper Jaffray, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

A registration statement relating to the offering was declared effective by the United States Securities and Exchange Commission on September 17, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Piper Jaffray & Co, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On September 19, 2019 Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Leukine (sargramostim), a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF), for the potential treatment of Stage IIb-IV melanoma (Press release, Partner Therapeutics, SEP 19, 2019, View Source [SID1234539653]).

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Melanoma is the most aggressive form of skin cancer and rates of melanoma have been rising for the past 30 years. The American Cancer Society estimates 96,480 new melanoma cases will be diagnosed in the US and 7,230 people will die from the disease in 2019. The FDA grants orphan drug designation to promote the development of promising treatments for conditions that affect 200,000 or fewer U.S. patients annually. If a product holding Orphan Drug Designation receives the first FDA approval for the disease in which it has such designation the company qualifies for, among other things, seven years of market exclusivity following marketing approval.

The Eastern Cooperative Oncology Group (ECOG) previously reported results of Study 1608, a Phase II study in which patients with advanced stage melanoma received a combination of sargramostim and ipilimumab or ipilimumab alone1. Among 245 patients, the addition of sargramostim led to longer survival (median 17.5 vs 12.7 months). The most common Grade 3-5 toxicities in patients treated with sargramostim and ipilimumab were diarrhea (12.7%) and rash (9.3%) and occurred at similar rate in patients receiving ipilimumab alone. Overall, severe toxicities occurred less frequently in patients treated with sargramostim plus ipilimumab vs ipilimumab alone (44.9% vs 58.3%, Grade 3-5); the most notable reductions were in gastrointestinal and pulmonary toxicities. The results of this study led to initiation of a larger Phase 2/3 study (ECOG 6141) evaluating sargramostim in combination with ipilimumab and nivolumab as initial treatment of advanced or metastatic melanoma. This ongoing study is being conducted by ECOG with support from the National Cancer Institute.2

"Leukine’s role as an immunomodulator was not the initial focus when it was first discovered decades ago. As we learn more about the immunologic effects of GM-CSF on antitumor immunity, we believe there is potential to develop Leukine to help more patients benefit from treatment with checkpoint inhibitors in melanoma and other difficult to treat cancers," said Bob Mulroy, PTx’s CEO. "This orphan designation is an important step in the development of Leukine. We are pleased FDA has programs such as Orphan Drug Designation to support research in rare diseases."

Leukine was initially approved in the United States in 1991 and has five hematologic oncologic indications. Leukine is currently not approved for the treatment of melanoma. The approval of an orphan drug designation request does not alter the standard regulatory requirements and processes for obtaining marketing approval of an investigational drug. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

Please see full Prescribing Information for LEUKINE at www.leukine.com

About Leukine (sargramostim)

Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity3.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.
Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
If ANC > 20,000 cells/mm3 or if WBC counts > 50,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
LEUKINE therapy should be discontinued if disease progression is detected during treatment.
Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.
Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
In Allogeneic BMT patients–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increase creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema
Please see full Prescribing Information for LEUKINE at www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL).
LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

On September 19, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported progress in its ongoing Phase 1 clinical study evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, in a trial-in-progress poster at The Annual Global Meeting of the International Gynecologic Cancer Society (IGCS 2019) in Rio de Janeiro, Brazil (Press release, Compugen, SEP 19, 2019, View Source [SID1234539654]).

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In a poster titled "COM701 (A Novel Immune Checkpoint Inhibitor) in Patients with Advanced Solid Tumors," the Company reported that it has completed enrollment in the seventh dose level in the COM701 monotherapy (Arm A) and second dose level in the combination of COM701 with Opdivo (Nivolumab) (Arm B) and that no dose-limiting toxicities were observed in these and prior dose level cohorts. COM701 as a monotherapy and in combination with Opdivo has shown an acceptable safety and tolerability profile at all dose levels tested. Study enrollment is advancing on schedule for additional dose levels.

The poster is available on Compugen’s website at www.cgen.com.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial of COM701 is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary antitumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy as well as COM701 in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

On September 19, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that Potomac Urology Center, PC ("PUC") has joined its Cchek early cancer detection study (Press release, Anixa Biosciences, SEP 19, 2019, View Source [SID1234539639]). PUC will provide patient samples for Anixa’s ongoing prostate cancer study, including support of clinical validation of Anixa’s Cchek Prostate Cancer Confirmation test.

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Dr. Nilay M. Gandhi, who will serve as the Principal Investigator at PUC for the study, stated, "We’re excited to take part in the development of Anixa’s Cchek prostate cancer detection test and we look forward to the impact this test may have on improving patient care."

"We are pleased to have PUC join us as a key collaborator in the development of Cchek, our artificial intelligence driven liquid biopsy for early cancer detection," stated Dr. Amit Kumar, CEO of Anixa. "Further, we look forward to PUC’s participation as we prepare for the commercial launch of our Cchek Prostate Cancer Confirmation test later this year."

PUC is an expert urology practice committed to providing the highest quality care to patients throughout the Northern Virginia area in the diagnosis and treatment of urology related conditions.