On May 15, 2018 Atossa Genetics Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it has received a second positive interim safety review on its Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement), a common condition in patients being treated for prostate cancer (Press release, Atossa Genetics, MAY 15, 2018, View Source [SID1234526610]). The Independent Safety Committee reviewed the blinded data generated from the second group in the study (eight subjects) and concluded that the study may advance to the final dosing level.

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Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa commented, "We can now advance to the next level of the study which is to escalate the dosage in the third and final cohort of subjects as we continue to monitor safety and tolerability in the first and second cohorts of the study. We plan to complete enrollment this quarter and announce results from the study next quarter," added Dr. Quay.

The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is to assess the pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.

About Gynecomastia

Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).

According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti-anxiety medications; cancer treatments (chemotherapy), and some heart medications. Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking these important medications.

There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.

On May 15, 2018 Agilvax, Inc., a biotechnology company that develops targeted cancer immunotherapies and vaccines, reported that it has completed a Series A1 financing, which complements the Series A round from 2014 (Press release, Agilvax, MAY 15, 2018, View Source [SID1234526657]). Both Series A and A1 were led by Hunt Holdings with a co-investment by Sun Mountain Capital. The funds will be used to expand the pre-IND studies for its lead program AX09 in triple negative breast cancer (TNBC). The Company is also evaluating the use of AX09 in combination with other cancer therapeutics, as well as strengthening its immunotherapy platform.

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Federica Pericle, Ph.D., MBA, Agilvax’s CEO, remarked, "This funding shows the belief our investors have in our progress and platform. With this additional funding, we will move AX09 closer to the clinic for TNBC, a truly unmet need in women’s health. We are also excited to continue to build our platform and pipeline."

TNBC is a histological subtype of breast cancer that is aggressive, with an overall poor prognosis due to a lack of effective treatment options. Chemotherapy remains the primary treatment for TNBC across the different settings: neoadjuvant, adjuvant, and metastatic.

AX09 is a virus-like particle (VLP) that displays a portion of the extracellular domain of the cystine-glutamate antiporter system protein xCT (SLC7A11), which has been found to be overexpressed in cancer stem cells. TNBC is enriched in cancer stem cells, which contributes to the aggressive nature of TNBC. Cancer stem cells have unique biological properties that represent a key cellular reservoir for relapse, metastatic progression and therapeutic resistance. Thus, the development of therapies that eliminate cancer stem cells is paramount to creating a durable response.

On May 15, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported on key clinical and operational developments for the first quarter ended March 31, 2018 (Press release, Celyad, MAY 15, 2018, View Source [SID1234526684]).

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FIRST QUARTER 2018 AND RECENT HIGHLIGHTS

Robust clinical development plan is foundation for new trials focusing on AML and CRC

Steady progress related to ongoing THINK, SHRINK and LINK trials

Good safety profile of CYAD-01 confirmed

Lead publication Haematologica publishes THINK Study Case Report
Dr. Christian Homsy, CEO of Celyad commented: "We had a productive first quarter, further defining our strategy that will guide CYAD-01 in becoming the foundation for cancer therapies. Not only have we progressed in the THINK trial, we have also treated our first patients in the SHRINK and LINK trial. The absence of any observed critical on target/off tumor toxicity in our trials is an important signal validating our technology. The next months will be exciting for our company and we look forward communicating results on our clinical trials in scientific congresses."

FIRST QUARTER 2017 OPERATIONAL AND FINANCIAL REVIEW

In February 2018, Celyad provided a detailed clinical update summarizing the promising results achieved in 2017: the THINK trial resulted in signs of clinical activity ranging from Stable Disease (SD) to Complete Response (CR), despite the absence of preconditioning therapy and the lower doses used at that stage of the trial. The company also announced that it will further evaluate CYAD-01 in a series of additional Phase 1 clinical trials in patients with AML and CRC.

Also in February 2018, Celyad organized a Key Opinion Leader meeting on CAR-T therapy in New York, USA. The meeting featured a presentation by Marco Davila, MD, PhD (Moffitt Cancer Center). The numerous attendants received information on the unmet medical need in blood cancers as well as details on Celyad’s clinical strategy.

1 THerapeutic Immunotherapy with CAR-T NKG2D
2 Standard CHemotherapy Regimen and Immunotherapy with NKG2D
3 Loco-regional Immunotherapy with NKG2D

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On the operation side, during this first quarter, Celyad progressed well in the THINK trial as well as the in LINK trial:

– The company dosed the three CRC patients in the third dose cohort in the solid arm of the THINK trial, and the two last AML patients in the second dose. Celyad plans to initiate the third dose in the AML arm in May 2018, and complete the recruitement of three additional CRC patients at the higher dose by mid-2018. In 2018, all patients were dosed with the our new production process adopted in December 2017.

– The company also treated its first CRC patient in the LINK trial. This patient received three planned injections at the first Dose level (3×108). LINK adopts a loco-regional approach in treating CRC by administering CYAD-01 through multiple hepatic transarterial injections.

The company ended the quarter with €25.1 million in cash, cash equivalents and short-term investrments. Use of cash over the first quarter of 2018 amounted to €8.8 million, in line with expectations. The company confirms that existing cash and cash equivalents and short term investments are sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until the end of Q1 2019.

EVENTS SUBSEQUENT TO QUARTER-END:

In April 2018, Celyad’s world’s first reported complete response by a CAR-T cell therapy in a patient with refractory and relapsed AML was published as a case report in the leading scientific publication Haematologica. The publication detailed the first objective response related to this patient that is still in remission, more than 9 months after study enrollment.

In May 2018, Celyad achieved an important milestone in its CYAD-01 clinical strategy by dosing the first metastatic CRC patients in the LINK and SHRINK trials. No drug related toxicity was observed in the first patients of both SHRINK and LINK trials.

Generally, Celyad’s progress is the result of the company’s clinical development plan aiming at defining the best of three approaches for CYAD-01 in patients with AML and CRC:

1) CYAD-01 as a stand-alone investigational therapy, currently being evaluated in the THINK trial with relapsed refractory AML and CRC patients. Promising results have already been reported including a complete response and stable diseases.

Based on data as of April 5, 2018, the date of Celyad’s most recent interim safety report for the THINK trial, Celyad had collected safety data from 20 patients treated with CYAD-01 in the THINK trial. Of the 20 patients included in the interim safety report of the THINK trial (11 solid and nine hematologic cancer patients), Celyad reported the following serious adverse events:

– Grade 4 serious adverse events occurred in two patients: one patient in the hematologic cohort experienced respiratory failure and other Grade 4

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adverse events after administration of dose level one of CYAD-01. The other patient, who was in the solid tumor cohort, experienced cytokine release syndrome and other Grade 4 adverse events after administration of dose level three of CYAD-01, which was adjudicated as a dose limiting toxicity (DLT).

– Those two patients each experienced a Grade 5 event that was deemed unrelated to administration of CYAD-01.

2) CYAD-01 administered concurrently with standard of care treatments. The SHRINK trial was recently initiated with the dosage of one CRC patient in April 2018. No Grade 4 or higher adverse event has been reported so far. This trial evaluates the concurrent administration of CYAD-01 with the standard chemotherapy FOLFOX. We expect that another similar trial aimed at AML patients, EPITHINK trial, will be initiated soon.

3) CYAD-01 administered after preconditioning of the patients using lymphodepletion. We expect trials in AML (DEPLETHINK AML) and CRC (DEPLETHINK CRC) patients to be initiated in the coming weeks.

On May 15, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that data from preclinical studies of its HER2-targeted CAR-T cell containing its dual-switch technology will be reviewed in an oral presentation at the 21st Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held in Chicago, Illinois from May 16-19 (Press release, Bellicum Pharmaceuticals, MAY 15, 2018, View Source [SID1234526611]).

