On January 21, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that Snehal Patel, CEO of Greenwich LifeSciences, will participate in the following upcoming virtual investor conferences, highlighting the Company’s GP2 Phase IIb trial data and the planned Phase III trial (Press release, Greenwich LifeSciences, JAN 21, 2021, View Source [SID1234574165]). In addition, a video of the Company’s corporate presentation with comments by Snehal Patel will be available on the investor section of the Company’s website here.

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B. Riley Securities Oncology Investor Conference:

The Company will present at the virtual B. Riley Securities Oncology Investor Conference today, January 21, 2021 at approximately 11:30am EST and will participate in a question and answer session. The presentation will be live and available to conference attendees.

BIO CEO & Investor Conference:

The Company will present at the virtual 2021 BIO CEO & Investor Conference to be held from February 16-18, 2021 and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. The presentation will include a pre-recorded audio track available to conference attendees on demand.

For more than 20 years, the BIO CEO & Investor Conference has fueled biotech industry networking with premier investor and banking communities, focused on established and emerging publicly traded and select private biotech companies. The virtual 2021 event, taking place February 16-18, will showcase the Biotechnology Innovation Organization’s (BIO) perspective on the new U.S. Congressional agenda, the record setting pace of biotech IPOs, and the hottest clinical developments and industry catalysts. In addition, there will be three days of BIO One-on-One Partnering meetings with institutional investors, industry analysts, and senior business development executives seeking potential investments and deal partners.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On January 21, 2021 Bristol Myers Squibb (NYSE:BMY) reported that it has changed the timing of its previously announced earnings conference call (Press release, Bristol-Myers Squibb, JAN 21, 2021, View Source [SID1234574162]). The Company will now host a conference call to discuss results for the fourth quarter of 2020 on Thursday, February 4, 2021 at 10 a.m. ET. During the call, company executives will review financial results and address inquiries from investors and analysts.

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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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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4121 or international +1 313-209-6672, confirmation code: 4441406, or using this link which becomes active fifteen minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 1:30 p.m. ET on February 4 through 1:30 p.m. ET on February 18, 2021. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4441406.

On January 20, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX – CALTX; NASDAQ – CALT) reported it will provide information on the near-term clinical development plans for setanaxib in primary biliary cholangitis (PBC) and oncology (Press release, Calliditas Therapeutics, JAN 20, 2021, View Source [SID1234576683]). It will also present additional data from the Part A of the NefIgArd Phase 3 study, which recently reported positive data.

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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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In Q4 of 2020 Calliditas acquired a controlling stake in Genkyotex, which has been developing a first in class platform for NOX inhibition and where the lead compound, setanaxib has been tested in various fibrosis related indications. Following the positive results from the Phase 1 study in January of 2021, which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC, starting in 2H 2021, with final design and protocol details subject to feedback from the US Food and Drug Administration (FDA). In addition, Calliditas plans to initiate a Phase 2 proof-of-concept study in head and neck cancer this year which will study administration of setanaxib in conjunction with immunotherapy targeting CAFs (cancer associated fibroblasts).

Calliditas will also provide select data from the recently concluded Part A of the Phase 3 study NefIgArd with the lead candidate drug Nefecon, for the treatment of IgA Nephropathy. The data to be presented include overall baseline characteristics, rate of discontinuation of study treatment (9.5%) and rate of discontinuation from the study (3.5%). It is also confirmed that no adverse clinical effects were seen with regards to weight gain, blood pressure or HbA1c, reflecting a safety profile in keeping with the Phase 2b trial.

In addition, presentations on the regulatory submission process, market access and commercial preparations in the US will be included.

The R&D Day will take place between 1pm and 5pm CET today and will be webcast live and accessible at: View Source

On January 20, 2021 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock (Press release, Inovio, JAN 20, 2021, View Source [SID1234574987]). All of the shares are being offered by INOVIO. In addition, INOVIO intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering.

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INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

BofA Securities, Jefferies and Cantor are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares are being offered by INOVIO pursuant to a shelf registration statement filed by INOVIO with the Securities and Exchange Commission (SEC) that became automatically effective on January 20, 2021. This offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected].

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 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.

On January 20, 2021 Kura Oncology reported that treatment of cancer in the next few years with its two, wholly-owned, small molecule compounds (Press release, Kura Oncology, JAN 20, 2021, View Source [SID1234574232]).

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One, KO-539, is a menin inhibitor with the potential to target 35% or more of acute myeloid leukemia (AML) patients with a new mechanism of action.

"It’s in the spotlight, the data is stunning, and it has a lot of promise," Troy Wilson, Ph.D., J.D., CEO, told BioSpace. It is generating a lot of interest both among investors and potential partners, and "is a highlight for the company."

KO-539 is an oral, reversible inhibitor of the menin-KMT2A protein-protein interaction. It inhibits the HOXA9/MEIS1 pathway, which appears to be a master switch for AML progression.

By targeting epigenetic dysregulation, KO-539 removes a critical block on leukemia cell differentiation.

"It allows leukemic blasts to differentiate into mature cells and ultimately die off, leaving the patient with clinical benefits that in some cases include complete remissions," Wilson explained during the recent J.P. Morgan Healthcare Conference.

Animals showed complete, durable remissions in multiple models of AML. Now, a Phase I/IIa dose escalation study is underway in patients with relapsed and/or refractory AML. Early results show encouraging safety and tolerability as well as efficacy data, including complete remissions.

"Once the dose is established, we will move to Phase II to determine safety, tolerability and anti-tumor activity," Wilson said.

So far, one patient in the trial experienced a complete remission at a 100 mg dosage, and another patient at the 200 mg dosage, even after failing seven previous therapies. The 600 mg dosage is being evaluated now, and Wilson expects to advance to Phase II by the end of this quarter.

Kura Oncology’s other, more advanced, program focuses on tipifarnib, a drug that originally was developed by Janssen, and which has shown impressive clinical benefits as a monotherapy in patients with HRAS mutant head and neck squamous cell carcinoma (HCSCC). Tipifarnib has FDA Fast Track designation and has the potential, Wilson said, to be the first small molecule targeted therapy approved for treatment of HNSCC (the seventh most common form of cancer in the world).

Tipifarnib is a farnesyltransferase inhibitor (FTI).

"FTIs were actively pursued 20 years ago by half a dozen pharmaceutical companies," Wilson said, "but at that time those companies didn’t have the understanding or the tools we have today."

"At Kura, we’re continuing to crack the code on tipifarnib and on FTIs in general," Wilson added. "We have a lot of intriguing data. We were the first to show that in HNSCC, you could drive meaningful benefit with tipifarnib if you knew which patients to approach. So, people are starting to take a fresh look."

As with any innovative therapy, "It takes multiple iterations and time to get things right," he pointed out.

"We are targeting a unique mechanism of action – the addition of a hydrophobic side chain to proteins that allow them to anchor to the cell membrane and disrupt post-translational modification, thus preventing HRAS from associating with the cell membrane," Wilson elaborated during J.P. Morgan week.

As a monotherapy, Phase II data with tipifarnib demonstrated an approximate 50% overall response rate with a six-month median progression-free survival and 15-month overall median survival in advanced recurrent and metastatic HRAS mutant HNSCC patients. Both progression-free survival and overall survival durations were approximately two to three times that of standard second-line therapies.

"This underscored the potential of tipifarnib to drive therapeutic benefit," Wilson said.

Although that Phase II trial is closed to enrollment, a new trial is now enrolling patients with a goal to generate data to support FDA approval for tipifarnib. That trial, termed AIM-HN, was amended last year to allow enrollment of all HRAS mutant HNSCC patients, regardless of the frequency of their variant alleles.

In addition to HRAS-dependent HNSCC, tipifarnib also shows activity against PI3Kα-dependent HNSCC. In preclinical studies involving four standard therapies and tipifarnib, in each case, the combination therapy of both drugs together showed significantly improved tumor regression relative to either drug candidate as a monotherapy.

"The data for the combination of tipifarnib plus a PI3Ka inhibitor is compelling, and we look forward to starting a combination study for HNSCC, combining tipifarnib with a PI3Kα inhibitor in mid-year," Wilson said.

Treating the entire population of cancer patients requires a polypharmacy approach that attacks cancer from multiple angles. As yet, there are gaps.

"At Kura, we’re helping to close those gaps by developing exquisitely potent compounds and stacking them up to drive long-term remissions or even cures," Wilson said.

Partnering isn’t in Kura Oncology’s immediate plans.

"We’re fortunate to have more than $600 million on hand – enough to fund both KO-539 and tipifarnib through key value inflection points in the next 12 to 24 months," Wilson said.

That allows the company to aggressively pursue therapeutics that are both first – and best-in-class.

"We are constantly asking ourselves whether we can maximize the value of our existing programs and do more with the resources and talent we have," he continued. "Last year was a terrific year for Kura Oncology, and we’re working to make 2021 and beyond even better."