On December 20, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), reported that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA) (Press release, Lineage Cell Therapeutics, DEC 20, 2021, View Source [SID1234597458]).

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Genentech will assume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. Genentech will pay Lineage a $50 million upfront payment and Lineage is eligible to receive up to $620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

"Genentech is a clear global leader in ophthalmology and has demonstrated a longstanding commitment to patients, innovative research and successful product development," said Brian M. Culley, Lineage’s CEO. "Their desire to combine our cell therapy technology with their ophthalmology expertise and capabilities will help advance the OpRegen program more rapidly and we believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration. Lineage’s objective is to pioneer a new branch of regenerative medicine, based on transplanting whole cells into the body to restore activity lost to aging, injury or disease. We believe the results we have demonstrated to date with OpRegen represent a paradigm change many did not believe possible with cell therapy, by restoring retinal tissue and potentially halting or reversing the expansion of geographic atrophy. I am incredibly proud of what the Lineage team has accomplished with the OpRegen program and look forward to joining forces with the Genentech team as they work to take this program to the next level and potentially to patients in need of treatment."

Mr. Culley continued, "Looking ahead, Lineage will remain focused on advancing our spinal cord injury and oncology programs as well as announcing new disease settings where we plan to deploy our technology, either on our own or through strategic alliances. All of us at Lineage are immensely proud to have the opportunity and responsibility to advance a new and exciting branch of medicine, and our aim is to make a profound impact on the patients who serve as our inspiration."

"Genentech has a longstanding commitment to discovering and developing novel drugs for the treatment of serious eye disorders such as with advanced dry AMD with GA, which is one of our focus areas within ophthalmology," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "We are excited to partner with Lineage Cell Therapeutics to advance potential new therapies in an area of high unmet medical need."

Conference Call Information

Lineage will host a live conference call and webcast today beginning at 8 a.m. ET to discuss the collaboration with the Roche Group and Genentech. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through December 27, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 5174206.

About OpRegen

OpRegen has been developed in part through contributions and financial grants made by Hadasit Medical Research Services and Development Ltd. ("Hadasit") and the Israeli Innovation Authority (the "IIA"). Lineage is obligated to pay a portion of upfront, milestone and royalty payments it receives to Hadasit and the IIA. OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events related to OpRegen or study procedures that have not been previously reported.

On December 20, 2021 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported the closing of its initial public offering of 4,200,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $21,000,000, before deducting underwriting discounts, commissions and offering expenses (Press release, Immix Biopharma, DEC 20, 2021, View Source [SID1234597457]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 630,000 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments.

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The shares began trading on the Nasdaq Capital Market on December 16, 2021 under the ticker symbol "IMMX."

ThinkEquity acted as sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering to fund a planned IMX-110 Phase 2a clinical trial in soft tissue sarcoma and IMX-110 + tislelizumab Phase 1b combination trial, for IND-enabling studies for IMX-111 (colorectal cancer) and IMX-120 (inflammatory bowel disease), and for working capital and other general corporate purposes.

A registration statement on Form S-1 (file No. 333-259591) relating to the shares was filed with the Securities and Exchange Commission (the "SEC") and become effective on December 15, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting ThinkEquity, 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by 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 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 December 20, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the company will present at two upcoming scientific meetings, the AACR (Free AACR Whitepaper) Special Conference: Targeting RAS, being held January 7-10, 2022 in Lake Buena Vista, Florida and the ASCO (Free ASCO Whitepaper) GI Cancers Symposium, being held January 20-22 in San Francisco, California (Press release, Kinnate Biopharma, DEC 20, 2021, View Source [SID1234597455]).

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"Since our founding, Kinnate has been driven by our mission to expand the availability of targeted therapies to all patients who may benefit from them," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "We are very pleased with the continued progress of both our RAF and FGFR inhibitor programs and look forward to sharing these updates with the oncology community at these upcoming meetings."

Details of the upcoming AACR (Free AACR Whitepaper) Special Conference: Targeting RAS presentation, which will be delivered by Paul Severson, Ph.D., Kinnate’s Senior Director of Translational Medicine and Bioinformatics, are as follows:

Abstract title: Real-World Clinico-Genomic Analysis of Patients with BRAF Mutated Solid Tumors Identifies BRAF Class II and III as a Significant Population of Unmet Need
Session: Poster Session A
Session date and time: Saturday, January 8, 2022, from 4:45PM -7:00PM ET
Additional information on the AACR (Free AACR Whitepaper) Special Conference: Targeting RAS is available through the conference website at: View Source

Details of the upcoming ASCO (Free ASCO Whitepaper) GI Cancers Symposium presentation, which will be delivered by Aleksandra Franovic, Ph.D., Senior Director of Translational Medicine at Kinnate, are as follows:

Abstract title: Activity of KIN-3248, a next-generation pan-FGFR inhibitor, against acquired FGFR-gatekeeper and molecular-brake drug resistance mutations
Session: Poster Session B
Session date and time: Friday, January 21, 2022, from 3:05PM – 4:35PM ET
Additional information on the ASCO (Free ASCO Whitepaper) GI Cancers Symposium is available through the conference website at: View Source

On December 20, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported preliminary Phase 2 results in patients with either advanced squamous non-small cell lung cancer (sqNSCLC) or head and neck squamous cell carcinoma (HNSCC), who were treated with CX-2029 – a CD71-directed conditionally activated antibody-drug conjugate (ADC) being co-developed by CytomX and AbbVie (Press release, CytomX Therapeutics, DEC 20, 2021, View Source [SID1234597454]).

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"We are pleased to report these first results from the ongoing Phase 2 expansion study of CX-2029, a novel ADC developed with the CytomX Probody Therapeutic platform. We are encouraged that the response rate in heavily-pretreated and unselected sqNSCLC patients at this recent data cut off is trending with our stated target of 20% and enrollment in this tumor type continues towards our goal of 25 efficacy-evaluable patients. No new safety signals were observed and we are also encouraged by the low discontinuation rate due to adverse events. These preliminary results corroborate our previous Phase 1 observations and open a potential sqNSCLC commercial opportunity in the growing post-checkpoint inhibitor setting where there are limited treatment options," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We continue to work closely with our partner, AbbVie, and look forward to completing the expansion phase of the CX-2029 development program and providing further data updates in 2022."

As of the data cutoff on October 29, 2021, 23 patients with sqNSCLC and 29 patients with HNSCC had received at least one dose of CX-2029 at 3 mg/kg (safety population), of whom 16 sqNSCLC patients and 25 HNSCC patients had at least one post baseline assessment (efficacy-evaluable population), including, per protocol, 5 patients (2 sqNSCLC and 3 HNSCC) enrolled in the previously reported Part B (tumor biopsy cohorts). The median follow-up time was 3.8 months (range, 0.2-20.1). In the 16 efficacy evaluable patients with sqNSCLC, objective response rate (ORR) by local investigator was 18.8 percent, including two confirmed partial responses (PRs) and one unconfirmed PR that confirmed seven days after the data cutoff. Two of these responses were ongoing and the third had a response duration of 5.6 months. The disease control rate (DCR), which includes patients with a complete response, PR or stable disease, was 87.5 percent. In the 25 efficacy evaluable patients with HNSCC, there was one confirmed PR (ORR 4.0%) and a DCR of 56.0 percent, including one unconfirmed PR. Below is a summary table.

sqNSCLC HNSCC
Safety Evaluable Efficacy Evaluable Confirmed PR Safety Evaluable Efficacy Evaluable Confirmed PR
Part B 2 2 1 3 3 1
Part C 21 14 2* 26 22 0**
Total 23 16 3 29 25 1
ORR 18.8% 4.0%
*Includes one unconfirmed PR that confirmed after the data cutoff. **One unconfirmed PR was observed (will not confirm).

Safety analysis was conducted on all sqNSCLC and HNSCC patients who received at least one dose of CX-2029 at 3 mg/kg (N=52), either in Part B (N=5), or in the expansion cohorts (N=47). The median number of prior therapies in the metastatic setting was two (range, 1-5) for sqNSCLC and three (range, 1-9) for HNSCC. All patients with sqNSCLC had received prior platinum and prior checkpoint inhibition; in HNSCC, all but one patient received prior platinum and all but two, prior checkpoint inhibition.