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"The potential of our novel dual-switch CAR-T platform to provide in vivo control over adoptive immunotherapies is very exciting," said Bellicum’s President & CEO Rick Fair. "These data suggest the potential to significantly reduce toxicities while prolonging efficacy using molecular switches activated by small molecule agents. We believe this technology may address some of the major challenges with CAR-T therapies, particularly when targeting solid tumors. We look forward to initiating clinical trials in 2019 with two CAR-T cell candidates engineered with dual switches."

Presentation Details:

Title: HER2-Targeted Dual-Switch CAR-T Cells Enable Post-Infusion Control of CAR-T Efficacy and Safety with Small Molecules
Session: 113 Cancer – Targeted Gene & Cell Therapy I
Date/Time:Wednesday, May 16th11:00 a.m. CDT

The presentation will be made available in the Events and Presentations section of the Bellicum website shortly after the presentation.

On May 15, 2018 CohBar, Inc. (NASDAQ: CWBR) ("CohBar" or the "Company"), an innovative biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported its financial results for the first quarter ended March 31, 2018 (Press release, CohBar, MAY 15, 2018, View Source [SID1234526641]).

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"We raised $4.6 million in additional funding since the beginning of the year to further support our pre-clinical and clinical activities," said Simon Allen, CohBar CEO, "and our latest findings regarding CB4211’s novel mechanism of action were accepted for presentation at a major scientific conference next month. Our planned clinical entry will mark significant milestones both for CohBar’s transition to a clinical-stage company, and for the transformation of naturally occurring mitochondrial peptides into a novel class of therapeutics for the potential treatment of a range of age-related diseases."

Recent and First Quarter 2018 Business and Preclinical Development Highlights:

CB4211 Mechanism of Action Findings Accepted for Presentation at Major Scientific Conference in June. The Company will be presenting its findings to date about the molecular mechanisms underlying CB4211’s efficacy in animal models of NASH at a major scientific conference in June 2018. The Company’s ongoing investigation identified CB4211’s interaction with a cell-surface receptor that plays a key role in metabolic regulation.

Completed Private Placement. With the final closing in April 2018, the Company issued and sold a total of $3.9 million of non-convertible unsecured promissory notes, together with warrants to purchase 780,500 shares of the Company’s common stock. Insider participation accounted for more than $500,000 of the financing. An additional $0.7 million was raised from warrant and option exercises during the first quarter.

Investment and Scientific Community Outreach. During the first quarter, CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the H.C. Wainwright & Co. 2nd Annual NASH Investor Conference, and met with institutional investors and NASH scientific and medical experts at the BIO CEO and Investor Conference, and at the 30th Annual ROTH Conference.

First Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash, cash equivalents and investments of $8,456,656 on March 31, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $2,680,983 in the three months ended March 31, 2018 compared to $1,292,780 in the prior year first quarter. The increase was due primarily to costs related to our clinical and IND-enabling activities, and an increase in stock-based compensation for option grants made during the current year quarter, and for prior grants to consultants that are revalued at each balance sheet date.

G&A Expenses. General and administrative expenses were $913,088 in the three months ended March 31, 2018, compared to $940,089 in the prior year quarter. The decrease in general and administrative expenses were related to lower stock-based compensation costs compared to the prior year first quarter, offset by increases in insurance premiums and directors fees related to the addition of a new Board member announced at the end of 2017.

Net Loss. For the three months ended March 31, 2018, net loss was $3,586,585, or $0.09 per basic and diluted share, compared to a net loss of $2,232,110, or $0.06 per basic and diluted share, for the three months ended March 31, 2017.

CohBar will not be hosting a first quarter 2018 investor conference call. The Company will be conducting an investor teleconference in conjunction with its Annual Shareholder Meeting scheduled for June 19, 2018. Details of the Annual Shareholder Meeting will be announced in early June.

About CohBar’s Lead Program

CohBar’s lead preclinical development program is based on MOTS-c, a mitochondrial-derived peptide (MDP) that was discovered in 2012 by CohBar founder Professor Dr. Pinchas Cohen and his academic collaborators, whose research has shown that MOTS-c plays a significant role in the regulation of metabolism. The Company has developed CB4211, a novel and improved analog of MOTS-c, which has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity.