On December 14, 2022 Solve Therapeutics, Inc. (SolveTx), an oncology-focused biopharmaceutical company, reported its mission to develop novel antibody-based therapies targeting tumor-specific antigens (Press release, Solve Therapeutics, DEC 14, 2022, View Source [SID1234625279]). The company’s formation reunites the former VelosBio Inc. (VelosBio) team, a highly experienced group with a proven ability to rapidly advance innovative therapeutics that address unmet medical needs in the treatment of cancer. SolveTx is supported by an accomplished board of directors and a top-tier investor syndicate. The company is fully operational with 25+ employees and is actively pursuing discovery and development efforts at its 10,000-square-foot, state-of-the-art laboratory in San Diego.

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SolveTx’s management team is headed by Chief Executive Officer (CEO) Dave Johnson. In previous roles as CEO, Mr. Johnson oversaw the development of a best-in-class Bruton’s tyrosine kinase inhibitor, acalabrutinib, at Acerta Pharma (established in 2012 and acquired by AstraZeneca for $7B in 2016) and a first-in-class, anti-ROR1 ADC, zilovertamab vedotin, at VelosBio (established in 2017 and acquired by Merck for $2.8B in 2020). The founding members of SolveTx from VelosBio who have worked with Mr. Johnson to establish the new company include Langdon Miller, MD, Executive Vice President of Development and Chief Medical Officer; Brian Lannutti, PhD, Executive Vice President of Research; Jeff Watkins, PhD, Senior Vice President, Protein Technology; and Katti Jessen, PhD, Senior Vice President, Translational Sciences. Collectively, SolveTx management possesses extensive expertise in drug discovery, development candidate selection, investigational new drug application (IND)-enabling evaluation, clinical trial conduct, and business development.

SolveTx’s initial $126 million Series A financing was completed with a syndicate of top-tier venture capital firms including Matrix Capital Management, Decheng Capital, General Atlantic, and Surveyor Capital/Citadel, each represented on the company’s board of directors.

"I am delighted to reassemble this highly collaborative and successful team of drug developers," said Dave Johnson, CEO of SolveTx. "Together with this incredible group of investors, we are empowered to apply our expertise and resources toward the ultimate goal of prolonging and improving the lives of patients with cancer."

SolveTx will use the proceeds for production of antibody-based therapeutics for nonclinical POC characterization, producer cell line generation, good manufacturing practices (GMP) drug production, IND-enabling pharmacology and toxicology studies, and Phase 1 clinical program initiation.

The foundation of SolveTx’s approach to oncology therapeutics development is the identification of novel cancer-specific targets and the generation of mAbs with ideal characteristics to serve as the backbones for antibody-based therapeutics. The company has signed a licensing agreement with the University of California San Diego for a series of antibodies that show high reactivity with tumors and no or low reactivity with normal tissues, which may enable the selective killing of tumor cells and a broad therapeutic index. SolveTx is reviewing other potential in-licensing opportunities as well as performing in-house antibody discovery research. The company’s focus is on the development of novel mAbs, ADCs incorporating next-generation linker and payload constructs, and bispecific antibodies.

On December 14, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that it priced an underwritten public offering of 3,250,000 of its ordinary shares at a price to the public of $56.50 per ordinary share, before the underwriting discount and estimated offering expenses (Press release, Prothena, DEC 14, 2022, View Source [SID1234625277]). All of the ordinary shares in the offering were sold by Prothena. In addition, Prothena has granted the underwriters a 30-day option to purchase up to an additional 487,500 of its ordinary shares.

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Net proceeds to Prothena from the ordinary shares to be sold by Prothena in the offering are expected to be $172.4 million, after deducting the underwriting discount and estimated offering expenses, but excluding any exercise of the underwriters’ option to purchase additional ordinary shares. The offering is expected to close on December 19, 2022, subject to customary closing conditions.

Jefferies, Evercore ISI and Cantor are acting as lead book-running managers, Oppenheimer & Co. is acting as book-running manager and JMP Securities, a Citizens Company, and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (the "SEC") on March 23, 2021 and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the final terms of the offering will be filed with the SEC and available on the SEC’s website located at View Source or may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888)474-0200, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by e-mail at [email protected].

On December 14, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that a clinical update for naxitamab and the Company’s SADA technology programs will be presented at the Company’s R&D event, which will take place today at 9 a.m. Eastern Time (Press release, Y-mAbs Therapeutics, DEC 14, 2022, View Source [SID1234625276]).

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Investors, analysts, members of the media and the public may access the event via a live webcast. The presentation materials can be found on the Company’s website under the Presentations tab under the heading For Investors.

