BiocurePharm, Korea (“BPK”) Announces the Submission of IND Application for Phase 1 Trial of CD19 CAR-T Therapy

On December 30, 2020 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that BiocurePharm Korea ("BPK") and Pharos Vaccine Inc. ("PVI") have jointly submitted an Investigational New Drug ("IND") application to the Korean Ministry of Food and Drug Safety ("KFDS") to proceed with clinical trial Phase 1 for CD19 CAR-T therapy to treat Acute Lymphocyte Leukemia ("ALL") (Press release, Biocure Technology, DEC 30, 2020, View Source [SID1234628750]).

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CD19 CAR-T is an immune cell therapy for relapse and refractory B-cell precursor acute lymphoblastic leukemia, demonstrating a significantly high CR ("Complete Remission") rate as an individual medical prescription for a custom-made product for an individual patient.

BPK plans to conduct a clinical trial at two renowned hospitals in Korea, Seoul A-San Medical Center and Seoul St. Mary`s Hospital upon the approval of the IND application by KFDS. BPK anticipates the completion of the Phase 2 clinical trial no later than the first half of 2023. Once completed and pending positive results in the clinical trials, the drug would be released for commercialization in Korea and potentially internationally.

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This is an important milestone for the Company to advance its CAR T technology. We are about to start a clinical trial in Korea and are confident that if we have positive outcomes from the Korean clinical trial, this should enable the therapy to be readily available and offer affordable CAR T Therapy to save more lives."

Scientists develop new drug that targets pathway found in several hard-to-treat cancers

On December 30, 2020 Cancer Research UK reported that scientists have finally found a way to target the KRAS mutation – a common mutation found in several hard-to-treat cancers (Press release, Cancer Research UK, DEC 30, 2020, View Source [SID1234573621]).

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By targeting two components of the KRAS signalling pathway, a new drug was much better at stopping the growth of pancreatic tumours with a KRAS mutation in mice compared to standard KRAS inhibitors, which only block one component of the pathway.

The drug, which has already shown promise in one sarcoma patient whose tumour had a KRAS mutation, will next be tested in patients with a variety of cancers in a larger Phase II clinical trial. The results are published in Annals of Oncology(link is external) today (Wednesday).

Changes to the KRAS gene, which is important in controlling cell growth, can lead to cells growing and dividing out of control to form tumours. Mutations in KRAS are found across 25% of cancers and are commonly found in several hard-to-treat cancers, including pancreatic, lung and colorectal tumours*.

Despite the prominent role of KRAS mutations in cancers and clear need for new treatments, scientists have been working for decades trying to find ways to target this pathway. Researchers say the main issue is because current KRAS inhibitors only target one component of the signalling pathway.

Now, a team of researchers led by Professors Caroline Springer and Richard Marais at the Cancer Research UK Manchester Institute have developed a new drug called CCT3833, which blocks two pathways in the KRAS signalling pathway called RAF and SRC.

The scientists tested CCT3833 in pancreatic, colorectal and lung cancer cell lines that had KRAS gene changes, as well as pancreatic tumours in mice, and compared the new drug with other standard KRAS inhibitors**.

Results showed that CCT3833 was able to restrict the growth of the cancer cells. It was also more effective in killing the cancer cells compared with other KRAS inhibitors. This was even more apparent when using 3D spherical tumour models, or ‘mini tumours’, which bridge the environment of cells grown in the lab and tumours in the body.

When tested in mouse models of pancreatic cancer with KRAS mutations, CCT3833 was more effective than other drugs in preventing cancer growth. CCT3833 also reduced tumour size.­

The study also describes the results of an early phase clinical trial of the drug tested in 31 patients with solid tumours. Whilst primarily designed to test safety, one patient in the trial who had a KRAS-mutant tumour that was growing larger after failing to respond to standard treatment had their tumour reduce in size for 8 months after receiving CCT3833.

The team is now planning to investigate the drug in further clinical trials.

Professor Caroline Springer, director of the drug discovery unit at the Cancer Research UK Manchester Institute, said: "Faulty KRAS signalling in cancer was identified over 35 years ago and yet, we still cannot block this pathway effectively. Our new drug stops the function of two critical growth pathways in KRAS-driven cells and has shown to be more effective than current drugs that only block one part of the pathway. We now need to run broader clinical trials to see how many cancer patients could benefit from this drug."

Professor Richard Marais, director of the Cancer Research UK Manchester Institute, said: "Cancers with a KRAS gene change have been notoriously difficult to treat. Because current drugs that target KRAS are only able to block one part of the pathway, cancer cells can easily outmanoeuvre treatments. It’s extremely encouraging to see that the impressive effects of the drug in the lab are already also showing promise in early-stage trials that include hard-to-treat cancers."

Michelle Mitchell, chief executive of Cancer Research UK, said: "This study has built upon almost 20 years of Cancer Research UK-funded research, and shows the importance of investing in basic research in the lab, which unpicks the biology of cancer. Breakthroughs in science are all about small steps that can lead to great change, and these results have brought us closer to a potential new option for people with these difficult-to-treat cancers."

Entry into a Material Definitive Agreement

On December 30, 2020, Lumos Pharma, Inc. (the "Company") reported that it entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co., as agent (the "Agent"), pursuant to which the Company may offer and sell from time to time through the Agent up to $50.0 million of shares of the Company’s common stock, $0.01 par value (the "Shares") (Filing, 8-K, NewLink Genetics, DEC 30, 2020, View Source [SID1234573332]). The offering and sale of the Shares has been registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-226366) (the "Registration Statement"), which was originally filed with the Securities and Exchange Commission ("SEC") on July 26, 2018 and declared effective by the SEC on July 22, 2019, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on December 30, 2020.

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Under the Sales Agreement, the Agent may sell the Shares by any method permitted by law and deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on or through The Nasdaq Global Market, on any other existing trading market for the Shares, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices and/or any other method permitted by law. The Company will notify the Agent of the number of Shares to be issued, the time period during which sales are requested to be made, any limitation on the number of Shares that may be sold in any one day and any minimum price below which sales may not be made. The Company intends to use the proceeds of the offering as described in the prospectus supplement.

The Sales Agreement contains customary representations, warranties and agreements by the Company, as well as indemnification and contribution obligations of the Company for certain liabilities under the Securities Act. Under the terms of the Sales Agreement, the Company will pay the Agent a commission of up to 3.0% of the gross sales price of the Shares sold through it under the Sales Agreement. In addition, the Company has agreed to reimburse certain expenses incurred by the Agent in connection with the offering.

The Company is not obligated to make any sales of the Shares under the Sales Agreement. The Sales Agreement may be terminated by the Agent or the Company at any time upon notice to the other party, as set forth in the Sales Agreement, or by the Agent at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the Shares.

The foregoing description of the material terms of the Sales Agreement is not intended to be complete and is qualified in its entirety by reference to the Sales Agreement, which is filed herewith as Exhibit 10.1 and incorporated herein by reference.

Wilson Sonsini Goodrich & Rosati P.C., counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Entry into a Material Definitive Agreement

On December 30, 2020, The Board of Directors (the "Board") of INmune Bio Inc., a Nevada corporation (the "Company"), approved and adopted a Rights Agreement, dated as of December 30, 2020 (the "Rights Agreement"), by and between the Company and VStock Transfer, LLC,, as rights agent. Pursuant to the Rights Agreement, the Board declared a dividend of one preferred share purchase right (each, a "Right") for each outstanding share of common stock, par value $0.001 per share, of the Company (each, a "Common Share" and, collectively, the "Common Shares") (Filing, 8-K, INmune Bio, DEC 30, 2020, View Source [SID1234573333]). The Rights are distributable to stockholders of record as of the close of business on January 11, 2021 (the "Record Date"). One Right also will be issued together with each Common Share issued by the Company after January 11, 2020, but before the Distribution Date (as defined below) (or the earlier redemption or expiration of the Rights) and, in certain circumstances, after the Distribution Date.

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Generally, the Rights Agreement works by causing substantial dilution to any person or group that acquires beneficial ownership of twenty percent (20%) or more of the Common Shares without the approval of the Board. As a result, the overall effect of the Rights Agreement and the issuance of the Rights may be to render more difficult or discourage a merger, tender or exchange offer or other business combination involving the Company that is not approved by the Board. The Rights Agreement is not intended to interfere with any merger, tender or exchange offer or other business combination approved by the Board. The Rights Agreement also does not prevent the Board from considering any offer that it considers to be in the best interest of its stockholders.

The following is a summary description of the Rights and material terms and conditions of the Rights Agreement. This summary is intended to provide a general description only, does not purport to be complete and is qualified in its entirety by reference to the complete text of the Rights Agreement, a copy of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and incorporated herein by reference. All capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Rights Agreement.

The Rights

Subject to the terms, provisions and conditions of the Rights Agreement, if the Rights become exercisable, each Right would initially represent the right to purchase from the Company one one-thousandth of a share of a newly-designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share, of the Company (each, a "Series A Preferred Share" and, collectively, the "Series A Preferred Shares"), at an exercise price of $300 per one one-thousandth of a Series A Preferred Share, subject to adjustment (the "Exercise Price"). If issued, each one one-thousandth of a Series A Preferred Share would give the stockholder approximately the same dividend, voting and liquidation rights as does one Common Share. However, prior to exercise, a Right does not give its holder any rights as a stockholder of the Company, including, without limitation, any dividend, voting or liquidation rights. A copy of the Certificate of Designation of Series A Junior Participating Preferred Stock (the "Series A Certificate of Designation") that the Company intends to file with the Secretary of State of the State of Nevada on December 30 2020 to designate the Series A Preferred Shares is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Initial Exercisability

Initially, the Rights will not be exercisable, certificates will not be sent to stockholders and the Rights will automatically trade with the Common Shares. Until the Rights separate from the Common Shares and become exercisable (or the earlier redemption or expiration of the Rights), the Rights will be evidenced by Common Share certificates, Rights relating to any uncertificated Common Shares that are registered in book entry form will be represented by a notation in book entry on the records of the Company, and the surrender for transfer of any Common Shares will also constitute the transfer of the associated Rights.

Subject to certain exceptions specified in the Rights Agreement, the Rights will separate from the Common Shares and become exercisable following the earlier to occur of the tenth (10th) business day (or such later date as may be determined by the Board) after (i) the day on which a public announcement or filing with the Securities and Exchange Commission (the "SEC") is made indicating that a person has become an Acquiring Person (as defined below) or that discloses information that reveals the existence of an Acquiring Person (the "Shares Acquisition Date"), or (ii) the commencement by any person (other than certain exempted persons) of, or the first public announcement of the intent of any person (other than certain exempted persons) to commence, a tender or exchange offer by or on behalf of a person, the successful consummation of which would result in any person (other than certain exempted persons) becoming an Acquiring Person, irrespective of whether any shares are actually purchased or exchanged pursuant to such offer (the earlier of these dates is called the "Distribution Date").

After the Distribution Date, separate rights certificates will be issued and the Rights may be transferred other than in connection with the transfer of the underlying Common Shares unless and until the Board has determined to effect an exchange pursuant to the Rights Agreement (as described below).

Acquiring Person

Under the Rights Agreement, an Acquiring Person is any person who or that, together with all Affiliates and Associates (as defined in the Rights Agreement) of such person, from and after the first public announcement by the Company of the adoption of the Rights Agreement, is or becomes the beneficial owner of twenty percent (20%) or more of the Common Shares outstanding, subject to various exceptions. For purposes of the Rights Agreement, beneficial ownership is defined to include the ownership of derivative securities.

The Rights Agreement provides that an Acquiring Person does not include the Company, any subsidiary of the Company, any employee benefit plan of the Company or any subsidiary of the Company, or any person organized, appointed, or established to hold Common Shares pursuant to any employee benefit plan of the Company or for the purpose of funding any such plan.

The Rights Agreement also provides that the following persons shall not be deemed an Acquiring Person thereunder: (i) any person who becomes the beneficial owner of twenty percent (20%) or more of the shares of Common Stock of the Company then outstanding solely as a result of the initial grant or vesting of any options, warrants, rights or similar interests (including restricted shares and restricted stock units) by the Company to its directors, officers and employees pursuant to any employee benefit or stock ownership plan of the Company, or the acquisition of shares of Common Stock of the Company upon the exercise or conversion of any such securities so granted; (ii) any person who as the result of an acquisition of shares of Common Stock by the Company (or any subsidiary of the Company, or any person organized, appointed, established or holding shares of Common Stock of the Company for or pursuant to the terms of any such plan) that, by reducing the number of shares of Common Stock of the Company outstanding, increases the proportionate number of shares of Common Stock of the Company beneficially owned by such person to twenty percent (20%) or more of the Common Shares then outstanding; (iii) any person who or that became the beneficial owner of twenty percent (20%) or more of the Common Shares then outstanding as a result of the acquisition of Common Shares directly from the Company; or (iv) any person who or that would otherwise be an Acquiring Person who or that the Board determines had become such inadvertently (including, without limitation, because (A) such person was unaware that it beneficially owned a percentage of the Common Shares that would otherwise cause such person to be an "Acquiring Person," or (B) such person was aware of the extent of its beneficial ownership of Common Shares but had no actual knowledge of the consequences of such beneficial ownership under the Rights Agreement), and who or that thereafter within five (5) business days of being requested by the Company, reduces such person’s beneficial ownership to less than twenty percent (20%) of the Common Shares then outstanding.

Histogen Announces Pricing of $14.0 Million Upsized Public Offering

On December 30, 2020 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has it has priced a public offering of an aggregate of 14,000,000 shares of common stock (or common stock equivalents offered through the issuance of pre-funded warrants), together with accompanying warrants to purchase up to an aggregate of 14,000,000 shares of common stock, at an effective public offering price of $1.00 per share and accompanying warrant. Each share of common stock (or common stock equivalent offered through the issuance of a pre-funded warrant) will be sold in the offering with one warrant to purchase one share of common stock (Press release, Conatus Pharmaceuticals, DEC 30, 2020, View Source [SID1234573478]). The warrants have an exercise price of $1.00 per share, are immediately exercisable, and expire five years following the date of issuance.

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

The gross proceeds of the offering are expected to be $14.0 million, prior to deducting placement agent’s fees and other estimated offering expenses payable by Histogen and assuming none of the warrants issued in the public offering are exercised for cash. The offering is expected to close on or about January 5, 2021, subject to the satisfaction of customary closing conditions.

Histogen intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include continued development of products for our CCM, hECM and HSC programs, further research and development, capital expenditures and general and administrative expenses.

The securities described above are being offered by Histogen pursuant to a registration statement on Form S-1 (File No. 333-251491) previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 30, 2020, and an additional registration statement on Form S-1 filed pursuant to Rule 462(b), which became automatically effective on December 30, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, electronic copies of the final prospectus relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

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