On April 26, 2022 SCYNEXIS, Inc. (Nasdaq: SCYX) reported the closing of its previously announced underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, APR 26, 2022, View Source [SID1234613005]). The shares and warrants were sold at a public offering price of $3.00 per share and accompanying warrants, and the pre-funded warrants were sold at a public offering price of $2.999 per pre-funded warrant and accompanying warrants. The total gross offering proceeds to SCYNEXIS from this offering were $45.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants were offered by SCYNEXIS.

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At closing, SCYNEXIS issued 3,333,333 shares of its common stock, pre-funded warrants to purchase an aggregate of 11,666,667 shares of common stock and warrants to purchase an aggregate of 15,000,000 additional shares of its common stock. The pre-funded warrants were issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of our common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants were issued separately. The warrants have a seven-year term and an exercise price of $3.45 per share. The pre-funded warrants and the warrants are exercisable immediately. The warrants were certificated and are being delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

In addition, SCYNEXIS has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock and/or warrants to purchase up to 2,250,000 shares of common stock, at their respective public offering prices, less the underwriting discounts and commissions.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. served as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and Maxim Group LLC served as co-lead managers for the offering. Aegis Capital Corp, Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC served as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on December 31, 2020, and was declared effective on January 8, 2021. The offering was made only by means of a preliminary and final prospectus supplement and accompanying prospectus. Copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, or by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022, or by email at [email protected]. The final terms of the offering were disclosed in the final prospectus supplement filed with the SEC.

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

On April 26, 2022 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported the positive results from the GLP toxicology study of PMC-403, the Company’s novel TIE2-activating antibody (Press release, PharmAbcine, APR 26, 2022, View Source;bmode=view&idx=11279911&t=board [SID1234649181]).

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PMC-403 can stabilize and repair damaged and pathologically leaky blood vessels, and it is being developed to treat AMD (Age-related Macular Degeneration), one of the most prevalent neovascular ophthalmology diseases.

With the goal of establishing safety profile in animal models before entering the human trial, the study was conducted to evaluate the toxicokinetics and toxicity of PMC-403. The drug was administered via monthly intravitreal injection to monkeys in different dosing groups.

The result of the study showed that there were no serious safety issues in the test subjects (n=32). There were no unscheduled deaths and no organ weight changes even when PMC-403 was administered with twice the dosage of that of the existing drugs.

"We concluded that PMC-403 is safe enough to be administered in human trials," said Dr. Jin-San Yoo, CEO of PharmAbcine. "The vessel-normalizing mechanism makes PMC-403 a potent drug that can offer longer dosing interval and also be utilized in many other vessel-related diseases, such as chronic kidney diseases, ARDS (Acute Respiratory Distress Syndrome), and sepsis."

Dr. Yoo added, "In addition to the study result, Dr. Quan Dong Nguyen, our newly appointed Scientific Advisory Board member and a world-renowned expert in ophthalmology from Stanford University, will provide tremendous insight to our development efforts. Both of these events are critical milestones in the preparation of PMC-403 for the Phase I clinical trial in ophthalmology. The Company will submit the IND package in 3Q22."

On April 26, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has opened patient enrollment in the Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma (Press release, Phio Pharmaceuticals, APR 26, 2022, View Source [SID1234612955]).

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"We are excited to advance our first-in-human clinical trial for our lead program, PH-762, to treat patients with melanoma. The start of this clinical study marks a significant milestone for Phio and our INTASYL therapeutic platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "This is an important study for patients with advanced melanoma as well, since currently, there are no neoadjuvant treatment options approved for these patients. In addition, the clinical program for PH-762 to treat melanoma is supported by a robust set of preclinical data generated over the past several years. These data show that local treatment of PH-762 inhibits not only local tumor growth, but also elicits an abscopal effect or systemic immune response in distal, untreated tumors."

The Phase 1b study, which is being conducted at the Gustave Roussy Institute, one of the largest cancer centers in Europe, will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. The clinical study will feature a dose escalation of PH-762 monotherapy and is designed to allow for a data driven evaluation of the recommended Phase 2 dose. This is the first clinical trial with PH-762.

PH-762, activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing cancer cells. When PH-762 reduces PD-1 expression, the "brakes" on the immune system are released and activates the T cells to kill the cancer cells. PH-762 is being developed as a standalone drug therapy with local administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy, more specifically to improve tumor cell killing capability of adoptively transferred tumor infiltrating lymphocyte (TIL) therapy.

On April 26, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported that it will host a conference call on Tuesday, May 3rd, 2022, at 4:30 pm ET to report its financial results for the first quarter of 2022 (Press release, Infinity Pharmaceuticals, APR 26, 2022, View Source [SID1234612971]).

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A live webcast of the conference call can be accessed in the Investors/ Media section of Infinity’s website at View Source and will be available on Infinity’s website for 30 days following the event.

On April 26, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported its upcoming presentation of preclinical data for the Company’s two lead TRACTr programs, PSMA-TRACTr (JANX007) and EGFR-TRACTr (JANX008), in separate poster presentations at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston Conference & Expo, scheduled to take place May 2-6, 2022, virtually and in-person at the Hynes Convention Center in Boston, Massachusetts (Press release, Janux Therapeutics, APR 26, 2022, View Source [SID1234612988]).

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Janux’s TRACTr candidates are a novel class of T cell engagers (TCEs) designed to be highly potent, half-life extended anti-tumor therapeutics with enhanced safety features and the potential to overcome problems with existing TCE approaches for solid tumors, which have been limited to date by cytokine release syndrome (CRS), on-target healthy tissue toxicity, poor pharmacokinetics (PK) profiles, and dose-limited efficacy. JANX007 is a novel TRACTr therapeutic targeting prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCPRC), and JANX008 is a novel TRACTr therapeutic targeting epidermal growth factor receptor (EGFR) for the treatment of multiple solid cancers including, metastatic colorectal cancer (mCRC), squamous cell carcinoma of the head and neck (SCCHN), and non-small cell lung cancer (NSCLC). JANX007 and JANX008 are the first development programs to emerge from Janux’s TRACTr platform.

"The preclinical data to be presented for JANX007 and JANX008 at PEGS Boston is an important step forward for Janux’s proprietary TRACTr technology platform and our pipeline of next-generation immunotherapies," said David Campbell, Ph.D., President, and CEO of Janux. "These data display our TRACTr platform’s ability to circumvent common clinical limitations of existing TCE approaches and support our goal of delivering product candidates with potential for significantly reduced risk of toxic CRS responses, as well as reduced risk of on-target, healthy tissue toxicities. We look forward to advancing the IND submissions for both next-generation immunotherapies over the course of this year."

In a poster titled, "Preclinical Activity and Safety Profile of JANX007, a Novel PSMA-Targeting Tumor-Activated T Cell Engager for Treatment of Metastatic Castration-Resistant Prostate Cancer," Janux highlighted:

– JANX007 exhibits enhanced safety and PK properties relative to the PSMA-TCE.

– The critical safety feature of JANX007 is a tumor protease-cleavable, inhibitory peptide mask, which decreases JANX007 binding to human CD3 by >600x, restricting T cell activation to the tumor microenvironment (TME).

– In vitro, JANX007 exhibits up to 500x decrease in potency to activate T cells and induce T-cell mediated tumor cell killing relative to non-masked PSMA-TCE.

– In a repeat dose, GLP toxicity study in non-human primates (NHPs) JANX007 demonstrated an enhanced safety profile featuring a decrease in cytokine CRS-associated proinflammatory cytokines and no signs of healthy tissue toxicity with no-observed-adverse-effect-level (NOAEL) ≥ 1.5 mg/kg/dose IV bolus once-weekly (QW) x5.

– Albumin-binding domain extends the circulating half-life of JANX007 to ~120 hours in NHPs, relative to 2 hour half-life of non-masked TCE, supporting the TRACTr’s projected once weekly clinical dosing.

– GMP drug substance and drug product production has been completed to support a planned Phase 1 clinical trial.

– Cleavage-dependent activity, half-life extended PK, potential for superior safety, and manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic.

– Janux plans to submit an investigational new drug (IND) application for JANX007 with the U.S. Food and Drug Administration (FDA) in the first half of 2022.

In a poster titled, "Preclinical Development of an EGFR-Targeted Tumor-Activated T Cell Engager with Enhanced Safety to Activity Multiple and Pharmacokinetics Profile," Janux highlighted:

– JANX008 exhibits enhanced safety and PK properties relative to the EGFR-TCE.

– The critical safety features of JANX008 are two tumor protease-cleavable peptide masks that inhibit EGFR and CD3 binding by >300x and >1,000x, respectively.

– Potent cleavage- and dose-dependent activity of JANX008 was demonstrated in multiple preclinical models, including EGFR antibody-resistant tumor and T cell co-culture assays, humanized mouse CRC model, and a fully human primary CRC tumor system with intact TME.

– Enhanced PK profile and high exposure of JANX008 were well tolerated in single dose and repeat dose NHP safety studies with limited CRS and healthy tissue toxicities with NOAEL ≥ 0.6 mg/kg/dose.

– GMP manufacturing has been completed to support a planned Phase 1 clinical trial.

– Preclinical data demonstrate key characteristics of JANX008 including cleavage-dependent activity, half-life extended PK, potential for superior safety, and manufacturability properties that could mitigate major limitations of TCEs and support JANX008 clinical development.

– Janux plans to submit an IND application for JANX008 with the FDA in the second half of 2022.

Details on Janux’s upcoming PEGS Boston presentations are as follows:

Poster: Preclinical Activity and Safety Profile of JANX007, a Novel PSMA-Targeting Tumor-Activated T Cell Engager for Treatment of Metastatic Castration-Resistant Prostate Cancer
Presenter: Shahram Salek-Ardakani, Ph.D. (Janux Chief Scientific Officer)
Poster Number: P078
Live Poster Sessions: May 2-5, 2022

Poster: Preclinical Development of an EGFR-Targeted Tumor-Activated T Cell Engager with Enhanced Safety to Activity Multiple and Pharmacokinetics Profile
Presenter: Shahram Salek-Ardakani, Ph.D. (Janux Chief Scientific Officer)
Poster Number: P079
Live Poster Sessions: May 2-5, 2022

The posters to be presented at PEGS Boston will be available beginning on May 2, 2022, on the "Scientific Publications" section of the Janux website at www.januxrx.com.