The Y-mAbs research and development day will feature presentations from Thomas Gad, founder, President and Interim-CEO, Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief Medical Officer at Y-mAbs), and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).

SADA Technology

Dr. Lisby will discuss the Company’s SADA Technology, including announcement of the Company’s first proprietary hematological SADA construct, CD38-SADA against Non-Hodgkin’s Lymphoma ("NHL"), and an update on GD2-SADA, which is being studied in an ongoing Phase 1 clinical trial in adults with small-cell lung cancer, sarcoma, and malignant melanoma.

DANYELZA (naxitamab-gqgk)

Dr. Rajah, will present an update on DANYELZA (naxitamab-gqgk), including potential label expansion into osteosarcoma, and a planned multicenter Phase 2 trial in patients with newly diagnosed high-risk neuroblastoma.

"We are excited to share these new updates on both our naxitamab program and the SADA Technology. We believe that the prospects for the SADA Technology, which combines antibodies and radioactive payloads, are highly encouraging and could potentially revolutionize cancer treatments known today. We believe a CD38-SADA construct will have high potential," said Thomas Gad, founder, President and Interim CEO. "We are redoubling our efforts and refining our focus on DANYELZA and are pleased to be working towards advancing the program with a potential label expansion into osteosarcoma, and a planned multicenter Phase 2 trial in patients with newly diagnosed high-risk neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 14, 2022 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the IDMC for the ongoing ENVASARC Phase 2 pivotal trial recommended continued accrual as planned in both cohorts: single agent envafolimab and envafolimab in combination with Yervoy (ipilimumab) (Press release, Tracon Pharmaceuticals, DEC 14, 2022, View Source [SID1234625272]).

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The IDMC reviewed interim safety and efficacy data from 18 patients enrolled into each cohort who completed a minimum of 12 weeks of efficacy evaluations (two on-treatment scans). The double-digit ORR assessed by blinded independent central review in each cohort more than satisfied the prespecified futility rule. Envafolimab monotherapy and in combination with Yervoy was well tolerated, with only a single related serious adverse event reported in 36 patients. Responses were noted in patients regardless of weight at the 600 mg dose of envafolimab that was instituted following the previous IDMC review of interim safety and efficacy data from patients in the ENVASARC trial treated at the 300 mg dose of envafolimab.

"We are pleased with the activity of the 600 mg dose of envafolimab that has demonstrated a double-digit objective response rate both as a single agent and in combination with Yervoy, even at this early 12-week time point," said James Freddo, M.D., TRACON’s Chief Medical Officer. "We are also encouraged with the safety data showing that envafolimab monotherapy and in combination with Yervoy are well tolerated. This interim analysis is a positive milestone and we look forward to the next interim analysis which will be conducted after the 46th patient in each cohort has completed a minimum of 12 weeks of efficacy evaluations. Importantly, accrual in ENVASARC remains ahead of projections and we are excited by the emerging data and for envafolimab’s potential to become a differentiated treatment for sarcoma patients."

"Achieving a double-digit ORR with a well tolerated safety profile, as both monotherapy and in combination, positions envafolimab to become a potential treatment option for patients with refractory UPS and MFS," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "The sole approved treatment for these patients is Votrient, which achieved a 4% ORR and carries a black box warning for fatal liver toxicity."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. In September 2022, TRACON received fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On December 14, 2022 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, reported that it has received a notification letter from Nasdaq Stock Market LLC that the Company has been granted an additional 180-day compliance period, with a new deadline of June 12, 2023, to regain compliance with Nasdaq’s minimum bid price rule (Press release, Tiziana Life Sciences, DEC 14, 2022, View Source [SID1234625271]).

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Nasdaq’s extension notice has no immediate effect on the continued listing status of the Company’s common stock on The Nasdaq Capital Market LLC under the trading symbol, "TLSA." If at any time during the additional 180-day extension, the bid price of the Company’s common stock closes at, or above, $1.00 per share for a minimum of ten (10) consecutive business days, the Company will regain compliance with this Nasdaq rule and this matter will be closed.

The Company was first notified by Nasdaq of its failure to maintain a minimum bid price of $1.00 per share under Rule 5550(a)(2) on June 14, 2022, and was given until December 12, 2022 to regain compliance. As part of its request for an extension, the Company transferred the listing of its common stock from the Nasdaq Global Market to the Nasdaq Capital Market.

The Company intends to monitor the closing bid price of its common stock between now and June 12, 2023, and has available options within the second compliance period to rectify the deficiency and regain compliance with the minimum bid price requirement. The Company’s common stock will continue to be listed and trade on the Nasdaq Capital Market during this period.

This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification.