On September 24, 2021 Secura Bio reported that The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there (Press release, Secura Bio, SEP 24, 2021, View Source [SID1234590541]).

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Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology
Tuesday, October 12 | 11am ET / 8am PT
Development of HPAPIs presents unique challenges for product containment and requires special consideration in equipment selection, operating procedures, and safety processes. This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization. The speakers will also share the key advantages of using micronization technology for the development and manufacturing of HPAPIs.
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The FDA is gathering an oncologic drugs advisory committee meeting on Dec. 2 to review whether two drugs should keep their conditional approvals, the agency said (PDF) Friday. The products are Secura Bio’s Farydak for previously treated multiple myeloma, and Aurobindo Pharma’s Marqibo indication for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) following two or more lines of treatments.

In the spring, the FDA’s Oncology Center of Excellence launched an industry-wide review of accelerated approvals that haven’t shown clinical benefits in confirmatory trials. The campaign cost PD-1/L1 inhibitors from Merck, Bristol Myers Squibb, Roche and AstraZeneca several U.S. indications, including small cell lung cancer, stomach cancer, bladder cancer, liver cancer and triple-negative breast cancer.

RELATED: Subcutaneous Velcade more tolerable in multiple myeloma trial

Now Secura and Farydak will have to prepare for the same scrutiny. Secura bought worldwide rights to Farydak from Novartis in 2019. The drug’s original FDA nod in 2015 was a hard-fought one, given that the FDA’s external experts voted against its approval due to concerns about side effects. Farydak is indicated for use with Takeda’s Velcade and the steroid dexamethasone.

The latest data on Fradyak, released earlier this year, came from a phase 2 trial dubbed Panorama 3. The trial tested Fradyak with a subcutaneous version of Velcade, rather than its original intravenous formulation. It showed that Fradyak, at its approved dosing strength, produced a similar response rate with the new regimen as that shown in the original Panorama 1 trial, but that it had a longer duration of response. Patients taking the combination with subcutaneous Velcade reported fewer side effects, such as severe diarrhea, than what was observed in the earlier trial."

In a statement to Fierce Pharma, Secura chief medical officer David Cohan, M.D., said the company remains "committed to working with the FDA on fulfilling all post-marketing requirements for Farydak in a timely manner."

As for Marqibo, that drug got its FDA go-ahead in 2012 and has since changed hands twice, first from Talon Therapeutics to Spectrum Pharmaceuticals in 2013 and then to Aurobindo in 2019. The drug earned its third-line ALL approval after a single-arm phase 2 study recorded a 15.4% complete response rate.

The phase 3 Hallmarq trial in patients over 60 with newly diagnosed ALL was supposed to serve as Marqibo’s confirmatory trial. The plan was to enroll 348 patients and compare Marqibo, a targeted version of chemotherapy vincristine, with standard vincristine. But Spectrum terminated the study in 2015, after recruiting just 26 participants over three years, according to clinicaltrials.gov.

RELATED: Bristol Myers pulls an Istodax lymphoma use 10 years after FDA accelerated approval

The upcoming advisory committee meeting "will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted," the FDA said in a notice Friday.

Some pharma companies seem to be realizing that the FDA is moving its house-cleaning beyond immuno-oncology agents. And they’re getting ahead of any negative decisions. Bristol Myers in August said it’s withdrawing Istodax’s indication as a monotherapy for previously treated peripheral T-cell lymphoma after a recent confirmatory phase 3 trial flop in newly diagnosed patients.

On September 24, 2021 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its fourth quarter and fiscal year end 2021 operating results on Wednesday, September 29, 2021, before the open of the U.S. financial markets (Press release, Palatin Technologies, SEP 24, 2021, View Source [SID1234590262]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on September 29, 2021, at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

Audio Webcast Live and Replay Access

View Source

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source.

On September 24, 2021 A group of long-time stockholders (the "Nominating Stockholders" or the "Group") of CytoDyn Inc. ("CYDY or the "Company") (OTC: CYDY) reported that has nominated five highly experienced director candidates to serve on the Company’s Board of Directors reported its comprehensive strategic plan to obtain cancer therapy approval for Leronlimab (Press release, CytoDyn, SEP 24, 2021, View Source [SID1234590261]). If implemented, the Group believes this plan would begin to generate much-needed revenue for CYDY and position the Company to earn FDA approval for the drug, while enhancing the value of all stockholders’ shares.

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The Group’s strategy is designed to overcome current CYDY management’s failures to implement a coherent, effective plan to generate revenue and obtain FDA approval for Leronlimab. While the Group has tried to discuss the enormous potential of its oncological strategy to reinvigorate CYDY with the Board and management team, they have refused to meaningfully engage every step of the way. Instead, incumbent Company leadership has decided to focus on entrenching themselves and clinging to their outsized compensation packages at the expense of shareholders.

The Group’s approach to cancer therapy will be scientifically valid and extremely efficient and will be critical to unleashing the potential value of Leronlimab and the investments of all stockholders. The full plan can be found here, and highlights are as follows:

Utilize real data based on precision medicine determination of Leronlimab binding cancers;
Apply both combination therapy with complementary immune-oncology blockbuster drugs and adjuvant monotherapy in CCR5+ tumors;
Prioritize cancer targets based on CCR5 expression; and
Partner with leading oncology companies that lack a CCR5 asset like Leronlimab.
Dr. Bruce Patterson, one of the Group’s five nominees and a renowned virologist, pathologist, and cancer technology pioneer, stated: "We are excited to present our plan on how to maximize the value of Leronlimab and save the lives of countless cancer patients. We believe we have put in place a strategy that is not only executable but also best positions CYDY for future success and will repair the Company’s standing among the medical, regulatory, and investment communities. In order to protect the value of your investment in CYDY, we strongly you recommend you for our highly qualified director nominees on the WHITE proxy card today."

Dr. Patterson added, "Immuno-oncology (IO) has revolutionized oncological therapy for many cancers and makes up one of the largest cancer drug market segments. However, CYDY’s Board and management have utterly failed to capitalize on this tremendous opportunity and have not publicly presented any strategic plan on how they might make Leronlimab a reality. On the other hand, our cancer program will combine the value that Leronlimab has as a potential adjuvant therapy following treatment with the urgent opportunities that exist in IO and in doing so, will create enormous value for CYDY and its stockholders. This carefully designed plan is critical to the Company’s success, and we are excited by the prospect of finally being able to implement it."

The full text of the Group’s cancer therapy approval plan can be accessed at: www.advancingll.com/cancerplan

All CYDY shareholders are reminded that your vote is essential to charting a course towards lasting value creation and holding the current Board and management team accountable for the immense value destruction they have overseen throughout their tenure. Help us enable CYDY to achieve its incredible potential by voting the WHITE proxy card to elect the Group’s five independent director nominees today.

Important Information

Paul Rosenbaum, Jeffrey Beaty, Arthur Wilmes, Thomas Errico, M.D., Bruce Patterson, M.D., Peter Staats, M.D., Melissa Yeager and CCTV Proxy Group, LLC (collectively the "Participants") have filed a definitive proxy statement and accompanying WHITE proxy card with the Securities and Exchange Commission (the "SEC") to be used in connection with the solicitation of proxies from the stockholders of CytoDyn Inc. (the "Company"). All stockholders are advised to read the definitive proxy statement and other documents related to the solicitation of proxies. The definitive proxy statement and an accompanying proxy card is available at no charge on the SEC’s website at View Source In addition, the Participants will provide copies of the proxy statement, without charge, upon request. Requests for copies should be directed to the Participants’ Proxy Solicitor, Okapi Partners LLC, by calling (844) 202-7428.

On September 24, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $4.20 per share (Press release, Onconova, SEP 24, 2021, View Source [SID1234590260]). The gross proceeds of the offering to the Company are expected to be $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above are being offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission (the "SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 2021 and is available on the SEC’s website at View Source The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 September 24, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens reported that it has entered into securities purchase agreements with certain healthcare-focused institutional investors to raise approximately $15 million in gross proceeds, before placement agent fees and other offering expenses payable by Kintara, through the issuance of 12,000,000 shares of its common stock (or common stock equivalents) and investor warrants to purchase up to an aggregate of 12,000,000 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Kintara Therapeutics, SEP 24, 2021, View Source [SID1234590259]). Each share of common stock (or common stock equivalent) is being sold together with one investor warrant to purchase one share of common stock at a combined offering price of $1.25. The investor warrants have an exercise price of $1.25 per share and are exercisable for three and one half years from the date of issuance. The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Company currently intends to use the net proceeds from the offering for funding its clinical studies, working capital and other general corporate purposes, including, but not limited to, funding acquisitions or investments in businesses, products or technologies that are complementary to the Company’s businesses, products and technologies.

The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at [email protected].

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