The safety profile was consistent with previous Phase 1 observations, with no new safety signals identified. The most common treatment-related adverse events (TRAEs) in 10% or more of patients (All Grade, Grade 3) were anemia (78.8%, 67.3%), infusion related reactions (69.2%, 3.8%), fatigue (19.2%, 1.9%), and nausea (13.5%, 0.0%), and decreased neutrophil count (13.6%, 9.6% (plus one Grade 4 event 1.9%)). The most common reason for treatment discontinuation was disease progression (44.2%), three patients (5.8%) discontinued for a treatment-related adverse event (anemia; 2 Grade 2, 1 Grade 3). TRAEs leading to dose interruption or reduction were 40.4% and 34.6%, respectively. Thirteen patients, eight with sqNSCLC and five with HNSCC, were still on treatment as of the data cut off.

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 5 p.m. ET (2 p.m. PT) to discuss these results. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 8065625. A live webcast of the call can be accessed via the Events and Presentations page of CytomX’s website at View Source A replay of the webcast will also be available for 30 days following the call.

About CX-2029
Co-developed by CytomX and AbbVie, CX-2029 is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD71-directed humanized monoclonal antibody conjugated via a cleavable linker to the microtubule inhibitor, monomethyl auristatin E (MMAE), with a drug-to-antibody ratio (DAR) of 2. A key feature of CX-2029 is its masking peptide, which covers and blocks the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, the masking peptide is designed to be removed in a protease-rich tumor microenvironment, enabling the then unmasked ADC to engage its target and deliver the toxic payload inside tumor cells. The goal is to have CX-2029 remain inert while in circulation, with the intent of limiting binding in healthy tissues until it is activated by tumor-associated proteases. CX-2029 is being evaluated as monotherapy in a Phase 2 expansion study (NCT03543813) designed to enroll patients in four cohorts; squamous non-small cell lung cancer, squamous head and neck cancer, esophageal and gastroesophageal junction cancers (both adenocarcinoma and squamous histologies), and diffuse large B-cell lymphoma.

On December 20, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept"), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported the final results of its previously announced tender offer to purchase up to 10,000,000 shares of its common stock, par value $0.001 per share, at a price not greater than $23.75 nor less than $20.75 per share, in cash, less any applicable withholding taxes and without interest (the "Tender Offer"), which expired one minute after 11:59 p.m., New York City time, on December 15, 2021 (Press release, Corcept Therapeutics, DEC 20, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-final-results-previously [SID1234597453]).

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Based on the final count by Continental Stock Transfer & Trust Company, the depositary for the Tender Offer (the "Depositary"), 31,661,302 shares of Corcept’s common stock were validly tendered and not properly withdrawn at or below a purchase price of $23.75 per share.

In accordance with the terms and conditions of the Tender Offer, and based on the final count by the Depositary, Corcept has accepted for purchase 10,000,000 shares of common stock at a purchase price of $20.75 per share, for an aggregate cost of $207,500,000, excluding fees and expenses relating to the Tender Offer. The number of shares that Corcept has accepted for purchase in the Tender Offer represents approximately 9% of the total number of shares of common stock outstanding as of December 15, 2021. Corcept had approximately 105,933,592 shares of common stock outstanding following payment for the shares of common stock purchased in the Tender Offer.

Due to the oversubscription of the Tender Offer, based on the final count described above, Corcept accepted for purchase on a pro rata basis approximately 35% of the shares of common stock properly tendered and not properly withdrawn at the purchase price of $20.75 per share (other than "odd lot" holders, whose shares of common stock were purchased on a priority basis).

Shares of common stock not accepted for purchase will be returned promptly to stockholders. The Depositary will promptly pay for all of the shares of common stock accepted for purchase in accordance with the terms and conditions of the Tender Offer.

The sole dealer manager for the Tender Offer is Truist Securities, Inc. D.F. King is serving as the information agent for the Tender Offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the Tender Offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

Important Notice

This press release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any securities of Corcept.