On December 15, 2022 Jacobio Pharma (1167. HK) reported that the Company’s in-house KRAS G12C inhibitor JAB-21822 was granted breakthrough therapy designations for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Press release, Jacobio Pharmaceuticals, DEC 15, 2022, View Source [SID1234625333]). The designation was granted based on the solid clinical efficacy and safety data of JAB-21822. It will help expedite the program registration to health authority and accelerate its early access to the patients.

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The Phase II pivotal clinical trial of JAB-21822 was approved in China on September 5, 2022. The multi-center, single-arm, open-label study aims to evaluate the efficacy and safety of JAB-21822 as a single agent for the treatment of NSCLC patients with KRAS G12C mutation.

JAB-21822 is the potential best-in-class program for KRAS G12C inhibitors. The preliminary phase I clinical data published at the 2022 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) shows that as of April 1, 2022, a total of 72 patients with advanced solid tumors were enrolled, and efficacy was assessed for 32 NSCLC patients with KRAS G12C mutation. The overall response rate (ORR) was 56.3% (18/32) and the disease control rate (DCR) was 90.6% (29/32).

JAB-21822 has a good safety profile, and most treatment related adverse events (TRAE) were grade 1-2. Among the 72 patients, the incidences of diarrhea and vomiting were 5.6% (4/72) and 6.9% (5/72) respectively, and no gastrointestinal disorder higher than grade 2 was observed.

Currently, JAB-21822 is simultaneously undergoing clinical trials for monotherapy and combination therapy in China, the United States and Europe, including the monotherapy for NSCLC patients with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody to treat patients with colorectal cancer; and the combination therapy with the inhouse SHP2 inhibitor JAB-3312 to treat patients with NSCLC.

About CDE’s Breakthrough Therapy Designation

CDE’s Breakthrough Therapy Designation (BTD) is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, the breakthrough therapy designation provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.

About JAB-21822

JAB-21822 is an oral, small molecule KRAS G12C inhibitor independently developed by the Company. The Company has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients harbouring KRAS G12C mutation with advanced solid tumors, including pivotal clinical trial to treat NSCLC in China; monotherapy for STK11 co-mutated NSCLC in the front-line setting; combination therapy with SHP2 inhibitor JAB-3312, anti-PD-1 monoclonal antibody and Cetuximab.

On December 15, 2022 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported the pricing of an underwritten public offering to sell 6,500,000 shares of its common stock at a public offering price of $10.00 per share, or $65 million worth of shares of its common stock (Press release, Novavax, DEC 15, 2022, View Source [SID1234625331]). In connection with the common stock offering, Novavax granted the underwriters a 30-day option to purchase up to an additional 975,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on December 20, 2022, subject to customary closing conditions.

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J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers and representatives of the underwriters for the common stock offering. B. Riley Securities and H.C. Wainwright & Co. are acting as co-lead managers for the common stock offering.

Concurrently with the pricing of the common stock, Novavax also announced today the pricing of its previously announced offering of $150 million aggregate principal amount of its 5.00% convertible senior notes due 2027 (the "notes") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the notes offering, Novavax has granted to the initial purchasers a 30-day option to purchase up to an additional $25.25 million aggregate principal amount of the notes. The offering of the notes is expected to close on December 20, 2022, subject to customary closing conditions. The common stock offering is not contingent upon the consummation of the concurrent offering of the notes, and the concurrent offering of the notes is not contingent upon the consummation of the common stock offering.

Novavax estimates that the net proceeds from the common stock offering after deducting underwriting discounts and commissions and estimated offering expenses payable by Novavax, will be approximately $60.7 million (or approximately $69.8 million if the underwriters in that offering exercise in full their option to purchase additional shares).

Novavax may use the net proceeds from the common stock offering and, if consummated, the concurrent offering of the notes, for general corporate purposes, including but not limited to, the continued global commercial launch of Nuvaxovid, repayment or repurchase of a portion of the $325 million in outstanding principal amount of its 3.75% convertible senior unsecured notes due February 1, 2023, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, repayments under its supply agreements, as well as acquisitions and other strategic purposes.

A registration statement relating to the common stock offering was filed with the Securities and Exchange Commission ("SEC") on March 11, 2020, and is effective. The common stock offering will be made only by means of a prospectus supplement and the accompanying prospectus. Before investing in the common stock offering, purchasers should read the prospectus supplement relating to and describing the terms of such public offering and the related registration statement and other documents Novavax has filed with the SEC for more complete information about Novavax and such public offering. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the common stock offering are available on the SEC’s website at www.sec.gov. An electronic copy of the prospectus supplement and accompanying prospectus relating to the common stock offering will be available on the SEC website at www.sec.gov, and may also be obtained, when available, from: J.P. Morgan, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected].

On December 15, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that the Company plans to present at the Biotech Showcase and host institutional investor and partnering meetings at this event and a Corporate Access Event organized by LifeSci Partners (Press release, Cyclacel, DEC 15, 2022, View Source [SID1234625330]). Both in-person events are taking place January 9-11, 2023 in San Francisco, California.

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Biotech Showcase:
Spiro Rombotis, President and Chief Executive Officer, and Paul McBarron, EVP, Finance & COO, will provide an overview of the Company including clinical progress and expected milestones.

Date/Time: Tuesday January 10, 2023, at 9:30 am PT
Location: Hilton San Francisco Union Square in San Francisco; Yosemite A (Ballroom Level)
To schedule a meeting with management, investors can register on the Biotech Showcase website

LifeSci Partners Corporate Access Event:
Spiro Rombotis, President and Chief Executive Officer, and Paul McBarron, EVP, Finance & COO, will be hosting meetings with institutional investors.

Date/Time: Monday, January 9, 2023
Location: Beacon Grand Hotel, San Francisco
Please click here to register for the conference and schedule a meeting with management via the online system managed by LifeSci Partners.

On December 15, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it presented new positive preclinical data for its drug candidate LP-284 for Mantle Cell Lymphoma (MCL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual meeting (Press release, Lantern Pharma, DEC 15, 2022, View Source [SID1234625328]).

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The ASH (Free ASH Whitepaper) poster highlights new results for LP-284 from preclinical studies for MCL and initial results from investigational new drug (IND) enabling studies. LP-284 treatment was demonstrated to have significantly greater tumor growth inhibition (TGI) in mice implanted with MCL cell derived xenograft (CDX) tumors, when compared to treatment with the standard-of-care (SOC) agents Ibrutinib or Bortezomib (see Table 1).

Table 1.

Agent (Dose; Administration)

LP-284

(4 mg/kg; i.v.)

LP-284

(2 mg/kg; i.v.)

Bortezomib

(1 mg/kg; i.p.)

Ibrutinib

(50 mg/kg; p.o.)

TGI (%)

113%

63%

22%

8%

Table Legend: Tumor growth inhibition (TGI); Intravenous (i.v.); Intraperitoneal (i.p.); Oral (p.o.)

Additionally, in mouse MCL CDX tumors that had been treated and then grown resistant to either Ibrutinib or Bortezomib, subsequent LP-284 treatment of 4 mg/kg (i.v.) resulted in near complete tumor regression in the SOC resistant MCL CDX tumors (see Figure 1). These new promising results are critically important from a clinical perspective as nearly all MCL patients eventually relapse from Ibrutinib and Bortezomib treatment.

New in vitro data was also presented that identified a potential mechanism of LP-284’s anti-tumor activity in MCL. LP-284 treatment of MCL cell lines significantly down-regulated key cancer promoting genes and pathways, including the onco-fusion gene CCND1 and genes in the MYC pathway. Combined, these new in vitro and in vivo preclinical data for LP-284 strongly support its anti-tumor activity in MCL over current SOC agents and its continued advancement towards a Phase 1 clinical trial.

"This compelling pre-clinical efficacy and tumor response data, in both new lymphomas and those that had become resistant to standard of care agents, is an exciting advancement for LP-284 in hematological cancers and positions Lantern to advance our discussions with biopharma companies for partnering and collaborative development opportunities," stated Panna Sharma, Lantern’s CEO and President. "Even with the vanguard of new CAR T-cell therapy approaches in B-cell cancers, there is a critical need for improved options for B-cell cancer patients that don’t qualify for, have access to, or can’t afford CAR T-cell therapy," continued Sharma.

The ASH (Free ASH Whitepaper) poster also shows initial results from the large animal non-GLP toxicology portion of the IND enabling studies for LP-284, where the no observed adverse effect level (NOAEL) of LP-284 was determined to be 0.3 mg/kg/dose. Establishment of the NOAEL will facilitate the completion of IND enabling studies, which Lantern is anticipating in Q1 of 2023, followed by an anticipated launch of a first in human Phase 1 clinical trial later in 2023.

A full version of the poster presentation can be found on Lantern’s website.

About LP-284:

LP-284 is a novel small molecule and DNA damaging agent being developed by Lantern for the treatment of several non-Hodgkin’s lymphomas (NHL) including MCL and double hit lymphoma (DHL). Lantern’s LP-284 program has been accelerated and de-risked using A.I. insights and biological modeling powered by RADR. Lantern has been able to advance LP-284 from initial RADR insights regarding anti-cancer activity and potential mechanisms of action in hematological cancers, to selection of specific subtypes of lymphomas with superior response, to late stage IND enabling studies and initial design of first in human clinical trials in less than 2 years.

On December 15, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that findings demonstrating the strong real-world performance of the Afirma Genomic Sequencing Classifier (GSC) were published in The Journal of Clinical Endocrinology & Metabolism (JCEM) (Press release, Veracyte, DEC 15, 2022, View Source [SID1234625327]). The data, from a meta-analysis of 13 independent studies, show that the Afirma GSC can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules (ITNs) and that, when the test identifies a nodule as suspicious, the patient’s risk of malignancy is consistent with, and higher than, that reported in the test’s original clinical validation (CV) study.

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"The original Afirma GSC clinical validation study demonstrated that the genomic test provides reliable, accurate information to help inform important thyroid nodule diagnoses," said Christian Nasr, M.D., division chief of Endocrinology at the University of Arizona College of Medicine and the lead author on the study. "Our analysis found that the test performs just as well – and on some measures better – in clinical practice. This is incredibly encouraging and reassuring for physicians who must determine the best clinical approach for patients with indeterminate thyroid nodules."

Among the 1,976 patients with ITNs included in the meta-analysis, researchers found that the Afirma GSC’s real-world ability to identify benign nodules (GSC-B) with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97 percent vs. 91 percent and 99 percent vs. 96 percent, respectively). Additionally, the meta-analysis data show that the Afirma test’s real-world performance surpasses that shown in the CV study when predicting the risk of malignancy in nodules labeled suspicious (GSC-S; 65 percent positive predictive value vs. 47 percent).

Researchers reported a benign call rate (BCR) of 67%, which also surpassed the validation study (54% BCR), and is consistent with the 66% BCR reported by Hu, et al. in an analysis of 50,000 consecutive Afirma tests. Finally, the authors noted that only 6% of patients in the meta-analysis with GSC-B results had surgery, suggesting that most clinicians are comfortable monitoring these patients rather than conducting potentially unnecessary surgery.

"The findings from this important post-validation analysis suggest that the Afirma GSC maintains its strong performance in real-world clinical practice, and that the results the test provides have a beneficial impact for patients – either by helping them avoid unnecessary surgeries or increasing the potential that those with suspicious nodules receive appropriate treatment in a timely manner," said Joshua Klopper, M.D., Veracyte’s medical director for endocrinology.

Veracyte estimates that each year approximately 565,000 people undergo fine-needle aspiration (FNA) biopsy evaluation for potentially cancerous thyroid nodules and that more than 110,000 of these patients receive indeterminate results – meaning their nodules are not clearly benign or malignant based on traditional cytopathology evaluation. Historically, most of these patients were directed to diagnostic surgery, even though 70 percent to 80 percent of the time, the nodules proved to be benign. Current American Thyroid Association guidelines include molecular testing as a recommended option to achieve definitive diagnoses for nodules classified as indeterminate following FNA biopsy.

About the Afirma GSC

The Afirma Genomic Sequencing Classifier helps physicians identify patients with benign thyroid nodules among those with indeterminate FNA results, so that they may avoid unnecessary thyroid surgery. Veracyte developed the genomic test using RNA whole-transcriptome sequencing and machine learning technology to provide physicians with clinically actionable results from the same FNA biopsy used for initial cytopathology. As part of the Afirma offering, the Xpression Atlas provides genomic alteration content from the same FNA samples used in Afirma GSC testing to help physicians decide, with greater confidence, on the surgical or therapeutic approach for their patients.